Lenacapavir Approval Fast-Tracked in South Africa for HIV Prevention

• Lenacapavir, a twice-yearly HIV prevention drug, is being fast-tracked for registration in South Africa, potentially revolutionizing the fight against new infections.
• Clinical trials have demonstrated lenacapavir's high effectiveness, with up to 100% protection against HIV in certain groups, marking it as a promising preventative measure.
• South African regulatory authorities are expediting the approval process, leveraging international programs to reduce review times from years to months.
• The drug's long-acting formulation enhances adherence to treatment, but its cost-effectiveness is under review to ensure affordability for the South African healthcare system.

South Africa is expediting the registration of lenacapavir, a novel HIV-prevention drug administered just twice a year, potentially transforming the nation's approach to curbing new infections. Lenacapavir has demonstrated remarkable effectiveness in clinical trials, offering up to 100% protection against HIV among certain high-risk groups.

Regulatory Acceleration

The South African Health Products Regulatory Authority (Sahpra) is in discussions to accelerate the approval process for lenacapavir, which is already in advanced regulatory stages in the U.S. and Europe. Sahpra intends to utilize the European Union’s Medicines for All (EU-M4all) program to expedite the review, potentially shrinking the approval timeline from years to months. This accelerated review is crucial, as delays due to staffing shortages have previously hampered the availability of essential treatments.

Advantages of Lenacapavir

Lenacapavir stands out due to its long-acting formulation, which significantly improves adherence to treatment regimens. The twice-yearly administration offers a practical advantage, making it easier for individuals to maintain consistent protection against HIV. The World Health Organisation suggests that long-acting injections like lenacapavir could substantially reduce new HIV infections due to their ease of use.

Cost-Effectiveness Review

Before lenacapavir can be widely distributed, the National Essential Medicines List Committee (NEMLC) must assess its safety and efficacy data and determine a cost-effective price point for South Africa. The Health Department can only procure medicines recommended by the NEMLC for inclusion on the country’s essential medicines list. Khadija Jamaloodien from the Health Department noted that the NEMLC has initiated its review of lenacapavir.

Broader Impact on HIV Prevention

While South Africa has made significant strides in reducing new HIV infections since 2010, the nation remains behind on the United Nations' goal to decrease new infections by 90% by 2030. The introduction of lenacapavir, with its potential to enhance prevention efforts, represents a crucial step toward achieving this target. The hope is that this fast-tracked regulatory approach will not only provide quicker access to cutting-edge drugs but also make them more affordable for the healthcare system.