ZAMRA approves new injectable HIV prevention drug

THE Zambia Medicines Regulatory Authority (ZAMRA) has approved an injectable antiretroviral (ARV) for HIV prevention known as Lenacapavir (LEN).

Speaking during the announcement in Lusaka, Minister of Health Elijah Muchima said the approval of Lenacapavir reaffirms Government’s commitment to ending HIV as a public health threat by 2030 through the introduction of innovative and highly effective prevention technologies.

Dr Muchima said Lenacapavir is administered once every six months and provides protection from HIV infection for the same duration.

He said the development builds upon the earlier introduction of another long-acting injectable ARV, Cabotegravir (CAB), which was launched in February this year.

The minister commended ZAMRA for the efficient and timely regulatory approval, saying it demonstrates Zambia’s readiness to fast-track safe, high-impact medical products without compromising quality or safety standards.

He said within six weeks, Zambia successfully registered the product, making it the second country in Africa, after South Africa, to do so.

Dr Muchima said the introduction of Lenacapavir has significant implications for HIV prevention in Zambia, which continues to record about 30,000 new infections annually, particularly among adolescent girls and young women.

“The availability of this drug gives hope to those who struggle to take daily or two-monthly HIV prevention doses, pregnant and breastfeeding mothers at risk of infection, and men who prefer to access prevention privately,” he said

The minister directed the Ministry’s HIV programme and the National AIDS Council to develop innovative delivery models that extend services beyond traditional health facilities.

He called for the use of community structures, adolescent-friendly centres and the private sector to ensure easy access to Lenacapavir.

Dr Muchima said Lenacapavir will be provided free of charge to all eligible Zambians and warned that no one should pay to access the drug.

He further acknowledged the technical and financial support from the Global Fund to Fight AIDS, the United States Government, UNITAID, UNAIDS, the World Health Organisation (WHO), the Clinton Health Access Initiative (CHAI) and various civil society organisations for their continued partnership with Government in strengthening the national HIV response.

Dr Muchima said Zambia continues to demonstrate strong leadership in the global HIV response under President Hakainde Hichilema’s administration.

“We are not waiting to follow, we are leading,” he said, adding that Government will work with urgency to ensure that Lenacapavir reaches all who need it most, leaving no one behind.

This is according to a statement issued by Ministry of Health principal public relations officer Georgia Chimombo.

(Mwebantu, Saturday, 8th November, 2025)