Cervical Cancer Screening and Management: Challenging Cases
Review the latest recommendations with
Emma L. Grabinski, MD, FACOG
Dr Grabinski, a generalist OBGYN, is System Chief of OBGYN & Perinatology at Swedish Medical Center, and a clinical adjunct Professor at UW in Seattle WA
Learning Objectives: Upon completion of this activity, participant should be better able to
- Discuss cervical screening and management of immunocompromised people
- Describe cervical screening and management post treatment for malignancy
- Counsel patients in unusual screening and management situations, applying knowledge of hrHPV biology
SUMMARY:
The new ASCCP management guidelines provide recommendations on the management of cervical cancer screening abnormalities. But sometimes, we have to deal with unusual or more challenging situations. The key point to remember with the following, less typical clinical scenarios is that successful outcomes hinge on not only following best practices but individualizing care.
CONTENTS:
- Case 1: Immunocompromise
- Case 2: Limited Prior Screening
- Case 3: Persistent hrHPV
- Case 4: Testing after History of Malignancy or CIN 2/3
- Case 5: Post Coital Bleeding
Case 1: Immunocompromise
17 year old recently became sexually active, wants to discuss contraception options. She has a history of Crohn’s disease that is well controlled with a biologic. You suggest cervical cancer screening, but the patient is surprised – she thought Pap screening didn’t start until age 21
- Immunocompromise, due to HIV and non-HIV related causes
- Increases the risk for hrHPV-related cervical dysplasia and malignancy
- Requires more intense screening, surveillance, and treatment
Who to Screen
- HIV infection
- Solid organ transplant recipients
- Hematopoietic stem cell transplant recipients
- IBD on immunosuppressants
- SLE – regardless of treatment
- RA on immunosuppressants
How to screen
- Starting age
- 21 years or within 1 year of sex if immunosuppressed <21 years
- Screening strategy
- <30 years: Cytology preferred
- ≥30 years: Co-testing preferred | Cytology acceptable
- Repeat every 1 to 3 years
- Recent data of HIV infected people suggests that after a period of intense screening, the interval can be lengthened
- When to stop
- Continue past age 65 | Discontinue screening based on shared discussion regarding quality and duration of life rather than age
How to Manage
- Neg Pap/hrHPV+ or ASCUS with unknown or hrHPV-
- Repeat in 6 to 12 months
- ASCUS or hrHPV+
- Colposcopy
- ASCUS or higher-grade lesion and hrHPV+
- Colposcopy
- Risk of immediate CIN 3+ is always >4% in the immunocompromised population
Case 2: Limited prior screening
32 year old new patient presents for pelvic pain discussion. They deny previous abnormal Pap results, but you do not have records. They are unsure when they last had a Pap. Current screening results show ASCUS and hrHPV+
- Risk of immediate CIN 3+ is >4% (based on cytology results)
- Recommendation is for colposcopy
- Rarely screened patients are at higher risk
- We are not able to be certain whether hrHPV+ result represents a new infection or persistence
- Race, ethnicity, and socioeconomic considerations all contribute to lower screening rates for cervical cancer
- Discrepancies in access to follow up results in higher rates of cervical cancer
- Opportunistic screening is important in the following clinical settings
- Limited prior screening
- Reliability for follow up is reduced (often related to social factors, including limited access to healthcare resources)
Case 3: Persistent hrHPV
52 year old established patient, presents for colposcopy due to a report that is negative for intra-epithelial lesions and malignancy (NILM) and hrHPV+. This is their 4th consecutive colposcopy for the same result. Current and previous colposcopy does not show CIN 2/3+. She is frustrated and wonder if they need to continue doing colposcopy
- HPV persistence is essential for development of cervical cancer
- Current ASCCP/ACOG guidelines recommend repeat co-testing in 1 year, with colposcopy if ASCUS+/hrHPV+
- The Swedescreen Study showed that HPV persistence (with normal colposcopy) over 6 years resulted in either high rates of CIN2+ or clearance
- No cases of invasive cancer were identified in this 6 year interval
- However, continued annual testing may result in non-attendance for follow up
- Loss to follow-up may potentially result in failure to identify people with CIN 2+
- Evidence of HPV persistence after treatment for CIN shows that there is significant clearance of HPV within 24 months after LEEP or conization
Counseling Options for This Patient
- Continued screening
- ASCCP approved interval: Annually until either clearance of HPV or development of CIN 2+
- May extend screening interval that is acceptable to patient | Should be demonstrated that patient will be reliable with follow up
- Treatment
- HPV clearance has been demonstrated after LEEP or conization: May be reasonable option for patients wishing to avoid long term follow up
- Hysterectomy is not recommended for treatment of hrHPV | However, in people with no desire for future fertility and who may have other indications for hysterectomy, this approach may be a reasonable option
Case 4: Testing after Malignancy or CIN 2/3
A 47 year old patient presents 5 years after radical hysterectomy for Stage 1(b)i squamous cell carcinoma of the cervix. They have ‘graduated’ from follow up with gyn oncology and are here for a preventive exam. They wonder whether they should still have pap smears.
Hysterectomy for CIN 2/3
- Primary vaginal cancer extremely rare – however is significantly higher in this population.
- 0.4-0.6/100,000
- hrHPV+ prevalence of the vagina is similar whether hysterectomy has, or has not been done
- Hysterectomy for CIN2/3 will NOT result in clearance of hrHPV
- Accuracy of vaginal cytology and hrHPV testing has not been determined for diagnosing VAIN2/3
- PPV ranges from 0-14%
- Per ASCCP, patients should be followed with cytology every 3 years for a minimum of 25 years after hysterectomy
- Depends on life expectancy and degree of co-morbid conditions
- Discuss whether patient would have further intervention for VAIN 2/3 or malignancy to determine whether to screen or when to stop screening
- Risk after hysterectomy for CIN 2/3 similar to risk of vaginal cancer after treatment for invasive cervical cancer
- Consider not performing after counseling based on low risk of developing malignancy
- Colposcopy recommended for the following
Endometrial Cancer
- Most recurrences happen at the vaginal cuff
- Cytology has been shown to be abnormal in 25% of recurrence
- However, most recurrence is detected based on clinical symptoms
- Abnormal cytology may also represent radiation changes
- Cytology has not been shown to add clinical benefit and is not recommended
Ovarian Cancer
- Cytology not recommended
Cervical Cancer
- 75% of recurrence occurs in first 3 years
- NCCN recommends follow up every 3 to 6 months in first 2 years, and then every 6 months for the next 3 years
- Most will present with symptoms (46 to 95%)
- Physical exam detects asymptomatic recurrence in 29 to 75% of people
- Abnormal cytology
- Rarely the only abnormal finding
- Does not significantly increase detection rates | Only up to 17% of cases will be based on cytology alone
- The rate of abnormal cytology in people with prior radiation and no recurrence can be up to 36% | Most are ASCUS
- SGO ‘Choosing Wisely Campaign’ recommends
- Vaginal cytology (if used) no more frequently than annually
- No colposcopy if cytology shows less than high grade changes
Vulvar/Vaginal Cancer
- Usually HPV mediated
- Cytology
- Not recommended for follow-up to detect recurrence | Reserved cytology for HPV related cervical premalignant disease
- Should have annual comprehensive vulvar exam to detect recurrence
Case 5: Post Coital Bleeding (PCB)
44 year old presents with a 6 month history of abnormal bleeding. On evaluation, the bleeding is occurring mainly after penetrative intercourse. She reports her last Pap was 3 years ago and was normal
- Cervical cancer screening guidelines (ASCCP, ACS, USPSTF) are for ASYMPTOMATIC patients only
- Patients with abnormal bleeding do not fit into these algorithms, and visualization of the cervix with sampling of the cervix with cytology and/or biopsy may be appropriate
- Send these results for ‘diagnostic’ NOT ‘screening’ interpretation
- Prevalence of cervical cancer is 3 to 5.5% in people with PCB
- PCB is the presenting complaint in 11% of people with cervical cancer
Cervical cancer is very unlikely in the following situations and therefore colposcopy may not be clinically appropriate if pelvic exam benign
- <21 yo
- Regardless of age:
- Negative cytology in the past 12 months
- Negative co-testing in the past 3 years
Consider colposcopy if the following applies, regardless of screening results
- Visible cervical lesion
- Persistent PCB
- PCB with persistent minor cytological anomalies
- Immunocompromised
- at risk for inadequate cytological screening
- Other causes to consider when assessing a patient with PCB
- Polyps | Infection | Atrophy | Other genital tract malignancy (vaginal or endometrial cancer) | Sexual abuse
REFERENCES:
Commercial Support
This educational activity is supported by Hologic
Faculty Disclosures
Dr. Grabinski reports that she has no relevant financial relationships to disclose
Cervical Cancer Screening Guidelines – Key Points for Shared Decision Making with Your Patients
Review the latest recommendations with
Emma L. Grabinski, MD, FACOG
Dr Grabinski, a generalist OBGYN, is System Chief of OBGYN & Perinatology at Swedish Medical Center, and a clinical adjunct Professor at UW in Seattle WA
Learning Objectives: Upon completion of this activity, participants should be better able to
- Apply current evidence regarding cytology and HPV detection when counseling patients about cervical cancer screening options
- Discuss the natural history of HPV infection and the impact of the virus in determining the risk of cervical dysplasia
- Describe the current screening recommendations for immunocompetent people
CONTENTS:
- Case
- Synopsis
- Professional Guidelines and Key Points for Shared Decision Making
- The Wrap-Up
- References
THE CASE:
- 36-year-old G1P1
- Presents for preventive exam | Otherwise well
Gyn History
- No significant gyn issues in past 10 years
- Pap smears (cervical cytology) every 3 years since age 21
- Monogamous | Received full HPV quadrivalent vaccine dose
- Previous cervical cancer screening results (3 yrs prior)
- Negative for intraepithelial lesion or malignancy (NILM) | Negative for high risk HPV (hrHPV)
- Patient has read there are new guidelines for screening and would like to discuss options, including continued co-testing, cytology alone, or HPV testing alone
SYNOPSIS:
Cervical Cancer Overview
- Cervix cancer is more common than vulva, vaginal, or penile cancer as HPV infects the transformation zone of the cervix, which is immature, metaplastic and hormonally responsive (McMurray et al. Int J Exp Pathol, 2001)
- HPV’s ability to infect immature tissue is thought to contribute to the higher likelihood of premalignant, and malignant transformation
- In contrast, the remainder of the genital tract is mature epithelium
- HPV Infectivity
- Most people will be become infected with HPV soon after first intercourse
- Most of these infections will clear
- 67% clear within first 12 months (Rodríguez et al. J Natl Cancer Inst, 2008)
- Long duration of infectivity predicts the risk of progression to pre-malignant and malignant transformation (Schiffman and Castle. NEJM 2005)
- Takes time for mutations to accumulate and for the cells to become immortal
- Mean age of diagnosis of cervical cancer (Wheeler et al. J Natl Cancer Inst, 2009)
- HPV 16: 48.1 years
- HPV 18: 45.9 years
- Other high-risk HPV types: 52.3 years
Professional Guidelines Options and Shared Decision Making for Women (30 to 65 years)
ACOG, ASCCP and SGO have endorsed the USPSTF cervical cancer screening recommendations
Co-testing (cervical cytology and hrHPV testing) every 5 years
- Pros
- Co-testing with cytology and hrHPV testing is more sensitive than cytology alone
- Identifies people at higher risk of developing precancerous lesions
- In women >30 years, liquid-based cytology/HPV cotesting improved screening for cervical cancer vs liquid-based cytology or HPV components alone (Kaufman et al. AJCP, 2020)
- Although not designed for this purpose, abnormal glandular lesions may be detected, possibly representing endometrial pathology
- Determines those who need shorter screening intervals
- Cons
- More costly than hrHPV testing alone or cytology alone
- Patient anxiety with prolonged screening intervals
Screening with cervical cytology alone every 3 years
- Pros
- High specificity when abnormal (Kudva. AJCP, 2015)
- Avoids detecting transient hrHPV infection
- May reduce psychological harm associated with being labelled as having an STI
- Cons
- Fewer cases of precancerous lesions detected
- Cytology is less sensitive than HPV testing with regards to detecting precancerous lesions (Perkins et al. J Low Genit Tract Dis, 2020)
- Cytology has a false negative rate of 10-20% | False positive rate of 10-20% (Kudva. AJCP, 2015)
- Adenocarcinoma is not well identified on cytology
- Fewer cases of precancerous lesions detected
HrHPV testing alone as an alternative screening strategy (re-screen not more frequently than every 3 years)
- Pros
- Fewer unnecessary diagnostic tests – as hrHPV testing has
- Higher sensitivity than cytology alone, especially in vaccinated populations
- Fewer unnecessary diagnostic tests – as hrHPV testing has
- Cons
- HPV testing has a false negative rate of up to 5%
- An insufficient pap can clue the provider that the HPV result may be falsely negative
- Has a lower specificity than co-testing (Kudva. AJCP, 2015)
- HPV infection common
- However, persistence less common
- HPV alone may result in more diagnostic testing for lesions that would have regressed (Kaufman et al. AJCP, 2020)
- Requires use of an FDA approved hrHPV testing platform
- This is not available in all settings and requires the clinician to know what platform the lab uses
- If not an appropriate platform, can result in inadequate screening for the patient
- Management of positive hrHPV recommendations require reflex cytology on the same sample
- Delay in obtaining results may increase anxiety for patient
