FDA: Second Protease Inhibitor Backed for Treating Hepatitis C

SILVER SPRING, MD. – A Food and Drug Administration advisory panel on April 28 unanimously supported the approval of the oral antiviral drug telaprevir as a treatment for genotype 1 chronic hepatitis C when combined with pegylated interferon and ribavirin, the current standard of care. The combination is to be used in adults with compensated liver disease, including cirrhosis.

At the meeting of the FDA’s Antiviral Drugs Advisory Committee, the panel voted 18-0 that the available data on the risk-benefit profile of the drug supported its approval for treatment of this group of patients, despite the increased risk of rash and anemia associated with the addition of telaprevir. The vote applied to patients who have never received treatment before and those who have been treated previously for genotype 1 hepatitis C virus (HCV), the most common and difficult-to-treat HCV subtype.

In three phase III studies of more than 2,000 treatment-naive and treatment-experienced patients, the addition of telaprevir, an HCV-specific protease inhibitor taken three times a day for up to 12 weeks, to pegylated interferon and ribavirin significantly increased the sustained virologic response (SVR) rate, compared with pegylated interferon and ribavirin therapy. The benefit was seen across a broad range of populations and demographic groups, including in black patients and in those with cirrhosis. (SVR was defined as undetectable HCV RNA levels 24 weeks after the last planned dose of the drug.)

The panel agreed that the risks of rash with treatment, which could be severe and treatment limiting, and the increased risk of anemia with the addition of telaprevir were outweighed by the benefit of the drug, which one panelist described as a "stunning success." Still, they agreed more studies are needed, including in more black patients and in patients over age 65 years.

The manufacturer, Vertex Pharmaceuticals has devised a plan to help clinicians and patients identify and manage rashes and is planning or conducting studies in different populations, including black patients, patients with cirrhosis, patients coinfected with HIV and HCV, post-transplant patients, and children and adolescents aged 3-17 years. The company is also planning to study a twice-daily dosing regimen.

The same advisory panel supported the approval of another oral HCV protease inhibitor, boceprevir, on April 27, for the same indication. Once the two drugs are approved, several panelists noted that it would no longer be considered ethical to conduct treatment studies using pegylated interferon and ribavirin as the control group. And panelists agreed that triple therapy would become the new standard of care, once the protease inhibitors are approved.

The FDA usually follows the recommendations of its advisory panels. A decision on telaprevir is expected by May 23, according to Vertex. Telaprevir is also under review in Canada and the European Union for treating people with genotype 1 chronic hepatitis C.

Members of FDA panels have usually been cleared of conflicts related to the product under review; occasionally, a panelist is given a waiver, but not at this meeting.

SILVER SPRING, MD. – A Food and Drug Administration advisory panel on April 28 unanimously supported the approval of the oral antiviral drug telaprevir as a treatment for genotype 1 chronic hepatitis C when combined with pegylated interferon and ribavirin, the current standard of care. The combination is to be used in adults with compensated liver disease, including cirrhosis.

At the meeting of the FDA’s Antiviral Drugs Advisory Committee, the panel voted 18-0 that the available data on the risk-benefit profile of the drug supported its approval for treatment of this group of patients, despite the increased risk of rash and anemia associated with the addition of telaprevir. The vote applied to patients who have never received treatment before and those who have been treated previously for genotype 1 hepatitis C virus (HCV), the most common and difficult-to-treat HCV subtype.

In three phase III studies of more than 2,000 treatment-naive and treatment-experienced patients, the addition of telaprevir, an HCV-specific protease inhibitor taken three times a day for up to 12 weeks, to pegylated interferon and ribavirin significantly increased the sustained virologic response (SVR) rate, compared with pegylated interferon and ribavirin therapy. The benefit was seen across a broad range of populations and demographic groups, including in black patients and in those with cirrhosis. (SVR was defined as undetectable HCV RNA levels 24 weeks after the last planned dose of the drug.)

