FDA Panel Backs Approval of Boceprevir for Chronic Hepatitis C

SILVER SPRING, MD. – A Food and Drug Administration advisory panel on April 27 voted 18-0 that the risk-benefit profile of the oral antiviral drug boceprevir supported its approval as a treatment for chronic hepatitis C, in combination with pegylated interferon-alpha and ribavirin, the current standard of care.

At the meeting, members of the FDA’s Antiviral Drugs Advisory Committee agreed that the protease inhibitor was effective when combined with standard therapy for the treatment of patients with chronic hepatitis C genotype-1 infections, the most common and least responsive type of hepatitis C virus (HCV). Despite concerns about some risks associated with treatment, such as an increased rate of anemia, panelists agreed that the risks were manageable and that the benefits of treatment were clear, with some describing it as a "marvelous" or "tremendous" advance in the treatment of chronic HCV.

But the panel emphasized the importance of appropriate patient selection and physician education about how to use the drug-as well as the need for postmarketing studies on drug-drug interactions and in different patient populations, such as in people over age 65 years and liver transplant recipients.

The recommended dosage of boceprevir, a potent inhibitor of HCV replication, is 800 mg three times a day, every 7-9 hours with food. The proposed indication is for the treatment of adults with compensated liver disease, who either have not been treated previously or who have failed previous therapy.

The addition of boceprevir to peginterferon-alpha and ribavirin for up to 44 weeks of therapy resulted in significant increase in efficacy of the standard of care regimen, based on sustained virologic responses, in two phase III studies: one study of 403 patients who had previously failed treatment (N. Engl. J. Med. 2011 March 31;364:1207-17) and another study of more than 1,097 treatment-naive patients (N. Engl. J. Med. 2011 March 31;364:1195-206). The safety of boceprevir was based on data from the two phase III studies and a phase II study of 595 treatment-naive patients: In the three trials, the two adverse events that occurred more than 20% more frequently among those treated with all three drugs, compared with those treated with the interferon-ribavirin combination, were anemia (49% vs. 29%) and dysgeusia (37% vs. 15%.).

The FDA usually follows the recommendations of its advisory panels, Panel members have been cleared of potential conflicts of interest related to the topic of the meeting, although occasionally, may be given a waiver, but not at this meeting.

Boceprevir is manufactured by Merck Research Laboratories If approved, Merck plans to market boceprevir as Victrelis. A decision on approval is expected by mid-May, according to the company. It is also under review as a treatment for chronic hepatitis C in the European Union.

On April 28, the same panel will review telaprevir, another HCV protease inhibitor as a treatment for chronic hepatitis C.

SILVER SPRING, MD. – A Food and Drug Administration advisory panel on April 27 voted 18-0 that the risk-benefit profile of the oral antiviral drug boceprevir supported its approval as a treatment for chronic hepatitis C, in combination with pegylated interferon-alpha and ribavirin, the current standard of care.

At the meeting, members of the FDA’s Antiviral Drugs Advisory Committee agreed that the protease inhibitor was effective when combined with standard therapy for the treatment of patients with chronic hepatitis C genotype-1 infections, the most common and least responsive type of hepatitis C virus (HCV). Despite concerns about some risks associated with treatment, such as an increased rate of anemia, panelists agreed that the risks were manageable and that the benefits of treatment were clear, with some describing it as a "marvelous" or "tremendous" advance in the treatment of chronic HCV.

But the panel emphasized the importance of appropriate patient selection and physician education about how to use the drug-as well as the need for postmarketing studies on drug-drug interactions and in different patient populations, such as in people over age 65 years and liver transplant recipients.

The recommended dosage of boceprevir, a potent inhibitor of HCV replication, is 800 mg three times a day, every 7-9 hours with food. The proposed indication is for the treatment of adults with compensated liver disease, who either have not been treated previously or who have failed previous therapy.

The addition of boceprevir to peginterferon-alpha and ribavirin for up to 44 weeks of therapy resulted in significant increase in efficacy of the standard of care regimen, based on sustained virologic responses, in two phase III studies: one study of 403 patients who had previously failed treatment (N. Engl. J. Med. 2011 March 31;364:1207-17) and another study of more than 1,097 treatment-naive patients (N. Engl. J. Med. 2011 March 31;364:1195-206). The safety of boceprevir was based on data from the two phase III studies and a phase II study of 595 treatment-naive patients: In the three trials, the two adverse events that occurred more than 20% more frequently among those treated with all three drugs, compared with those treated with the interferon-ribavirin combination, were anemia (49% vs. 29%) and dysgeusia (37% vs. 15%.).

The FDA usually follows the recommendations of its advisory panels, Panel members have been cleared of potential conflicts of interest related to the topic of the meeting, although occasionally, may be given a waiver, but not at this meeting.

Boceprevir is manufactured by Merck Research Laboratories If approved, Merck plans to market boceprevir as Victrelis. A decision on approval is expected by mid-May, according to the company. It is also under review as a treatment for chronic hepatitis C in the European Union.

On April 28, the same panel will review telaprevir, another HCV protease inhibitor as a treatment for chronic hepatitis C.

SILVER SPRING, MD. – A Food and Drug Administration advisory panel on April 27 voted 18-0 that the risk-benefit profile of the oral antiviral drug boceprevir supported its approval as a treatment for chronic hepatitis C, in combination with pegylated interferon-alpha and ribavirin, the current standard of care.

At the meeting, members of the FDA’s Antiviral Drugs Advisory Committee agreed that the protease inhibitor was effective when combined with standard therapy for the treatment of patients with chronic hepatitis C genotype-1 infections, the most common and least responsive type of hepatitis C virus (HCV). Despite concerns about some risks associated with treatment, such as an increased rate of anemia, panelists agreed that the risks were manageable and that the benefits of treatment were clear, with some describing it as a "marvelous" or "tremendous" advance in the treatment of chronic HCV.

But the panel emphasized the importance of appropriate patient selection and physician education about how to use the drug-as well as the need for postmarketing studies on drug-drug interactions and in different patient populations, such as in people over age 65 years and liver transplant recipients.

The recommended dosage of boceprevir, a potent inhibitor of HCV replication, is 800 mg three times a day, every 7-9 hours with food. The proposed indication is for the treatment of adults with compensated liver disease, who either have not been treated previously or who have failed previous therapy.

The addition of boceprevir to peginterferon-alpha and ribavirin for up to 44 weeks of therapy resulted in significant increase in efficacy of the standard of care regimen, based on sustained virologic responses, in two phase III studies: one study of 403 patients who had previously failed treatment (N. Engl. J. Med. 2011 March 31;364:1207-17) and another study of more than 1,097 treatment-naive patients (N. Engl. J. Med. 2011 March 31;364:1195-206). The safety of boceprevir was based on data from the two phase III studies and a phase II study of 595 treatment-naive patients: In the three trials, the two adverse events that occurred more than 20% more frequently among those treated with all three drugs, compared with those treated with the interferon-ribavirin combination, were anemia (49% vs. 29%) and dysgeusia (37% vs. 15%.).

The FDA usually follows the recommendations of its advisory panels, Panel members have been cleared of potential conflicts of interest related to the topic of the meeting, although occasionally, may be given a waiver, but not at this meeting.

Boceprevir is manufactured by Merck Research Laboratories If approved, Merck plans to market boceprevir as Victrelis. A decision on approval is expected by mid-May, according to the company. It is also under review as a treatment for chronic hepatitis C in the European Union.

On April 28, the same panel will review telaprevir, another HCV protease inhibitor as a treatment for chronic hepatitis C.