- HPV testing has a false negative rate of up to 5%
American Cancer Society (ACS)
Recommended for women 25 to 65 years of age
- HPV testing every 5 years
- Aside from risks related to higher false negative rates based ‘HPV only’ strategy (see above), there are also other concerns regarding the ACS strategy of HPV only spaced 5 years apart
- Management and follow-up: ACS recommendations differ in that there is no reflex cytology if abnormal hrHPV
Other Issues With ACS Recommendations
- Race, ethnicity and socioeconomic factors (Curry et al. JAMA, 2018)
- African American population: Receive screening at the same rate as white populations but 2x the rate of death from cervical cancer | Likely due to discrepancies in follow up and diagnosis
- Native/Indigenous populations, Hispanic populations, and Asian populations: Have lower screening rates than white populations
- White populations in poorer, rural areas are also disproportionally affected by cervical cancer
- Appropriate patient profile for ACS requires the following
- Patient is average risk given history of normal screening
- NO risk factors for immunocompromise
- Has demonstrated compliance with screening and follow up
- HPV vaccination rates in the USA are not high enough currently to factor vaccination into screening guidelines
The ACOG Practice Advisory
- The ACOG Practice Advisory Update recommends individualizing care, providing counseling, and allowing patients to choose the option that best suits them
The specific strategy selected is less important than consistent adherence to routine screening guidelines. Inadequate cervical cancer screening remains a significant problem in the United States, with persistent health inequities across the entire spectrum of cervical cancer care
The Wrap-Up
Patients Are Individuals and Deserve Individualized Care
- Screening for asymptomatic individuals currently include the following options
- Cytology with co-testing | Cytology alone | HPV with or without reflex cytology
- HPV 16/18 have the highest risk for development of CIN 3+ – do genotyping whenever possible!
- Cytology is not effective at detecting adenocarcinoma
- The most effective way of preventing cervical adenocarcinoma is with HPV vaccination
- Cytology is important for individualizing the follow-up interval (see ASCCP risk-based guidelines in ‘References’ below)
- Patient should be aware that even in the setting of HPV only strategy, an HPV positive report will default to ASCCP recommended follow up, which includes cytology
- New recommendations that favor HPV testing alone do not account for
- US HPV vaccination rates
- Lack of universal health care
- Race and ethnicity related differences in cancer rates and access to care
- Educate your patients that
- A preventive visit does NOT equal a pap smear
- Not needing a pap smear does NOT mean you don’t need a preventive visit
REFERENCES:
Biology of human papillomaviruses (McMurray et al. Int J Exp Pathol, 2001)
The Promise of Global Cervical-Cancer Prevention (Schiffman and Castle. NEJM 2005)
ACOG Practice Advisory: Updated Cervical Cancer Screening Guidelines
Commercial Support
This educational activity is supported by Hologic
Faculty Disclosures
Dr. Grabinski reports that she has no relevant financial relationships to disclose
The Evidence Behind Testing Strategies for Cervical Cancer Screening – Implications for Your Practice
Review the latest recommendations with
Sarah M. Temkin, MD, FACOG
Dr. Temkin is a gynecologic oncologist and equity advocate
Learning Objectives: Upon completion of this activity, participants should be better able to
- Understand the benefits and the risks of cervical cancer screening
- Become familiar with the clinical trials that led to the evidence for current cervical cancer screening guidelines and recommendations
- Compare the efficacy of different screening options, cytology, contesting, primary HPV testing for different age groups
- Consider the best frequency and type of screening for an individual patient and your practice population
CONTENTS:
Currently, women ages 30 to 65 have multiple options when it comes to cervical cancer screening. These options include (1) co-testing (cervical cytology and HPV testing), (2) cervical cytology only and (3) HPV only. How clear is the evidence behind these options?
BACKGROUND:
- Cervical cancer remains a major public health concern
- Globally: > 500,000 women per year affected | Fourth most common cause of cancer death among women worldwide (Arbyn et al. Lancet Global Health, 2020)
- US: Estimated 13,800 women will be diagnosed with cervical cancer in 2020 and more than 4,000 of women will die(Siegal et al. A Cancer Journal for Clinicians, 2020)
- Human papillomavirus (HPV) causes most cervical cancers
- ≥70 percent of cervical cancer cases attributed to HPV-16 and HPV-18 | The remainder are caused by other high-risk HPV types (Munoz et al. NEJM, 2003)
- Sexual transmission is a nearly exclusive pathway of HPV transmission | HPV estimated to be most common sexually transmitted infection in the US | By age 50 approximately 80% of women have been infected with some type of HPV (Nielsen et al. Sexually Transmitted Diseases, 2008)
- Most women who acquire the HPV virus do not develop cervical cancer
- 90% of HPV infections resolve on their own within 2 years | A small number of women do not clear the HPV virus and are considered to have a persistent infection (Munoz et al. NEJM, 2003)
- Cervical cancer is a preventable malignancy and worldwide eradication is a feasible goal
Cervical Cancer: New Cases, Deaths and 5-Year Relative Survival (credit SEER)
Note: Most women who have abnormal cervical cell changes that progress to cervical cancer have never had a Pap test or have not had one in the previous three to five years
KEY CONCEPTS WHEN IT COMES TO SCREENING:
What are the Harms of Overscreening?
- Tumor biology drives the efficacy of screening for an individual disease (Esserman et al. Lancet Oncology, 2014)
- For very slow growing conditions or precancerous lesions that may regress without treatment such as cervical cancer, screening too frequently may lead to overdiagnosis – the diagnosis of a condition that would not have required treatment if it had not been diagnosed
- Screening has downstream consequences
- Cost | Time away from work and other activities | Occasional physical discomfort
- False positive screening results can lead to unnecessary follow-up tests (e.g., invasive biopsies, anxiety)
- Colposcopies, LEEPs and cone biopsies are uncomfortable
- Excisional biopsies in nulliparous patients may increase the risk of preterm delivery
Overdiagnosis: Size vs Time (credit NCI)
What are the Benefits Related to Cervical Cancer Screening?
- Cervical cancer is a preventable malignancy and worldwide eradication is a feasible goal
- Screening can alter the natural history
- Screening allows for detection and removal of high-grade precancer
- Allows for the early detection of invasive cervical cancer
- Widespread adoption of pap smear screening in the US during the 1950’s and 60’s led to significant declines in incidence and mortality
- Overall incidence rates for invasive cervical cancer decreased by 54% over the 35 years from 1973 to 2007
- Most women who have abnormal cervical cell changes that progress to cervical cancer have never had a Pap test or have not had one in the previous three to five years
KEY PUBLICATIONS:
HPV vs Cytology
Ronco et al. Lancet, 2014
- Combined results of 4 randomized trials in Europe (Sweden, Netherlands, England and Italy)
- Participants
- Women ages 20 to 64
- Study design
- Different protocols between studies
- Randomized to HPV-based or cytology-based screening
- Results
- 176,464 participants
- HPV-based screening provides 60-70% greater protection against invasive cervical carcinomas vs cytology
- Rate ratio of 0.60 (95% CI, 0.04-0.89) in favor of HPV testing for the detection of invasive carcinoma
Leinonen et al. BMJ, 2012
- Prospective randomized trial in Finland
- Participants
- Women ages 25 to 65
- Study design
- Participants followed over one screening round of five years
- HPV group (followed by cytology if positive): 101,678 women
- Primary cytology group: 101,747 women
- Participants followed over one screening round of five years
- Results
- Hazard ratio: 1.36 (95% CI, 1.09-1.59) for detection of CIN3/AIS for primary HPV screening
- Cumulative detection rate was 0.0057 (0.0045 to 0.0072) for HPV screening vs 0.0046 (0.0035 to 0.0059) for conventional screening
- “HPV screening could increase the overall detection rate of cervical precancerous lesions only slightly”
Ogilvie et al. JAMA, 2018
- Prospective randomized clinical trial in Canada
- Participants
- Women ages 25 to 65
- Study design
- Participants followed for (CIN) grade 3 or CIN3+ detected up to and including 48 months
- HPV group: 9552 women | Negative status returned in 48 months | Reflex cytology for positive HPV results
- Cytology group: 9457 women | Negative status returned in 24 months | If negative at 24 months, returned at 48 months | Followed by reflex HPV testing for women with ASCUS
- Participants followed for (CIN) grade 3 or CIN3+ detected up to and including 48 months
- Results
- The CIN3+ incidence rate (primary outcome)
- HPV group: 2.3/1000 (95% CI, 1.5-3.5)
- Cytology group: 5.5/1000 (95% CI, 4.2-7.2)
- CIN3+ risk ratio: 0.42 (95% CI, 0.25-0.69)
- For patients who were negative at baseline
- HPV-negative women, had a significantly lower cumulative incidence of CIN3+ at 48 months than cytology-negative women | CIN3+ risk ratio, 0.25 (95% CI, 0.13-0.48)
- “…by adding cytology to the intervention group, an additional 3 CIN2+ lesions were detected in HPV-negative women. In contrast, by adding HPV testing to the control group, HPV testing detected 25 CIN2+ lesions that would not have been detected by cytology alone”
- The CIN3+ incidence rate (primary outcome)
Sankaranarayanan et al. NEJM, 2009
- Prospective randomized trial in rural India
- Participants
- Women ages 30 to 59
- Low resource setting
- Randomized to 4 groups
- HPV group
- Cytology group
- Visual inspection with acetic acid (VIA) group
- No screening (standard of care)
- Results
- There was a decrease in cervical cancer deaths among the HPV group vs standard care (no screening)
- Hazard ratio 0.52 (95% CI, 0.33 to 0.83)
- Reduction is deaths driven by ‘stage migration’ (a lower stage at diagnosis for women who developed cervical cancer)
- Cytologic screening or VIA did not lower the cervical cancer mortality rate
- There was a decrease in cervical cancer deaths among the HPV group vs standard care (no screening)
Relative Contributions of Cytology and HPV tests within Cotesting
Kaufman et al. AJCP, 2020
- There are no head-to-head studies that evaluate co-testing vs HPV only
- Kaufman et al. performed a review on a large commercial database (2010 to 2018)
- 13,633,071 women ≥30 years | Diverse population in the US
- 18,832,014 cotest results
- Goal of the study: To evaluate the results of liquid-based cytology and HPV testing in cotesting preceding cervical cancer and precancer diagnoses
- Results
- 1,615 cotests preceded 1,259 cervical cancer diagnoses | 11,164 cotests preceded 8,048 cervical precancer diagnoses
- More women subsequently diagnosed with cervical cancer within 1 year of cotesting were identified by cytology result (P<.0001)
- Cytology: 85.1%
- HPV: 77.5%
- More women subsequently diagnosed with CIN3/AIS within 1 year of cotesting were identified by HPV result (P<.0001)
- Cytology: 89.3%
- HPV: 97.6% was more frequently positive than LBC prior
- False-negative rate in women with cervical cancer
- Positive cytology/negative HPV: 13.1%
- Rate increases if testing >12 months
- The authors conclude
…Liquid-based cytology (LBC)/human papillomavirus (HPV) cotesting enhances screening for detection of cervical cancer in women 30 years an older, more so than LBC or HPV alone among women receiving cotesting
…detection of prevalent “precancers” (detection sensitivity) is likely to overestimate the effectiveness of any screening formulation in preventing invasive cancer
Because of this bias, the performance of screening tests targeting the diagnosis of invasive cancer as the primary end point of screening effectiveness is especially relevant
THE WRAP UP:
Evaluating the Studies
- HPV‐based cervical cancer screening has superior sensitivity and long‐term negative predictive value compared with cytology‐alone screening demonstrated in several randomized controlled trials
- However, there are no direct randomized head-to-head studies between HPV only vs co-testing
- Large retrospective database studies of a heterogeneous population that compared HPV to co-testing suggest that HPV only may be better at detecting precancerous lesions but including cytology leads to better detection of cancers within the subsequent year
- Data from randomized controlled trials that assessed HPV only strategies may not be representative of the US population
- Adherence to follow-up in the real world may be quite different
- Few participants from under-represented minority populations with higher disease burden (Black and Hispanic participants in particular) were included in these trials
- Model‐based studies create a composite of epidemiologic, clinical, and resource data from various empirical studies and databases, yet uncertainties in the data and model structures are unavoidable
- Areas of remaining uncertainty include the following
- The effect of persistent HPV infection and reactivation
- Clinical course after acquisition of new infections at older ages | Increasing life expectancies and potential cohort effects because of changes in lifetime sexual behaviors of US women over time are unknown
When to Consider More Frequent Testing
- The new ACS guidelines recommend HPV only testing every 5 years, however, these guidelines assume this patient is not immunocompromised or is not at otherwise medically higher risk for persistent HPV infection
- Patients who are at higher risk and should be screened more frequently
- Immunocompromised: HIV | History of solid organ or stem cell transplant | DES exposure | Other conditions associated with decreased immune response
- Medical history: Previous CIN2, CIN3, or AIS | Extend screening past age 65
- Are there factors that may lead to patient being less likely to adhere to screening at a date later than when she is in the office?
