Clinical trial NCT04391985: Sofosbuvir/Ombitasvir/Paritaprevir/ Ritonavir and Ribavirin for Hepatitis C Virus Genotype 4 Patients
Official title: Retreatment Efficacy of Sofosbuvir/Ombitasvir/Paritaprevir/ Ritonavir + Ribavirin for Hepatitis C Virus Genotype 4 Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Chronic Hepatitis C Virus Infection
Keywords: Sofosbuvir
Ombitasvir
Paritaprevir
Ribavirin
Ritonavir
HCV GT 4
Experienced Egyptian Patients
Cirrhotic
Non-Cirrhotic
Lead sponsor: Beni-Suef University
Sponsor class: OTHER
First posted: 2020-05-18
Enrollment: 113
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

Eligibility criteria: 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.

Primary outcomes:
measure: Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12) in Each Treatment Arm
timeFrame: 12 weeks after last dose
measure: Number of Participants With Adverse Events in Each Treatment Arm
timeFrame: Screening up to 12 weeks after last dose]
Secondary outcomes:
measure: Percentage of Participants With Viral relapse
timeFrame: Up to 12 weeks after last dose
Other outcomes:
Locations:
city: Beni-Suef
country: Egypt
facility: Beni-Suef University
Study officials:
References:
citation: Abdel-Moneim A, Aboud A, Abdel-Gabbar M, Zanaty M, Ramadan M. Retreatment Efficacy of Sofosbuvir/Ombitasvir/Paritaprevir/Ritonavir + Ribavirin for Hepatitis C Virus Genotype 4 Patients. Dig Dis Sci. 2018 May;63(5):1341-1347. doi: 10.1007/s10620-018-5005-8. Epub 2018 Mar 15.