(GIST OF SCIENCE REPORTER) LENACAPAVIR DRUG

(AUGUST-2025)

US FDA approves HIV prevention drug Lenacapavir.About Lenacapavir (Yeztugo/Sunlenca)

Lenacapavir is a novel capsid inhibitor developed by Gilead Sciences, initially approved for the treatment of multi-drug resistant HIV in December 2022 under the name Sunlenca in the U.S., EU and Canada World Health Organization.
On June 18, 2025, the U.S. Food and Drug Administration approved injectable lenacapavir (brand name Yeztugo) for pre-exposure prophylaxis (PrEP) in adults and adolescents weighing at least 35 kg, to prevent sexually acquired HIV. This marks the first-ever twice-yearly PrEP option globally.
Clinical trials (PURPOSE‑1 & PURPOSE‑2) showed near-100% efficacy approximately 96% in cisgender women and 100% in men who have sex with men and other gender-diverse populations.
WHO issued guidelines on July 14, 2025, endorsing injectable lenacapavir as an additional PrEP option worldwide.

HIV (Human Immunodeficiency Virus) attacks the immune system, which, without treatment, can progress to AIDS (Acquired Immunodeficiency Syndrome).
PrEP (Pre-Exposure Prophylaxis) refers to preventive antiretroviral medications taken by HIV-negative individuals at high risk of infection.
Before lenacapavir’s approval, PrEP regimens included daily oral Truvada/TDF-based pills, event-driven PrEP and long‑acting injections like cabotegravir (Apretude) given every 2 months.
Indian Context & Government Initiatives

In late 2024, Indian pharmaceutical firms (including Dr. Reddy’s and Emcure) signed royalty-free licensing agreements with Gilead to produce generic lenacapavir, targeting distribution in 120 resource-limited countries (pending regulatory approval).
Estimates suggest potential Indian annual pricing could fall to ₹200–₹300 from roughly ₹24 lakh (US $28,000) for imported branded injections.
National Programs & Law
India’s National AIDS Control Organisation (NACO), under the Ministry of Health, has led HIV/AIDS policy and implementation through regional prevention and control societies since 1992.
Although PrEP is not yet part of NACO’s public programmes, pilot discussions and stakeholder advocacy are ongoing.
In 2017, the Human Immunodeficiency Virus and AIDS (Prevention & Control) Act was enacted, guaranteeing rights to healthcare access, counselling, and non-discrimination for those living with or affected by HIV/AIDS in India.