- Social factors
- Health insurance insecurity
- Transportation barriers
- Trauma with pelvic examinations
- Is this patient symptomatic?
- Postcoital bleeding is a typical early sign of cervical cancer | A mass on the cervix requires a biopsy
- Interval cervical cancer screening may be indicated for patients with persistent vaginal discharge, pain, etc.
- Does this patient have a new partner? Does her partner have a new partner?
- This may especially impact discontinuation of screening in older patients
Disparities
- Disparities have decreased but continue to exist in incidence and mortality from cervical cancer based upon geographic location, rural/urban residence and for racial/ethnic minorities (Fleming et al. PLoS One, 2014; Temkin et al. Gynecologic Oncology, 2018)
- The contributors to these inequities include barriers such as access to follow-up and treatment
- Provider bias contribute to inequities | Be an upstander and find ways to help patients overcome structural inequities that may impact care (Temkin et al. Gynecologic Oncology, 2018)
Cervical Cancer Screening for Women <30 years
- While ACOG/ASSCP/UPSTF recommend starting screening at age 21, ACS recommends beginning screening at age 25
- Substantially higher HPV positivity rates have been demonstrated leading to higher colposcopy rates than with cytology alone or co-testing (Ronco et al. Lancet, 2014)
- In the prospective US screening study evaluating the performance of primary HPV screening in women aged ≥25 years, however, HPV testing was significantly more sensitive for the detection of CIN3+ than cytology alone (Wright et al. Gynecologic Oncology, 2015)
- Both HPV16/HPV18 positivity and cytologic abnormalities were highest in women aged 25 to 29 years, and more than one‐half of the women in this age group who had CIN2+ (or CIN3+) identified on colposcopy had a negative cytology result
- In light of the increased detection of abnormalities in this age group, adherence to conservative management guidelines is recommended
Cervical Cancer Screening for Women >65 years
- The evidence from randomized trials for screening after age 65 is limited
- Most trials included women up to age 65, not older
- Limited data for screening older patients who have a new partner
- Guidelines generally recommend to stop screening average-risk women >65 for cervical cancer no history of cervical intraepithelial neoplasia grade 2/3 or cancer and documented adequate negative prior screening
- However, because approximately 20% of new cases of cervical cancer are diagnosed in women ≥65 years of age, attention to patients in whom screening should continue is extremely important and include the following
- Patient without adequate prior negative screening defined as 2 consecutive negative HPV tests, or 2 consecutive negative co-tests, or 3 consecutive negative cytology tests within the past 10 years | Underscreening is common among patients over age 50 as the need for gynecologic care is often decreased
- Patients who are currently under surveillance for abnormal screening results
- Patients who are immunosuppressed
- Cervical cancer screening may be discontinued in individuals of any age with limited life expectancy
Vaccination
- Best public health strategy remains prevention associated with a substantially reduced risk of invasive cervical cancer at the population level
- HPV vaccine has been available since 2006 (Schiller et al. Vaccine, 2012)
- Vaccines if administered prior to the acquisition of HPV infection are highly effective at cancer prevention
- Wide variation across the US, with only about 50 percent of adolescents ages 13 to 17 up to date with the recommended regimen (Elam-Evans et al. MMWR Morb Mortal Wkly Rep, 2020)
- Vaccination rates in your community may impact population prevalence of HPV infection which will change the positive and negative predictive value of cytology or HPV testing
- Recent attenuation of declines in incidence, an increase in diagnoses of metastatic disease and growing percentages of adenocarcinomas underscore the importance of continued efforts to further reduce the burden of cervical cancer in the U.S (Islami et al. Preventative Medicine, 2019)
REFERENCES:
Cancer statistics, 2020 (Siegal et al. A Cancer Journal for Clinicians, 2020)
Screening for Cervical Cancer in Rural India (Sankaranarayanan et al. NEJM, 2009)
Commercial Support
This educational activity is supported by Hologic
Faculty Disclosures
Dr. Temkin reports that she is an advisor for Tesaro/GSK and Clovis for which she has received honoraria
Related ObG Project Topics
Screening for Cervical Cancer in the Woman at Average Risk
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Sexual History Taking 101: How Do I Start the Conversation with My Patients?
Review the latest recommendations with
Jonathan Shuter, MD, a Professor of Medicine in the Division of Infectious Diseases at Montefiore Medical Center and the Albert Einstein College of Medicine
Uriel Felsen, MD, an Associate Professor of Medicine in the Division of Infectious Diseases at Montefiore Medical Center and the Albert Einstein College of Medicine
Raffaele M. Bernardo, DO, an Assistant Professor of Medicine in the Division of Infectious Diseases at Montefiore Medical Center and the Albert Einstein College of Medicine
Learning Objectives:
- Define sexual health and how it is applied in clinical settings
- Detail the burden of sexually transmitted infections (STI) in the United States
- Describe standardized guidelines to sexual history-taking
- Identify affirming approaches to successful sexual history-taking
CONTENTS:
- Clinical Case
- Overview of Taking a Sexual History
- Defining and Centering Sexual Health
- The Context of Taking A Sexual History in Clinical Settings
- Words Matter: Avoiding Judgmental and Stigmatizing Language
- Standardized Approaches to Sexual History-Taking
- The Wrap-Up
- Learn More – Primary Sources
- Glossary of Sexual History Terms and Language
THE CASE:
A 34-year-old cis-woman comes to your office for a routine check-up and STI screening. She is asymptomatic and denies any genitourinary symptoms or concerns.
- She married at a younger age and is now divorced. She has two young children and is taking her first steps towards returning to the dating world and sexual activity. She wants to discuss options where she can enjoy sex again but can also empower herself with tailored approaches to STI and HIV prevention
- She has always been attracted to both men and women, but only had sex with her husband for the 10 years they were married. She is open to either gender for a sexual relationship moving forward
- She has no medical conditions and is currently not taking any medications. She would consider condoms and birth control for contraception, but is interested in what may work best for her
Overview of Taking a Sexual History
The sexual history is a vital, yet often overlooked aspect of the clinical history and physical in medical settings
- Topics regarding sexuality, sexual orientation and behavior, and gender identity are vital aspects of the social history that can direct providers to identify
- sexual health and wellness recommendations
- screening tests
- tailored HIV and STI prevention approaches
- When it comes to HIV pre-exposure prophylaxis, or “PrEP,” it is impossible to hold a fluent conversation about HIV prevention before first becoming proficient in talking about sex
Defining and Centering Sexual Health
The definition of sexual health has been debated and modified over the years, but most sexual health experts refer to the World Health Organization (WHO) definition:
“Sexual health is fundamental to the overall health and well-being of individuals, couples and families, and to the social and economic development of communities and countries. Sexual health, when viewed affirmatively, requires a positive and respectful approach to sexuality and sexual relationships, as well as the possibility of having pleasurable and safe sexual experiences, free of coercion, discrimination and violence.”
- In many health professional schools, students have historically been taught to address sex from a pathological framework centered on disease states (i.e., HIV and STIs), screening for these conditions, and treating them appropriately
- Today’s approach to STI and HIV prevention and treatment now is proactive, focusing instead on sexual health, wellness, and prevention by creating spaces where patients feel more comfortable discussing their full and authentic selves
- Most people receiving new HIV diagnoses report contracting it through sexual transmission | To reduce the continued burden of STI and HIV rates, eliciting a good sexual history is crucial
The Context of Taking A Sexual History in Clinical Settings
When beginning as sexual history, it is important to recognize the complex dynamics that take place within the patient-clinician encounter:
- Patients prefer active inquiry about sexual health issues from clinicians (Ryan et al., 2018)
- Generational differences matter in communication about sexual health (Rabathaly and Chattu, 2019)
- Providers’ perception of how sexual history questions will be received by patients influences if a sexual history will be elicited and perceived competence led to more frequent screening (Tong et al., 2013)
- Sexual history-taking education in medical school curricula shows promise in improving students’ confidence in and comfort with conducting sexual histories with their patients (Bourne et al., 2020)
Competing interests and within-clinic demands also contribute to difficulty with competency in sexual history taking on a visit-by-visit basis:
- Not having enough time to discuss sensitive sexual information in a 15-minute clinical visit
- Building trust quickly without offending with personal questions
- Competing clinical priorities – chief complaint, other medical issues, health care maintenance
- Requirements for screening
- Interruptions from other clinical staff and other patients needing assistance
These contexts can put barriers in the way of clinicians having meaningful conversations with our patients around sexual health
- Learning to address these hurdles and incorporate language and behaviors in your practice will become easier with practice
- Implementation will, over the long term, will become seamless and improve the efficiency with which you take a sexual history
Routine review of sexual history can lead to improved patient outcomes
Words Matter: Avoiding Judgmental and Stigmatizing Language
Introductions
A provider’s approach to taking a comprehensive sexual history begins as soon as you introduce yourself to your patient
- Consider how we greet patients and the ways in which our perceptions of their physical appearance and gender expression leads to the insertion of the titles “Mr.” or “Mrs./Ms.” before their last name.
