All FDA Approved Drugs To Treat Hepatitis C


Stay Updated
Drug Pipeline – Monthly Report

July 18, 2017
FDA Approved Gilead's VoseviTM Sofosbuvir/Velpatasvir/Voxilaprevir
Genotype 1, 2, 3, 4, 5 or 6 - Re-treatment of
chronic hepatitis C virus

April 7, 2017
FDA Approves HCV Sovaldi and Harvoni For Children Ages 12 to 17

Mar 2017
AbbVie Granted Priority Review in Japan for HCV Regimen of Glecaprevir/Pibrentasvir (G/P)

Feb 2017
U.S. FDA Grants Priority Review to AbbVie’s Investigational HCV Regimen of Glecaprevir/Pibrentasvir (G/P)

Dec 2016
Gilead Submits New Drug Application to U.S. Food and Drug Administration for the Investigational Single Tablet Regimen Sofosbuvir/Velpatasvir/Voxilaprevir

2017 - Of Interest
Current therapy for chronic hepatitis C: The role of direct-acting antivirals.
Antiviral Res. 2017 Jun;142:83-122. doi: 10.1016/j.antiviral.2017.02.014. Epub 2017 Feb 24.
Highlights
• HCV genotype-specific drugs evolve to pan-genotypic drugs.
• Drug potency increases from moderate (∼60%) to high (>90%) levels of sustained virologic response.
• Treatment durations are shortened from a 48-week to 12-week or 8-week period.
• HCV therapies based upon multiple pills per day are simplified to a single pill per day.
• HCV therapies are administered orally regardless of prior treatment history and cirrhotic status.

Current Updates
2017-HCV Genotypes/Treatment
Offered on this page is research updates with a focus on treating HCV according to genotype using FDA approved and investigational medicines.

April 2017
Drug Induced Pneumonitis Secondary to Treatment with VIEKIRA PAK® Hepatitis C: Case Report of an Unexpected Life-Threatening Adverse Reaction

March 20,2017
Hepatitis C: Down but Not Out - Oral Direct-Acting Agent Therapy for HCV

Feb 2017
FDA 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)

Feb 2017
Liver Specialist Refutes Study Claiming Hepatitis C Drug Dangers 

Feb 2017
New HCV fact sheets at TAG - Epclusa, HCV Genotypes, with updates on Viekira XR and Technivie

Jan 2017
Novel emerging treatments for hepatitis C infection: a fast-moving pipeline




FDA Approved Medications To Treat The Hepatitis C Virus


Brand Name
Generic
Names
Manufacturer
Name
Indication




VoseviSofosbuvir/Velpatasvir
/Voxilaprevir
Gilead
Re-treatment of chronic hepatitis C virus (HCV) infection in adults with genotype 1, 2, 3, 4, 5 or 6 previously treated with an NS5A inhibitor-containing regimen, or with genotype 1a or 3 previously treated with a sofosbuvir-containing regimen without an NS5A inhibitor.

July 18, 2017
VoseviTM (sofosbuvir 400 mg/velpatasvir 100 mg/voxilaprevir 100 mg) tablets, a single-tablet regimen for the re-treatment of chronic hepatitis C virus (HCV) infection in adults with genotype 1, 2, 3, 4, 5 or 6 previously treated with an NS5A inhibitor-containing regimen, or with genotype 1a or 3 previously treated with a sofosbuvir-containing regimen without an NS5A inhibitor.

HIGHLIGHTS OF PRESCRIBING INFORMATION
Press Release
EPCLUSAsofosbuvir
velpatasvir
Gilead
HCV genotype 1, 2, 3, 4, 5, or 6 infection

Jan 2017
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
Press Release
Zepatier elbasvir and grazoprevirMerck
HCV genotypes 1 or 4 infection

Mar 2017
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 
Press Release
DaklinzadaclatasvirBristol-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
Patient Information
FDA Press Release
Technivieombitasvir,
paritaprevir, ritonavir
AbbVie
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
Patient Information
VIEKIRA PAK

VIEKIRA XR

ombitasvir,
paritaprevir, ritonavir,
and dasabuvir
AbbVie
HCV genotype 1infection

HCV Advocate:
Easy Facts
VIEKIRA PAK

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
VIEKIRA XR
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.

VIEKIRA XR full Prescribing Information, including the Medication Guide.
Press Release
HarvoniLedipasvir
Sofosbuvir
Gilead Sciences

Indicated for the treatment of chronic hepatitis C virus HCV genotype 1, 4, 5 or 6 infection

April 7, 2017
FDA Approves HCV Harvoni For Children Ages 12 to 17
Harvoni is indicated for the treatment of pediatric patients 12 years of age and older or weighing at least 35 kilograms with HCV genotype 1, 4, 5 or 6 infection without cirrhosis or with compensated cirrhosis.
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
SovaldisofosbuvirGilead Sciences

HCV Advocate:


Sovaldi: Genotype 4 Triple Therapy

April 7, 2017
FDA Approves HCV Sovaldi For Children Ages 12 to 17
Sovaldi in combination with ribavirin is indicated for the treatment of pediatric patients 12 years of age and older or weighing at least 35 kilograms with genotype 2 or 3 HCV infection without cirrhosis or with compensated cirrhosis.
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
OlysiosimeprevirJanssen
HCV genotype 1infection

Nov 6 2014
FDA approves 
Olysio in combination with Sovaldi
Expanded indication includes both treatment-naive and treatment-experienced adult patients with or without cirrhosis

HCV Advocate:
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
IncivektelaprevirVertex
Aug 2014
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
VictrelisboceprevirMerck & 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.
Pegasyspegylated interferonRochetreatment of adults with chronic hepatitis C virus infection who have compensated liver disease and have not been previously treated with interferon alpha
Pegintronpegylated interferon alpha-2bSeptember 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
RebetolribavirinThe 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
Infergeninterferon aphacon-1Three Rivers PharmaInfergen FDA-Approved Prescribing Information

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