Essentialdrugs.org Reports Viraday may be too expensive to help

Viraday may still be too expensive

Generic versions of the new once-a-day FDC of TDF/FTC/EFV are being developed in India and their approximate market launch in India (to start with) could be expected within the coming months (see Times of India article below). This new combination is crucial as an improved first-line and alternative to the FDC containing d4T/3TC/NVP, which is commonly used in the developing world today. WHO recommends combinations containing TDF, as they have fewer side effects than those containing d4T.

Generic companies have already applied for marketing approval in India and therefore the generic equivalent of this new once-a-day FDC could be available within months of US FDA approval of Gilead/BMS’s version of the new FDC. The generic price of US$ 2,160 per patient per year as reported by the Times of India is much more affordable than the US market price of nearly US$14,000. The price is still very high compared to current first-line FDC prices, but when generic competition exists, prices can be expected to fall over time.

However, Gilead’s patent application on TDF is being examined in India. In May 2006, MSF supported PLWHA groups and the lawyers that represent them in filing a pre-grant opposition to this patent application. If the patent is granted on TDF, for which there was no generic production pre-2005, any generic production could be effectively blocke"