- Most of the time we guess correctly, but at times we may guess incorrectly and create a stigmatizing atmosphere for our patients before the full encounter even starts
- As a result, patients may shut down and not give a fully open and honest history; some may even question if they want to follow up with us altogether
We suggest an introduction like this: “Hi, my name is Dr./NP/PA _________________. My pronouns are she/her. What would you prefer to be called and what are your pronouns?”
- Using more open-ended language lets your patients know you are not assuming anything when it comes to their sexual and gender identities
- Additionally, it lets them know you respect them and will address them how they would like to be addressed, not based on your assumptions
When in doubt, ask patients how they prefer to be addressed | Never make assumptions.
Language
Language is key in sexual history-taking, and questions should be framed in open-ended and affirming language that allows patients to tell their own narrative:
- “I’m going to ask some personal questions about your sexual history now”
- “I ask these questions to all my patients to help get a sense of their sexual health needs”
- “What are the genders of your sexual partners”
- “What behaviors do you enjoy when having sex”
- “What forms of STI and HIV prevention do you use with your partners”
- “Do you have any specific sexual health concerns you want to talk about?”
Leading with open-ended questions avoids assuming certain sexual and gender identities (or the genders of their sexual partners):
- It allows patients to understand you are receptive to any response
- It creates a space where they will not be judged if they acknowledge having multiple sexual partners and regardless of the consistency of their HIV/STI prevention choices
- It allows communication to remain honest
- It facilitates identification of necessary testing, vaccination needs, and how to move forward with a sexual health and wellness plan that works for them
Standardized Approaches to Sexual History-Taking
There are many good resources to standardize the approach to sexual history-taking
The 5 P’s (CDC)
The most popular standardized approach to sexual history-taking comes from the CDC and is entitled “The 5 Ps” – which stand for:
- Partners
- Practices, including previous or current sex work
- Protection from STIs
- Past history of STIs
- Prevention of Pregnancy
These are commonly accepted categorization of the broad topics clinicians should cover during the encounter
- They are guidelines more than hard and fast rules, ensuring thorough content in a way that feels natural to the provider
- Flexibility is key to improve comfort and competence, including order of questions and wording
Essential Questions – Physicians for Reproductive Health
Physicians for Reproductive Health (PRH) suggests a template for sexual history-taking, particularly adolescents and emerging adults. They emphasize how to best set the atmosphere to ask sensitive sexual health questions, highlighting effective communication techniques that will help patients feel comfortable. These include:
- Minimize note-taking, particularly during sensitive questioning
- Talk in terms the adolescent will understand
- Ask developmentally appropriate questions
- Ask open-ended questions
- Practice listening skills
- Avoid the surrogate parent and adolescent roles
- It’s a conversation…not an interrogation!
- What purpose does the information serve?
- Healthy respect and regard for privileged information
Their recommended sexual history questions cover:
- Gender identity : “What names and pronouns do you use for yourself?”
- Sexual orientation “What genders are you interested in romantically?” and “Are you comfortable with your feelings?”
- Sexual coercion, abuse, and prior or current sex work “Who makes the decisions about when to have sex and what contraception to use?” and “have you exchanged sex for goods or services?” or “have you engaged in sex work in the past or currently?”
- Sexual activity
- Number of partners
- Frequency of intercourse
- Type of sex practices
- STI history and risk assessment “Have you ever been diagnosed with an infection?”
- Pregnancy history and risk assessment “Have you ever been pregnant or gotten anyone pregnant?” and “What are you doing to prevent pregnancy right now?”
- Contraceptive behaviors “What are your experiences with contraception to prevent pregnancy?”
- Substance use
Approaching the sexual history with respect, no assumptions, and a collaborative spirit will go a long way in fostering the trust needed for honest communication about sexual health and wellness
Note: It may be helpful to explain or collaborate with the patient on how the information they provide on their sexual health will be documented in the medical record to build trust
The Wrap-Up
The above patient will benefit from an open-ended sexual history
She is at a transitional time of her life where she is entering a new phase and would benefit from an affirming and empowering approach to her sexual health
- Start with a discussion of her current sexual and gender identities
- Explore what her sexual and romantic needs and desires are at this point
- Inquire regarding her concerns and worries about returning to dating and sexual activity after recently ending years of marriage
- Discuss her preferred approaches to contraception
- Evaluate her thoughts and preferred options for HIV and STI prevention (including PrEP) moving forward
KEY POINTS:
- STI and HIV prevention discussions begin with a sexual health conversation
- Patient-centered and tailored approaches should meet patients where they are
- Utilize affirming language over a judgmental and discriminatory tone
- Incorporate models of sexual history-taking that work best for your patients
Learn More – Primary Sources:
Centers for Diseases Control and Prevention
American College of Obstetricians and Gynecologists
Physicians for Reproductive Health
Human Rights Campaign Glossary of Terms
American Academy of Family Physicians
National LGBT Health Education Center
New York City Department of Health
Glossary of Sexual History Terms and Language
When taking a sexual history, it is important to lead without assuming that everyone is cis-gendered and heterosexual. Approaching the questions and how to phrase them is the art of medicine, beginning with familiarizing oneself with key sexual orientation and gender identity (SOGI) terms that will help facilitate an open atmosphere in which patients feel comfortable discussing their sexual lives
Below is an abbreviated list of terms. A more expansive glossary is found on the HRC website. While it is possible that the majority of patients you encounter in clinical practice may identify as cis-gendered and heterosexual, it is paramount to create clinical spaces that are affirming and inclusive of all patients along the sexual and gender identity continuum. You may not need to use these terms with every patient and during your clinical sessions, but it is important to at least familiarize yourself with the terminology. This way we can service anyone’s sexual health needs and priorities, regardless of how they identify
According to the Human Rights Campaign (HRC), these are some basic terms and definitions around sexual identity and gender identity (SOGI) with which clinicians can familiarize themselves:
Sexual orientation | An inherent or immutable enduring emotional, romantic, or sexual attraction to other people
Lesbian | A woman who is emotionally, romantically, or sexually attracted to other women
Gay | A person who is emotionally, romantically, or sexually attracted to members of the same gender
Bisexual | A person emotionally, romantically, or sexually attracted to more than one sex, gender, or gender identity though not necessarily simultaneously, in the same way or to the same degree
LGBTQ | An acronym for “lesbian, gay, bisexual, transgender and queer”
Queer | A term people often use to express fluid identities and orientations. Often used interchangeably with “LGBTQ”
Gender identity | One’s innermost concept of self as male, female, a blend of both or neither—how individuals perceive themselves and what they call themselves. One’s gender identity can be the same or different from their sex assigned at birth
Cisgender | A term used to describe a person whose gender identity aligns with those typically associated with the sex assigned to them at birth
Transgender | An umbrella term for people whose gender identity and/or expression is different from cultural expectations based on the sex they were assigned at birth. Being transgender does not imply any specific sexual orientation. Therefore, transgender people may identify as straight, gay, lesbian, bisexual, etc.
Gender dysphoria | Clinically significant distress caused when a person’s assigned birth gender is not the same as the one with which they identify. According to the American Psychiatric Association’s Diagnostic and Statistical Manual of Mental Disorders (DSM), the term—which replaces Gender Identity Disorder—”is intended to better characterize the experiences of affected children, adolescents, and adults”
Gender expression | External appearance of one’s gender identity, usually expressed through behavior, clothing, haircut or voice, and which may or may not conform to socially defined behaviors and characteristics typically associated with being either masculine or feminine
Genderqueer | Genderqueer people typically reject notions of static categories of gender and embrace a fluidity of gender identity and often, though not always, sexual orientation. People who identify as “genderqueer” may see themselves as being both male and female, neither male nor female, or as falling completely outside these categories
Gender transition | The process by which some people strive to more closely align their internal knowledge of gender with its outward appearance. Some people socially transition, whereby they might begin dressing, using names and pronouns, and/or be socially recognized as another gender. Others undergo physical transitions in which they modify their bodies through medical interventions
Non-binary | An adjective describing a person who does not identify exclusively as a man or a woman. Non-binary people may identify as being both a man and a woman, somewhere in between, or as falling completely outside these categories. While many also identify as transgender, not all non-binary people do
Sex assigned at birth | The sex (male or female) given to a child at birth, most often based on the child’s external anatomy. This is also referred to as “assigned sex at birth”
Commercial Support
This educational activity is supported by an independent educational grant from Gilead Sciences
Faculty Disclosures
Dr. Shuter has no relevant financial relationships to disclose
Dr. Felsen has no relevant financial relationships to disclose
Dr. Bernardo has no relevant financial relationships to disclose
Special Thanks
Special thanks to David Malebranche, MD, MPH and Ariel Watriss, MSN, NP for their insights and contribution.
HIV Pre-Exposure Prophylaxis (PrEP) – Who’s it for?
Review the latest recommendations with
Jonathan Shuter, MD, a Professor of Medicine in the Division of Infectious Diseases at Montefiore Medical Center and the Albert Einstein College of Medicine
Uriel Felsen, MD, an Associate Professor of Medicine in the Division of Infectious Diseases at Montefiore Medical Center and the Albert Einstein College of Medicine
Raffaele M. Bernardo, DO, an Assistant Professor of Medicine in the Division of Infectious Diseases at Montefiore Medical Center and the Albert Einstein College of Medicine
SUMMARY:
There are now three types of PrEP approved by the Food and Drug Administration (FDA) currently available – oral formulations (Truvada and Descovy) and an intramuscular injection, cabotegravir. All treatments work by stopping the HIV replication process. While HIV PrEP is recommended for all individuals that it is applicable for, at this time, Descovy is not approved for the prevention of HIV for those at risk through receptive vaginal sex – including cisgender women, transgender men, and others.
- Truvada brand name (Emtricitabine (F) 200mg with tenofovir disoproxil fumarate (TDF) 300mg) daily
- Descovy brand name (Emtricitabine (F) 200mg with tenofovir alafenamide (TAF) 25mg) daily
- Vocabria brand name (Cabotegravir 600mg) gluteal IM injection at month zero, month one, then every two months
Of note, we refer to Truvada as F/TDF, Descovy as F/TAF, and Vocabria as Cabotegravir throughout
BACKGROUND:
Providing Pre-exposure Prophylaxis
- Goal of PrEP is to reduce the acquisition of HIV and its subsequent costs to individuals and society
- PrEP has been a part of the HIV prevention landscape since 2012
- Both HIV PrEP oral tablets contain two antiretroviral medications called nucleoside reverse transcriptase inhibitors (NRTIs)
- These medications work by inhibiting the enzyme reverse transcriptase that HIV needs to replicate
- Both tablets are used in many common HIV treatment regimens
- The intramuscular injection contains an integrase strand-transfer inhibitor (INSTI) which works by inhibiting the enzyme that HIV uses to integrate its own DNA into the CD4 cell’s nucleic DNA
Oral PrEP medications
FDA Approved Regimens:
- Truvada | Emtricitabine (F) 200mg and tenofovir disoproxil (TDF) 300mg) | one tablet orally daily, with or without food
- Descovy | Emtricitabine (F) 200mg and tenofovir alafenamid (TAF) 25mg) | one tablet orally daily, with or without food
Alternative formulations of PrEP medications
Cabotegravir 600mg gluteal IM injection was granted FDA approval in December 2021
- Requires IM injection at month zero, month one, then every two months afterwards
- One three mL injection in the gluteal muscle
- Only available for HIV negative patients without contra-indications to the medication
What many clinicians wonder next is “What patients would be good candidates for PrEP?” PrEP is a sexual health option for people interested in HIV prevention and could be appropriate for many patients you see on a daily basis.
