UpdatesFDA approved class labeling revisions regarding the risk of hepatitis B virus reactivation in patients coinfected with hepatitis C virus (HCV) and hepatitis B virus (HBV)
New HCV fact sheets at TAG - Epclusa, HCV Genotypes, with updates on Viekira XR and Technivie
Novel emerging treatments for hepatitis C infection: a fast-moving pipeline
Offered on this page is research updates with a focus on treating HCV according to genotype using FDA approved and investigational medicines.
Liver Specialist Refutes Study Claiming Hepatitis C Drug Dangers
FDA Approved Medications To Treat The Hepatitis C Virus
HCV genotype 1, 2, 3, 4, 5, or 6 infection
Epclusa for Hep C: What Pharmacists Should Know
|June 28 2016 |
EPCLUSA is a fixed-dose combination of sofosbuvir, a hepatitis C virus (HCV) nucleotide analog NS5B polymerase inhibitor, and velpatasvir, an HCV NS5A inhibitor, and is indicated for the treatment of adult patients with chronic HCV genotype 1, 2, 3, 4, 5, or 6 infection
• without cirrhosis or with compensated cirrhosis
• with decompensated cirrhosis for use in combination with ribavirin
Prescribing Information: EPCLUSA
|Zepatier||elbasvir and grazoprevir||Merck|
HCV genotypes 1 or 4 infection
Grazoprevir/Elbasvir Effectively Induces SVR in HCV with Prior Failure
|ZEPATIER is a fixed-dose combination product containing elbasvir, a hepatitis C virus (HCV) NS5A inhibitor, and grazoprevir, an HCV NS3/4A protease inhibitor, and is indicated with or without ribavirin for treatment of chronic HCV genotypes 1 or 4 infection in adults|
The FDA previously granted two Breakthrough Therapy designations to ZEPATIER, for the treatment of chronic HCV GT1 infection in patients with end stage renal disease on hemodialysis, and for the treatment of patients with chronic HCV GT4 infection. Breakthrough Therapy designation is given to investigational medicines for serious or life-threatening conditions that may offer substantial improvement over existing therapies.
Prescribing Information for ZEPATIER
Patient Information for ZEPATIER
|Daklinza||daclatasvir||Bristol-Myers Squibb |
HCV genotype 3 infection
HCV Advocate Easy Facts
Genotype 3: Daklinza plus Sofosbuvir
|Daklinza (daclatasvir), an NS5A replication complex inhibitor is indicated for use with sofosbuvir for the treatment of patients with chronic HCV genotype 3 infection. Sustained virologic response (SVR) rates are reduced in HCV genotype 3-infected patients with cirrhosis receiving this regimen. The recommended dosage of DAKLINZA is 60 mg, taken orally, once daily in combination with sofosbuvir for 12 weeks. DAKLINZA may be taken with or without food.The optimal duration of DAKLINZA and sofosbuvir for patients with cirrhosis has not been established.|
Update Feb 5 2016
FDA has approved Expanded Use for Daklinza (daclatasvir) in combination with sofosbuvir with or without ribavirin to treat HCV genotypes 1 and 3.
Download Daklinza Full Prescribing Information
FDA Press Release
HCV genotype 4 infection
HCV Advocate Easy Facts
Genotype 4: TECHNIVIE plus Ribavirin
Tuesday, February 28, 2017
TECHNIVIE (fixed-dose combination of ombitasvir, paritaprevir, and ritonavir) label was updated to expand the indication
|TECHNIVIE, a fixed-dose combination containing ombitasvir, a hepatitis C virus NS5A inhibitor; paritaprevir, a hepatitis C virus NS3/4A protease inhibitor; and ritonavir, a CYP3A inhibitor. The product is indicated in combination with ribavirin for the treatment of patients with genotype 4 chronic hepatitis C virus (HCV) infection without cirrhosis.|
The recommended dosage of TECHNIVIE in adults is two tablets taken orally once daily (in the morning) with a meal without regard to fat or calorie content. TECHNIVIE is intended to be used in combination with ribavirin for 12 weeks. TECHNIVIE administered without ribavirin for 12 weeks may be considered for treatment-naïve patients who cannot take or tolerate ribavirin.
Download TECHNIVIE Full Prescribing Information
HCV genotype 1infection
|VIEKIRA PAK includes ombitasvir, a hepatitis C virus NS5A inhibitor, paritaprevir, a hepatitis C virus NS3/4A protease inhibitor, ritonavir, a CYP3A inhibitor and dasabuvir, a hepatitis C virus non-nucleoside NS5B palm polymerase inhibitor.|
VIEKIRA PAK with or without ribavirin is indicated for the treatment of patients with genotype 1 chronic hepatitis C virus (HCV) infection including those with compensated cirrhosis.
VIEKIRA PAK is not recommended for use in patients with decompensated liver disease
Download VIEKIRA PAK FULL PRESCRIBING INFORMATION
Update July 25, 2016
FDA approves a New Drug Application (NDA) for VIEKIRA XR (dasabuvir, ombitasvir, paritaprevir and ritonavir)VIEKIRA XR is a once-daily, extended-release co-formulation of the active ingredients in VIEKIRA PAK (ombitasvir, paritaprevir, and ritonavir tablets; dasabuvir tablets) and is for the treatment of patients with chronic genotype 1 (GT1) hepatitis C virus (HCV) infection, including those with compensated cirrhosis (Child-Pugh A). VIEKIRA XR is not for people with decompensated cirrhosis.
VIEKIRA XR differs from VIEKIRA Pak in that all of the HCV antiviral drugs are now combined in one fixed dose combination tablet for once daily dosing. The daily mg dose of dasabuvir is higher, and dasabuvir is administered once daily as part of the fixed dose combination.
