Current Updates
January 2020 What are the best hepatitis C drugs? Archives January 08, 2019 Japan’s Ministry of Health, Labour and Welfare Approves Gilead’s Epclusa® (Sofosbuvir/Velpatasvir) October 2018 World J Hepatol. Oct 27, 2018; 10(10): 670-684 Era of direct acting anti-viral agents for the treatment of hepatitis C
Sept 2018
Gilead Subsidiary to Launch Authorized Generics of Epclusa® (Sofosbuvir/Velpatasvir) and Harvoni® (Ledipasvir/Sofosbuvir) for the Treatment of Chronic Hepatitis C -- List Price of Authorized Generics to Reflect Discounts in the System Today May 2018
May 24, 2018
Offered on this page is research updates with a focus on treating HCV according to genotype using FDA approved and investigational medicines.
Research Articles
Current full text articles covering every aspect of hepatitis C.
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FDA Approved Medications To Treat The Hepatitis C Virus
| Brand Name | Generic Names |
Manufacturer Name |
Indication |
|---|---|---|---|
| Mavyret |
glecaprevir pibrentasvir |
AbbVie Genotype 1, 2, 3, 4, 5 or 6 without cirrhosis or with mild cirrhosis FDA Hepatitis Updates MAVYRET Treatment Duration, Overall Adverse Reactions and Drug Interactions On This Blog News and Updates |
Aug 3, 2017 MAVYRET™ a once-daily, ribavirin-free treatment for adults with chronic hepatitis C virus (HCV) infection across all major genotypes (GT1-6). MAVYRET is an 8-week, pan-genotypic treatment for patients without cirrhosis and who are new to treatment. Up to 95 percent of HCV patients in the U.S. may be eligible for treatment with MAVYRET, including patients with compensated cirrhosis or without cirrhosis and those with limited treatment options, such as patients with chronic kidney disease (CKD).* HIGHLIGHTS OF PRESCRIBING INFORMATION Press Release |
| Vosevi |
Sofosbuvir/ 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 23, 2017 |
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 |
| EPCLUSA | sofosbuvir velpatasvir |
Gilead HCV genotype 1, 2, 3, 4, 5, or 6 infection Jan 2017 Epclusa for Hep C: What Pharmacists Should Know Aug 1, 2017 FDA Approves Expanded Labeling for Epclusa® for Hepatitis C in Patients Co-Infected with HIV |
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 grazoprevir | Merck 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 |
| 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 Patient Information FDA Press Release |
| Technivie | ombitasvir, 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 full Prescribing Information, including the Medication Guide. 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. Press Release |
| Harvoni | Ledipasvir 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. Press Release 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 | sofosbuvir | Gilead Sciences HCV Advocate: 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 |
| Olysio | simeprevir | Janssen Genotype 1 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 |
| Incivek | telaprevir | Vertex 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 |
| 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 |
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