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FDA: HCV Drug Interferes With HIV Meds
By Michael Smith, North American Correspondent, MedPage Today
Published: February 09, 2012
http://www.medpagetoday.com/HIVAIDS/HIVAIDS/31103
WASHINGTON -- A new drug for hepatitis C can reduce the effectiveness of some HIV medications if they are taken together and vice versa, the FDA is warning.
In a drug safety communication, the agency warned that there are important drug interactions between boceprevir (Victrelis) and anti-HIV protease inhibitors boosted with ritonavir (Norvir).
Boceprevir, approved last year, is a novel direct-acting agent targeting the NS3/4A protease of hepatitis C. It's taken with ribavirin and pegylated interferon-alfa to treat genotype 1 disease.
Another such drug, telaprevir (Incivek), was also approved last year and its prescribing information already includes cautions about drug interactions with HIV medications.
Neither drug is approved to treat patients coinfected with both viruses.
For boceprevir, the FDA said a pharmacokinetic study in 39 healthy volunteers found that giving the drug with ritonavir-boosted HIV protease inhibitors reduced exposure to the HIV drugs and vice versa. Specifically:
* Boceprevir reduced average trough concentrations of ritonavir-boosted atazanavir (Reyataz), lopinavir (Kaletra), and darunavir (Prezista) by 49%, 43% and 59%, respectively.
* On average, reductions of 25% to 36% were seen in peak concentration of the three drugs, when given with boceprevir, along with declines of 34% to 44% in exposure (area under the curve).
* Coadministration 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 said patients being treated with such combinations should not stop taking any medications without consulting their doctors. Doctors in such cases were urged to monitor patients closely for hepatitis treatment response and for potential hepatitis and HIV virologic rebound.
Hector
Published: February 09, 2012
http://www.medpagetoday.com/HIVAIDS/HIVAIDS/31103
WASHINGTON -- A new drug for hepatitis C can reduce the effectiveness of some HIV medications if they are taken together and vice versa, the FDA is warning.
In a drug safety communication, the agency warned that there are important drug interactions between boceprevir (Victrelis) and anti-HIV protease inhibitors boosted with ritonavir (Norvir).
Boceprevir, approved last year, is a novel direct-acting agent targeting the NS3/4A protease of hepatitis C. It's taken with ribavirin and pegylated interferon-alfa to treat genotype 1 disease.
Another such drug, telaprevir (Incivek), was also approved last year and its prescribing information already includes cautions about drug interactions with HIV medications.
Neither drug is approved to treat patients coinfected with both viruses.
For boceprevir, the FDA said a pharmacokinetic study in 39 healthy volunteers found that giving the drug with ritonavir-boosted HIV protease inhibitors reduced exposure to the HIV drugs and vice versa. Specifically:
* Boceprevir reduced average trough concentrations of ritonavir-boosted atazanavir (Reyataz), lopinavir (Kaletra), and darunavir (Prezista) by 49%, 43% and 59%, respectively.
* On average, reductions of 25% to 36% were seen in peak concentration of the three drugs, when given with boceprevir, along with declines of 34% to 44% in exposure (area under the curve).
* Coadministration 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 said patients being treated with such combinations should not stop taking any medications without consulting their doctors. Doctors in such cases were urged to monitor patients closely for hepatitis treatment response and for potential hepatitis and HIV virologic rebound.
Hector
HIV patients take a cocktail of meds on an ongoing basis to suppress the HIV virus. There is no cure, only management which is a life long process. They must continually take the antiretrovirals to remain healthy.
So if a patient also has hepatitis C and their doctor decides to treat their hepatitis C off label (with unapproved HCV antivirals) there will be drug interactions that can affect the efficacy of both treatments. Not something that anyone would want to happen.
Hector
So if a patient also has hepatitis C and their doctor decides to treat their hepatitis C off label (with unapproved HCV antivirals) there will be drug interactions that can affect the efficacy of both treatments. Not something that anyone would want to happen.
Hector
Great article Hector! So if you have Hep C and HIV they treat them simultaneously? I would think you would have to tx one before the other. And in that case which would you treat first? Also I thought HIV and HCV went hand in hand. (and my thoughts are only thoughts not knowingly facts)
Have a great day!
Jules
Have a great day!
Jules
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