Drugmaker Cipla has received regulatory approval in India to sell its version of Truvada as a preventive that can be given to healthy people to reduce their risk of getting HIV.

Commonly referred to as PrEP (pre-exposure prophylaxis) in healthcare circles, Truvada sold by US drugmaker Gilead is the only medicine globally approved as a preventive in managing HIV.  And the recent approval in India as a preventive marks a significant step in HIV prevention efforts, especially in couples where one partner is HIV positive.

Confirming the development, Cipla’s Medical Director Jaideep Gogtay told BusinessLine that Cipla was the first company to get an approval from the Drug Controller General of India to sell its version of the drug (Tenvir EM) as a preventive.

The same drug is presently used in India for about eight years now, but for the treatment of people with the HIV infection, he said. The big difference now is that it is used to prevent infection in healthy people. “It has added a big new weapon in the fight against the HIV epidemic,” Gogtay said. Cipla’s drug is priced at Rs 2200 for a month.

Sold only on a doctor’s prescription to healthy uninfected people in the high risk category, he said, the medicine if taken every day reduces an individual’s  risk of getting infected by as much as 90 per cent. But that’s in addition to other safe practices that individuals in high-risk categories are required to follow.

Treatment vs prevention

The first step was to get it approved as a preventive in India. “Now we go to the other countries,” Gogtay said.  Cipla already sells the drug in South Africa, for treatment purposes.

There are other generically similar versions of the drug in India, but they too are only for treatment, he said, adding that there were none that have got DCGI approval to be used as a preventive.

With the added indication, Tenvir EM can now be used by private doctors in “sero-discordant” couples (where one partner is HIV positive). But on a larger level, it can also be used as part of the national public health programme to bring down new HIV infections, estimated at about 80,000 in India.

Industry experts point out that other generic companies such as Mylan, Hetero, Emcure etc also sell the drug, but for treatment.

The next important step will depend on the National AIDS Control Organsiation (NACO) and its inclusion of the drug as a preventive in the national programme.

Explaining the significance of the drug as a preventive, YRG Care’s Chief Medical Officer, N Kumarasamy, said that late last year the World Health Organisation had issued guidelines on PrEP.  While the national programme here looks at getting treatment to everyone who needs it, the NACO will also be planning on how to introduce PrEP into the programme to control new infections.

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