Tanzania registers Lenacapavir in major boost to HIV prevention and treatment

Chief Government Pharmacist, Mr Daud Msasi, said on February 24, 2026 that the drug has been registered by the Tanzania Medicines and Medical Devices Authority (TMDA) and incorporated into the national HIV treatment guidelines.

“We have adopted it and included it in our national guidelines. We are now engaging stakeholders to ensure reliable access for the targeted beneficiaries,” said Mr Msasi.

He clarified that Lenacapavir is not a vaccine but a long-acting antiretroviral medicine administered subcutaneously. Once injected, it binds to cells and prevents the virus from replicating, remaining active in the body for more than six months.

“This is a unique medicine. A patient receives only two injections per year. It stays in the body for a long period before being cleared, which is why it offers protection for over six months,” he explained.

Lenacapavir was registered in 2025 by the United States Food and Drug Administration (FDA) and has since been recognised in the World Health Organisation (WHO) treatment guidelines.

Unlike conventional HIV medicines that require daily use, Lenacapavir offers a long-acting alternative that could significantly improve adherence to treatment and prevention regimens.

According to Mr Msasi, the drug can be used both as pre-exposure prophylaxis (PrEP) for individuals at high risk of infection and as part of treatment regimens for people living with HIV, depending on clinical guidance.

He noted that its extended duration of action has attracted global attention, as it addresses challenges associated with missed doses and treatment fatigue among patients.

The rollout of Lenacapavir in Tanzania and other African countries is being coordinated in collaboration with international partners, including the Global Fund, PEPFAR and UNAIDS, alongside WHO.

“Tanzania continues to work closely with the Global Fund in combating malaria, tuberculosis and HIV. Lenacapavir is among the new medicines we are integrating into our national strategy,” he said.

Following its registration and inclusion in the national guidelines, the next phase will focus on securing supply and ensuring equitable distribution through partnerships with development stakeholders.

Boost to national targets

The registration comes as Tanzania intensifies efforts to reduce new HIV infections and enhance access to treatment services.

Health experts say long-acting options such as Lenacapavir could improve adherence, reduce stigma linked to daily pill-taking and accelerate progress towards national and global targets to end AIDS by 2030.

The Government has stressed that the new drug complements, rather than replaces, existing preventive measures, including safe practices, testing and early treatment.