SAHPRA Approves Lenacapavir for HIV-1 Prevention

The South African Health Products Regulatory Authority (SAHPRA) has given the green light to Lenacapavir, a novel antiviral medicine designed for pre-exposure prophylaxis (PrEP) to avert HIV-1 infection. The drug is recommended for adults and adolescents with a minimum weight of 35 kg. This decision follows Gilead's submission of the application in March, which underwent a thorough review through the European Medicines for All Procedure (EU-M4all). The approval is seen as a significant step in accelerating access to essential medicines, with Lenacapavir being administered as a six-monthly injection, initiated with a subcutaneous dose and supported by tablets on days one and two. This treatment is intended for HIV-negative adults and adolescents at risk of infection, with SAHPRA emphasizing the importance of using it in conjunction with safer sex practices, such as condom use, to reduce the risk of other sexually transmitted infections.

Key Takeaways:

• Lenacapavir is a novel antiviral medicine approved by SAHPRA for pre-exposure prophylaxis (PrEP) to prevent HIV-1 infection in adults and adolescents weighing at least 35 kg. It was submitted by Gilead in March and reviewed through the European Medicines for All Procedure (EU-M4all).
• The drug is administered as a six-monthly injection, initiated with a subcutaneous dose, and supported by tablets on days one and two.
• SAHPRA emphasized that Lenacapavir should always be used in conjunction with safer sex practices, such as condom use, to reduce the risk of other sexually transmitted infections.
• Dr Boitumelo Semete-Makokotlela, CEO of SAHPRA, described the approval of Lenacapavir as a "game-changer," highlighting its high efficacy in prevention.
• Minister in the Presidency, Khumbudzo Ntshavheni, welcomed the approval, noting the importance of ensuring uninterrupted HIV prevention services.
• The initial rollout of Lenacapavir is scheduled for March or April 2026, targeting 23 high-incidence districts across six provinces and around 360 high-performing public clinics.
• The programme forms part of broader HIV prevention efforts supported by the US President's Emergency Plan for AIDS Relief (PEPFAR) Bridge Plan, which aims to strengthen HIV service delivery in South Africa.
• SAHPRA emphasized the importance of holistic approaches to HIV prevention, combining pharmaceutical interventions with education and awareness campaigns.

Statistics:

• 35 kg: the minimum weight recommended for using Lenacapavir.
• 6 months: the duration of the injection cycle for Lenacapavir.
• 23: the number of high-incidence districts targeted for the initial rollout of Lenacapavir.
• 6: the number of provinces involved in the initial rollout.
• 360: the number of high-performing public clinics targeted for the initial rollout.
• 2026: the scheduled year for the initial rollout of Lenacapavir.
• High-prevalence rate of HIV in South Africa: a concern emphasized by Dr Boitumelo Semete-Makokotlela.

Sources:

• "SAHPRA gives the go-ahead to Gilead's Lenacapavir for HIV prevention". IOL News