A groundbreaking clinical trial in South Africa and Uganda has revealed that a twice-yearly injection of a new pre-exposure prophylaxis (PrEP) drug, lenacapavir, provides young women with total protection against HIV infection. This discovery represents a significant advance in the fight against HIV, particularly in regions where the virus remains a major public health challenge.
Purpose 1 Trial Overview
The Purpose 1 trial, sponsored by Gilead Sciences, tested the efficacy of lenacapavir alongside two other PrEP drugs, Truvada (F/TDF) and Descovy (F/TAF), which are taken as daily pills. Conducted across three sites in Uganda and 25 sites in South Africa, the trial included 5,000 participants, all young women between the ages of 16 and 25, who are among the most vulnerable to new HIV infections.
Lenacapavir, administered as an injection once every six months, is a fusion capsid inhibitor that interferes with the HIV capsid, a protein shell essential for the virus’s replication. The trial aimed to determine whether lenacapavir provided better protection than the existing daily PrEP options and to assess the safety and effectiveness of the newer daily pill, Descovy.
Remarkable Results
The trial’s findings were striking: none of the 2,134 women who received lenacapavir contracted HIV, demonstrating 100% efficacy. In contrast, 16 of the 1,068 women (1.5%) on Truvada and 39 of the 2,136 women (1.8%) on Descovy contracted the virus. These results prompted an independent data safety monitoring board to recommend ending the trial’s blinded phase and offering lenacapavir to all participants.
This breakthrough is especially significant for young women in eastern and southern Africa, who face numerous social and structural challenges in maintaining a daily PrEP regimen. An injection every six months could vastly improve adherence and reduce the risk of HIV infection, offering a more practical and less stigmatized prevention method.
Early Reactions and Future Implications
The trial’s results have generated excitement among HIV researchers and advocates. Dr. Jason Zucker, an infectious disease expert at Columbia University, praised the potential of a biannual injection to improve adherence compared to daily pills. Dr. Philip Grant from Stanford University also highlighted the benefit for populations with adherence challenges.
The Purpose 1 trial’s focus on women in sub-Saharan Africa is crucial, given that this region accounts for two-thirds of the global HIV population. With approximately 4,000 new infections among teenage girls and young women in Africa each week, lenacapavir could significantly impact HIV prevention efforts.
Next Steps and Broader Impact
Following the trial’s success, the plan is to continue in an open-label phase where participants can choose their preferred PrEP option. A sister trial, Purpose 2, is also underway to evaluate lenacapavir’s effectiveness among cisgender men, transgender individuals, and non-binary people in various regions, including Africa and the Americas.
The rollout of lenacapavir will depend on regulatory approvals. Gilead Sciences intends to submit the trial results to regulators in Uganda, South Africa, and other countries, as well as to the World Health Organization (WHO). The company also plans to license lenacapavir to generic drug manufacturers to ensure affordability and accessibility in resource-limited settings.
While the cost of lenacapavir is a concern, with its price as HIV treatment in the United States being $42,250 per year, efforts are underway to make it affordable in low- and middle-income countries. Activists and advocacy groups are pushing for rapid licensing and generic production to avoid delays similar to those experienced with other PrEP medications.
Final Thoughts
The discovery that a twice-yearly injection of lenacapavir can provide total protection against HIV is a monumental step forward in HIV prevention. This innovative approach could transform how we combat the HIV epidemic, particularly in high-incidence regions, and bring us closer to achieving global targets for reducing new infections and ultimately ending AIDS by 2030.
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