The panel agreed that the risks of rash with treatment, which could be severe and treatment limiting, and the increased risk of anemia with the addition of telaprevir were outweighed by the benefit of the drug, which one panelist described as a "stunning success." Still, they agreed more studies are needed, including in more black patients and in patients over age 65 years.

The manufacturer, Vertex Pharmaceuticals has devised a plan to help clinicians and patients identify and manage rashes and is planning or conducting studies in different populations, including black patients, patients with cirrhosis, patients coinfected with HIV and HCV, post-transplant patients, and children and adolescents aged 3-17 years. The company is also planning to study a twice-daily dosing regimen.

The same advisory panel supported the approval of another oral HCV protease inhibitor, boceprevir, on April 27, for the same indication. Once the two drugs are approved, several panelists noted that it would no longer be considered ethical to conduct treatment studies using pegylated interferon and ribavirin as the control group. And panelists agreed that triple therapy would become the new standard of care, once the protease inhibitors are approved.

The FDA usually follows the recommendations of its advisory panels. A decision on telaprevir is expected by May 23, according to Vertex. Telaprevir is also under review in Canada and the European Union for treating people with genotype 1 chronic hepatitis C.

Members of FDA panels have usually been cleared of conflicts related to the product under review; occasionally, a panelist is given a waiver, but not at this meeting.

SILVER SPRING, MD. – A Food and Drug Administration advisory panel on April 28 unanimously supported the approval of the oral antiviral drug telaprevir as a treatment for genotype 1 chronic hepatitis C when combined with pegylated interferon and ribavirin, the current standard of care. The combination is to be used in adults with compensated liver disease, including cirrhosis.

At the meeting of the FDA’s Antiviral Drugs Advisory Committee, the panel voted 18-0 that the available data on the risk-benefit profile of the drug supported its approval for treatment of this group of patients, despite the increased risk of rash and anemia associated with the addition of telaprevir. The vote applied to patients who have never received treatment before and those who have been treated previously for genotype 1 hepatitis C virus (HCV), the most common and difficult-to-treat HCV subtype.

In three phase III studies of more than 2,000 treatment-naive and treatment-experienced patients, the addition of telaprevir, an HCV-specific protease inhibitor taken three times a day for up to 12 weeks, to pegylated interferon and ribavirin significantly increased the sustained virologic response (SVR) rate, compared with pegylated interferon and ribavirin therapy. The benefit was seen across a broad range of populations and demographic groups, including in black patients and in those with cirrhosis. (SVR was defined as undetectable HCV RNA levels 24 weeks after the last planned dose of the drug.)

The panel agreed that the risks of rash with treatment, which could be severe and treatment limiting, and the increased risk of anemia with the addition of telaprevir were outweighed by the benefit of the drug, which one panelist described as a "stunning success." Still, they agreed more studies are needed, including in more black patients and in patients over age 65 years.

The manufacturer, Vertex Pharmaceuticals has devised a plan to help clinicians and patients identify and manage rashes and is planning or conducting studies in different populations, including black patients, patients with cirrhosis, patients coinfected with HIV and HCV, post-transplant patients, and children and adolescents aged 3-17 years. The company is also planning to study a twice-daily dosing regimen.

The same advisory panel supported the approval of another oral HCV protease inhibitor, boceprevir, on April 27, for the same indication. Once the two drugs are approved, several panelists noted that it would no longer be considered ethical to conduct treatment studies using pegylated interferon and ribavirin as the control group. And panelists agreed that triple therapy would become the new standard of care, once the protease inhibitors are approved.

The FDA usually follows the recommendations of its advisory panels. A decision on telaprevir is expected by May 23, according to Vertex. Telaprevir is also under review in Canada and the European Union for treating people with genotype 1 chronic hepatitis C.

Members of FDA panels have usually been cleared of conflicts related to the product under review; occasionally, a panelist is given a waiver, but not at this meeting.