Search Results for: Sofosbuvir

Hepatitis C

Chronic hepatitis C is a common infection that is a major cause of chronic liver disease, liver failure, and hepatocellular carcinoma (HCC), and it is the leading indication for liver transplantation in the Western world.  Prior to 2011, the combination of pegylated interferon and ribavirin was the gold standard of therapy for the treatment of chronic hepatitis C.  Since 2014, several therapies have been approved to treat hepatitis C offering patients new options for treating the chronic illness.

Interventions of interest:

Simeprevir (Olysio®, Janssen Products, LP) + sofosbuvir (Sovaldi®, Gilead Sciences, Inc.)
Ledipasvir/sofosbuvir (Harvoni®, Gilead Sciences, Inc.)
Daclatasvir (Daklinza, Bristol-Myers Squibb Company) + sofosbuvir (Sovaldi®, Gilead Sciences, Inc.)
Paritaprevir/ritonavir/ombitasvir + dasabuvir with ribavirin (Viekira Pak, AbbVie, Inc.)
Simeprevir (Olysio®, Janssen Products, LP)+ pegylated interferon and ribavirin

Sofosbuvir (Sovaldi®, Gilead Sciences, Inc.) + ribavirin
Sofosbuvir (Sovaldi®, Gilead Sciences, Inc.) + pegylated interferon and ribavirin

Date of review: December 2014

Interventions of interest:

Sofosbuvir (Sovaldi®, Gilead Sciences, Inc.)
Simeprevir (Olysio®, Janssen Products, LP)

Date of review: March 2014


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Treatments for Hepatitis C: Final Report

This assessment addresses the following questions:

1) among patients with genotype 1, are treatment regimens incorporating simeprevir and sofosbuvir equivalent or superior to the previous standard of care: pegylated interferon plus ribavirin and one of the first generation protease inhibitors telaprevir or boceprevir;

2) among patients with genotypes 2 and 3, is the combination of sofosbuvir and ribavirin equivalent or superior to the previous standard of care, pegylated interferon plus ribavirin; and

3) among interferon‐ineligible or intolerant patients, is the combination of sofosbuvir plus ribavirin or sofosbuvir plus simeprevir equivalent or superior to no treatment.

The purpose of this assessment is to help patients, providers, and payers address these important questions and to support dialogue needed for successful action to improve the quality and value of health care for patients with hepatitis C.

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Newest Treatments for Hepatitis C, Genotype 1

CTAF assessed the comparative effectiveness and value of multiple new, all-oral direct-acting antiviral agent (DAA) regimens for the treatment of hepatitis C. The review covers treatments under review by the FDA, including those developed by Gilead Sciences, Inc., AbbVie Inc., and Bristol-Myers Squibb Co. CTAF examined the first two DAAs approved for treating hepatitis C (sofosbuvir and simeprevir) at its March 2014 meeting, and the December 2014 meeting furthered discussion to help clinicians, patients, and policymakers understand the evolving evidence base on how best to treat hepatitis C. A policy roundtable discussion focused on the issue of drug pricing and payment models for costly drugs.

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Next Public Meeting of CTAF to Examine Newest Treatments for Hepatitis C

San Francisco, Calif., August 18, 2014 – The California Technology Assessment Forum (CTAF), a core program of the Institute for Clinical and Economic Review (ICER), will hold a public meeting on December 18, 2014 in Oakland, CA to assess the comparative effectiveness and value of multiple new, all-oral direct-acting antiviral agent (DAA) regimens for the […]

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Treatments for Hepatitis C: Intial Draft Report

A draft report reviewing the comparative clinical effectiveness and value of Sofosbuvir (Sovaldi®, Gilead Sciences, Inc.) and Simeprevir (Olysio®, Janssen Products, LP). This draft report was updated based on public comments received.

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