US Food and Drug Administration (FDA) approves new HIV prevention drug Lenacapavir

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FDA approval also paves the way for WHO prequalification, which can accelerate national regulatory approvals.

WHO Prequalification of Medicines Programme (PQP) helps ensure that medicines supplied by procurement agencies meet acceptable standards of quality, safety and efficacy.

About Lenacapavir

Lenacapavir is an antiretroviral medicine that is used for HIV prevention as a Pre-Exposure Prophylaxis or PrEP.
- PrEP is a medication that can reduce the risk of HIV infection for individuals who are HIV-negative but are at risk of contracting the virus.
- WHO currently recommends oral PrEP, the dapivirine vaginal ring, and long-acting injectable cabotegravir (CAB-LA) as options for HIV PrEP.

Human Immunodeficiency Virus (HIV) is a virus that attacks the body’s immune system.
Mechanism: HIV damages the immune system by infecting and destroying CD4 cells (CD4 T lymphocytes), a type of white blood cells.
Transmission: HIV is spread from the body fluids of an infected person, including blood, breast milk, semen and vaginal fluids.
- It can also spread from a mother to her baby.
Treatment: HIV can be prevented and treated with antiretroviral therapy (ART).
- Untreated HIV can progress to Acquired immunodeficiency syndrome (AIDS).
According to HIV Estimations 2023 report, over 2.5 million people are living with HIV in India.

National AIDS Control Programme Phase-V (2021-26) aims at achieving 80% reduction in new infections.
- 95-95-95 Target: 95% of HIV-positive individuals know their status, 95% of those diagnosed are on treatment, and 95% of those patients achieve viral suppression.
HIV and AIDS (Prevention and Control) Act 2017 prohibits discrimination against HIV-positive people.
Commitment to End HIV/AIDS as a public health threat by 2030.
Youth-targeted initiatives like Red Ribbon Clubs in educational institutions.