Prime
Injectable HIV drug trial returns promising results
What you need to know:
- Lenacapavir, which is administered twice yearly, was subjected to a phase three trial in which 5,300 girls and young women aged 16-25 in Uganda and South Africa participated.
A new drug for HIV prevention has revived hope in the fight against rising infections after it gave total protection to young women and adolescent girls who participated in a clinical trial.
The injectable drug, Lenacapavir, which is administered twice yearly, was subjected to a phase three trial in which 5,300 girls and young women aged 16-25 across three sites in Uganda and 25 sites in South Africa participated.
The oral drug, which is currently approved for HIV prevention (Pre-Exposure Prophylaxis --PrEP), is taken daily, with the issue of low adherence reported by researchers as one of the hindrances to its effectiveness in reducing infections.
Dr Flavia Matovu Kiweewa, the director for research at Makerere University – Johns Hopkins University (MU-JHU) Research Collaboration, who is leading the trial in Uganda, said it has been done in Masaka, Kalangala, and Mityana. The other leaders in the trial in Uganda are Dr Godfrey Kigozi, who was in charge of Masaka, and Prof Noah Kiwanuka, who was in charge of Kalangala.
“After more than a decade of working on HIV PrEP trials, it’s extremely fulfilling to get such amazing results from the Purpose1 study,” he said.
“I am overwhelmed! It’s difficult catching any sleep over the past two nights, thinking of how far we have come with the study, the amount of effort by study teams, how well the study has been executed, and what these results mean to HIV prevention field,” Dr Kiweewa added.
Uganda is struggling to attain its goal of ending HIV/Aids as a public health by 2030, according to health experts. More than 50,000 new infections and over 17,000 Aids-related deaths are recorded each year, according to data from the Uganda Aids Commission. Infections remain highest among adolescent girls and young women, according to the Aids Commission.
“This is going to change the approach to HIV pre-exposure prophylaxis worldwide. I am confident that as we continue to promote PrEP uptake and adherence in our setting, long-acting formulations like the six-monthly injection will address most of the challenges currently faced by young women and other populations,” Dr Kiweewa noted.
Optimism
When the trial was launched in Uganda, the Aids Control Programme at the Health ministry and the Uganda Aids Commission (UAC) were optimistic about it.
Dr Nelson Musoba, the UAC director-general, told the Daily Monitor earlier that they are increasing efforts to make sure the injectable HIV prevention drug is “available to the public for general use” because of its importance in the HIV fight.
He explained that the drug is important for people who are in risky professions or if one partner doesn’t have the virus and the one who is infected wants to protect them to remain HIV-negative.
The trial report comes about six months after an HIV vaccine trial in Uganda failed to stop HIV infections among the study participants. Prof Pontiano Kaleebu, the director of the Uganda Virus Research Institute, said scientists are increasing efforts to come up with HIV vaccine as one of the tools for effective control of infections.
Trial
The maker of the new HIV prevention drug, Gilead Sciences, an American-based pharmaceutical company, said in a press statement on their website that PURPOSE 1, a Phase 3, double-blind, is a randomised study, which evaluated the safety and efficacy of a twice-yearly, lenacapavir for pre-exposure prophylaxis (PrEP) and once-daily oral Descovy® (emtricitabine 200mg and tenofovir alafenamide 25mg; F/TAF).
The company also said 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.
“PURPOSE 1 met its key efficacy endpoints of the superiority of twice-yearly lenacapavir to once-daily oral Truvada® (emtricitabine 200mg and tenofovir disoproxil fumarate 300mg; F/TDF) and background HIV incidence (bHIV),” the drug maker said in the statement.
“Based on these results, the independent Data Monitoring Committee (DMC) recommended that Gilead stop the blinded phase of the trial and offer open-label lenacapavir to all participants,” it added.
Community speaks
Ms Lillian Mworeko, the executive director of the International Community of Women living with HIV Eastern Africa (ICWEA) who is one of the advisors in the PURPOSE study, said the study is a big milestone in the HIV fight. She applauded the girls and women who accepted to participate in the study.
“We receive with excitement the ground breaking news of yet another scientific breakthrough in the history of HIV prevention,” she said.
“The twice-yearly injectable drug, Lenacapavir, if approved, will be a significant addition to the prevention toolkit, that complements what is in existence already and therefore underscores the call to action by the African Women Prevention Community Accountability Board (AWPCAB) for more prevention options and choices,” she added.
Ms Mworeko further explained that the demonstration of 100 percent efficacy for Lenacapavir in preventing new HIV infections among women and adolescent girls aged 16-25 from an interim analysis “marks a pivotal moment in our collective fight against HIV infections.”
“Especially for Sub-Saharan Africa, the region that continues to register high new HIV infections among adolescent girls and young women. We call on Gilead to demonstrate its commitment by immediately ensuring access through open-label extension studies. We also call for immediate regulatory approvals by the World Health Organisation, Food and Drug Administration (of United States) and African regulatory authorities,” she added.
