Pakistan is exploring the possibility of producing a new HIV prevention injection locally as global health agencies and local pharmaceutical manufacturers assess options to expand access to the long-acting medicine lenacapavir.
Officials from the Joint United Nations Programme on HIV/AIDS (UNAIDS) in Pakistan say discussions are underway with domestic drug makers and other stakeholders to examine the feasibility of manufacturing the medication in the country, which could improve availability as HIV infections continue to rise among key populations.
A UNAIDS official said the agency is helping facilitate consultations with Pakistani pharmaceutical companies to map out potential pathways for local production and broader access to the medicine in the future.
Lenacapavir is a long-acting antiretroviral drug used for pre-exposure prophylaxis (PrEP), a preventive treatment given to people who are HIV-negative but at higher risk of infection. Unlike conventional PrEP tablets that must be taken daily, the drug is administered as an injection once every six months.
Public health specialists say the extended dosing schedule could address one of the biggest challenges in HIV prevention programmes — maintaining consistent daily medication adherence.
Global attention on lenacapavir
The drug has attracted global attention after World Health Organization Director-General Dr. Tedros Adhanom Ghebreyesus highlighted its potential during a media briefing on March 5.
He described lenacapavir as a major advance in HIV prevention, noting that while it is not a vaccine, clinical trial results show very high effectiveness when administered on the recommended six-month schedule.
WHO issued guidance on the medicine’s use last year and later granted it prequalification status, a step designed to make procurement easier for international donors supporting HIV programmes in low- and middle-income countries.
Regulatory process yet to begin in Pakistan
Industry sources in Pakistan say several local manufacturers are considering developing generic versions of lenacapavir, although progress will depend on regulatory approvals and licensing arrangements.
Officials at the Drug Regulatory Authority of Pakistan (DRAP) said the medicine has not yet entered the country’s approval pipeline. A senior DRAP official confirmed that the regulator has not received any application to register lenacapavir or a generic equivalent.
Any future application would be evaluated through the standard regulatory process to assess safety, quality and effectiveness before approval, the official said.
Challenges in Pakistan’s HIV response
Health experts say long-acting prevention options such as lenacapavir could strengthen HIV prevention efforts, particularly for people who find it difficult to maintain daily medication schedules.
However, specialists caution that the injection alone will not address all drivers of HIV transmission in Pakistan.
A significant portion of infections in the country has been linked to unsafe medical practices, including the reuse of contaminated syringes, unsafe intravenous drips and transfusions involving unscreened blood. Such practices have contributed to outbreaks in recent years, including cases affecting children.
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Globally, AIDS-related deaths have declined significantly over the past two decades due to expanded access to treatment. The same class of antiretroviral medicines is increasingly being used for prevention among people at higher risk of infection.
Public health specialists say that if access to long-acting prevention tools expands through procurement, licensing or local manufacturing, they could become an important addition to HIV prevention strategies in Pakistan and other countries.
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