E-DRUG: MSF: First ever ATV/r combination pill improves treatment options for second-line
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On 18 November 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.
http://msf-utw.tumblr.com/post/13260793909/first-ever-atv-r-combination-pill-improves-treatment
Kind regards,
Michelle Vilk
Coordination and Communications Assistant
Medecins Sans Frontieres
Campaign for Access to Essential Medicines
Rue de Lausanne 78
1211 Geneva, Switzerland
Tel: + 41(0) 22 849 89 02
Fax: + 41 (0) 22 849 84 04
www.msfaccess.org
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michelle.vilk@geneva.msf.org