VICTRELIS™ (boceprevir) and Ritonavir-Boosted HIV Protease Inhibitors May Indicate Clinically Significant Drug Interactions for Patients Coinfected with Chronic Hepatitis C and HIV

IMPORTANT DRUG WARNING

SUBJECT: Results of Pharmacokinetic Study in Healthy Volunteers Given VICTRELIS™
(boceprevir) and Ritonavir-Boosted HIV Protease Inhibitors May Indicate Clinically Significant Drug
Interactions for Patients Coinfected with Chronic Hepatitis C and HIV

Dear Health Care Professional,

The purpose of this communication is to inform you of recent pharmacokinetic study results evaluating drug
interactions between VICTRELIS, an oral chronic hepatitis C virus (HCV) NS3/4A protease inhibitor, and
ritonavir-boosted human immunodeficiency virus (HIV) protease inhibitors in healthy volunteers (n=39).
VICTRELIS is indicated for the treatment of chronic hepatitis C virus (HCV) genotype 1 (G1) infection, in
combination with peginterferon alfa and ribavirin (PR), in adult patients (18 years and older) with
compensated liver disease, including cirrhosis, who are treatment-naïve or who have failed previous
interferon and ribavirin therapy. In the pharmacokinetic study, concomitant administration of VICTRELIS
with Norvir® (ritonavir) in combination with Reyataz® (atazanavir) or Prezista® (darunavir), or with Kaletra® (lopinavir/ritonavir) resulted in reduced exposures of the HIV medicines and VICTRELIS. Specifically, VICTRELIS reduced mean trough concentrations of ritonavir-boosted atazanavir, lopinavir, and darunavir by 49%, 43%, and 59%, respectively. Mean reductions of 34% to 44% and 25% to 36% were observed in AUC and Cmax of atazanavir, lopinavir, and darunavir. Coadministration of ritonavir-boosted atazanavir with VICTRELIS did not alter the exposure of VICTRELIS, but coadministration of VICTRELIS with lopinavir/ritonavir or ritonavir-boosted darunavir decreased the exposure of VICTRELIS by 45% and 32%, respectively.

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