Chronic Hepatitis C Virus Infection
Conditions
Keywords
Sofosbuvir, Daclatasvir, Ribavirin, HCV GT 4
Brief summary
This study aims to evaluate the efficacy and safety of DCV plus sofosbuvir (SOF) with or without ribavirin (RBV) for treatment of Egyptian participants infected with HCV GT4.
Detailed description
Egyptian participants infected with HCV GT4 were classified into two groups: group 1 (easy to treat) was treated with a dual therapy of SOF/DCV daily for 12 weeks and group 2 (difficult to treat) was treated with a triple therapy of SOF/DCV/RBV daily for 12 weeks. SOF dose was 400 mg/day given orally DCV was given in a dose of 60 mg/day, orally. RBV was given as oral tablets in the morning and in the evening based on patient's weight and tolerability (starting dose 600 mg/day to reach 1200 mg/day.
Interventions
DRUG(SOF and DCV)
DRUG(SOF, DCV, and RBV)
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
* Non-cirrhotic treatment-naïve participants * FIB-4 \< 3.25 * albumin \> 3.5 * total bilirubin \< 1.2 mg/dl * international normalized ratio (INR) \< 1.2 * platelet count \> 150,000 mm3. * experienced participants who had previously failed treatment with peg-IFN-α-/RBV, SOF/peg-IFN-α +RBV, or SOF/SMV * Naïve cirrhotic participants were confirmed by ultrasonographic features of cirrhosis
Exclusion criteria
* liver disease of non-HCV etiology * hepatitis B or human immune-deficiency virus (HIV) infection * poorly controlled diabetic (HbA1C \> 9) participants * hepatocellular carcinoma * a history of extra-hepatic malignancy within 5 years prior to the study * pregnant or breast feeding * renal disease; serum creatinine \> 2.5 mg/dl or eGFR \< 30 ml/min * evidence of hepatic decompensation; INR \> 1.7, serum albumin \< 2.8 g/dl, total bilirubin \> 3 mg/dl * blood picture abnormalities such as anemia (hemoglobin concentration of 10 g/dl or less) and thrombocytopenia (platelet count \< 50,000 cells/mm3) * major severe illnesses such as congestive heart failure and respiratory failure.
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) level \< 15 IU/m 12 weeks after the last dose of drugs. |
| Number of Participants With Adverse Events in Each Treatment Arm | up for 12 weeks after planned End of Treatment (EOT). | 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 | 12 weeks after last dose | Viral relapse was HCV RNA level ≤ 15 IU/ml at EOT, but detectable HCV RNA level \> 15 IU/ml 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