LONDON, UK (GlobalData), 20 July 2012 - On Monday, the food and drug administration (FDA) approved Gilead’s Truvada (emtricitabine and tenofovir disoproxil fumarate) for Pre-Exposure Prophylaxis (PrEP) to prevent the spread of HIV to high-risk, healthy individuals. ViiV Healthcare, a joint venture between pharmaceutical giants Pfizer and GlaxoSmithKline, hopes that its anti-HIV drug Selzentry (maraviroc) can also diversify its indication from therapeutic to prophylactic. The national institute of health (NIH) has funded a clinical trial entitled Novel Exploration of Therapeutics for PrEP (NEXT PrEP) to compare the following HIV PrEP therapies: Selzentry, Selzentry plus emtricitabine, Selzentry plus tenofovir disoproxil fumarate, Truvada, and a placebo.
The two-year study, being run by the HIV Prevention Trials Network and AIDS Clinical Trials Group, will assess the tolerability of the various PrEP therapies in 400 HIV-negative homosexual and bisexual men in the United States over 48 weeks. Compliance with their dosing regime will also be evaluated. Participants will be educated on how to decrease their chance of contracting HIV and will be routinely screened for HIV during the trial period.
The study may provide the clinical trial data required to get Selzentry approved for HIV PrEP therapy, which would increase ViiV Healthcare’s visibility in the HIV market and increase its revenue. It may seem counterintuitive that Gilead would agree to aid the development of an HIV PrEP competitor by donating three of its drugs (emtricitabine, tenofovir disoproxil fumarate, and Truvada) to the study. Gilead is likely hoping that the study generates data that could be used to extend the exclusivity of emtricitabine and tenofovir disoproxil fumarate, whose patents are set to expire in 2021 and 2017 respectively. The trial will also generate Truvada safety and compliance data that Gilead is required to obtain as part of its recent FDA approval.
The approval of Truvada created a new indication for HIV therapy by expanding into a virtually untapped market segment, the HIV-negative population. The NEXT PrEP study could be a harbinger of other HIV therapeutics that may attempt to diversify into the HIV PrEP market. Companies will likely work towards market diversification by broadening their drug indications and extension of market exclusivity of commercialized HIV drugs, but the unknown efficacy and tolerability of long-term HIV PrEP therapy makes this indication risky for novel compounds. The HIV PrEP market is even less attractive for active research and development, when companies consider that the majority of the HIV disease burden exists in low-income countries. This presents an opportunity for collaboration between Big Pharma and non-government agencies, such as the Bill and Melinda Gates Foundation or the GAVI Alliance, to share the cost and risk associated with developing novel HIV PrEP therapies.
*PrEParing the NEXT Generation of HIV Prophylactic Therapies
This expert insight was written by GlobalData infectious disease analyst, Dr Brad Tebbets, and follows on from a previous GlobalData expert insight, Gilead Receives FDA Approval for Truvada Use as a Preventative Measure against HIV Infection. If you would like an analyst comment or to arrange an interview, please contact us on the details below.
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