The Nigerian government has commenced the rollout of a new long-acting HIV prevention injection, Lenacapavir, but says pregnant women will not use it due to insufficient safety data.
The rollout, which will begin in eight states – Anambra, Ebonyi, Gombe, Kwara, Akwa Ibom, Cross River, Benue, and the Federal Capital Territory (FCT)- is part of efforts to expand access to innovative HIV prevention options.
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The Director-General of the National Agency for the Control of AIDS (NACA), Temitope Ilori, disclosed this on Monday at a media briefing organised by the National HIV, Viral Hepatitis and STDs Control Programme (NASCP) under the Federal Ministry of Health and Social Welfare in Abuja.
Ms Ilori said while global trials suggest the drug is largely safe, there is insufficient evidence to support its use during pregnancy.
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“Even though LenPrEP is considered very safe based on global studies, it is not recommended for pregnant women. It is important to emphasise that this is a preventive intervention, not a treatment,” she said.
She described Lenacapavir as a highly innovative addition to HIV prevention tools but cautioned against overestimating its capabilities, stressing that it does not protect against other infections.
“We must stress that it does not prevent sexually transmitted infections, unwanted pregnancy or other infections like hepatitis. People must continue to take comprehensive precautions,” she said.
Lenacapavir and Nigeria’s HIV burden
Lenacapavir is a long-acting injectable antiretroviral developed by Gilead Sciences for HIV prevention.
It is to be administered once every six months as pre-exposure prophylaxis (PrEP) and offers an alternative to daily oral pills, particularly for individuals who struggle with adherence.
The drug has gained global attention for its potential to simplify HIV prevention, especially among high-risk populations.
However, health experts emphasise that it is not a standalone solution and must be used alongside other preventive measures such as condom use and regular testing.
Nigeria ranks fourth on HIV burdens globally, with an estimated 1.9 million people living with HIV, according to NACA.
While access to antiretroviral therapy has improved in recent years, gaps in prevention persist, particularly among young people and key populations with challenges such as stigma, limited awareness, and inconsistent access to prevention services continue to drive new infections.
Phased rollout
Speaking at the briefing, the Minister of State for Health and Social Welfare, Iziaq Salako, said Nigeria was selected as one of nine early adopter countries by the Global Fund after expressing interest in March 2025 and receiving approval.
Mr Salako noted that the drug rollout, administered twice yearly, marked a significant step toward ending HIV/AIDS as a public health threat by 2030, through strengthened prevention, treatment and care services across the country.
“About 52,000 doses of Lenacapavir have been provided to catalyse its introduction into our arsenal for HIV prevention and control,” he said.
He said the first batch of the drug had already arrived, adding that preparations were ongoing for national launch and facility-level rollout across the selected states.
He emphasised that the drug was not a treatment but a prevention option for HIV-negative individuals at substantial risk of infection.
He added that the government adopted a phased approach to ensure proper monitoring of safety outcomes before nationwide expansion.
He further said the rollout activities would include a national launch, media engagement, and facility-level flag-offs across the selected states as part of implementation efforts.
“The National Pre-Exposure Prophylaxis Implementation Plan 2025 to 2028 would guide scale-up, covering service delivery, supply chain, financing and community engagement,” he said.
Speaking on local production, the minister said the government will, over time, engage manufacturers directly and explore pathways for local production.
He added that discussions around technology transfer and domestic manufacturing would be critical to ensuring long-term sustainability and reducing dependence on external donors.
Complement, not replacement
The National Coordinator of NASCP, Adebobola Bashorun, said programme data and stakeholder collaboration informed the rollout plan.
Mr Bashorun stressed that the drug is not a cure and would only complement existing prevention options, including oral pre-exposure prophylaxis and long-acting injectable cabotegravir, expanding choices for individuals at risk.
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“We already have multiple prevention options. Individuals can still use oral PrEP. National policy guidelines will determine how best to integrate this new option into existing programmes,” he said.
He added that no major adverse events have been recorded so far, with only mild injection-site pain observed as a common side effect.
He cautioned that the availability of the drug should not encourage risky behaviour.