Indicated for the treatment of chronic hepatitis C virus HCV genotype 1, 4, 5 or 6 infection
|HARVONI is a fixed-dose combination of ledipasvir, a hepatitis C virus (HCV) NS5A inhibitor, and sofosbuvir, an HCV nucleotide analog NS5B polymerase inhibitor, and is indicated for the treatment of chronic hepatitis C (CHC) genotype 1 infection in adults.|
Update November 2015
In November of 2015 The U.S. Food and Drug Administration (FDA) has approved Harvoni® (ledipasvir/sofosbuvir) for expanded use in patients with genotype 4, 5 and 6 chronic hepatitis C virus (HCV) infection and in patients co-infected with HIV. In addition, Harvoni plus ribavirin (RBV) for 12 weeks was approved as an alternate therapy to 24 weeks of Harvoni for treatment-experienced, genotype 1 patients with cirrhosis. Harvoni received regulatory approval for the treatment of chronic HCV genotype 1 infection in adults in the United States in October 2014.
View Gilead Sciences Press Release
View FDA - Label Update
Feb - 2016 FDA Label Update
FDA approved changes to the Harvoni (ledipasvir and sofosbuvir) fixed-dose combination label to expand the patient population to include those with chronic hepatitis C virus genotype 1, infection who are liver transplant recipients, genotype 4 infection who are liver transplant recipients without cirrhosis, or with compensated cirrhosis, and genotype 1 infection with decompensated cirrhosis.
View FDA - Label Update
Download U.S. Prescribing Information
Download Patient Information
|SOVALDI is a hepatitis C virus (HCV) nucleotide analog NS5B polymerase inhibitor indicated for the treatment of chronic hepatitis C (CHC) infection as a component of a combination antiviral treatment regimen.|
Sovaldi is approved in HCV genotypes 1 and 4, treatment-naive adults in combination with PEG-IFN and ribavirin and the first approved interferon-free treatment regimen for people with HCV genotypes 2 and 3. Overall cure rates are at 80%, response rates and treatment duration varies, depending on genotype, viral and host factors. *Gilead states that Sovaldi in combination with ribavirin alone for 24 weeks can be considered for patients with genotype 1 infection who are interferon ineligible. Additionally, Sovaldi should be used in combination with ribavirin for treatment of HCV patients with hepatocellular carcinoma awaiting liver transplantation for up to 48 weeks or until liver transplantation to prevent post-transplant hepatitis C infection.
Sovaldi (sofosbuvir) - Summary of the basis of approval and highlights from prescribing information download sofosbuvir FDA review package
HCV genotype 1infection
Nov 6 2014
Olysio in combination with Sovaldi
Expanded indication includes both treatment-naive and treatment-experienced adult patients with or without cirrhosis
Easy Fact Sheet
Olysio (Simeprevir) combined with pegylated interferon plus ribavirin
March 1, 2016
FDA Update - OLYSIO (simeprevir) label revised to include pharmacokinetic, safety and efficacy data in treatment-naïve adult patients of East Asian ancestry with chronic hepatitis C virus genotype 1 infection.
|OLYSIO is a hepatitis C virus (HCV) NS3/4A protease inhibitor indicated for the treatment of chronic hepatitis C (CHC) infection as a component of a combination antiviral treatment regimen.|
OLYSIO (Simeprevir) is approved for the treatment of HCV genotype 1, in combination with peginterferon alfa and ribavirin in adults with compensated liver disease, including cirrhosis, who are treatment-naive or who have failed previous interferon therapy (pegylated or non‑pegylated) with ribavirin.
Simeprevir - Prescribing Information
Simeprevir - Patient Information
Vertex to stop selling hepatitis C drug Incivek
|Vertex used in combination with peginterferon alfa and ribavirin, for the treatment of genotype 1 chronic hepatitis C (CHC) in adult patients with compensated liver disease, including cirrhosis, who are treatment-naive or who have been previously treated with interferon-based treatment, including prior null responders, partial responders, and relapsers|
|Victrelis||boceprevir||Merck & Co|
On Jan 20,2015 The Food and Drug Administration (FDA) is informing that Victrelis (boceprevir; Merck) 200mg capsules will be discontinued..
|Treatment of chronic hepatitis C (CHC) genotype 1 infection, in combination with peginterferon alfa and ribavirin, in adult patients (older then 18 years of age) with compensated liver disease, including cirrhosis, who are previously untreated or who have failed previous interferon and ribavirin therapy.|
|Pegasys||pegylated interferon||Roche||treatment of adults with chronic hepatitis C virus infection who have compensated liver disease and have not been previously treated with interferon alpha|
|Pegintron||pegylated interferon alpha-2b||September 2015|
The Food and Drug Administration (FDA) announced that Rebetol(ribavirin; Merck) capsules and PegIntron (peginterferon alfa-2b; Merck) for Injection are being discontinued. The decision is business-related and not due to safety or efficacy issues with the drugs.
|Rebetol, is indicated for the treatment of chronic hepatitis C in patients 3 years of age and older with compensated liver disease use alone for the treatment of chronic hepatitis C in patients with compensated liver disease previously untreated with interferon alpha and who are at least 18 years of age and intolerant to ribavirin|
|Rebetol||ribavirin||The Food and Drug Administration (FDA) announced that Rebetol(ribavirin; Merck) capsules and PegIntron (peginterferon alfa-2b; Merck) for Injection are being discontinued. The decision is business-related and not due to safety or efficacy issues with the drugs.||Rebetol (ribavirin) FDA-Approved Prescribing Information|
|Infergen||interferon aphacon-1||Three Rivers Pharma||Infergen FDA-Approved Prescribing Information|