Dar es Salaam. South Africa has become the first African nation to approve the use of an injectable HIV prevention drug, marking a major milestone in the continent’s fight against the virus.
The South African Health Products Regulatory Authority (SAHPRA) has registered the drug Lenacapavir, which the World Health Organisation (WHO) approved on June 19, 2025, after finding it to be 99.9 percent effective in preventing HIV infection. The twice-yearly injection was earlier approved by the US Food and Drug Administration (FDA).
South Africa’s Health minister Dr Aaron Motsoaledi announced that the country will roll out the injection by March 2026, noting that it will help bridge gaps in existing HIV prevention efforts.
SAHPRA said its review of Lenacapavir was conducted in collaboration with the European Medicines Agency (EMA) under the European Medicines for All (EU-M4all) initiative, which fast-tracks access to essential medicines in non-EU countries.
The drug is given as a subcutaneous injection, starting with an initial dose and oral tablets taken on the first and second days. It is intended for adults and adolescents weighing at least 35 kilogrammes who are HIV-negative but at substantial risk of infection.
SAHPRA stressed that Lenacapavir, when used as pre-exposure prophylaxis (PrEP), should be combined with safe sexual practices such as condom use to minimise exposure to other sexually transmitted infections.
“The registration of Lenacapavir is a significant step for a country with one of the highest HIV prevalence rates. This is one of the most advanced prevention options available,” said SAHPRA chief executive Boitumelo Semete-Makokotlela.
Tanzania’s position
According to the Ministry of Health, the introduction of any new medicine in Tanzania must be approved by the National Medicines and Therapeutics Committee.
Chief Government Pharmacist Daudi Msasi explained that pharmaceutical companies may apply for registration once drugs have been cleared by WHO and the Global Fund, paving the way for importation and local distribution.
“Registration is open to any company or individual wishing to market or distribute the drug in Tanzania. Therefore, if any entity seeks to register Lenacapavir, they are free to do so at any time,” said Mr Msasi.
However, he noted that the initial cost remains prohibitive—estimated at Sh75 million per person per year—making large-scale adoption currently unfeasible.
“India is likely to start producing the drug later, which should reduce the price considerably. At the moment, it would not be practical to register a drug that people cannot afford. Those who can purchase it from South Africa may import it with the required documentation,” Mr Msasi added.
South Africa’s rollout
The South African government plans to integrate Lenacapavir into its national health system within two years.
Gilead Sciences, which developed the drug, has partnered with six manufacturers, including one in Egypt, to produce the injection at US$40 (about Sh98,600) per person annually—a dramatic reduction from the original US$28,000 (Sh69 million).
Companies such as Hetero and organisations like The Gates Foundation are also working on generic production, while the government encourages local manufacturing.
South Africa formally registered Lenacapavir on October 21, 2025, under the name Lenacapavir 464mg solution injection – Gilead, completing approval in only 65 days, faster than the Johnson & Johnson COVID-19 vaccine in 2021.
How it works
Lenacapavir acts as a capsid inhibitor, blocking HIV’s outer shell from entering immune cells (CD4) and replicating.
The injection is given twice yearly, accompanied initially by four oral tablets—two on the first day and two on the second—to achieve full protection within three days.
Minor side effects include mild pain, redness, or swelling at the injection site, and small nodules or skin irritation.
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