In Clinical Trials. Persons with genotype 1 who were treatment-naïve (never treated before), did not have cirrhosis and were treated with Harvoni® for 12 weeks had a 99% response (cure) rate. Those who had a baseline viral load of less than 6 million and were treated for 8 weeks had a 97% response rate. Persons with cirrhosis who were treatment-naïve had a 94% response rate. Persons without cirrhosis in whom prior treatment failed and were treated for 12 weeks had a 95% response rate. Persons with cirrhosis in whom prior treatment failed and were treated for 24 weeks had a 100% response rate.
In Clinical Trials. Persons with genotype 3 who were treatment-naïve and were given sofosbuvir in combination with peginterferon and ribavirin had a 95% response rate. Persons with genotype 4 who were treatment-naïve had a 96% response rate to sofosbuvir in combination with peginterferon and ribavirin for 12 weeks. Note, the number of genotype 4 patients in clinical trials was small (28 patients studied). For those with genotypes 5 and 6, sofosbuvir in combination with peginterferon and ribavirin for 12 weeks is an alternative treatment. In one clinical trial all 6 subjects with genotype 6 and the 1 subject with genotype 5 responded to treatment.
In Clinical Trials. The treatment response (cure) rate for Epclusa® given for 12 weeks was 99% overall for persons with genotypes 1, 2, 4, 5, and 6 who were never treated before or were treated in the past with peginterferon and ribavirin with or without a protease inhibitor, who did not have cirrhosis, or had compensated (mild) cirrhosis (ASTRAL-1). Persons with genotype 1a had a 98% response rate (ASTRAL -1). Persons with genotype 1b had a 99% response rate (ASTRAL -1). Persons with genotype 2 had a 99% response rate (ASTRAL-2). Persons who were genotype 4 had a 100% response rate (ASTRAL -1). Persons with genotype 5 had a 97% response rate (ASTRAL -1). Persons with genotype 6 had a 100% response rate (ASTRAL -1). The treatment response rate for Epclusa® given for 12 weeks was 95% overall for persons with genotype 3 (ASTRAL-3). For persons with genotype 3 who were treatment naïve without cirrhosis, the response rate was 98% (ASTRAL -3). Persons with genotype 3 who were treatment experienced without cirrhosis had a response rate of 94% (ASTRAL -3). Persons with genotype 3 who were treatment naïve (never before treated) and had compensated (mild) cirrhosis had a 93% response rate (ASTRAL -3). Persons with genotype 3 who were treatment experienced with compensated (mild) cirrhosis had an 89% response rate (ASTRAL -3).
In Clinical Trials. Persons with genotype 1 who were treatment-naïve (never treated before), did not have cirrhosis, and were treated with Harvoni® for 12 weeks had a 99% response (cure) rate. In persons with a baseline viral load of less than 6 million who did not have cirrhosis, the response rate was 97% with 8-week treatment and 96% with 12-week treatment. Persons with cirrhosis who were treatment-naïve had a 94% response rate. Persons without cirrhosis in whom prior treatment with peginterferon, ribavirin and/or a protease inhibitor failed were treated for 12 and 24 weeks with Harvoni®. The response in those who took 12 weeks was 95% and for those who received 24 weeks the response was 99%. Persons with cirrhosis in whom prior treatment with peginterferon, ribavirin, and/or a protease inhibitor failed had an 86% response to 12 weeks and 100% response rate to 24 weeks of Harvoni®. There are no data available on the use of Harvoni for 24 weeks in decompensated cirrhosis. However, in one study of this regimen in persons with genotype 1 with compensated cirrhosis the response was 71%. Persons with genotypes 4, 5, or 6 regardless of prior treatment experience or the presence or absence of compensated cirrhosis took Harvoni® for 12 weeks. Persons who were genotype 4 or 5 had a 93% or better treatment response (cure) rate. Those who were genotype 6 had a 96% response rate.
In Clinical Trials. Persons with genotype 1 who were treatment-naïve (never treated before) and did not have cirrhosis and were treated with sofosbuvir in combination with peginterferon and ribavirin for 12 weeks had a 90% response (cure) rate. Persons who were treatment-naïve genotype 1 with cirrhosis, had an 80% response rate. Those with multiple factors that affect treatment (advanced fibrosis, IL-28b CT or TT genotype (see explanation of test page 2), virus > 800,000 IU/ml) had a 71% response rate. Those who failed previous peginterferon/ribavirin therapy are expected to have approximately this same rate of cure (71%) based on computer modeling. Persons with genotype 1 who were treatment-naïve and were given sofosbuvir plus ribavirin (no peginterferon) for up to 24 weeks had response rates from 50-84% in clinical trials with an overall response rate of 72%. Persons with genotype 2 who were treatment naïve had a ≥ 95% chance of achieving a sustained virologic response from sofosbuvir and ribavirin for 12 weeks. Those with cirrhosis had a response rate of 83% in clinical trials. Persons with genotype 3 who were treatment-naïve, regardless of cirrhosis status had a ≥ 92% response rate to sofosbuvir in combination with ribavirin for 24 weeks. For those who were treatment-experienced, the response rate was 77% and treatment-experienced with cirrhosis, the response rate was 60%. Persons with genotype 3 who were treatment-naïve and were given sofosbuvir in combination with peginterferon and ribavirin (4 to 12 weeks) had a 97% response rate (39 patients studied). Persons with genotype 4 who were treatment-naïve had a 96% response rate to sofosbuvir in combination with peginterferon and ribavirin for 12 weeks. Note, the number of genotype 4 patients in clinical trials was small (28 patients studied). Few data from clinical trials are available for genotypes 5 and 6. Therefore if patients with genotype 5 or 6 need immediate treatment, daily sofosbuvir in combination with peginterferon and ribavirin therapy for 12 weeks is recommended by the American Association for the Study of Liver Diseases (AASLD) and Infectious Disease Society of America (IDSA). No data supports use of a peginterferon-free treatment regimen for those with genotype 5 or 6.
In Clinical Trials. The overall treatment response (cure) rate for Epclusa® and ribavirin given for 12 weeks was 94% for persons with hepatitis C genotypes 1, 2, 3, and 4 with decompensated cirrhosis (Child- Xxxx B or C) who were never treated before or were treated in the past with peginterferon and ribavirin with or without a protease inhibitor (ASTRAL-4). Persons with genotype 1a had a 94% (51/54) response rate. Those with genotype 1b had a 100% (14/14) response rate. Persons with genotype 2 had a 100% (4/4) response rate. Those with genotype 3 had an 85% (11/13) response rate. Persons with genotype 4 had a 100% (2/2) response rate. Genotype 3 subjects with pretreatment Y93H resistance associated polymorphisms (RAPs) treated for 12 weeks with Epclusa® had an 80% response rate. Those with compensated cirrhosis and pretreatment RAPs had a 67% response rate. It is expected that the sustained virologic response rate will improve with the addition of ribavirin.
In Clinical Trials. Persons with genotype 3 who were treatment-naïve and were given sofosbuvir in combination with peginterferon and ribavirin had a 97% response rate (39 patients studied). Persons with genotype 4 who were treatment-naïve had a 96% response rate to sofosbuvir in combination with peginterferon and ribavirin for 12 weeks. Note, the number of genotype 4 patients in clinical trials was small (28 patients studied). Few data from clinical trials are available for genotypes 5 and 6. Therefore if persons with genotype 5 or 6 need immediate treatment, daily sofosbuvir in combination with peginterferon and ribavirin therapy for 12 weeks is recommended by the AASLD and IDSA. No data supports use of a peginterferon-free treatment regimen for those with genotype 5 or 6.