Who It’s For – CDC Guidance and Other Considerations
The CDC recently updated guidance to recommend routine counseling of risks of transmission of HIV and PrEP options as well as routine prescribing of PrEP to appropriate candidates. Now, discussion of PrEP is recommended for all individuals who are sexually active.
Although “risk groups” have been defined by the CDC, we caution the idea of patients as levels of “risk,” particularly when it comes to sexual health. What it involves is taking a good sexual history and documenting what behavioral choices they make, then offering PrEP as an option for HIV prevention.
PrEP is for people without HIV who could be exposed to HIV from sex or injection drug use.
The CDC provides the following recommendations:
CDC recommends the following patients should be assessed for PrEP including
- Sexually active gay and bisexual men without HIV
- Sexually active heterosexual men and women without HIV
- Sexually active transgender persons without HIV
- Persons without HIV who inject drugs
- Persons who have been prescribed non-occupational post-exposure prophylaxis (PEP) and report behaviors that could expose them to HIV, or who have used multiple courses of PEP
For sexually active adults and adolescents:
- Anal or vaginal sex in the past six months; and
- HIV-positive sexual partner (especially if partner has unknown or detectable viral load); or
- Recent bacterial STI; or
- History of inconsistent or no condom use with sexual partner(s)
For Persons who inject drugs:
- HIV-positive injecting partner; or
- Shares drug preparation or injection equipment
All persons eligible for PrEP:
- Documented negative HIV test result before prescribing PrEP; and
- No signs/symptoms of acute HIV infection; and
- Normal renal function; and
- No contraindicated medications
NOTE: While the CDC compartmentalizes “risk groups” as listed above, as clinicians we must remember that sexual health does not fit neatly into static compartments. Sexuality and sexual behavior are fluid, and individuals may change their partners, behavior, and condom use over time and situation – and invite us to explain in detail
Thus, the CDC guidance is exactly what it is – guidance. Nothing replaces taking a good sexual history to discover which patients may be good candidates for PrEP.
- Individuals who do not fit in the categories mentioned above could still benefit from PrEP – so be sure not to limit offering PrEP to just certain groups of people
- Anyone who is sexually active could be a candidate for PrEP.
- Patients who ask for PrEP may not feel comfortable sharing all their sexual behavior with medical providers due to fear of judgment and stigma
- If a patient comes into your office inquiring about PrEP, even if they don’t verbally describe specific behaviors that the CDC defines as “risky,” they are asking for a reason
Dosage Regimen
These medications are approved to prevent HIV infection in adults and adolescents weighing at least 35 kg (77 lb) as follows:
- Daily oral PrEP with F/TDF (Truvada) is recommended to prevent HIV infection among all persons at risk through sex or injection drug use.
- Daily oral PrEP with F/TAF (Descovy) is recommended to prevent HIV infection among persons at risk through sex, excluding people at risk through receptive vaginal sex. F/TAF has not yet been studied for HIV prevention for receptive vaginal sex.
Selecting a Regimen
- Determination of which oral regimen is appropriate depends on a patient’s clinical status, comorbidities, as well as potential side effects and medication interactions
- Both F/TDF and F/TAF are equally effective in reducing HIV transmission
- F/TDF (Truvada) is the only FDA-approved PrEP option for cis women who have receptive vaginal sex | May be better for people with a history of hypercholesterolemia
- F/TAF (Descovy) is FDA-approved for use by transgender women, transgender men, and MSM | the best option for persons with osteoporosis and can be used for patients with chronic kidney disease with a CrCl as low as 30 ml/min
- Comorbidities
- Hepatitis B
- HIV
- Renal disease
- Common side effects
- The majority of people experience no side effects at all
- Mild to moderate gastritis at start of med course- usually tapers within three to four weeks | Can sometimes include diarrhea
- Headaches
- Medication interactions
- Other drugs that could affect renal function may require closer renal function while PrEP is being used
- Other antiviral medications can impact PrEP response and need to be reviewed with clinical use on a case by case basis
“On-demand” PrEP
“On-demand” PrEP is not currently FDA-approved for use in the United States but many clinicians many use it in an “off-label” manner as appropriate with the needs of their patients and reflective of the studies in Europe that demonstrate its effectiveness in reducing HIV transmission.
- Would be an option for people who may not engage in sex regularly or plan sexual encounters
- Involves the following regimen schedule for TDF/FTC only
- Take two tablets at least two hours and not more than 24 hours before sex
- Take one tablet 24 hours after first two pills taken
- Take one tablet 48 hours after first two pills taken
PrEP Safety and Efficacy
PrEP, when used as indicated, has been determined to be safe and effective in the prevention of HIV transmission among diverse populations, including
- Men who have sex with men and transgender women: 85 – 100% risk reduction
- Heterosexual women and men: 63 – 90% risk reduction
- Persons who Inject Drugs (PWID) regardless of sexual activity: 73.5% risk reduction
- Adolescents who weigh over 35kg: >95% risk reduction
Clinical considerations with initiation
- Consider sexual health needs beyond HIV prevention- PrEP only offers prevention for HIV, not other STIs
- These medications must be monitored closely for patients with chronic active Hepatitis B (persistent positive Hepatitis B Surface Antigen)
- These medications require healthy kidney function (eCrCl >60 ml/min for TDF/FTC and eCrCl >30 ml/min for TAF/FTC)
- Can be prescribed by primary care providers without requiring infectious disease specialist or consult prior to initiation [for more information see Initial Visit, Dosing, and Follow Up or Implement and Maintain a Prep Clinic in the Resource Center]
- Cabotegravir, the intramuscular injection pending FDA approval, can be used in individuals without requiring creatinine or renal clearance, Hepatitis B status, lipid panels, or liver function tests
- Cabotegravir may be a better option for individuals who prefer injections every two months, have poor adherence with daily medication, or have other co-morbidities such as renal or liver disease
Learn More – Primary Sources:
CDC Pre-Exposure Prophylaxis for HIV Prevention
Commercial Support
This educational activity is supported by an independent educational grant from Gilead Sciences
Faculty Disclosures
Dr. Shuter has no relevant financial relationships to disclose
Dr. Felsen has no relevant financial relationships to disclose
Dr. Bernardo has no relevant financial relationships to disclose
Special Thanks
Special thanks to David Malebranche, MD, MPH and Ariel Watriss, MSN, NP for their insights and contribution.
Initial Visit, Dosing, and Follow Up
Review the latest recommendations with
Jonathan Shuter, MD, a Professor of Medicine in the Division of Infectious Diseases at Montefiore Medical Center and the Albert Einstein College of Medicine
Uriel Felsen, MD, an Associate Professor of Medicine in the Division of Infectious Diseases at Montefiore Medical Center and the Albert Einstein College of Medicine
Raffaele M. Bernardo, DO, an Assistant Professor of Medicine in the Division of Infectious Diseases at Montefiore Medical Center and the Albert Einstein College of Medicine
SUMMARY:
The initial visit for HIV PrEP will establish the start of the patient’s PrEP experience. It is a blend of education, clinical care, and establishing a new health practice for the patient
Initial Visit: What to Include
The initial visit needs to include both a comprehensive history of the patient, their sexual history, eligibility for PrEP as well as laboratory workup prior to initiation
Sexual Health History and Comprehensive Screening
- A comprehensive sexual health history review and review of eligibility for PrEP includes
- Gender and number of sexual partners
- Specific sexual behaviors (oral, vaginal, anal)
- HIV-status of sexual partners
- Condom use practices
- Substance use/abuse screening
- History of sexually transmitted infections (STI)
- Confirmation of HIV negative status (see lab tests below)
- Assessment for acute HIV
- A patient’s HIV negative status must be confirmed in the context of recent sexual or other possible exposure contexts in the preceding thirty days
- If there is concern for acute HIV and someone has an initial negative HIV Ag/Ab, that may require HIV RNA testing before initiating PrEP
- Symptoms of acute HIV may include:
- Fever
- Pharyngitis
- Lymphadenopathy
- Many other symptoms (diarrhea, headache, flu-like symptoms) or NONE AT ALL
- Assessment for medical cautions or contraindications include
- Hepatitis B, renal or hepatic insufficiency
- Discussion with patients of potential, yet rare side effects, including:
- Truvada (F/TDF 200mg/300mg): worsening renal function including kidney failure, bone thinning
- Descovy (F/TAF 200mg/25mg): elevated cholesterol levels, weight gain
- Other sexual health needs including STI testing or contraception, as needed
Laboratory Tests and Other Diagnostic Procedures
Initiation of Oral PrEP
- HIV testing | must be performed and results must be negative within one week before starting PrEP to document that patients do not have HIV
- Fourth generation HIV Ag/Ab serologic testing is preferred over either oral/fingerstick rapid Ab or serologic Ab testing
- Renal function
- Truvada (F/FTC) | eCrCl should be documented at >60 ml/min prior to starting PrEP
- Descovy (F/TAF) | eCrCl should be >30 ml/min
- Hepatitis B surface antigen should be documented negative before initiating PrEP
- Both medications are active against Hepatitis B
- If an individual taking HIV PrEP also has chronic active Hepatitis B and suddenly stops PrEP, they could experience a symptomatic acute Hepatitis B flare
- Exhibit caution and educate patients about this dynamic if they have chronic active Hepatitis B
- Urine Pregnancy Test (UPT) for individuals who may become pregnant
- Sexually Transmitted Infection (STI) testing
- Hepatitis C antibody screening for PWID and MSM
Initiation of intramuscular PrEP
- Administration of cabotegravir 600mg via one 3mL intramuscular injection in the gluteal muscle
- Can consider trial of cabotegravir 30mg daily for four weeks prior to initiation of IM injections if patients are anxious about side effects
- Initiation of cabotegravir requires a second dose four weeks after the first dose (one month follow up visit) and every eight weeks after with HIV testing at visits
- Schedule is initial administration (month 0), one month after initiation (month one), then every eight weeks afterwards (month three, five, seven, etc.)
- Follow-up visit one month after initial injection should include second dose and HIV Ag/Ab test and HIV-1 RNA assay with subsequent two-month intervals
- The following laboratory tests are NOT indicated before starting CAB injection or for monitoring patients during its use:
- Creatinine or eCrCl
- hepatitis B serology
- lipid panels
- liver function tests
Medication choices and dosing
- The two current choices for oral PrEP are F/TDF 200/300 (Truvada) and F/TAF 200/25 (Descovy)
- Only F/TDF (Truvada) is FDA-approved for cis women engaging in vaginal sex
- Both are FDA-approved for men who have sex with men and transgender women
- Both are fixed-dose, daily tablets that can be taken with or without food
- Prescriptions can be written either as thirty days with two refills or as a ninety-day course depending on insurance coverage allowance
- Cabotegravir is now FDA-approved, administered at month zero, month one, then every two months (eight weeks) afterwards starting from month three, five, seven, etc.
