-
24 November 2011
First ever ATV/r combination pill improves treatment options for second-line
On 18 Novermber 2011, the US Food and Drug Administration granted tentative approval for Matrix’s atazanavir sulfate and ritonavir fixed-dose combination (FDC) tablets, 300/100 mg.
MSF has long advocated for generic manufacturers to develop a heat-stable FDC of atazanavir/ritonavir (ATV/r). This is the first such FDC to receive approval from a stringent regulatory authority or the WHO prequalification programme.
Atazanavir – which needs to be boosted with ritonavir - is one of the two protease inhibitors drugs recommended by WHO in its 2010 ARV treatment guidelines for adults and adolescents as backbone for second-line regimens, in combination with two Nucleoside Reverse Transcriptase Inhibitors.
The introduction of this heat-stable formulation represents a step forward for access to second-line ARVs, as it provides the first FDC alternative to heat-stable lopinavir/ritonavir (LPV/r). It also has the added benefit of reducing the pill burden for patients – down from four pills a day for heat-stable LPV/r, to one pill a day for ATV/r.
However, unlike first-line HIV regimens which now come as one or two pills per day, as of now no three-in-one FDC exists that covers the full second-line regimen as per WHO recommendations.
Matrix has communicated to MSF the price of this new tablet. At US$ 25 per pack of 30 tablets (FCA Mumbai. Freight & Insurance charges are additional), this means a price of $307 per patient per year (0.84 per unit).
Web Updates
Regularly updated news feed of updates to the online version of Untangling the Web as well as related news articles.
