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Long-Acting Injectable HIV Treatment and Prevention: Key Considerations for Women

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Yvonne Gilleece, MB BCh, BAO

Honorary Clinical Professor in HIV Medicine and Sexual Health
Department of Global Health & HIV
Brighton & Sussex Medical School
Consultant in HIV Medicine and Sexual Health
HIV Department
University Hospitals Sussex NHS Foundation Trust
Brighton, United Kingdom

Yvonne Gilleece, MB BCh, BAO: educational meetings: ViiV; consultant/advisor/speaker: Gilead Sciences, ViiV; conference sponsorship: Gilead Sciences.

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Released: October 13, 2022

The question may arise as to why long-acting injectable (LAI) therapies for the treatment and prevention of HIV are needed given that we have so many different oral daily options already.  Despite the availability of varied oral options, there are still many people with HIV who are not engaged in care, who are in care but not receiving HIV treatment, and who are receiving HIV treatment but still have a detectable viral load. Data from the CDC suggest that only 56% of individuals in HIV care in 2018 had viral suppression. This situation demands more support for adherence and engagement in care, including different HIV treatment paradigms. Because current LAI therapies do not require adherence to a daily oral regimen or keeping medications at home, they have the potential to address long-standing inequities within communities that experience the greatest unmet need for HIV treatment and generally poor access to healthcare. They also offer the opportunity for innovative approaches to reduce stigma and improve quality of life. Different groups and individuals may express varying levels of interest in LAI modalities, so it is important to ensure that individuals from diverse communities and risk groups are educated about the availability of long-acting treatment and prevention. Several challenges that may influence preferences for types of treatment are particularly relevant for women, including gender inequity (social/economic), caregiver roles, pregnancy, self-efficacy, and intimate partner violence. In this commentary, I focus specifically on key LAI therapy considerations for women with or at risk of HIV. 

What Women Want in HIV Prevention and Treatment
In 2022, Irie and colleagues reported results from an assessment of preferences for HIV pre-exposure prophylaxis (PrEP) products in a nationwide sample of 315 Black women in the United States. The data showed that only one third of respondents (32.1%) were aware of PrEP, with 41.6% expressing interest in using it once they were made aware. Interest in use increased to 62.2% if it were provided free of charge. The most preferred option was oral PrEP (51.1%), followed by LAI PrEP (25.7%) and vaginal gel (16.5%), with vaginal ring representing the least preferred option (6.7%). When comparing preferences for oral vs LAI PrEP alone, LAI PrEP was preferred by 37.8% of women. The likelihood of preferring LAI PrEP was increased among respondents who expressed concerns about costs of healthcare or PrEP-related stigma. LAI PrEP was also more likely to be preferred over oral PrEP among respondents who reported inconsistent or no condom use and multiple sexual partners in the past 6 months, key risk factors for HIV acquisition. 

As LAI therapies have been increasing in use for other indications, such as contraception, treatment of several mental health disorders, diabetes management, and opioid use disorder, another study involving in-depth interviews with 89 women (n = 59 with HIV, n = 30 without HIV) across 6 different sites in the United States’ Women’s Interagency HIV study evaluated perceptions of LAI HIV therapies according to experience with other types of injections. Overall, 50% of participants would prefer LAI PrEP and 56% would prefer LAI ART over daily pills. The interviews revealed 4 thematic categories of women:

  1. Had received episodic injections and had few concerns related to LAI therapies
  2. Had received frequent injections and would refuse additional injections
  3. Had history of injection drug use, mixed views; some feared LAI therapies may trigger recurrence, and some had few concerns related to LAI therapies
  4. Currently injecting drugs, had few concerns related to LAI therapies

Interview discussions also revealed participant perceptions of how LAI strategies may improve adherence by freeing them from treatment fatigue associated with taking daily pills, reducing potential stigma, and even improving perception of confidentiality. Frequency of clinic attendance was also raised with women preferring to receive multiple interventions at a single appointment.

Pregnancy Considerations
A major concern for women and transgender men regarding the use of LAI HIV therapies is compatibility with pregnancy. Although there are reassuring data on the safety of rilpivirine in pregnancy, we do not yet have sufficient information on cabotegravir use in pregnancy, either from clinical trials or real-world experience. In addition, there have been concerns regarding the potential for lower rilpivirine concentrations during the second and third trimesters of pregnancy with oral dosing. Pregnancy was an exclusion criterion in the phase II/III trials that evaluated the efficacy and safety of LAI cabotegravir plus rilpivirine for HIV treatment as well as in the phase II/III trials that evaluated LAI cabotegravir for HIV PrEP. Participants who became pregnant discontinued the study drug(s). In the treatment trials and compassionate use program, 26 pregnancies were reported: 21 in women receiving LAI cabotegravir plus rilpivirine and 5 in women with only exposure to oral cabotegravir plus rilpivirine. There were 11 live births (10 with LAI exposure and 1 with oral only exposure) and 15 nonlive births (6 first trimester spontaneous abortions, 1 second trimester spontaneous abortion, 7 elective terminations, and 1 ectopic pregnancy). Among the 11 live births, 1 congenital anomaly (ptosis) was reported in an infant with intrauterine growth restriction. In the HPTN084 prevention study, there were 63 confirmed pregnancies during the blinded study period and through 1 year of unblinded follow-up among women receiving LAI cabotegravir for HIV prevention resulting in 31 live births as of the time of reporting (23 pregnancies ongoing; 10 pregnancies lost). Among the 31 live births, there were no reported congenital abnormalities.   

Limited data for LAI cabotegravir plus rilpivirine are available from the Antiretroviral Pregnancy Registry (www.apregistry.com). Data through January 31, 2022, show that among 3 live births in persons with periconception cabotegravir exposure, there has been 1 unspecified (non–central nervous system, nonneural tube defect, nonencephalocele) defect reported. Therefore, although no safety signal has emerged thus far regarding cabotegravir, pregnancy numbers and outcomes remain very small. Until further data are available, contraception should be established before switching to LAI HIV treatment or initiating LAI HIV PrEP.

In conclusion, LAI therapies have the potential to radically change HIV healthcare delivery and overcome challenges that limit the feasibility of daily oral therapy for some people, including many women. Nonetheless, questions regarding the long-term acceptability and safety of LAI approaches outside the setting of a clinical trial remain unanswered. Candidates for LAI HIV treatment and prevention should be counseled using the available evidence base regarding efficacy and consequences of treatment failure and should also be supported to have their care delivered in a patient-centered manner that minimizes stigma, overcomes individual challenges, and optimizes their HIV treatment experience.

Your Thoughts?
How are you counseling women in your clinical practice on the availability of LAI HIV treatment and PrEP options? What level of interest have they expressed? Join the discussion by posting a comment and sharing your experiences.

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