By Michael Gwarisa
The Medicines Control Authority of Zimbabwe (MCAZ) has announced the expedited approval of Lenacapavir, an innovative long-acting medicine for pre exposure prophylaxis (PrEP) to prevent HIV-1 infection.
The MCAZ Director-General, Mr. Richard T. Rukwata, said “the rapid approval of Lenacapavir reflects the Authority’s dedication to accelerating access to trusted, high-quality health products and brings new hope for HIV prevention while reinforcing its commitment to safeguarding public health.”
Lenacapavir was assessed and approved by the Registration Committee under the expedited review process, as it is considered to be of major public health importance both in Zimbabwe and globally. The application, submitted by Gilead on the 29th of October 2025, underwent a rigorous evaluation and was finalised in twenty-three (23) days, demonstrating the Authority’s commitment to ensuring timely access to essential and life-saving health products.
Lenacapavir is recommended, together with safer sex practices, for PrEP in adults and adolescents weighing at least 35 kg. The product is administered as a six-monthly subcutaneous injection following an initiation phase that includes one injection and oral tablets taken on Days 1 and 2. It is intended for individuals who are HIV-negative and at substantial risk of HIV infection. Lenacapavir must always be used alongside safer sex practices, including condom use and behavioural risk-reduction measures.
The registration of Lenacapavir marks a significant advancement in Zimbabwe’s HIV prevention strategy. By providing a long-acting alternative to daily oral PrEP, the product has the potential to improve adherence and expand prevention options for populations most vulnerable to HIV infection.
