Islamabad: Some Pakistani pharmaceutical companies are planning to locally develop generic versions of lenacapavir, a long acting HIV prevention drug described by the World Health Organization as one of the most significant breakthroughs in the fight against HIV in decades because it can prevent almost all infections among people at risk when taken once every six months.
Speaking at a global media briefing on March 5, WHO Director General Dr Tedros Adhanom Ghebreyesus said the newly approved medicine represents the most important development in HIV prevention since the first antiretroviral medicines were introduced nearly four decades ago.
“It is not a vaccine, but it is the next best thing,” Dr Tedros said, noting that clinical trials have shown the drug to be highly effective in preventing HIV infection among people at risk when administered once every six months.
Lenacapavir is a long acting antiretroviral medicine used for pre exposure prophylaxis, or PrEP, which is given to people who are HIV negative but at high risk of infection. Unlike conventional preventive medicines that must be taken daily, lenacapavir is administered as an injection twice a year.
Industry sources say several Pakistani pharmaceutical manufacturers are exploring the possibility of developing generic versions of the medicine once regulatory and licensing pathways become clearer.
However, officials at the Drug Regulatory Authority of Pakistan (DRAP) said the authority has so far not received any application for the registration of lenacapavir or its generic versions.
A senior DRAP official said the regulator would review the medicine for safety, quality and efficacy once any company formally applies for its registration in Pakistan.
Health experts say long acting medicines such as lenacapavir could significantly improve adherence and expand HIV prevention efforts, particularly among populations that struggle with daily preventive medication.
However, some public health experts warn that despite the promise of lenacapavir, the drug cannot be used as a universal preventive tool for the general population in Pakistan because the country’s HIV transmission pattern differs from many other regions.
They note that a large proportion of infections in Pakistan occur due to poor infection prevention and control practices in healthcare settings, including the reuse of contaminated syringes, unsafe intravenous drips and transfusion of unscreened blood.
Experts say these practices have led to several HIV outbreaks in recent years, particularly affecting children, and warn that unless basic safety standards in healthcare are strengthened, new prevention medicines alone will not be sufficient to control the spread of HIV in the country.
The WHO chief noted that the global fight against HIV has made major progress over the past two decades, with annual AIDS related deaths declining by around 70 percent due to the availability of effective antiretroviral treatment.
In recent years, the same medicines used to treat HIV infection have also been used to prevent transmission among people at risk. Experts believe the arrival of long acting medicines such as lenacapavir could transform HIV prevention programmes.
WHO issued guidelines for the use of lenacapavir in July last year and granted the drug prequalification status in October, enabling international donors such as the Global Fund to procure it for use in low and middle income countries.
Dr Tedros said WHO took the unusual step of developing guidelines and prequalification simultaneously to accelerate equitable access to the medicine.
Over the past eight months, WHO has supported nine African countries including Eswatini, Kenya, Lesotho, Mozambique, Nigeria, South Africa, Uganda, Zambia and Zimbabwe to begin rolling out lenacapavir for people at risk of HIV infection.
South Africa became the first African country to approve the drug through its national regulator and is now planning a large scale rollout as part of its national HIV prevention strategy. Authorities there have also announced plans to manufacture the medicine locally.
Public health specialists say the availability of long acting HIV prevention tools could significantly strengthen global and regional responses to the epidemic if access expands in low and middle income countries.
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