Chronic Hepatitis C Virus Infection
Conditions
Keywords
Sofosbuvir, Ombitasvir, Paritaprevir, Ribavirin, Ritonavir, HCV GT 4, Experienced Egyptian Patients, Cirrhotic, Non-Cirrhotic
Brief summary
enrolled participants were treated orally with SOF plus a fixed dose combination of OBV/PTV/r plus RBV.
Detailed description
Enrolled participants were treated orally with SOF plus a fixed dose combination of Sofosbuvir/Ombitasvir/Paritaprevir/ Ritonavir plus Ribavirin (OBV/PTV/r plus RBV), which was administered orally based on the participants' tolerability. The primary end point was a sustained virological response (HCV RNA level \< 15 IU/ mL), observed 12 weeks after the end of the treatment (SVR12).
Interventions
DRUGSOF plus (OBV/PTV/r) plus RBV
They were given SOF in a dose of 400 mg/day, and a fixed dose combination of OBV (25 mg), PTV (150 mg), and r (100 mg) taken with food once daily. RBV was supplied in 200 mg capsules, and the recommended dose was 600 mg/ day to reach 1200 mg/day based on patient's body 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 No maximum
Healthy volunteers
No
Inclusion criteria
* The experienced participants who were treated previously with (SOF/DCV) , (SOF/SMV), (SOF/RBV), or (SOF/pegINF/RBV). * The presence of compensated liver cirrhosis was documented by ultrasonographic examination, liver biopsy, results of Fibroscan or FIB-4 score, and laboratory markers, like FIB-4 \> 3.25 (advanced fibrosis or cirrhosis), albumin \< 3.5, total bilirubin \> 1.2, and also confirmed by clinical characteristics such as lower limb edema, splenomegaly, esophageal varices.
Exclusion criteria
* liver disease of non-HCV GT4 etiology, coinfection with hepatitis B or HIV * poorly controlled diabetes (HbA1C \> 8) * participants, hepatocellular carcinoma, a history of extrahepatic malignancy in the 5 years prior to the study * renal failure * evidence of hepatic decompensation * blood picture abnormalities such as anemia (hemoglobin concentration of \< 10 g/dL) * thrombocytopenia (platelets count \< 50,000 cells/mm3). * major severe illness 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 | 12 weeks after last dose | SVR12 is defined as hepatitis C virus ribonucleic acid (HCV RNA) level \< 15 IU/ml 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