Sunday Mail Reporter
ZIMBABWE has approved the use of Lenacapavir, the long-acting injectable medicine used as a pre-exposure prophylaxis (PrEP), in a major step towards enhancing HIV prevention.
The Medicines Control Authority of Zimbabwe (MCAZ) announced on Saturday that the ground-breaking drug, which is administered only twice a year, was cleared after an expedited 23-day review, highlighting its importance to public health.
MCAZ said Lenacapavir, submitted by Gilead on October 29, was assessed under its fast-track process because of its potential to significantly reduce new HIV infections by offering an alternative to daily oral PrEP, which some users struggle to adhere to.
Lenacapavir is approved for adults and adolescents weighing at least 35 kilogrammes who are HIV-negative and at substantial risk of infection.
It is given as a six-monthly subcutaneous injection after an initial phase consisting of one injection and oral tablets taken on days one and two.
The authority said the medicine must be used alongside safer sex practices, including condom use and behavioural risk-reduction measures.
MCAZ director-general Mr Richard Rukwata said the rapid approval demonstrated the authority’s commitment to expanding access to life-saving tools in the fight against HIV.
“The rapid approval of Lenacapavir reflects MCAZ’s dedication to accelerating access to trusted, high-quality health products,” he said.
“This milestone brings new hope for HIV prevention and reinforces our commitment to safeguarding public health.”




