India's HIV infections are rising. Why twice-yearly lenacapavir matters

The Central Drugs Standard Control Organisation (CDSCO) has permitted two Indian drugmakers to make generic lenacapavir without local clinical trials amid a steady and worrying rise of new HIV infections in many states in the country.India’s Human Immunodeficiency Virus (HIV) epidemic has come a long way from the rapid expansion seen in the 1990s and early 2000s. Sustained prevention efforts, wider testing and access to antiretroviral therapy helped bring annual new infections down substantially after the epidemic peaked.But the decline has not been linear.After reaching 57,549 new HIV infections in 2020, the number rose for three consecutive years – to 62,970 in 2021, 66,410 in 2022 and 68,451 in 2023 – before easing to 64,470 in 2024. While this remains nearly 49% below the 2010 level of about 1.25 lakh new infections, the recent rise is a reminder that HIV transmission has not been eliminated.AIDS is the most advanced stage of HIV infection. Without effective treatment, it weakens the immune system and leaves people vulnerable to serious infections, including tuberculosis and hepatitis, as well as some cancers. Against this backdrop, the has moved closer to making one of the most promising new HIV-prevention medicines more widely available.An expert panel under the Central Drugs Standard Control Organisation (CDSCO) has recommended waiving local Phase III clinical trials and bioequivalence studies for generic lenacapavir for pre-exposure prophylaxis (PrEP) applications from Dr Reddy’s Laboratories and Emcure Pharmaceuticals. The recommendation could shorten the regulatory pathway for Indian manufacturers to bring generic lenacapavir to the country.The timing is significant. India’s adult HIV prevalence remains relatively low at about 0.20%, but an estimated 2.56 million people are living with HIV, making India one of the countries with the largest HIV-positive populations globally.New infections are also concentrated among particular populations and geographical areas, underscoring the need for more effective and convenient prevention options.A QUIET WARNINGThe latest figures should not be read as a reversal of India’s long-term progress. AIDS-related deaths have fallen sharply, reflecting wider access to treatment, while annual new infections remain substantially below their 2010 level.What is concerning is the interruption in the downward trajectory after 2020.Experts have pointed to vulnerabilities among younger people and adolescents, people who inject drugs, transgender people and men who have sex with men, along with persistent high-burden states such as Maharashtra, Andhra Pradesh, Karnataka and Telangana and several north-eastern states.Karnataka, for instance, continues to report prevalence above the national average, with around 2.91 lakh people estimated to be living with HIV and roughly 4,700 new infections annually, according to recent government data.This makes prevention particularly important. HIV treatment has transformed the infection into a manageable chronic condition for people who can access and adhere to sustained therapy. But preventing infection in the first place remains critical.And with PrEP, effectiveness depends not only on the medicine itself but also on whether people can take it consistently.WHY LENACAPAVIR MATTERSDeveloped by Gilead Sciences, lenacapavir is a long-acting HIV-1 capsid inhibitor. It interferes with the HIV capsid, the protein shell that plays a crucial role at multiple stages of the virus’s life cycle.For prevention, however, its biggest potential advantage may be how often it needs to be taken.Instead of a daily PrEP pill, the approved prevention regimen involves an initial oral dosing schedule followed by two subcutaneous injections every six months. HIV-negative status must be confirmed before starting PrEP and monitored regularly because taking PrEP during an undiagnosed HIV infection can contribute to drug resistance.The results from clinical trials have generated considerable interest.In the Phase III PURPOSE 1 trial among adolescent girls and young women in South Africa and Uganda, there were zero HIV infections among the 2,134 participants who received twice-yearly lenacapavir. This translated to 100% efficacy in the trial.In PURPOSE 2, involving cisgender men and transgender and gender-diverse people who have sex with partners assigned male at birth, two infections occurred among 2,179 participants receiving lenacapavir. The regimen reduced HIV incidence by 96% compared with background incidence and was superior to once-daily oral Truvada.The 100% figure needs context: it reflects zero infections observed in PURPOSE 1, not a guarantee that no person receiving lenacapavir can ever acquire HIV.For Dr Ishwar Gilada, a Mumbai-based AIDS specialist, the major advantage is the combination of high efficacy and infrequent dosing.“PrEP medicines currently available in India include tenofovir disoproxil fumarate with emtricitabine and tenofovir alafenamide with emtricitabine. The major advantage of lenacapavir is that it is given twice a year, which could significantly improve adherence.”That could be particularly important for people who find daily tablets difficult to maintain because of forgetfulness, stigma, privacy concerns, mobility or simply the burden of taking a preventive drug while feeling healthy.INDIA'S ACCESS OPPORTUNITYThe CDSCO recommendation could help reduce the time and cost involved in bringing generic lenacapavir to India.Hyderabad-based Dr Reddy’s and Pune-based Emcure had sought waivers for local Phase III trials and bioequivalence requirements for the PrEP indication, citing evidence generated for the innovator product and regulatory approvals in other jurisdictions.The SEC accepted the rationale for the prevention indication but recommended post-marketing Phase IV studies in India, with efficacy as the primary endpoint. The companies would have to submit their Phase IV protocols to CDSCO within three months of marketing authorisation.The waiver recommendation does not, however, extend to every use of lenacapavir.The committee did not recommend the requested waiver for its use in treating people with heavily treatment-experienced, multidrug-resistant HIV whose existing regimen is failing. It cited evidence gaps, including pharmacokinetic and ethnicity-related data. The prevention and treatment indications therefore remain separate regulatory questions.According to experts, the bigger opportunity is affordability. Indian generic manufacturers already play a major role in supplying affordable HIV medicines globally.If generic lenacapavir becomes available at an accessible price, it could give people who cannot or do not want to take daily oral PrEP access to a highly effective, long-acting prevention option, they stress.- EndsPublished On: Aug 25, 2026 16:36 IST