A US Food and Drug Adminsitration (FDA) advisory committee has recommended Gilead Sciences’ Truvada for approval in the US in the prevention of HIV as well as in combination with three other therapies as Quad for the treatment of the virus.The panel voted in favour of approving Truvada (emtricitabine and tenofovir disoproxil fumarate) to reduce the risk of HIV-1 infection among uninfected adults, an HIV prevention strategy called pre-exposure prophylaxis (PrEP).
This indication was divided into three different sub-groups: men who have sex with men, non-infected partners of people with HIV, and other individuals at risk for acquiring HIV through sexual activity. Voting results were 19 to 3, 19 to 2 (with one abstaining) and 12 to 8 (with two abstaining) respectively.
If it does gain final approval, Truvada would be the first drug to gain such an indication in the US, although its use in preventing the virus has drawn concerns from some quarters.
The HIV charity, Avert, said that some healthcare professionals “believe that use of PrEP in this way may give rise to complacency, an increase in risky sexual behaviour and a false perception about an AIDS cure”.
Reuters also reported quoted Dr Lauren Wood of the US National Cancer Institute, who voted against all preventive applications as she thought that the clinical studies had not measured the potential for increased risk of renal problems among the black population, who are more susceptible to kidney problems as a side effect of drugs.
According to Gilead, two large placebo-controlled phase II trials sponsored by the US National Institutes of Health and the University of Washington, supported the use of Truvada for a reduction in the risk of HIV infection if taken as prescribed.
Accessibility to the product has been touted as another potential issue, given its price and the US populations most at risk of HIV, however, with drug resistance a potential for patients who are not compliant in their treatment regimen.
In addition to its recommendation for HIV prevention in its own right, Truvada is also part of Quad – a single tablet regimen also including elvitegravir and cobicistat – that has also been recommended by an FDA panel for the treatment of HIV-1 infection in treatment-naïve adults.
The combined treatment showed non-inferiority compared to Gilead and Bristol-Myers Squibb’s Atripla and to a regimen containing ritonavir-boosted atazanavir plus Truvada.
If approved, it would be the first ever once-daily integrase inhibitor available to treat HIV in the US. It is developed to work by preventing the virus from binding with the DNA of host cells, adding another alternative for patients who may have developed resistance to other treatments.
It’s once-daily regimen could also boost adherence for the single pill.
The FDA’s panels are only recommendations, with a final decision on Truvada in its prevention indication of June, 2012, with Quad’s fate to be determined by August, 2012.
Source: Pmlive
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