Hepatitis C, Chronic
Conditions
Brief summary
The purpose of the study is to study the combination of Sofosbuvir in Combination With Daclatasvir or Simeprevir for 12 Weeks in Non-cirrhotic Subjects Infected With Chronic Hepatitis C Virus (HCV) Genotype 1.
Detailed description
In this open-label, single-center, head-to-head non-inferiority trial, treatment-naive or pegylated interferon treatment-experienced patients with GT1 infection were randomized to receive once-daily SOF 400 mg plus DCV 60 mg or SIM 150 mg for 12 weeks.
Interventions
DRUGDaclatasvir + Sofosbuvir
Sofosbuvir 400 mg tablet + Daclatasvir 60 mg tablet oral dosing once daily for 12 weeks
DRUGSimeprevir + Sofosbuvir
Sofosbuvir 400 mg tablet + Simeprevir 150 mg tablet oral dosing once daily for 12 weeks
Sponsors
Federal University of São Paulo
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
Genotype 1 HCV infection confirmed a positive test for anti-HCV antibody and detectable serum HCV RNA by PCR Never taken DAAs for HCV Patients must be able to understand and agree to/comply with the prescribed dosing regimens and procedures, report for regularly scheduled study visits, and reliably communicate with study personnel about adverse events and concomitant medications No Liver Cirrhosis Liver fibrosis Metavir F3 APRI \> 1,5 FIB4 \> 3,25
Exclusion criteria
Infection with HCV other than GT-1 or subjects with mixed infections of any genotype Liver Cirrhosis Evidence of decompensated liver Subjects Infected with HIV-1 Hepatitis B virus (HBV) coinfection Liver or any other organ transplant (including hematopoietic stem cell transplants) other than cornea and hair Current or known history of cancer Documented or suspected hepatocellular carcinoma, as evidenced by previously obtained imaging studies or liver biopsy Pregnancy or impossibility to use birth control methods by the couple, or breastfeeding Regular use of: erythromycin, clarithromycin, rifampicin, rifabutin, telithromycin, itraconazole, ketoconazole, posaconazole, fluconazole, voriconazole, dexamethasone, cisapride, rifapentine, carbamazepine, phenytoin, phenobarbital, oxcarbazepine, St. John's wort (Hypericum perforatum), silymarin (Silybum marianum) and some antiarrhythmic drugs such as amiodarone
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Genotype 1 Hepatitis C Virus (HCV)-Infected Non-cirrhotic Subjects With Sustained Virologic Response at Follow-up Week 12 (SVR12) | At follow-up Week 12 | SVR12 was defined as hepatitis C virus RNA levels to be \< lower limit of quantitation ie, 12 IU/mL at follow-up Week 12 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Subjects With Rapid Virologic Response at Week 4 (RVR) | Week 4 | RVR was defined as hepatitis C virus RNA levels to be \< lower limit of quantitation ie, 12 IU/mL at Week 4. |
| Percentage of Subjects With End of Treatment Response (EOTR) | Week 12 | EOTR was defined as hepatitis C virus RNA levels to be \< lower limit of quantitation ie, 12 IU/mL at the end of treatment. |
| Treatment safety measured by the number of incidence of serious adverse event (SAEs), discontinuations due to adverse event (AEs), Grade 3/4 AEs and Grade 3/4 clinical laboratory abnormalities through the end of treatment. | From start of study treatment up to 7 days post last dose of study treatment | — |
| Percentage of Genotype 1 Hepatitis C Virus (HCV)-Infected Non-cirrhotic Subjects With Relapse at Follow-up Week 12 (SVR12) | At follow-up Week 12 | Relapse was defined as hepatitis C virus RNA levels to be \> lower limit of quantitation ie, 12 IU/mL at follow-up Week 12 |
Countries
Brazil
Outcome results
None listed