Hepatitis C Virus Infection
Conditions
Keywords
HCV genotype 4, sofosbuvir, Peg-interferon α-2, ribavirin, Egyptian patients, Experinced, Naive
Brief summary
This study aims to assess the efficacy and safety of sofosbuvir (SOF) with pegylated interferon (PegINF)/ribavirin (RBV) for chronic HCV GT4 participants
Detailed description
Between March 2015 and November 2015, 99 participants (59 naïve and 40 experienced) infected with HCV GT4 were enrolled in the study. Eligible participants received daily oral 400 mg SOF ( (Sovaldi, Gilead Sciences, Inc., USA), RBV (Copegus, Roche, Europe) based on body weight: \< 75 kg, 1000 mg; ≥75 kg, 1200 mg), the dose modified according to participants tolerability, plus 180 μg PegINFα-2 once weekly for 12 weeks. Experienced participants included participants with a prior relapse or a null response to PegINF/RBV therapy.
Interventions
DRUGSOF/RBV/PegINFα-2
SOF: block the hepatitis C NS5B protein. RBV: a nucleoside inhibitor PegINFα-2: chemically modified form of the standard interferon that treats hepatitis C
Sponsors
Beni-Suef University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
The study population consisted of treatment-naïve and treatment-experienced adults patients aged 20-65 with HCV RNA level \> 10,000 IU/ml. Experienced participants included those with a prior relapse or a null response to PegINF/RBV therapy. \-
Exclusion criteria
Participants with one or more of * HCV coinfected with hepatitis B virus (HBV) * human immunodeficiency virus (HIV) * had any liver disease other than chronic HCV GT4 infection. * had a history of liver decompensation * serum a-fetoprotein (AFP) \> 100 ng/ml * evidence of hepatocellular carcinoma * major severe illness such as respiratory, renal, heart failure or autoimmune disease * non-compliance with treatment.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12) in Each Treatment Arm SVR12 | 12 weeks after last dose | SVR12 was defined as hepatitis C virus ribonucleic acid (HCV RNA) \< 15 IU/m 12 weeks after the last dose of drugs. |
| Number of Participants With Adverse Events in Each Treatment Arm | Screening until 30 days after last dose | An adverse event (AE) is defined as any untoward medical occurrence in a participant or i clinical investigation after administering a pharmaceutical drugs serious adverse event (SAE) is an event that results in death, life-threatening, requires hospitalization, or significant disability/incapacity |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Viral relapse | 12 weeks after last dose | Viral relapse was HCV RNA undetectable at EOT, but detectable HCV RNA \> 15 IU/ml levels 12 weeks after planned EOT. |
| Percentage of Participants With On-treatment Virologic Failure | up tp 24 weeks | On-treatment virologic failure was defined as quantifiable HCV RNA throughout the entire treatment period with HCV RNA greater than 15 IU/ml |
Outcome results
None listed