Drug Interactions between Protease Inhibitors: Boceprevir (Victrelis) for HCV and Ritonavir (Norvir) for HIV

Pharmacists, doctors and consumers have been notified of the identified drug interactions between the protease inhibiting drug for Hepatits C Virus (HCV), Boceprevir (Victrelis), and the protease inhibiting drug for Human Immunodeficiency Virus (HIV), Ritonavir (Norvir).

Persons already under medication for chronic Hepatitis C with Boceprevir (Victrelis), and at the same time doing an antiretroviral therapy based on Ritonavir (Norvir) are being warned of the counteractive effect which could lead to adverse impacts on the patient’s health.

FDA Alert on Ritonavir (Norvir) and Boceprevir (Victrelis) drug interactions

The drug interaction is indicated for simultaneous treatment for HCV with Victrelis (Boceprevir) and antiretroviral therapy based on the protease inhibiting action of Ritonavir (Atazanavir, Lopinavir, Darunavir), which in combined use, realize minimized efficacy.

In a recent study analyzing the drug interaction between Boceprevir and Ritonavir which is combined with Darunavir (Prezista), Atazanavir (Reyataz), or with Ritonavir/Lopinavir (Kaletra), was identified as reduced levels of both Boceprevir and Ritonavir-based antiretrovirals in the bloodstream.

Simply put, the drugs minimized each other’s efficacy in the patient’s treatment therapy.

Consequently, the FDA in conjunction with the manufacturer for Victrelis (Boceprevir) will enact a label change that will indicate the above realized drug interaction with Norvir (Ritonavir) based antiretrovirals.

Background of Ritonavir (Norvir) for HIV and Boceprevir (Victrelis) for HCV

Ritonavir (Norvir) and Boceprevir (Victrelis) are both protease inhibiting drugs whereby, more specifically:

Ritonavir:

• a HIV (Human Immunodeficiency Virus) protease inhibitor
• used to enhance the effect of other protease inhibitors for HIV
• Ritonavir increases the blood level of other HIV protease inhibitors to enhance the clinical efficiency of the antiretroviral therapy

Boceprevir:

• a HCV (Hepatitis C Virus) protease inhibitor
• it is used together with Ribavirin and Peginterferon alfa in treating chronic HCV infections identified in adults

FDA Recommendation

“ Patients should not stop taking any of their medicines without talking to their healthcare professional.

Patients should contact their healthcare professional if they have any questions or concerns.

Healthcare professionals who have started patients infected with both chronic HCV and HIV on Victrelis and antiretroviral therapy containing a ritonavir-boosted protease inhibitor should closely monitor patients for HCV treatment response and for potential HCV and HIV virologic rebound. ”

Contacting the FDA to report cases relating to Boceprevir and Ritonavir drug interaction

Any adverse side effects or incidences relating to the combined use of Boceprevir (Victrelis) for HCV and Ritonavir (Norvir) for HIV should immediately be reported to the FDA.

This should be done by contacting or informing the FDA’s MedWatch Safety Information & Adverse Event Reporting Program through any of the following ways:

• Filling and submitting an online report at: http://www.fda.gov/MedWatch/report.htm
• Download the case reporting form at:http://www.fda.gov/Safety/MedWatch/HowToReport/DownloadForms/default.htm
• Dialing 1-800-332-1088 and requesting to get a report form, filling it and returning it to the address indicated on the form
• Faxing the filled-up form to the fax number: 1-800-FDA-0178

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