FDA approves telaprevir for hepatitis C

May 23, 2011

FDA approved telaprevir (Incivek, Vertex) tablets to treat certain adults with chronic hepatitis C infection.

FDA approved telaprevir (Incivek, Vertex) tablets to treat certain adults with chronic hepatitis C infection. Incivek is used for patients who have either not received interferon-based drug therapy for their infection or who have not responded adequately to prior therapies. Incivek is approved for use with interferon therapy made up of peginterferon alfa and ribavirin.

Incivek is a protease inhibitor, which works by binding to the virus and preventing it from multiplying.

Hepatitis C can lead to serious liver disease including liver cancer, liver failure, and the need for a transplant, according to Amy Pasqua, Vertex spokesperson. “Importantly, a majority of these people have been infected for decades and have scarring of the liver [cirrhosis] and are at risk for other serious consequences,” she said.

“People have been putting off treatment in anticipation for better medicines, including Incivek and we believe Incivek gives people the best chance at a viral cure,” Pasqua told Formulary. “Seventy-nine percent of people new to treatment achieved a cure with Incivek.”

Left untreated, hepatitis C total medical costs are expected to double from $30 billion to $85 billion in 10 years and commercial insurance and Medicare costs are projected to more than double.

On May 13, FDA approved boceprevir (Victrelis, Merck), another new treatment for chronic hepatitis C.

The approvals of telaprevir and boceprevir (click here for story) mark significant advancements in the treatment of hepatitis C, a disease that affects more than 3 million patients in the United States, according to Aimee Tharaldson, PharmD, senior clinical consultant at Express Scripts.

“The new protease inhibitors are approved to treat patients with genotype 1 chronic hepatitis C, which accounts for about 75% of all cases,” Dr Tharaldson said. “The current standard of care [weekly subcutaneous injections of pegylated interferon with twice daily oral ribavirin for 48 weeks] achieves a sustained virologic response [SVR) or viral cure in less than half of patients with genotype 1 chronic hepatitis C. When Victrelis and Incivek are included as part of a patient’s treatment regimen, SVR rates improve significantly in previously untreated patients and in those who have not adequately responded to pegylated interferon and ribavirin.”

Until recently, approximately 40% of people with hepatitis C achieved a viral cure despite a year of difficult-to-tolerate treatment, Pasqua said. “People have been waiting for medicines that would improve this rate of viral cure. We believe people deserve the best chance at a cure,” she said.

The current standard of care for patients with chronic hepatitis C infection is peginterferon alfa and ribavirin taken for 48 weeks. Less than 50% of patients respond to this therapy.

“More than 60% of people new to treatment and relapsers are expected to complete treatment in 24 weeks-half the time needed if you were to take pegylated-interferon and ribavirin alone,” Pasqua said. “Importantly, Incivek is given from the start of treatment along with pegylated-interferon and ribavirin.”

The safety and effectiveness of Incivek was evaluated in 3 phase 3 clinical trials with about 2,250 adult patients who were previously untreated, or who had received prior therapy. In all studies patients also received the drug with standard of care. In previously untreated patients, 79% of those receiving Incivek experienced a sustained virologic response (ie, the infection was no longer detected in the blood 24 weeks after stopping treatment) compared to standard treatment alone.

The sustained virologic response for patients treated with Incivek across all studies, and across all patient groups, was between 20% and 45% higher than current standard of care.

The studies indicate that treatment with Incivek can be shortened from 48 weeks to 24 weeks in most patients. Sixty percent of previously untreated patients achieved an early response and received only 24 weeks of treatment (compared to the standard of care of 48 weeks). The sustained virologic response for these patients was 90%.

When a person achieves a sustained virologic response after completing treatment, this suggests that the hepatitis C infection has been cured.

Sustained virologic response can result in decreased cirrhosis and complications of liver disease, decreased rates of liver cancer (hepatocellular carcinoma), and decreased mortality.

Incivek is taken 3 times a day with food. Incivek should be taken for the first 12 weeks in combination with peginterferon alfa and ribavirin. Most people with a good early response to the Incivek combination regimen can be treated for 24 weeks rather than the recommended 48 weeks of treatment with the standard of care.

The most commonly reported side effects in patients receiving Incivek in combination with peginterferon alfa and ribavirin include rash, low red blood cell count (anemia), nausea, fatigue, headache, diarrhea, itching (pruritus), and anal or rectal irritation and pain. Rash can be serious and can require stopping Incivek or all 3 drugs in the treatment regimen.