PrEP (pre-exposure prophylaxis) is an HIV-prevention strategy for protection from HIV infection. The only drug which any health organization recommends for PrEP is Truvada. In India, Cipla has got approval to sell its version of Truvada, ‘Tenvir EM‘.
The drug Truvada, manufactured by Gilead Sciences, has been approved by the FDA for PrEP since 2012. In May 2016, Cipla got approval to sell this drug by Drug Controller General of India (DCGI). Cipla’s drug is priced at 2,200/- for a month.
The Centers for Disease Control (CDC) says that “PrEP is a powerful HIV prevention tool. People who use PrEP must commit to taking the drug every day.
Important facts about PrEP:
- First of all, the drug is for prevention, not for cure. It can be used by people who do not have HIV/AIDS but have substantial risk of it.
99% protection is achievable if the drugs are taken every day.
- Truvada (Tenofovir disoproxil/emtricitabine ) was approved by the FDA for PrEP on 16 July 2012.
- PrEP is intended for use with condoms, so that each method can compensate for essential or casual efficacy deficits of the other.
- USA, France, Australia, Israel, Canada, Kenya and South Africa have approved PrEP.
How it works?
One of PrEP’s active ingredients, tenofovir disoproxil (TDF),effectively blocks HIV from incorporating its genetic material into the host’s genome, and thus prevents HIV infection.
Who can use it? (FDA recommended)
- Gay or bisexual men who have have had anal sex without a condom,
And who have been diagnosed with an STD in the past 6 months.
- Discordant partners where one partner is HIV-positive and the other HIV-negative.
- Men or women who do not regularly use condoms during sex with partners of unknown HIV status.
- Anyone who has injected illicit drugs in the past six months, with sharing of equipment
- Persons with HIV should never use PrEP, and an HIV test is necessary before starting to use PrEP.
Kidney and Hepatitis B patients have safety problems with this drug.
Only minor side effects such as nausea or diarrhea.
Results from Research:
- The iPrEx study demonstrated 42% reduction of HIV infection among men who have sex with men.
- Subsequent analysis of the data has suggested that 99% protection is achievable if the drugs are taken every day.
- In a population of 400 gay men in France and Canada at high risk for HIV, this strategy led to an 86% drop in HIV infections over the average 9
month follow-up of the study.
The recent approval in India as a preventive marks a significant step in HIV prevention efforts. It has added a big new weapon in the fight against the HIV epidemic. 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.
FDA approval copy: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm312210.htm