FDA approves simeprevir for hepatitis C virus

FDA has simeprevir (Olysio, Janssen Therapeutics, Division of Janssen Products, LP) for the treatment of chronic hepatitis C infection as part of an antiviral treatment regimen in combination with pegylated interferon and ribavirin in genotype 1 infected adults with compensated liver disease, including cirrhosis.

Olysio, an NS3/4A protease inhibitor, may benefit patients with chronic hepatitis C, including those who are treatment naïve or who have failed prior interferon-based therapy.

Chronic hepatitis C is a blood-borne infectious disease of the liver that affects approximately 3.2 million people in the United States.

“Hepatitis C is often an undiagnosed condition and the recent FDA approval of Olysio offers another line of treatment for individuals who are diagnosed,” said Formulary advisor Abimbola Farinde, PharmD, MS, who serves on the faculty at Columbia Southern University, Orange Beach, Ala. “The approval of Olysio has the potential to reduce the incidence of deaths that can result from associated illnesses such as cirrhosis or liver cancer.”

Olysio is the third FDA-approved protease inhibitor to treat chronic hepatitis C virus (HCV) infection. In 2011, boceprevir (Victrelis, Merck) and telaprevir (Incivek, Vertex Pharmaceuticals) were approved for the treatment of hepatitis C.

Olysio works by blocking the viral protease enzyme that enables the hepatitis C virus to replicate in host cells. The goal of treatment for chronic hepatitis C is cure, also known as sustained virologic response (SVR), which is defined as undetectable levels of HCV in the patients’ blood 12 to 24 weeks after the end of treatment. For treatment-naïve and prior-relapser patients, a fixed treatment regimen of 12 weeks of Olysio combined with 24 weeks of pegylated interferon and ribavirin is recommended. For prior partial- and null-responder patients, a treatment regimen of 12 weeks of Olysio combined with 48 weeks of pegylated interferon and ribavirin is recommended.

Olysio must not be taken alone. The efficacy of Olysio in combination with peginterferon and ribavirin is greatly decreased in patients who have genotype 1a Q80K. Patients are urged to speak to a healthcare professional about testing for genotype 1a Q80K and using a different therapy when genotype 1a Q80K is present. It is not known if Olysio is safe and effective in children under aged 18 years.

The safety and effectiveness of Olysio were evaluated in 5 clinical studies of 2,026 treatment-naive and treatment-experienced participants randomly assigned to receive Olysio plus peginterferon-alfa and ribavirin or placebo plus peginterferon-alfa and ribavirin. The studies were designed to measure whether a participant’s HCV was no longer detected in the blood at least 12 weeks after finishing treatment (sustained virologic response), suggesting a participant’s infection had been cured.

Results showed 80% of treatment-naive participants given Olysio plus peginterferon-alfa and ribavirin achieved sustained virologic response, compared to 50% of participants receiving peginterferon-alfa and ribavirin alone. In one of the studies with treatment-experienced participants whose infection returned (prior relapsers), 79% receiving Olysio plus peginterferon-alfa and ribavirin achieved sustained virologic response compared to 37% of participants receiving peginterferon-alfa and ribavirin alone.

Another study examined Olysio’s safety and effectiveness in treatment-experienced participants, including prior relapsers, those who partially responded to prior therapy (partial responders) and those who did not respond to prior therapy (null responders). Adding Olysio improved response rates in each of these subgroups compared to peginterferon-alfa and ribavirin alone.

A reduction in Olysio’s effectiveness was observed in participants infected with the genotype 1a HCV with an NS3 Q80K polymorphism, a strain of the hepatitis C virus commonly found in the United States. Olysio’s drug label includes a recommendation to screen for the presence of the strain prior to beginning therapy and to consider alternative therapy if the strain is detected.

The most common side effects reported in clinical study participants treated with Olysio in combination with peginterferon-alfa and ribavirin were rash (including photosensitivity), itching (pruritis), and nausea. Serious photosensitivity reactions resulting in hospitalization were reported. Patients will be advised to limit sun exposure and to use sun protective measures during treatment with Olysio in combination with peginterferon alfa and ribavirin.