FDAnews
www.fdanews.com/articles/89579-group-wants-tenofovir-registered-in-south-africa

GROUP WANTS TENOFOVIR REGISTERED IN SOUTH AFRICA

February 14, 2007

The aid group Treatment Action Campaign (TAC) is lobbying South Africa's Medicines Control Council (MCC) to register the HIV drug tenofovir. The drug is marketed by Gilead as Viread, which was approved in the U.S. in 2001.

The TAC plans tohold protests later this month at the offices of the MCC and Aspen Pharmacare, which locally produces generic tenofovir under an agreement with Gilead.

Currently the drug is only available under an exemption clause, which is impractical for widespread use among public-sector patients, according to the TAC. Furthermore, the South African HIV treatment guidelines don't include tenofovir since it is not registered, and the drug, when available, is too expensive at $17 per month, the TAC says.

If approved, tenofovir would be a useful first-line, once-a-day antiretroviral therapy and an alternative to stavudine, according to the TAC. Also, while stavudine is associated with serious and sometimes fatal side effects, tenofovir has a favorable side-effect profile.

Médecins Sans Frontières has also called for increased access to tenofovir in South Africa, saying that Gilead's deal with Aspen has only delayed MCC registration of the drug.