Ongoing monitoring
The current recommendations for ongoing care for oral PrEP include:
- In-person or telehealth follow up visit every three months
- Prescription refills every three months
- HIV test every three months (typically done as part of refill of prescription on the same timeline and can be administered as at-home testing)
- Renal and hepatic labs every six months
- UPT as indicated
- STI testing as directed by sexual health review done at each follow up visit.
- Assessment of sexual and general health needs
- Review of any new medications and medical updates
Similar recommendations apply to intramuscular PrEP, with timing intervals every two months but would not require renal or hepatic lab results at initiation or during follow-up
Learn More – Primary Sources
PrEP Provider Toolkit
ACHA Guidelines: HIV Pre-Exposure Prophylaxis
Preexposure Prophylaxis for the Prevention of HIV Infection in the United States – 2017 Update
Commercial Support
This educational activity is supported by an independent educational grant from Gilead Sciences
Faculty Disclosures
Dr. Shuter has no relevant financial relationships to disclose
Dr. Felsen has no relevant financial relationships to disclose
Dr. Bernardo has no relevant financial relationships to disclose
Special Thanks
Special thanks to David Malebranche, MD, MPH and Ariel Watriss, MSN, NP for their insights and contribution.
The PrEP Guidelines Center
Review the latest recommendations with
Jonathan Shuter, MD, a Professor of Medicine in the Division of Infectious Diseases at Montefiore Medical Center and the Albert Einstein College of Medicine
Uriel Felsen, MD, an Associate Professor of Medicine in the Division of Infectious Diseases at Montefiore Medical Center and the Albert Einstein College of Medicine
Raffaele M. Bernardo, DO, an Assistant Professor of Medicine in the Division of Infectious Diseases at Montefiore Medical Center and the Albert Einstein College of Medicine
SUMMARY:
The Centers for Disease Control and Prevention (CDC) makes recommendations for the use of PrEP as biomedical HIV prevention. Based on a systematic review of the literature, these evidence-based guidelines offer a practical approach to identifying patients who would be appropriate candidates for PrEP, ordering relevant tests and laboratory procedures, and how to conduct initial and follow-up visits for patients. Given the evolving nature of PrEP research, these recommendations will be revised and updated for clinical practice on a regular basis. This section will also review other supportive guidelines and statements from ACOG and USPSTF
General Guidelines for PrEP
Safety and Efficacy
PrEP, when used as indicated, has been determined to be safe and effective in the prevention of HIV transmission among diverse populations and should be a consideration to anyone who is sexually active, including:
- Men who have sex with men and transgender women: 92% to 100% reduction in HIV transmission in clinical trials and real-world analysis
- Heterosexual women and men – 63% to 93% reduction in HIV transmission
- Persons who Inject Drugs (PWID) – 73.5% reduction in HIV transmission
- Adolescents who weigh over 35kg – over 95% reduction in HIV transmission
Eligibility
The United States Prevention Services Task Force (USPSTF) recommends offering PrEP with effective antiretroviral therapy to persons at high risk of HIV acquisition
- FDA approved oral formulation is one pill taken once a day or intramuscular injection is once very eight weeks
- Either F/TDF 200/300mg (Truvada) or F/TAF 200/25 (Descovy) are currently approved for oral use and cabotegravir is approved for intramuscular use
- Insurance must provide medication coverage for preventive services with Grade A recommendation
CDC Guidelines for Screening Eligibility
- The CDC recommends that providers should
Inform all sexually active adults and adolescents that PrEP can protect them from getting HIV
Note: We caution against seeing patients as levels of “risk,” particularly when it comes to sexual health | What it involves is taking a good sexual history and documenting what behavioral choices they make, then offering PrEP as an option for HIV prevention
- PrEP is for people without HIV who could be exposed to HIV from sex or injection drug use
- CDC recommends the following should be assessed for PrEP including
- Sexually active gay and bisexual men without HIV
- Sexually active heterosexual men and women without HIV
- Sexually active transgender persons without HIV
- Persons without HIV who inject drugs
- Persons who have been prescribed non-occupational post-exposure prophylaxis (PEP) and report behaviors that could expose them to HIV, or who have used multiple courses of PEP
- For sexually active adults and adolescents
- Anal or vaginal sex in the past six months and
- HIV-positive sexual partner (especially if partner has unknown or detectable viral load) or
- Recent bacterial STI or
- History of inconsistent or no condom use with sexual partner(s)
- For persons who inject drugs
- HIV-positive injecting partner or
- Shares drug preparation or injection equipment
- All persons eligible for PrEP
- Documented negative HIV test result before prescribing PrEP and
- No signs/symptoms of acute HIV infection and
- Normal renal function and
- No contraindicated medications
Note: While the CDC compartmentalizes “risk groups” as listed above, clinicians should remember that sexual health does not fit neatly into static compartments | Sexuality and sexual behavior are fluid, and individuals may change their partners, behavior, and condom use over time and situations
Other Considerations
Follow-up
- Patients taking PrEP can be followed closely by medical staff who are both clinical and non-clinical to assure proper usage and safety
- Current recommended follow-up every three months for oral PrEP or every two months for intramuscular PrEP
- Use of in-person and telemedicine visits
- Specific laboratory testing is indicated upon initial visit and subsequent follow-up
Women’s Health
The American College of Obstetricians and Gynecologists (ACOG) recommends providers working with women at risk of HIV transmission be aware and up to date on this preventative health tool and encourage strong adherence as key to its effectiveness
Future Directions
- Future delivery systems of PrEP are in various stages of clinical development and research and will likely become available as options in the future:
- Long acting injectables – now FDA approved!
- Implants
- Long-acting oral agents
- Patches
Learn More – Primary Sources:
CDC Guidelines Pre-Exposure Prophylaxis
National Clinician Consulting Center: PrEP: Pre-Exposure Prophylaxis
National Institute of Health (NIH): Pre-Exposure Prophylaxis (PrEP)
World Health Organization (WHO) compendium of PrEP publications
ACOG: Preexposure Prophylaxis for the Prevention of Human Immunodeficiency Virus
Commercial Support
This educational activity is supported by an independent educational grant from Gilead Sciences
Faculty Disclosures
Dr. Shuter has no relevant financial relationships to disclose
Dr. Felsen has no relevant financial relationships to disclose
Dr. Bernardo has no relevant financial relationships to disclose
Special Thanks
Special thanks to David Malebranche, MD, MPH and Ariel Watriss, MSN, NP for their insights and contribution.
Implement and Maintain a PrEP Program in Your Clinic
Review the latest recommendations with
Jonathan Shuter, MD, a Professor of Medicine in the Division of Infectious Diseases at Montefiore Medical Center and the Albert Einstein College of Medicine
Uriel Felsen, MD, an Associate Professor of Medicine in the Division of Infectious Diseases at Montefiore Medical Center and the Albert Einstein College of Medicine
Raffaele M. Bernardo, DO, an Assistant Professor of Medicine in the Division of Infectious Diseases at Montefiore Medical Center and the Albert Einstein College of Medicine
SUMMARY:
Pre-exposure prophylaxis (PrEP) should be viewed as a sexual health program that our patients can utilize. It involves integration of targeting sexual history-taking, comprehensive behavioral evaluations, and a discussion of a patient’s approach to achieving sexual pleasure while also incorporating HIV prevention options tailored to their needs
KEY POINTS:
- PrEP is a highly effective prevention tool that can reduce HIV transmission among our patients
- PrEP is a service that can be folded into a clinical practice similar to other specialized services
- Successful PrEP delivery requires passion, planning, and utilization of innovative delivery systems
- PrEP is an HIV prevention option that can be used by anyone who is sexually active
PrEP is a program, not a pill
PrEP Regimens
- Currently there are two daily oral PrEP regimens that patients can access and an intramuscular regimen every eight weeks
- F/TDF 200mg/300mg orally daily (Truvada)
- F/TAF 200mg/25mg orally daily (Descovy)
- Cabotegravir 600mg IM every eight weeks after initiation phase of administration at week zero and week four
- Promotes overall sexual health
- Monitors and screens actively for sexual transmitted infections (STIs)
- Serves as a gateway to normalizing routine health care
- Will soon involve other delivery systems beyond pills and injections
PrEP as a collaborative effort
- Involvement with local community-based organizations to create programs
- Continued involvement with community to evaluate and improve services
- Provision of other social programs can help assist in healthcare access
Innovative models
PrEP has been FDA-approved as an HIV prevention option since 2012
Traditional Models
- Traditional models for PrEP evaluation and distribution were primarily clinic-based
- over time these models have evolved to include approaches that provide more ways in which patients can access this sexual health option
Telemedicine
- Telemedicine: While telehealth models for PrEP were being explored earlier, the onset of the COVID-19 pandemic accelerated the use of telemedicine for PrEP services
- As an option for in person visits
- As a bridge between in person visits
- Coupled with at home HIV and STI testing
- Used to access “PrEP mentors” who provide expert guidance
Pharmacy-Based
- Pharmacy-based: Given the demand to see more patients placed on primary care providers in outpatient clinics, there may not be enough time for them to conduct a thorough sexual history and PrEP evaluation. PrEP programs that are pharmacist-led have been shown to be effective, as pharmacists are uniquely poised to bring a level of expertise that many clinicians may not have:
- Experienced guidance on medications, side effects, and drug interactions
- Familiarity with navigating the red tape PrEP with varied insurance plans
- Familiarity with patient assistance programs for patients who are uninsured or underinsured
Multi-disciplinary and other models
- Multidisciplinary models
- Community-led and maintained
- Peer-navigators facilitate linkage to care and continued engagement
- Nurse-led programs
Ongoing monitoring
See our post on Initial Visit, Dosing, and Follow-up for initiation of PrEP
The current recommendations for ongoing care once oral PrEP has been initiated include:
- In-person or telehealth follow up visit every three months
- Prescription refills every three months
- HIV test every three months (typically done as part of refill of prescription on the same timeline and can be administered as at-home testing)
- Renal and hepatic labs every six months
- UPT as indicated
- STI testing as directed by sexual health review done at each follow up visit.
- Assessment of sexual and general health needs
- Review of any new medications and medical updates
The current recommendations for ongoing care once IM PrEP has been initiated include all the above at two-month intervals except renal and hepatic lab monitoring
Practical Tip
While there is no “how-to” manual about starting and maintaining a PrEP program, there are some things you should consider when establishing one at your workplace:
- Personnel
- Recruit staff who are passionate and interested in doing sexual health & PrEP work
- Some of the routine follow ups and other visits do not have to be conducted by a medical provider
- You can have medical assistants and peer navigators involved as much as they would like
- Timing
- consider either integrating PrEP visits as part of everyday sessions OR make special clinic days or sessions devoted to seeing patients interested in PrEP
- You can always start small and ramp up available hours of service if needed
- Pharmacy
- Get pharmacy staff involved from the beginning throughout the process if you have a pharmacy on site
- Skilled pharmacists can help to navigate patients through patient assistance programs and copay cards as well as insurance coverage for generic versus brand name PrEP
- If you don’t have a pharmacy on-site, identify a local pharmacy who handles HIV and PrEP often to make the process easier for patients
Note: Mail-order delivery is a must-have option for many patients
- Optimize Electronic Medical Records
- Create “smart sets” for PrEP visits, both initial and follow-up
- This can help providers walk patients through appropriate history, physical exam details, and appropriate lab orders
- Telehealth is an essential aspect of many PrEP programs that allows for quick “check-ins” and other follow-up
- Ensures that patients have enough refills for PrEP
- Can identify what testing is necessary if they cannot make a visit in person
- Marketing
- Make sure your clinic’s website, waiting area, and exam rooms include information about PrEP services you offer will help ease some of the stigma patients may feel about asking about PrEP themselves
Learn More – Primary Sources:
Funding Resources
- National Institute of Health (NIH)
- Ending the HIV Epidemic (EHE)
- Center for Disease Control and Prevention (CDC)
- National Alliance of State and Territorial AIDS Directors (NASTAD)
Primary Sources
Commercial Support
This educational activity is supported by an independent educational grant from Gilead Sciences
Faculty Disclosures
Dr. Shuter has no relevant financial relationships to disclose
Dr. Felsen has no relevant financial relationships to disclose
Dr. Bernardo has no relevant financial relationships to disclose
Special Thanks
Special thanks to David Malebranche, MD, MPH and Ariel Watriss, MSN, NP for their insights and contribution.
