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PURPOSE 1, a Phase 3, double-blind, randomized study, is evaluating the safety and efficacy of twice-yearly, subcutaneous lenacapavir for pre-exposure prophylaxis (PrEP) and once-daily oral Descovy® (emtricitabine 200mg and tenofovir alafenamide 25mg; F/TAF) in more than 5,300 cisgender women and adolescent girls aged 16-25 across 25 sites in South Africa and three sites in Uganda. The drugs are being tested in parallel, with one group receiving twice-yearly lenacapavir and one group taking once-daily oral Descovy. Additionally, a third group was assigned once-daily oral Truvada. Study participants were randomized in a 2:2:1 ratio to lenacapavir, Descovy and Truvada, respectively. Because effective PrEP options already exist, there is broad consensus in the PrEP field that a placebo group would be unethical; thus, the trial used bHIV as the primary comparator and Truvada as a secondary comparator.
There were 0 incident cases of HIV infection among 2,134 women in the lenacapavir group (incidence 0.00 per 100 person-years). There were 16 incident cases among 1,068 women in the Truvada group (incidence 1.69 per 100 person-years). The results demonstrated superiority of twice-yearly lenacapavir over bHIV (primary endpoint, incidence 2.41 per 100 person-years) and superiority of twice-yearly lenacapavir over once-daily Truvada (secondary endpoint), with p<0.0001 for both endpoints. In the trial, lenacapavir was generally well-tolerated and no significant or new safety concerns were identified.
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Gilead expects results in late 2024/early 2025 from the program’s other pivotal trial, PURPOSE 2, which is assessing twice-yearly lenacapavir for PrEP among cisgender men who have sex with men, transgender men, transgender women and gender non-binary individuals who have sex with partners assigned male at birth in Argentina, Brazil, Mexico, Peru, South Africa, Thailand and the United States.
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This is a legitimately amazing result and a huge win against HIV. I hope it replicates in PURPOSE 2. Zero incident cases in an at-risk population is, frankly, fantastic, in a country where prevalence of HIV ranges from 12-27% depending on the province.
I read that as cisgendered && (women || adolescent girls) && (16 <= age <= 25). Basically 'cisgendered' and the age range are describing all study participants which which are all either women or adolescent girls which makes sense to me based on how I believe these trials are generally constructed.
Very often "women" and "men" in medicine refers to adults, i.e., 18+.
Likewise, we use the term "girl's/boy's" tennis in high school but "women's/men's tennis" in college because most people in high school are under 18 even though they are "women" and "men" in many relevant senses.
The term matters to the study, because they were interested in a comparable group of women. I don't expect HRT is realistically available in that area, so they're just reporting that they didn't need to deal with that complication.
This prevalence is true in the US (and most Western countries I think, though not as certain), is definitely not true in Sub-Saharan Africa (where 75% of the world's HIV+ population lives). Women and girls are more likely to have it in Sub-Saharan Africa. See https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10126805/ estimates that over 60% of all new infections in SSA are in women. Parts of that region the HIV+ prevalence rate is above 5%. That is why they are focused on testing that population in that region, they are the most at risk.
For the existing HIV-preventing medications we have, such as PrEP, the treatments are much more effective in men than women. It can easily take a month for PrEP to be effective in Assigned Female At Birth folks, but I saw studies during the COVID era that a few days were plenty for Assigned Male At Birth folks. There's some logic to focusing on the cohort that usually has the lowest success rate with these kinds of medication.
The difference in efficacy has to do with the way the body is designed to absorb fluids, and its one of the few areas where hormones and surgery don't make a difference. (A trans guy on HRT with a full set of surgeries generally has male chances of cardiovascular issues, male levels of calorie consumption/muscle-building, etc.)
I see, so you're saying that "cisgender female" means Female As Identified at Birth, but includes both trans and not trans groups regardless? Thus, "cisgender female" includes both homosexuals and non-homosexuals (and non-binary etc), but actually some from this group may presently identify as male? I did not know this.
A bit simpler: cisgender means same/matching gender, basically the opposite of trans-gender. If the gender you identify as is the one matching your birth sex default, you're cisgender.
But it's completely separate from your attraction to other people, so straight, gay, anything is fine in either category.
" PURPOSE 1, a Phase 3, double-blind, randomized study, is evaluating the safety and efficacy of twice-yearly, subcutaneous lenacapavir for pre-exposure prophylaxis (PrEP) and once-daily oral Descovy® (emtricitabine 200mg and tenofovir alafenamide 25mg; F/TAF) in more than 5,300 cisgender women and adolescent girls aged 16-25 across 25 sites in South Africa and three sites in Uganda. The drugs are being tested in parallel, with one group receiving twice-yearly lenacapavir and one group taking once-daily oral Descovy. Additionally, a third group was assigned once-daily oral Truvada. Study participants were randomized in a 2:2:1 ratio to lenacapavir, Descovy and Truvada, respectively. Because effective PrEP options already exist, there is broad consensus in the PrEP field that a placebo group would be unethical; thus, the trial used bHIV as the primary comparator and Truvada as a secondary comparator.
There were 0 incident cases of HIV infection among 2,134 women in the lenacapavir group (incidence 0.00 per 100 person-years). There were 16 incident cases among 1,068 women in the Truvada group (incidence 1.69 per 100 person-years). The results demonstrated superiority of twice-yearly lenacapavir over bHIV (primary endpoint, incidence 2.41 per 100 person-years) and superiority of twice-yearly lenacapavir over once-daily Truvada (secondary endpoint), with p<0.0001 for both endpoints. In the trial, lenacapavir was generally well-tolerated and no significant or new safety concerns were identified.
[...]
Gilead expects results in late 2024/early 2025 from the program’s other pivotal trial, PURPOSE 2, which is assessing twice-yearly lenacapavir for PrEP among cisgender men who have sex with men, transgender men, transgender women and gender non-binary individuals who have sex with partners assigned male at birth in Argentina, Brazil, Mexico, Peru, South Africa, Thailand and the United States. "