Sofosbuvir/Ombitasvir/Paritaprevir/ Ritonavir and Ribavirin for Hepatitis C Virus Genotype 4 Patients

Chronic Hepatitis C Virus Infection Clinical Trial

Official title:

Retreatment Efficacy of Sofosbuvir/Ombitasvir/Paritaprevir/ Ritonavir + Ribavirin for Hepatitis C Virus Genotype 4 Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04391985
• Other study ID #: Qu-RBV
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: March 1, 2017
• Est. completion date: October 31, 2017

Study information

• Verified date: May 2020
• Source: Beni-Suef University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

enrolled participants were treated orally with SOF plus a fixed dose combination of OBV/PTV/r plus RBV.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 113
• Est. completion date: October 31, 2017
• Est. primary completion date: October 31, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Hepatitis C Virus Infection
• Hepatitis
• Hepatitis A
• Hepatitis C
• Hepatitis C, Chronic

Intervention

Drug:
• SOF 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.

Locations

Country	Name	City	State
Egypt	Beni-Suef University	Beni-Suef

Sponsors (1)

Lead Sponsor	Collaborator
Beni-Suef University

Country where clinical trial is conducted

Egypt, 

References & Publications (1)

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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12) in Each Treatment Arm	SVR12 is defined as hepatitis C virus ribonucleic acid (HCV RNA) level < 15 IU/ml 12 weeks after the last dose of drugs.	12 weeks after last dose
Primary	Number of Participants With Adverse Events in Each Treatment Arm	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	Screening up to 12 weeks after last dose]
Secondary	Percentage of Participants With Viral relapse	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.	Up to 12 weeks after last dose

External Links

•   This link clarify the retreatment efficacy and safety of the SOF with OBV/PTV/r + RBV, for chronic HCV GT4-experienced patients who failed treatment with DAA-based regimens.