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

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).

• SOF plus (OBV/PTV/r) plus RBV (Drug), also known as Paritaprevir (ABT-450) is inhibitor of the NS3-4A serine protease, Sovaldi is a trade name of sofosbuvir, Ombitasvir (ABT 267) is an NS5A inhibitor: 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.

Primary outcomes

• 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 outcomes

• 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.

Sex: All, ages: 18 Years to any

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.

• Results publication: 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. PMID 29546644