Downloadable Infographics
For Healthcare Professionals | For Your Patients
Feel free to download and use these infographics
For Healthcare Professionals
Infographics for Your Patients
Take Control of Your Sexual Health
This information was prepared for you by
Jonathan Shuter, MD, a Professor of Medicine in the Division of Infectious Diseases at Montefiore Medical Center and the Albert Einstein College of Medicine
Uriel Felsen, MD, an Associate Professor of Medicine in the Division of Infectious Diseases at Montefiore Medical Center and the Albert Einstein College of Medicine
Raffaele M. Bernardo, DO, an Assistant Professor of Medicine in the Division of Infectious Diseases at Montefiore Medical Center and the Albert Einstein College of Medicine
SUMMARY:
Who you have sex with and what kind of sex you have are your choices. Some things, like who else your partner or partners have sex with, are out of your control but can affect you. The group of infections that can be passed through sex have been called many different names: venereal diseases or VDs, sexually transmitted diseases or STDs, and sexually transmitted infections or STIs. On this site, we will call them STDs.
How You Can Take Control of your Sexual Health
- It’s possible to have sex with someone and not know they have an STD or HIV, but there are tools available that can help you take control of your sexual health
- When you take PrEP, you take control of your risk for HIV
- You choose your health care team
- You choose your PrEP medicine
- By checking in with your healthcare professional, you can make sure that
- PrEP is a good option and safe for you
- You check, treat, and control your risk for other STDs
- Making the decision to take control of your sexual health is powerful | Your sexual health is just as important as other parts of your health
- Some additional things you can discuss with your healthcare professional include
- Eating healthier
- Exercising more
- If you smoke, talk to your health care team about quitting
- If you use alcohol or other drugs, talk to your health care team about getting help to cut down or quit
- If you have depression, anxiety, or other mental health issues, work with your healthcare team so you can get the help that you need
- Vaccines can prevent serious infections, and new vaccine information comes out every year | Make sure with your health care team that you get all the vaccines that are right for you
- Remember that heart disease is the #1 killer in the US | Keeping your heart healthy can add years to your life
- If you have high blood pressure, work with your health care team to get it under control
- If you have diabetes, work with your health care team to manage your sugar
- If you have high cholesterol, work with your health care team to bring it down
Remember, you are driving this train. Do everything that you can to make sure that the ride is smooth, the journey is enjoyable, and that you reach your destination safely and in good health
Learn More – Primary Sources
There are many good websites with information people interested in learning more about PrEP. Here are a few:
CDC: PrEP (Pre-exposure Prophylaxis)
New York State Department of Health
PleasePrEPMe (California State)
CDC: PrEP Is for Women (cdc.gov)
Commercial Support
This educational activity is supported by an independent educational grant from Gilead Sciences
Faculty Disclosures
Dr. Shuter has no relevant financial relationships to disclose
Dr. Felsen has no relevant financial relationships to disclose
Dr. Bernardo has no relevant financial relationships to disclose
Women’s Health (PrEP to Protect You and Your Baby)
This information was prepared for you by
Jonathan Shuter, MD, a Professor of Medicine in the Division of Infectious Diseases at Montefiore Medical Center and the Albert Einstein College of Medicine
Uriel Felsen, MD, an Associate Professor of Medicine in the Division of Infectious Diseases at Montefiore Medical Center and the Albert Einstein College of Medicine
Raffaele M. Bernardo, DO, an Assistant Professor of Medicine in the Division of Infectious Diseases at Montefiore Medical Center and the Albert Einstein College of Medicine.
SUMMARY:
If you are thinking about getting pregnant, are pregnant, or have a baby, you are probably thinking a lot about both your health and the health of the baby. If you are trying to get pregnant and your partner is living with HIV, it is VERY important that you speak to your health care team about ways to lower the chance of HIV transmission. The group of infections that can be passed through sex have been called many different names: venereal diseases or VDs, sexually transmitted diseases or STDs, and sexually transmitted infections or STIs. On this site, we will call them STDs. In addition to HIV, other STDs, like herpes and syphilis, can also be dangerous for the baby. It is important that you speak with your health care team about controlling your risk for STDs and treating any you may have before, during, and after your pregnancy
What is PrEP?
- PrEP stands for Pre-Exposure Prophylaxis
- “Pre-exposure” means having medicine in your system even before you have sex
- “Prophylaxis” means the medicine prevents you from getting HIV even if your partner has it
What’s Changed?
- Until 2012
- The only ways to avoid getting HIV from sex were
- To not have sex
- Never have sex with someone with HIV
- Use condoms properly every single time
- And still … way too many people still got HIV from sex
- The only ways to avoid getting HIV from sex were
- Today, there are more ways to reduce your risk of HIV
- Newer medications for people with HIV that really work
- If your partner has HIV, make sure your partner takes HIV meds and has an undetectable HIV viral load | “Undetectable” means that the HIV virus cannot be found in the person’s blood
- Someone who STAYS undetectable by taking meds the right way can’t give anyone else the virus through sex
- Take PrEP to protect yourself if you don’t have HIV
- Newer medications for people with HIV that really work
More on PrEP
- When PrEP medicine is taken correctly it provides safe and excellent protection against HIV
- IF YOU DON’T TAKE IT, IT CAN’T WORK
- In most states, you cannot get PrEP without a physician prescription | In certain states, pharmacists may provide PrEP to people without a doctor’s prescription
What You Need to Know About PrEP Medications During Pregnancy
TDF/FTC (pills)
- TDF/FTC is one pill that contains 2 medicines and is also known as
- Truvada
- Tenofovir disoproxil fumarate/emtricitabine
- Takes about a week to build up to protective levels in your system, except in the vagina where it can take three weeks
- TDF has been used as a medicine for HIV since 2001 and FTC since 2004
- These meds have been around for a long time
- Use of TDF/FTC in pregnancy
- Many pregnant women have used TDF/FTC, both women living with HIV and women on PrEP
- It is considered safe for both mom and baby
- Less is known about TDF/FTC if you’re breastfeeding (more below)
Cabotegravir (injection)
- Cabotegravir injection is also known as
- Apretude
- CAB-LA
- Has been used in the US as a medicine for HIV since January 2021
- Cabotegravir use in pregnancy
- Has been used by very few pregnant and breastfeeding women
- There is no sign yet of any significant risk, but it is too early to say anything about its safety with confidence
Note: TAF/FTC is another combination pill that is effective at preventing HIV but has not been approved as a PrEP medication for vaginal sex, so TDF/FTC and cabotegravir are the only medicines for use in people who are or are trying to get pregnant
If You are Already on PrEP Medication During the Time You are Trying to Get Pregnant
TDF/FTC
- Continue it unless you, together with your health care team, decide that the chance of HIV transmission from your partner(s) is extremely low, such as
- If you stop having sex during pregnancy
- If your partner is HIV negative (and both you and your partner have no other partners)
- If your partner is living with HIV, takes meds consistently and correctly, and has kept an undetectable viral load
Note: Remember that it will take up to three weeks to be safely back on PrEP again if you decide to restart it
Cabotegravir
- Discuss with your health care team whether to
- Continue
- Stop
- Switch to TDF/FTC
Breastfeeding
- TDF/FTC
- Appears to be safe for mom and baby if you are breastfeeding
- However, there is not enough experience to know for sure
- Cabotegravir
- Almost nothing is known about cabotegravir and breastfeeding since this is a newer medication
Note: If you are thinking about taking PrEP and breastfeeding, you should discuss this with your health care team, including your baby’s pediatrician
Learn More – Primary Sources
There are many good websites with information people interested in learning more about PrEP. Here are a few:
CDC: PrEP Is for Women (cdc.gov)
CDC: PrEP (Pre-exposure Prophylaxis)
International Association of Providers of AIDS Care (iapac.org): Pre-Exposure Prophylaxis (PrEP)
New York State Department of Health
PleasePrEPMe (California State)
Commercial Support
This educational activity is supported by an independent educational grant from Gilead Sciences
Faculty Disclosures
Dr. Shuter has no relevant financial relationships to disclose
Dr. Felsen has no relevant financial relationships to disclose
Dr. Bernardo has no relevant financial relationships to disclose
Why PrEP?
This information was prepared for you by
Jonathan Shuter, MD, a Professor of Medicine in the Division of Infectious Diseases at Montefiore Medical Center and the Albert Einstein College of Medicine
Uriel Felsen, MD, an Associate Professor of Medicine in the Division of Infectious Diseases at Montefiore Medical Center and the Albert Einstein College of Medicine
Raffaele M. Bernardo, DO, an Assistant Professor of Medicine in the Division of Infectious Diseases at Montefiore Medical Center and the Albert Einstein College of Medicine
SUMMARY:
PrEP is one of the most effective ways for you to lower your chance of getting HIV infection. It can be used in combination with other methods including condoms, making sure any sexual partners living with HIV are taking their meds the right way and staying undetectable, and not sharing needles or injection equipment if you inject drugs. PrEP can work for everyone regardless of biological sex, gender identity, or sexual orientation and can also reduce the chance of HIV transmitted through injection drug use. PrEP puts YOU in control of your sexual health.
What is PrEP?
