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FDA: Don't Mix New HCV Drug with HIV Drugs

MedPageToday, 2012

The FDA has issued a warning against using boceprevir (Victrelis) and anti-HIV drugs that contain the protease inhibitor ritonavir (Norvir) because of possibly dangerous drug interactions.
But the agency cautioned that patients already taking boceprevir and one of the HIV regimens containing ritonavir should not stop their medications without consulting their doctors.
Physicians with patients taking boceprevir and any HIV regimen containing ritonavir should monitor them carefully to ensure that: Hepatitis C treatment response – defined as no virus detected in the blood – continues.
Hepatitis C or HIV virologic rebound -- defined as either virus detected in the blood again after previously being undetectable -- does not occur.
The update comes in the wake of a in February in which the FDA warned that drug interactions had been seen between boceprevir and three HIV medications boosted with ritonavir -- atazanavir (Reyataz), lopinavir (Kaletra), and darunavir (Prezista).
Boceprevir, approved last year, is a novel direct-acting agent that targets the NS3/4A protease of hepatitis C.
Ritonavir is a weak HIV protease inhibitor, but it is mainly used to boost the action of other anti-HIV drugs.
The prescribing information of another newly approved hepatitis C drug, telaprevir (Incivek), already includes cautions about drug interactions with HIV medications.
In February, the FDA noted, a pharmacokinetic study in 39 healthy volunteers found that giving boceprevir with ritonavir-boosted HIV protease inhibitors reduced exposure to the HIV drugs and vice versa.
For example, boceprevir reduced average trough concentrations of ritonavir-boosted atazanavir, lopinavir, and darunavir by 49%, 43% and 59%, respectively.
Co-administration of ritonavir-boosted atazanavir did not alter the exposure of boceprevir, but giving it with lopinavir/ritonavir or darunavir/ritonavir decreased the exposure of boceprevir by 45% and 32%, respectively, the agency reported.