Rings and Injectable Things: Moving from Options to Choices for HIV Prevention in Cisgender Women
Speakers: Drs Sinead Delany-Moretlwe and Kenneth Ngure
Moderators: Danielle Campbell and Breanne Lesnar
Wednesday 23 February 2022
Kenneth Ngure opened Margarita/Breakfast Community Club Session #4 with 105 community participants. Kenneth presented the results of MTN-034/REACH, an open-label study designed to fill important gaps in information about the safety and acceptability of the monthly dapivirine vaginal ring and Truvada as daily oral pre-exposure prophylaxis (PrEP) by adolescent girls and young African women (AGYW), who account for most new HIV acquisitions in Sub-Saharan Africa. The ring and oral PrEP must be used consistently to prevent HIV – for the ring, a full month at a time, and daily for oral PrEP– which previous studies of these products found to be especially challenging for adolescents and younger women.
REACH enrolled 247 HIV-negative AGYW aged 16-21 from South Africa, Zimbabwe, and Uganda. For the first six months, participants were randomised to use the monthly ring or daily oral PrEP. Then they switched to the other product for six more months. The important point is that participants were given a choice of ring, oral PrEP, or neither in the third 6-month period. This is the first time in a biomedical HIV prevention study where a choice is given in this way.
Of the 92% who continued in the choice period, 67% chose the ring, 31% oral PrEP, and 2% chose neither product. High adherence to oral PrEP in the crossover period was strongly associated with choice of oral PrEP, while the same association was not observed for the ring. Adherence was much higher than has ever been reported in similar clinical trials.
The main lesson learnt from this study is that AGYW can make informed choices about HIV prevention products and can use products effectively with proper support. More broadly, people need options and adhere better if they can follow their preferences.
Sined Delany-Moretlwe presented on HPTN 084, a study conducted to evaluate the safety and efficacy of the injectable agent cabotegravir (CAB-LA) compared to daily oral Truvada (TDF/FTC) for pre-exposure prophylaxis (PrEP) in HIV-uninfected women.
The blinded arm of the study, originally intended to continue through 2022, was suspended in 2020 with data showing superiority for long-acting CAB compared to the oral dosing. Additionally, unprecedentedly assessed data on pregnancy and breastfeeding have been presented during CROI, showing that safety and drug concentration reported slightly low grade adversity (very few adverse events) that were not related to the study product.
Residual CAB-LA in women who stopped CAB was well tolerated and did not result in a risk. Continuous dosing during pregnancy was offered as an option. Ongoing studies will examine the safety and pharmacology of CAB-LA in women who choose to continue CAB-LA through pregnancy. Overall, the safety data provided a lot of reassurance, but more studies on pregnancy and breastfeeding are needed to come to solid conclusions. Likewise, further research would be needed to evaluate the impact of CAB-LA on the long term and on drug-drug interaction between contraceptives and CAB. Meanwhile, data on CAB-LA are being reviewed by regulators and recommendations are being prepared particularly for its use in contexts such as the sub-Sharan African region. The question of what testing strategy should be used (including viral load testing) remains central, especially in relation to the proper implementation of long-acting PrEP.
The main takeaways from this session are that expanding the pipeline for prevention is pivotal if we want to ensure that women are offered as many options as needed, both systemic and topic, and that research must provide more evidence relevant to the value of investing in dapivirine vaginal rings. A general community disappointment emerged in relation to the fact that, due to its low efficacy shown in previous trials and the harmful narrative on women not being able to adhere, the dapivirine ring is not considered in the U.S. market and in other regions, Europe included. More advocacy efforts should therefore be channelled towards increasing resources and access to rings, while refocusing the narrative around the options, choices, needs and desires of women.
Resources
Click here to watch the recording of the session!
More about the MBCs: https://www.eatg.org/events/margarita-breakfast-clubs-at-croi-2022/
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