- PrEP stands for Pre-Exposure Prophylaxis
- “Pre-exposure” means having medicine in your system even before you have sex
- “Prophylaxis” means the medicine prevents you from getting HIV even if your partner has it
- There are different PrEP options to choose from (read more about these medications by tapping the ‘More About PrEP Meds’ entry’ at the top of this entry)
TDF/FTC (pills)
- TDF/FTC is one pill that contains two medicines and is also known as
- Truvada
- Tenofovir disoproxil fumarate/emtricitabine
TAF/FTC (pills)
- TAF/FTC, similar to TDC/FTC, is one pill that contains two medicines and is also known as
- Descovy
- Tenofovir alafenamide/emtricitabine
Cabotegravir (injection)
- Cabotegravir injection is also known as
- Apretude
- CAB-LA
PrEP Works
- Many studies done across the globe have proven that when PrEP is taken correctly and consistently it is HIGHLY effective in preventing HIV infection
- When PrEP doesn’t work, it is usually because people miss too many doses of the medicine or don’t take it at all
PrEP is Safe
- Most people who take PrEP don’t have side effects
- When side effects do happen, they are usually mild and often go away after a few weeks of taking PrEP
Other Considerations:
- By law, almost all health insurances in the US must cover the costs of PrEP including
- Medicine
- Doctor visits
- Blood tests
- HIV testing
- STD testing
- PrEP can adapt to what’s happening in your life since your risk for HIV can change
- It’s a good idea to talk to your health care team about stopping PrEP before making that decision
- If things change again, you can restart
- PrEP does not protect against other STDs like gonorrhea, chlamydia, or syphilis
- Condoms are very good at preventing these infections when used correctly
NOTE: You have to be on most PrEP medicines for at least one week before you can be sure that they’re working, and for at least three weeks if you are a cisgender woman or transgender man who has vaginal sex | You will also need an HIV test before restarting
Learn More – Primary Sources
There are many good websites with information people interested in learning more about PrEP. Here are a few:
JAMA: Preventing HIV With PrEP
CDC: PrEP (Pre-exposure Prophylaxis)
International Association of Providers of AIDS Care (iapac.org): Pre-Exposure Prophylaxis (PrEP)
New York State Department of Health
PleasePrEPMe (California State)
CDC: PrEP Is for Women (cdc.gov)
Commercial Support
This educational activity is supported by an independent educational grant from Gilead Sciences
Faculty Disclosures
Dr. Shuter has no relevant financial relationships to disclose
Dr. Felsen has no relevant financial relationships to disclose
Dr. Bernardo has no relevant financial relationships to disclose
More About PrEP Meds
This information was prepared for you by
Jonathan Shuter, MD, a Professor of Medicine in the Division of Infectious Diseases at Montefiore Medical Center and the Albert Einstein College of Medicine
Uriel Felsen, MD, an Associate Professor of Medicine in the Division of Infectious Diseases at Montefiore Medical Center and the Albert Einstein College of Medicine
Raffaele M. Bernardo, DO, an Assistant Professor of Medicine in the Division of Infectious Diseases at Montefiore Medical Center and the Albert Einstein College of Medicine.
SUMMARY:
There are three PrEP Meds Available in the US. Two types you can take in a pill form by mouth and one type is a needle injection. All three can reduce your risk of HIV if taken according to instructions. Below, we review these medications that can help keep you safe and healthy.
TDF/FTC
- TDF/FTC is one pill that contains two medicines and is also known as
- Truvada
- Tenofovir disoproxil fumarate/emtricitabine
- Takes about a week to build up to protective levels in your system, except in the vagina where it can take three weeks
- TDF has been used as a medicine for HIV since 2001 and FTC since 2004
- These meds have been around for a long time
- The combination of these two medications, TDF/FTC, has been used in the US for PrEP since 2012
- Generic TDF/FTC has been used in the US since 2020
- This means that the pill can look different based on which company makes it
- Generic TDF/FTC is just as effective as “brand-name” Truvada
- When and how to take TDF/FTC
- It is a tablet that you take once a day, every day, if there’s a chance you could get HIV from your partner(s)
- You can take it with or without food
Side Effects
- TDC/FTC has very few side effects | In fact, most people will have no significant side effects
- Stomach
- Sometimes TDC/FTC can upset your stomach
- Unless it is making you very sick, this side effect usually passes after two to four weeks if you stay on the medicine
- Kidney (also known as renal)
- Side effects are very rare
- Your healthcare professional will want to do a blood test every six to twelve months to check your kidneys
- If there is a kidney problem on TDF/FTC, it usually gets better after stopping the medicine
- Thinning of bones
- Side effects are very rare but can also occur
- TDC/FTC does not usually cause pain
- Taking calcium and vitamin D pills may help to avoid bone side effects
TAF/FTC
- TAF/FTC, similar to TDC/FTC, is one pill that contains two medicines and is also known as
- Descovy
- Tenofovir alafenamide/emtricitabine
- Takes about a week to build up to protective levels in your system
- TAF has been used as a medicine for HIV since 2015 and FTC since 2004
- These meds have been around for a long time
- TAF/FTC has been used in the US for PrEP since 2019
- TAF/FTC is ONLY approved for use by
- Cisgender men
- Transgender women
- It is not known whether it works in cisgender women since its ability to prevent HIV in the vagina is uncertain
- When and how to take TAF/FTC
- Taken the same way as TDF/FTC
- One pill once per day, if there’s a chance you could get HIV from your partner(s)
- You can take it with or without food
Side Effects
- TAF/FTC has very few side effects | In fact, most people will have no significant side effects
- Stomach
- Sometimes it can upset your stomach
- Unless it is making you very sick, this side effect usually passes after two to four weeks if you stay on the medicine
- Kidney and bone effects
- TAF/FTC probably has fewer kidney and bone side effects than TDF/FTC
- Your healthcare professional will want to do a blood test every six to twelve months to check your kidneys
- Taking calcium and vitamin D pills may help to avoid bone side effects
Note: You don’t have to take PrEP pills at exactly the same time every day | It’s more important that if you’re taking oral PrEP you make sure to get it in your system every day
Cabotegravir
- Cabotegravir injection is also known as
- Apretude
- CAB-LA
- Cabotegravir has been used in the US as a medicine for HIV since January 2021
- In December 2021, cabotegravir was approved for PrEP as a long-acting injection every two months
- The protection that you get from cabotegravir every two months is at least as good as taking TDF/FTC or TAF/FTC every day
- One of the best things about cabotegravir is that you get the injection every two months, and you don’t have to worry about taking pills
- If you decide to take cabotegravir PrEP
- You will have to see your healthcare professional every two months for the injection
- If you’re worried you might miss an injection, you should speak to your healthcare professional
- To start cabotegravir PrEP
- You either have to get an injection every month for the first two months or
- You can take cabotegravir pills every day for a month before switching to an injection every two months
- It is not known how long you have to wait after your first injection until you are protected
- It would make sense to wait seven days as is done for the other types of PrEP
- If you are switching from TDF/FTC or TAF/FTC to cabotegravir, you do not have to wait
- The cabotegravir injections must be given in the buttocks
Side Effects
- In general, cabotegravir is considered safe
- The only common side effect is pain or swelling where you get the injection
- This usually happens less and less as you stay on the drug
- You can take over the counter pain relievers (like Tylenol) and/or use heating pads to relieve the pain
- It is rare for people to stop cabotegravir because of the pain
Other Things You Should Know
- What if you don’t want to take a pill every day?
- Depending on how frequently someone is at risk for HIV, taking a pill every day may not be the best option
- People with less frequent risk who have decided to take TDF/FTC may talk to their provider about the possibility of “on-demand” or “2-1-1” PrEP instead of taking a pill every day
- This is an option that has only been recommended for men who have sex with men, and you should discuss it with your provider if you don’t want to take a pill every day
- Switching from one PrEP drug to another
- If you want to switch from one PrEP medicine to another, it can probably be done safely, but it is something that you should discuss with your healthcare professional to make sure it is done safely and correctly
- Stopping and restarting PrEP
- You might consider stopping PrEP if you are no longer at risk for HIV
- Remember that once PrEP is stopped, you will no longer have protective levels of the medication in your system
- If you stop PrEP, you will need an HIV test first to make sure it is negative before you can restart
Learn More – Primary Sources
There are many good websites with information people interested in learning more about PrEP. Here are a few:
CDC: PrEP (Pre-exposure Prophylaxis)
International Association of Providers of AIDS Care (iapac.org): Pre-Exposure Prophylaxis (PrEP)
New York State Department of Health
PleasePrEPMe (California State)
Commercial Support
This educational activity is supported by an independent educational grant from Gilead Sciences
Faculty Disclosures
Dr. Shuter has no relevant financial relationships to disclose
Dr. Felsen has no relevant financial relationships to disclose
Dr. Bernardo has no relevant financial relationships to disclose
Staying Healthy with PrEP: What to Expect at Your Visit
This information was prepared for you by
Jonathan Shuter, MD, a Professor of Medicine in the Division of Infectious Diseases at Montefiore Medical Center and the Albert Einstein College of Medicine
Uriel Felsen, MD, an Associate Professor of Medicine in the Division of Infectious Diseases at Montefiore Medical Center and the Albert Einstein College of Medicine
Raffaele M. Bernardo, DO, an Assistant Professor of Medicine in the Division of Infectious Diseases at Montefiore Medical Center and the Albert Einstein College of Medicine
SUMMARY:
What is PrEP?
- PrEP stands for Pre-Exposure Prophylaxis
- “Pre-exposure” means having medicine in your system even before you have sex
- “Prophylaxis” means the medicine prevents you from getting HIV even if your partner has it
What’s Changed?
- Until 2012
- The only ways to avoid getting HIV from sex were
- To not have sex
- Never have sex with someone with HIV
- Use condoms properly every single time
- And still … way too many people still got HIV from sex
- The only ways to avoid getting HIV from sex were
- Today, there are more ways to reduce your risk of HIV
- Newer medications for people with HIV that really work
- If your partner has HIV, make sure your partner takes HIV meds and has an undetectable HIV viral load | “Undetectable” means that the HIV virus cannot be found in the person’s blood
- Someone who STAYS undetectable by taking meds the right way can’t give anyone else the virus through sex
- Take PrEP to protect yourself if you don’t have HIV
- Newer medications for people with HIV that really work
More on PrEP
- When PrEP medicine is taken correctly it provides safe and excellent protection against HIV
- IF YOU DON’T TAKE IT, IT CAN’T WORK
- In most states, you cannot get PrEP without a physician prescription | In certain states, pharmacists may provide PrEP to people without a doctor’s prescription
WHAT TO EXPECT WHEN YOU GO FOR A VISIT:
The Health Care Team Will Probably Ask You About
- Your sexual history, your sexual preferences, and your sexual risks
- Don’t be embarrassed
- These questions are important to help you and your health care team create an HIV prevention plan that works for you to keep you healthy
- Ask you about your other medical history
- Do a physical examination
- Test your blood for
- HIV test: You can’t take PrEP if you already have HIV
- Kidney test to see how your kidneys are working: Needed before starting some PrEP meds
- Pregnancy test (if you are able to get pregnant). Most PrEP treatments are considered to be safe during pregnancy, but pregnant women should review any medicines that they take with their health care teams.
- Test you for other infections that can be spread through sex
- These infections are also known as Sexually Transmitted Diseases or STDs | They are also sometimes called STIs (Sexually Transmitted Infections)
- The STDs that you will most likely be tested for are syphilis, gonorrhea, and chlamydia
- The tests usually involve swabs from the genital, anal, and oral areas | The syphilis test is a blood test
- Often, patients can collect their own swabs (like Q-tips) from these areas
- Hepatitis B: Tests for liver infection | Some of the PrEP medicines can cause problems in people who have hepatitis B infection (a type of liver infection caused by a virus)
The Healthcare Team Will Probably Discuss the Following with You
- What is PrEP?
- What are your different PrEP choices?
- How to take PrEP correctly
- What are the side effects to look for?
- Serious side effects are very rare!
- Safer sex: What are ways to avoid other STDs
Next Steps Before You Leave
- You will likely get a prescription
- To start PrEP right away or
- Start taking it after your blood tests come back okay
- Until December 2021, PrEP was only available as pills
- There is now another choice – an injection that you take every two months
- Your health care team may discuss with you the choice of pills or injections
- You will get an appointment for a follow-up visit in 1 to 3 months
- As long as you are on PrEP, your health care team will probably need to see you 2 to 4 times a year for a check-up, an HIV test, and STD testing
Learn More – Primary Sources
There are many good websites with information people interested in learning more about PrEP. Here are a few
CDC: PrEP (Pre-exposure Prophylaxis)
New York State Department of Health
PleasePrEPMe (California State)
Commercial Support
This educational activity is supported by an independent educational grant from Gilead Sciences
Faculty Disclosures
Dr. Shuter has no relevant financial relationships to disclose
Dr. Felsen has no relevant financial relationships to disclose
Dr. Bernardo has no relevant financial relationships to disclose
Downloadable Infographics
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