Chronic Hepatitis C Virus Infection
Conditions
Keywords
Chronic HCV GT4, Sofosbuvir, Simeprevir, Daclatasvir, Ribavirin, Experienced
Brief summary
Experienced participants who had HCV GT4 infection were treated with Sofosbuvir/Simeprevir/Daclatasvir/Ribavirin (SOF/SMV/DCV/RBV)
Detailed description
Experienced participants, who had chronic infection with HCV GT4 , and failed prior DAA treatments, SOF/DCV (71/92) or SOF/SMV (15/92) or SOF/pegylated interferon/RBV (2/92) or SOF/RBV (4/92) were enrolled in the current study. In the present study, the regimen used was designed by the combination of triple DAAs with different mechanisms of action and non-overlapping resistance profiles, SOF/SMV/DCV, plus RBV.
Interventions
DRUGSOF/SMV/DCV/RBV
SOF was given orally at a dose of 400 mg/day DCV was given orally at a dose of 60 mg/day SMV was given orally at a dose of 150 mg/day. RBV was given in a total daily oral dose of 600 mg/day up to 1,200 mg/day according to the participant's weight and tolerability.
Sponsors
Beni-Suef University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Experienced Egyptian participants with HCV GT4 infection who had failed prior DAA treatments \[SOF/DCV or SOF/SMV or SOF/pegylated interferon/RBV or SOF/RBV\] * Fibrosis-4 score in non-cirrhotic participants is \<1.45-3.25: (None or moderate fibrosis) * Fibrosis-4 score in cirrhotic participants is \>3.25: (Advanced fibrosis or cirrhosis)
Exclusion criteria
* HCV coinfected with hepatitis B virus (HBV) or 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 | 12 weeks after last dose | SVR12 is defined as hepatitis C virus ribonucleic acid (HCV RNA) level \< 15 IU/m 12 weeks after the last dose of drugs. |
| Number of Participants With Adverse Events in Each Treatment Arm | Screening up to 12 weeks after last dose | An adverse event (AE) is defined as any untoward medical occurrence in a participant 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 | Up to 12 weeks after last dose | Viral relapse was HCV RNA level undetectable at End of Treatment (EOT) (≤ 15 IU/ml), but detectable HCV RNA ( \> 15 IU/ml) levels 12 weeks after planned EOT. |
Countries
Egypt
Outcome results
None listed