The global effort to prevent HIV transmission is hinging on the swift action of Indian drug regulators. A new injectable medication, potentially a game-changer in HIV prevention, is awaiting approval that would pave the way for its distribution in 115 low- and middle-income countries.
This long-acting pre-exposure prophylaxis (PrEP) injection, offers a promising alternative to daily oral medications. Studies have shown it to be highly effective in reducing the risk of HIV infection. For instance, Apretude (cabotegravir extended-release injectable suspension) is given as two initiation injections one month apart, and then every two months thereafter. Clinical trials have indicated that Apretude is significantly more effective than daily oral Truvada in preventing HIV.
Lenacapavir, another long-acting PrEP option, is administered via an injection just twice a year. Clinical trials have demonstrated that lenacapavir can eliminate 99% of HIV transmission, positioning it as one of the most effective preventative measures available.
The availability of generic versions of these injectable PrEP medications at an affordable price of $40 per year could revolutionize HIV prevention efforts in low- and middle-income countries. This would significantly increase access to HIV prevention, particularly for individuals who face challenges with taking daily oral medications.
Two Indian generic manufacturers, Hetero Labs and Dr. Reddy's Laboratories, are set to produce affordable versions of lenacapavir. These efforts are supported by organizations like the Gates Foundation, Unitaid, and the Clinton Health Access Initiative (CHAI).
However, the distribution of these generics is restricted to the 115 low- and middle-income countries covered by Gilead's voluntary license. This excludes several countries with high HIV rates, such as Argentina, Brazil, and Mexico. Activists are advocating for broader access to affordable generics in all low- and middle-income countries.
The role of Indian regulators is now critical. Expedited approval in India is essential to enable generic manufacturers to obtain the necessary certifications and enter global supply chains. Any delays in regulatory approval could slow down the accessibility.
It's important to note that while these injectable PrEP medications are highly effective in preventing HIV, they do not protect against other sexually transmitted infections (STIs). Consistent STI testing and the use of condoms are still recommended. Furthermore, individuals must test negative for HIV before starting Apretude, and must continue to test negative before each subsequent injection. Apretude is for HIV prevention only, and can lead to drug resistance if taken when a person is already infected with HIV.
