HIV jab for 115 nations rests on Indian regulators

Mumbai: There will be a dramatic shift in how the world prevents HIV and the timelines depend on how quickly Indian drug regulators act. A US-based pharma giant has granted royalty-free licences to four Indian generic manufacturers to produce lenacapavir, which prevents transmission by almost 100%, at $40 per person per year, roughly 0.1% of the original cost.Lenacapavir is an injectable drug whose protection from one jab lasts six months. The licensed manufacturers by Gilead Sciences include Dr Reddy’s, Hetero, Emcureand Mylan. The first two have announced their pricing. The drugs are estimated to roll out in 2027. But, it could be much sooner or delayed, and what happens in India will impact local access as well as 115 low- and middle-income countries as these firms will be key exporters. Twenty-six additional such countries where people participated in crucial clinical trials are excluded from it as per licence terms.The exports depend on registration and a certificate of pharmaceutical product from Indian FDA. Besides, there could be regulatory demand for local clinical trials despite strong phase-3 trial data from elsewhere. “In that case, the delays could spill over into 2027,” said Leena Menghaney, public health lawyer. There is another pathway to faster access. FDA could provide a waiver for local clinical trials on the grounds that HIV is an epidemic. India reports more than 60,000 new HIV infections annually. There is precedent for such a move. “Waivers have been given for HIV and TB drugs. These decisions are based on the results of phase-3 clinical trials in countries with very strong regulatory systems,” Menghaney said. In 2015, the apex committee of the regulator Central Drugs Standard Control Organisation also granted a waiver of local trials for antiviral drugs against Hepatitis C. Even if local production moves ahead quickly, access in India will be limited. National AIDS Control Organisation (Naco) has so far included only condoms as pre-exposure prophylaxis (PrEP) in its HIV prevention programme. There have been drugs similar to lenacapavir, although not on a par in terms of protection and cost, that were not included in the national programme. Naco officials had previously defended this position, saying condoms also help prevent the spread of other STDs and STIs, which increased in some countries when PrEP was introduced and condom use declined. However, Dr Ishwar Gilada, an HIV specialist, said, “Bringing about behaviour change is difficult, but sex education and awareness are also part of Naco’s responsibilities. For the first time in over 40 years, we have a way to control HIV’s transmission by almost 100%. This will reduce the number of people requiring lifelong treatment.” Ganesh Acharya, a city-based HIV-TB survivor, said, “Other such drugs so far have been needed to be taken monthly, are costly and offer relatively lower protection. Even condoms carry a risk of tearing. This drug could bring down new HIV numbers.”