HIV Breakthrough: Twice-Yearly Injection Shows 100% Effectiveness Against Infection

A groundbreaking clinical trial in South Africa and Uganda has revealed that a twice-yearly injection of a new pre-exposure prophylaxis (PrEP) drug provides 100% protection against HIV infection in young women. The trial, sponsored by Gilead Sciences, tested the efficacy of lenacapavir, a fusion capside inhibitor, against two other PrEP drugs, Truvada F/TDF and Descovy F/TAF.

The trial, known as the Purpose 1 trial, involved 5,000 participants aged 16-25 years and was conducted at 25 sites in South Africa and three sites in Uganda. The participants were randomly assigned to one of three arms: a six-monthly injection of lenacapavir, a daily pill of Truvada F/TDF, or a daily pill of Descovy F/TAF. The results showed that none of the 2,134 women who received lenacapavir contracted HIV, while 16 of the 1,068 women who took Truvada F/TDF and 39 of the 2,136 women who received Descovy F/TAF contracted the virus.

Physician-scientist Linda-Gail Bekker, the principal investigator for the South African part of the study, explained that the significance of this breakthrough lies in the fact that it provides a proven, highly effective prevention tool to protect people from HIV. “This gives great hope that we have a proven, highly effective prevention tool to protect people from HIV,” she said.

The trial’s results are significant because they show that a twice-yearly injection of lenacapavir is more effective than daily pills in preventing HIV infection. This is particularly important for young women in eastern and southern Africa, who are disproportionately affected by HIV and often struggle to maintain a daily PrEP regimen due to social and structural barriers.

The trial’s findings have led to the recommendation that the trial’s “blinded” phase be stopped, and all participants be offered a choice of PrEP. The results will now be reviewed by the World Health Organization, and Gilead Sciences will submit the data to country regulators in the coming months.

The company has also announced that it will offer licenses to companies that make generic drugs, which will help to reduce prices and increase access to the drug in the public sector. The goal is to make the drug affordable and available to all who need it.

The breakthrough is a significant step towards achieving the UNAIDS target of fewer than 500,000 new HIV infections globally by 2025 and potentially ending AIDS by 2030. However, PrEP should be used in conjunction with other prevention tools, such as HIV self-testing, condoms, and access to contraception.

The trial will now continue in an “open label” phase, where participants will be told which treatment they received and will be offered the choice of PrEP they prefer. A sister trial, Purpose 2, is also underway, testing the effectiveness of lenacapavir among cisgender men, transgender and nonbinary people who have sex with men.

The results of the trial are a major step forward in the fight against HIV, and it is hoped that the drug will be rolled out soon, providing a new and effective way to prevent HIV infection.

Historical Context:

• The fight against HIV/AIDS has been ongoing for decades, with significant advancements in treatment and prevention methods. In the 1980s, the first antiretroviral therapy (ART) was developed, which has since become the standard treatment for HIV.
• In the 2000s, pre-exposure prophylaxis (PrEP) was introduced as a prevention method, which involves taking a daily pill to prevent HIV infection. Truvada F/TDF and Descovy F/TAF are two of the most commonly used PrEP drugs.
• In recent years, there has been a growing focus on increasing access to PrEP, particularly in low- and middle-income countries where HIV prevalence is high. However, adherence to daily PrEP regimens can be challenging, especially among young women who may face social and structural barriers.
• The UNAIDS target of fewer than 500,000 new HIV infections globally by 2025 and potentially ending AIDS by 2030 has been a driving force for continued research and innovation in HIV prevention and treatment.

Summary in Bullet Points:

• A clinical trial in South Africa and Uganda has shown that a twice-yearly injection of lenacapavir, a fusion capside inhibitor, provides 100% protection against HIV infection in young women.
• The trial, known as the Purpose 1 trial, involved 5,000 participants aged 16-25 years and compared lenacapavir to two other PrEP drugs, Truvada F/TDF and Descovy F/TAF.
• None of the 2,134 women who received lenacapavir contracted HIV, while 16 of the 1,068 women who took Truvada F/TDF and 39 of the 2,136 women who received Descovy F/TAF contracted the virus.
• The results show that a twice-yearly injection of lenacapavir is more effective than daily pills in preventing HIV infection, particularly important for young women in eastern and southern Africa who struggle to maintain a daily PrEP regimen.
• The trial’s findings have led to the recommendation that the trial’s “blinded” phase be stopped, and all participants be offered a choice of PrEP.
• Gilead Sciences will offer licenses to companies that make generic drugs, which will help to reduce prices and increase access to the drug in the public sector.
• The breakthrough is a significant step towards achieving the UNAIDS target of fewer than 500,000 new HIV infections globally by 2025 and potentially ending AIDS by 2030.
• PrEP should be used in conjunction with other prevention tools, such as HIV self-testing, condoms, and access to contraception.
• The trial will continue in an “open label” phase, where participants will be told which treatment they received and will be offered the choice of PrEP they prefer.
• A sister trial, Purpose 2, is also underway, testing the effectiveness of lenacapavir among cisgender men, transgender and nonbinary people who have sex with men.