In a breakthrough event, a new pre-exposure prophylaxis drug, lenacapavir, showed total protection against HIV infection in young women, according to a major clinical trial involving young women in South Africa and Uganda. The trial, called Purpose 1, examined the efficacy of twice-yearly injections of lenacapavir with two daily oral PrEP drugs: Truvada versus Descovy.
According to the physician-scientist Linda-Gail Bekker, principal investigator for the South African part of this study, none of the women who received lenacapavir contracted HIV, thus it is 100%. This was completely contrasted with 16 out of 1 068 who had been taking Truvada and 39 out of the 2 136 on Descovy.
Lenacapavir is a fusion capsid inhibitor that disrupts the HIV capsid, a protein shell protecting the genetic material of the virus. As noted above, it is a next-generation medicine, dosed once every six months as an injection, clearly not like any everyday pill.
“This breakthrough gives great hope that we have a proven, highly effective prevention tool to protect people from HIV,” Bekker said. The results are impactful in their own right, particularly for young women in eastern and southern Africa, who bear a large share of the world’s new HIV infections. To date, daily PrEP regimens have been very hard to sustain in the face of a raft of social and structural barriers. A biannual injection may dramatically lighten the burden, improving both adherence and protection.
Such promising results mean the Purpose 1 trial will now continue into an “open label” phase. A sibling trial called Purpose 2 is currently underway, which aims at cisgender men, transgender and nonbinary people who have sex with men in diverse geography including some sites in Africa.
Gilead Sciences will submit the results of the trial to the regulators in Uganda and South Africa, as well as to the World Health Organization, within the next few months. Plans are underway to add lenacapavir in WHO and national guidelines to allow access to, and the affordability of this, for people at large, particularly via licensing agreements with generic manufacturers.
This points to a breakthrough in reducing the global infection rate of HIV. On the other hand, the tests for young people remain a challenge for continuous use despite the availability of different prevention tools. Biannual injection of Lenacapavir, simplification in prevention, increased access, and reduced new infections above all, in vulnerable populations.
This places lenacapavir at the forefront in a world working towards attaining the UNAIDS target set of less than 500,000 new infections by 2025 and the ultimate goal to end AIDS by 2030.