A co-packaged combination of four drugs for second-line antiretroviral treatment for developing countries will be made available from early 2010 for $425, the Clinton HIV/AIDS Initiative announced today.
With immediate effect the drugs – tenofovir, lamivudine (3TC), atazanavir and a boosting dose of ritonavir – will be available at a price of $475. That’s $115 less than the previous cheapest option for second-line treatment, lopinavir/ritonavir plus tenofovir/3TC, currently being offered to qualifying countries in the developing world by the Clinton HIV/AIDS Initiative Procurement Consortium at a ceiling price of $590 a year.
The reduced prices compare to a cost of $210 a year for a fixed dose combination of tenofovir, lamivudine (3TC) and efavirenz, and $89 a year for d4T, 3TC and nevirapine, the most commonly used first-line drug combinations.
Next year, the Indian generic drug maker Matrix will put the drugs in one package to offer once-daily second-line treatment in a box, the first time that a second-line drug regimen has been packaged in this way anywhere in the world.
Matrix is able to manufacture the products because they are not patented in India, and is able to offer them at low prices because of efforts to improve the efficiency of production and due to the guarantee of large order volumes.
CHAI says it will begin to offer the Matrix products once the atazanavir and ritonavir formulations receive prequalification from the World Health Organization. The products will be available to low and middle-income countries that have joined the consortium.
Second-line drug purchases are being funded by UNITAID, the international drug purchase facility, and UNITAID has granted an extension of funding for second-line treatment to the end of 2011 in order to encourage rapid uptake of the new formulations.
President Clinton also announced that Pfizer has agreed to make its TB drug rifabutin available at a 60% discount, at $1 per day, the equivalent of $90 for a full course of TB treatment, making it cheaper than rifampicin-based treatment. Rifabutin is more suitable for use alongside ritonavir-boosted protease inhibitors because it does not reduce ritonavir levels.
CHAI estimates that between 6000 and 10,000 patients with TB will benefit from this offer, although numbers could increase substantially if a French government-sponsored study due to commence shortly in Vietnam shows that it is safe and effective to use rifabutin alongside nevirapine, one of the components of first-line treatment. Treatment guidelines currently recommend the use of the more expensive first-line drug efavirenz in TB patients due to its lack of negative interaction with rifampicin; some studies, although not all, have shown a negative effect of rifampicin on nevirapine levels.