Africa-Press – Zimbabwe. THE Medicines Control Authority of Zimbabwe (MCAZ), the country’s medicine regulator, has approved a revolutionary six-monthly HIV prevention injection, Lenacapavir, as it accelerates its pace in the fight against HIV and Aids.
MCAZ fast-tracked the innovative pre-exposure prophylaxis (PrEP) for adults and adolescents. MCAZ director-general Richard Rukwata said the approval process, which took 23 days, demonstrated Zimbabwe’s commitment to ensuring timely access to essential, life-saving health products for its citizens.
Zimbabwe was selected as one of the 10 countries globally to roll out Lenacapavir, which is described as one of the most promising new HIV prevention tools that have emerged, offering protection against the virus with twice-yearly injections.
The ground-breaking intervention by the US President’s Emergency Plan for Aids Relief through an initiative by the Global Fund to Fight Aids, TB and Malaria, is expected to provide Lenacapavir to up to two million people in countries with high burdens of HIV across the world.
The drug has already been rolled out in Eswatini and Zambia, with US officials indicating that Zimbabwe could leverage on its considerable experience with oral PrEP.
Rukwata said the application from Gilead was submitted on October 29 and was finalised in 23 days by the MCAZ registration committee under an expedited review process, as Lenacapavir is considered to be of major public health importance.
“Lenacapavir is recommended for adults and adolescents weighing at least 35kg who are HIV-negative and at substantial risk of HIV infection,” he said in a statement.
“It must always be used alongside safer sex practices, including condom use and behavioural risk-reduction measures. 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.”
He said the registration of Lenacapavir marks a significant advancement in Zimbabwe’s HIV prevention strategy.
“By providing a long-acting alternative to daily oral PrEP, this product has the potential to improve adherence and expand prevention options for populations most vulnerable to HIV infection,” Rukwata said.
“We conducted a comprehensive assessment of the product’s safety, efficacy and quality. Our authority applied a regulatory reliance approach, drawing on scientific assessments from the World Health Organisation pre-qualification programme to support an efficient and robust review process. The milestone brings new hope for HIV prevention and reinforces our commitment to safeguarding public health.
Health experts and activists hailed the approval, calling for an expedited distribution of the drug while making sure that it is affordable.
Community Working Group on Health executive director Itai Rusike called for public awareness campaigns to close the information gap.
“The general population should be made aware of this wonder drug to make informed choices. This could serve us quite well if put to good use, that is, within a comprehensive continuum of care,” he said.
“The domestic health financing landscape requires a full revitalisation and redesign to address issues of sustainability in HIV and Aids programming.
“The over-reliance on external partners is risky and unsustainable as donors can withdraw financial support anytime, should their interests shift for some reason or another.”
Medical practitioner Johannes Marisa echoed the same sentiment, adding that Zimbabweans were waiting to witness the drug’s affordability and availability.
He said there was, however, a need to have some form of domestic funding for the cause.
“It is possible to have earmarked taxes for this measure, similar to such taxes as the sugar tax that is supposed to be used to finance cancer treatment,” he said.
Zimbabwe HIV and Aids Union president Stanley Takaona applauded MCAZ for quickly checking on the safety, efficiency and quality of the medicine.
“We have to take prevention as a treatment as a country and it is not sugar-coated; it has to be seen on the ground, how much we are doing in terms of prevention.
“So with this new medicine, with this new PrEP coming in, as a consumer, as an activist, I feel the key issue is on affordability, accessibility to the vulnerable.”
Takaona called on authorities to ensure accessibility of the medicine, including providing information to Zimbabweans.
The approval of Lenacapavir comes on the back of Zimbabwe having made strides in the fight against HIV and Aids. The country has surpassed the UNAids 95-95-95 targets for adults. This means that 95% of people with HIV know their status, 95% of those diagnosed are on antiretroviral treatment (ART) and 95% of those on ART have a suppressed viral load.
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