The Gilead Women’s PrEP Study will enroll about 5,000 participants — only adolescent girls and young women at high risk of HIV infection. It will take place in Uganda and South Africa.
After a successful trial that gave the world a long-term injectable antiretroviral (ARV), Cabotegravir, Uganda is set for another study on another injectable that can last six months. Cabotegravir was found to confer a reduced risk of contracting HIV by 89% for two months.
The new clinical trial will evaluate the safety and efficacy of an ARV known as Lenacapavir and an oral daily pill, Descovy, as pre-exposure prophylaxis (PrEP) products. PrEP is what you take when you are not sick to prevent the sickness. An HIV PrEP can offer some protection from HIV.
These products, Lenacapavir and Descovy, will be compared to Truvada, which is already in use as PrEP in many African countries, including in Uganda, for preventing HIV infection.
The Gilead Women's PrEP Study will enroll about 5,000 participants — only adolescent girls and young women at high risk of HIV infection. It will take place in Uganda and South Africa.
In Uganda, the study will be led by Dr. Flavia Matovu Kiweewa of the Makerere University-Johns Hopkins University (MU-JHU) Research Collaboration.
According to the doctor, it will be conducted at the sites in Kalangala, Masaka, Mubende, Mityana, Lwamata, Hoima, and Kapeeka.
Alex Kintu, a member of the Gilead research team, said the primary objective is to see whether Lenacapavir and Descovy can protect adolescent girls and young women from acquiring HIV.
"We would like for the studies to be conducted in regions with a high background of HIV incidence so that we know that the drugs we will be assessing can work for HIV prevention," said Kintu.
The US Food and Drug Administration approved Descovy as a second option for PrEP in men who have sex with men and transgender women following findings from the DISCOVER trial in the US, Canada, and western Europe. The results were released in 2019.
Moupali Das, the executive director of PrEP clinical development at Gilead Sciences, said they are conducting this study specifically on African women, who have the highest burden of HIV.
The study will be only for adolescent girls and young women aged 16-18 years, who are at high risk of HIV infection.
"Studies have shown that girls in this age group have a high HIV incidence. Prevention of HIV in these adolescent girls may have a significant impact on life course and trajectory," said Kintu.
Unlike other studies, study participants who become pregnant and those who are breastfeeding will be allowed to continue after providing informed consent.
"We will be evaluating two new options of prevention at the same time — the long-acting injectable Lenacapavir and a smaller pill, Descovy, for PrEP, compared to Truvada for PrEP," said Das.
Ruth Owori, an HIV-positive adolescent, said this is a good development.
"I look at this as an opportunity for us to cut down on the levels of HIV transmission. One of the reasons people are not suppressing the virus is because they are not adhering, but this will be addressed by this single injection," she said.
Participants in a closed-in virtual meeting, held on November 12, agreed that the long-acting injection, given twice a year as PrEP, will be convenient.
The meeting was attended by key stakeholders, such as the health ministry, the National Drug Authority, and the Uganda National Council for Science and Technology. Others were from the Institutional Review Boards, scientists, PrEP implementing partners, and civil society participants.
Philippa Musoke, an associate professor at the department of child health at Makerere University, said the long-acting PrEP is important for women at risk.
"Truvada is effective, but we do not know if women take it. The idea of trying to take a pill a day is hard, so, I think the long-acting PrEP is so important for women. The longer, the better," said Musoke, who is also the principal researcher at MUJHU, said.
The current oral PrEP, a pill, has had challenges, including low uptake due to stigma and poor access due to long distances. Women find it difficult to continuously go to health facilities and also forget to swallow the daily pill.
Dr. Herbert Kadama, the chairperson of the PrEP Technical Working Group at the health ministry, said women would embrace PrEP if the issues around poor access and uptake are solved.
"Using a long-acting injection for six months will solve some of the barriers of adherence to PrEP," she said.
Joshua Musinguzi, the head of the AIDS Control Programme at the health ministry, said every intervention is welcome.
"Whereas we have a wide range of interventions that we are implementing to address HIV, we continue to experience significant deaths. We think we need to expand PrEP. This is a game-changer of sorts on how we can approach PrEP. Longer-acting technologies will move us a long way and help us in programming and impacting our intervention," Musinguzi said.
A young lady at the virtual meeting, who said was HIV-negative, said PrEP kept her negative in the three-and-a-half years she has been married to her HIV-positive husband.
"Our relationship is more interesting and stronger. PrEP has enabled us to have an HIV-negative baby, who is now three years old. That would not have been possible with condoms," she said.
Matt Birnholz, MDPeer