Hepatitis C

CTAF

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


ASSOCIATED MEETING & MATERIALS

CTAF
March 10, 2014 10:00AM-4:00PM (PST)

Mission Bay Conference Center, UCSF, San Francisco, CA

Key Dates

Associated Materials

02/12/2014

02/12/2014

03/10/2014

03/10/2014

03/17/2014

Public comments received on the Draft Evidence Report.


03/17/2014

04/15/2014

04/15/2014
Action Guide For Clinicians

04/15/2014
Action Guide For Payers and Policymakers

04/15/2014
Action Guide For Patients

Other Materials

Webcast Recording Policy Roundtable
Webcast Recording Deliberation and Voting
Webcast Recording Evidence Presentation and Public Comments

ASSOCIATED MEETING & MATERIALS

CTAF
December 18, 2014 9:30AM-4:30PM (PT)

The California Endowment, Oakland, CA

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.

Key Dates

Associated Materials

11/17/2014

11/17/2014

12/08/2014

Public comments received on the Draft Evidence Report.


12/08/2014

12/18/2014

12/18/2014

01/30/2015

01/30/2015
Action Guide For Patients

01/30/2015
Action Guide For Clinicians

01/30/2015
Action Guide For Payers and Policymakers