HIV pharma leaders are in Kigali, Rwanda for IAS 2025, touting their latest advancements in HIV and PrEP development on the heels of the landmark Yeztugo approval.
The HIV space saw a historic moment last month with the approval of Gilead’s Yeztugo, a long-acting preventive injectable for HIV.
Yeztugo isn’t the first long-acting pre-exposure prophylactic option—ViiV Healthcare’s Apretude also provides prolonged protection—but Gilead’s option only needs to be dosed twice a year, giving patients a more convenient option. Analysts and global health authorities have lauded the approval, with Mizuho at the time saying that Yeztugo “has the potential to ‘redefine’ the PrEP market.”
The annual meeting of the International AIDS Society (IAS) is riding these tailwinds. The conference, currently being held in Kigali, Rwanda, is headlined by pharmas with some of the biggest developments in the field presenting the latest developments in their pipelines.
BioSpace looks at some of the most interesting presentations here.
Gilead Broadens Evidence Base for Yeztugo in Pregnancy and Young People
On Thursday, Gilead will present additional data from its Phase III PURPOSE program for Yeztugo, showing that the drug was “efficacious and well tolerated” when used in different vulnerable patient populations.
In the PURPOSE 1 study, which enrolled cisgender women and adolescent girls across sub-Saharan Africa , none of the 184 pregnant and lactating women treated with Yeztugo contracted HIV, according to a press announcement on Monday. The twice-yearly PrEP injection was also safe in these women, with no notable differences in adverse events compared with non-pregnant women. Infant exposure through breastfeeding was also “minimal,” according to Gilead.
Meanwhile, data from PURPOSE 1 and PURPOSE 2—which together encompass a geographically and gender diverse population—showed that Yeztugo maintained its efficacy in young people aged 16 through 25 years. In this age group, only two cases of HIV were detected after Yeztugo treatment. Gilead did not say the size of the patient population in these trials.
Gilead also presented modeling data which suggest that Yeztugo, when given at a slightly altered dosing regimen, can retain its efficacy in patients with tuberculosis, who often take other medications that can otherwise interfere with PrEP’s overall activity.
Yeztugo is currently only approved in the U.S., but Gilead is working on securing regulatory clearances around the world, including South Africa. The pharma last week signed an agreement with the Global Fund to provide the HIV prophylactic to low- and middle-income countries at the same time as in high-income countries.
A spokesperson at the time declined to disclose specific pricing details for Yeztugo under the Global Fund partnership, but told BioSpace that it will provide the product to the program at no profit to Gilead.
ViiV Finds Patients ‘Happy’ to Switch to Apretude from Daily Oral PrEP
ViiV unveiled data from the PILLAR and EBONI implementation trials showing that the use of Apretude, a long acting PrEP given every other month, is both acceptable and feasible for patients across different demographic groups, including transgender men, Black women and men who have sex with men (MSM). Apretude was the first injectable long acting HIV PrEP, approved in the US in 2021. Viiv is a joint venture between GSK, Pfizer and Shionogi that is focued on HIV care.
EBONI, which focused on Black cis- and transgender women, found Apretude to be “highly appropriate” and “feasible” for the prevention of HIV in this population, as per Monday’s release. PILLAR, meanwhile, enrolled MSM and transgender men, among whom 95% reported being “happy” with switching from oral PrEP medications to Apretude.
ViiV additionally presented data from several real-world studies, showing that the combination of cabotegravir and rilpivirine—marketed as the injectable drug Cabenuva in the U.S.—not only sustains viral suppression in patients but also improves their overall experience.
For instance, results in the Phase IIIb VOLITION study showed that 89% of patients with HIV who had reached viral suppression chose to switch to Cabenuva from oral daily pills. Largely, patients opted for Cabenuva so they wouldn’t have to worry about missing a dose and so they wouldn’t have to bring their medication all the time. Cabenuva can be dosed monthly or every two months, according to its label.
Meanwhile, results from the two-year prospective observational study BEYOND found that of 308 patients who decided to switch to Cabenuva, 97% were able to maintain viral suppression at 24 months.
Merck Pushes Monthly PrEP Pill to Phase III
Merck announced on Monday that it will launch the Phase III EXPrESSIVE program to study MK-8527, a once-monthly and orally available nucleoside reverse transcriptase translocation inhibitor to prevent HIV infection.
The program will include EXPrESSIVE-11, which will test the PrEP candidate in more than 8,500 high-risk participants across 16 countries. That trial is set to start enrolling in August. Meanwhile, the EXPrESSIVE-10 study will focus on women and adolescents in sub-Saharan Africa and is set to start recruiting “in the next few months,” as per Monday’s release.
Phase II data for MK-8527, which will be presented at IAS 2025 on Wednesday, is supporting the advancement of the drug into late-stage development, according to Merck, with encouraging pharmacokinetic and safety findings. 350 people with low risk of HIV-1 exposure participated in the mid-stage study.
The EXPrESSIVE program represents Merck’s comeback in the late-stage PrEP arena after discontinuing the prophylaxis program for oral islatravir in September 2022, after safety concerns led the company to suspend dosing in a Phase II study in November 2021. Like MK-8527, the pharma was proposing islatravir as a once-monthly oral option to prevent HIV infection.
However, Merck continued to assess islatravir as a therapeutic option for patients with HIV in combination with another HIV drug called doravirine. The FDA last week accepted a new drug application for this combo regimen for adults with virologically suppressed HIV-1.
