Sofosbuvir/Pegylated-interferon Plus Ribavirin With HCV Genotype 4
Study Details
Study Description
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
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 1/Phase 2 |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Treatment-naive Naive Egyptians having HCV GT4 received SOF, RBV, and PegINFα-2 once weekly for 12 weeks Intervention: 1 DDA: Sofosobuvir (SOF) plus Ribavirin (RBV) and pegylated-interferon (PegINFα-2) |
Drug: SOF/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
|
| Active Comparator: Treatment-experienced Experienced Egyptians having HCV GT4 received SOF, RBV, and PegINFα-2 once weekly for 12 weeks Intervention: 1 DDA: Sofosobuvir (SOF) plus Ribavirin (RBV) and pegylated-interferon (PegINFα-2) |
Drug: SOF/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
|
Outcome Measures
Primary Outcome Measures
- 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 Outcome Measures
- 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
Eligibility Criteria
Criteria
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.
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Exclusion Criteria:Participants with one or more of
-
HCV coinfected with hepatitis B virus (HBV)
-
human immunodeficiency virus (HIV)
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had any liver disease other than chronic HCV GT4 infection.
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had a history of liver decompensation
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serum a-fetoprotein (AFP) > 100 ng/ml
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evidence of hepatocellular carcinoma
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major severe illness such as respiratory, renal, heart failure or autoimmune disease
-
non-compliance with treatment.
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Beni-Suef University
Investigators
- Principal Investigator: Mohammed Abdel-Gabbar, Ass. Prof, Biochemistry Dep., Faculty of Science, Beni-Suef University, P.O. Box 52621
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- SOF-PEG