Boceprevir Treatment for Hepatitis C-FDA


Boceprevir (Victrelis, Merck) has been approved as treatment drug for hepatitis C virus (HCV) infection, by The US Food and Drug Administration (FDA) making it the first new drug for HCV in 20 years.

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Boceprevir is approved for the treatment of chronic hepatitis C genotype 1 infection, along with peginterferon alfa and ribavirin, for people aged 18 and older with compensated liver disease, including cirrhosis, who are formerly untreated or who have failed preceding interferon and ribavirin therapy.

The FDA’s approval was expected considering the Antiviral Drugs Advisory Committee’s 18 to 0 vote on April 27 was in support of Boceprevir as medication for Hepatitis C Virus (HCV). The approval was done based on trial data analysis from the inferences of a couple phase 3 randomized trials, that were done in 1500 previously cases of treatment and untreated patients.

Studies found that patients who were treated with Boceprevir showed considerably higher rate of sustained virologic response compared to the control group who received the standard treatment of ribavirin plus pegylated interferon.”When a person sustains a virologic response after completing treatment, this suggests that HCV infection has been cured,” the FDA release notes.

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“[Boceprevir] is an important new advance for patients with hepatitis C,” noted Edward Cox, MD, MPH, director, Office of Antimicrobial Products in FDA’s Center for Drug Evaluation and Research. “This new medication provides an effective treatment for a serious disease and offers a greater chance of cure for some patients’ hepatitis C infection compared to currently available therapy.”

The drug company says that with the FDA approval on their favor, Boceprevir will be shipped to pharmacies within a week. Also the company is making use of resources that include couposn to help eligible patients with cost of medication, compensation support to aid patients comprehend their insurance coverage for Boceprevir and also 24/7 nurse support through phone.

How does Boceprevir treat HC? The medication interferes with the functionality of the HCV to replicate by stopping a key viral enzyme called NS3/4A serine protease. As we talk about Boceprevir, another medicine of the same class of agents called Telaprevir (Vertex) has also been given thumbs-up by the antiviral d Antiviral Drugs Advisory Committee and is awaiting FDA approval.

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