Tags: GS Paper 2 – Health; GS Paper 3 – Biotechnology, Pharmaceutical Industry
For Prelims: Lenacapavir, PrEP, capsid inhibitor, PEPFAR, voluntary licence, Medicines Patent Pool, NACO, UNAIDS 95-95-95, Pharmacy of the World
For Mains: Role of Indian generic manufacturers in global health access, long-acting HIV prevention, India’s HIV/AIDS programme
Why in News?
Dr. Reddy’s Laboratories has received US FDA tentative approval under PEPFAR for its generic lenacapavir, a twice-yearly injectable for HIV pre-exposure prophylaxis (PrEP). It is approved for adults and adolescents weighing at least 35 kg. The first supplies are expected by December 2026, with wider rollout in eligible countries in 2027.
About Lenacapavir
- A first-in-class HIV-1 capsid inhibitor that interferes with the protein shell (capsid) of the virus at several stages of its life cycle. It was developed by Gilead Sciences.
- For prevention it is given as a subcutaneous injection every six months. The US FDA approved it in June 2025 as Yeztugo, and the WHO recommended it for HIV prevention in July 2025.
- Trial results: The PURPOSE trials showed near-complete protection, with almost no infections among women in sub-Saharan Africa.
Why does it Matter?
- Adherence: Daily oral PrEP pills often fail because people stop taking them. Two shots a year remove that problem.
- Stigma: Being discreet helps key populations and young women.
- Access: In 2024 Gilead gave royalty-free voluntary licences to six generic makers, including Indian firms, to supply 120 low- and middle-income countries.
- Tentative approval: An FDA approval for PEPFAR procurement in countries where patents block full US approval.
India and HIV
- India has about 25 lakh people living with HIV, and adult prevalence is about 0.2%.
- National AIDS and STD Control Programme (Phase V, 2021–26) is run by NACO. Antiretroviral therapy is free.
- HIV and AIDS (Prevention and Control) Act, 2017: Prohibits discrimination and requires informed consent and confidentiality.
- Indian generics supply most of the world’s antiretroviral drugs, which is why India is called the ‘pharmacy of the developing world’.
Global Targets
- UNAIDS 95-95-95 by 2025: 95% of people living with HIV know their status, 95% of them are on treatment, and 95% of those are virally suppressed.
- SDG 3.3: End AIDS as a public health threat by 2030.
Frequently Asked Questions (FAQs)
1. How often is lenacapavir given for HIV prevention?
Twice a year, as an injection.
2. What is PrEP?
Pre-exposure prophylaxis: medicine taken by HIV-negative people to prevent infection.
3. Which body runs India’s HIV programme?
The National AIDS Control Organisation (NACO).