Hepatitis C Virus Infection
Conditions
Keywords
Ombitasvir, Paritaprevir, Ritonavir, Ribavirin, HCV, Genotype 4, Naïve, Egyptians
Brief summary
The objective of the investigators was to delineate the efficacy and safety of Ombitasvir, paritaprevir with ritonavir (OBV/PTV/r) plus ribavirin (RBV) on chronic HCV GT4 Egyptian naïve patients
Detailed description
Direct-acting antivirals (DAAs) combination therapies from various mechanisms of action and families have been revolutionized the management landscape of chronic hepatitis C virus (HCV). Ombitasvir, paritaprevir with ritonavir (OBV/PTV/r) ± ribavirin (RBV) are approved to treat HCV genotype 4 (GT4) infection. Here, investigators' objective was to delineate the efficacy and safety of OBV/PTV/r plus RBV of HCV GT4 in the treatment of Egyptian naïve patients. Between 5 January and 8 September 2017, a cohort of 100 Egyptian patients infected with HCV GT4 was allocated and administered orally OBV/PTV/r with RBV, for 12 weeks, which given as oral tablets based on patient tolerability. The primary endpoint of investigators' study was a sustained virological response (HCV RNA \< 12 IU/mL) 12 weeks from the cessation of the treatment (SVR12).
Interventions
Sponsors
Beni-Suef University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
100 Egyptian naive patients infected with HCV GT4 was allocated and administered orally OBV/PTV/r with RBV which given as oral tablets based on patient tolerability
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
Treatment-naïve patients with HCV GT4 with plasma HCV RNA level \>10,000 IU/ml
Exclusion criteria
* Hepatitis of non-HCV cause * Coinfection with other than HCV GT4 * Poorly controlled diabetics (HbA1C \>8) patients * a history of extra-hepatocellular malignancy in the last 5 years * Major severe illness such as congestive heart failure, respiratory failure, evidence of hepatic decompensation. * Laboratory and blood picture abnormalities such as anemia (hemoglobin concentration of 10 \<g/dl) and thrombocytopenia (platelets \<50,000 cells/mm3) and (serum albumin \<2.8 g/dL, international normalized ratio (INR) of \> 2.3, serum total bilirubin concentration of \>3.0 mg/dL.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12) | 12 weeks after last dose | SVR12 was defined as hepatitis C virus ribonucleic acid (HCV RNA) level less than 12 IU/mL 12 weeks after the last dose of study drug. |
| adverse event (AE) | Screening up to 30 days after last dose | An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation observed after administering a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. A serious adverse event (SAE) is an event that results in, death, participant hospitalization, life-threatening, significant disability/incapacity, or a congenital anomaly. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Post-treatment Relapse Within 12 Weeks Following End of Treatment | Up to 12 weeks after last dose | Post-treatment relapse was defined as defined as confirmed HCV RNA \> 12 IU/ml between the end of treatment and 12 weeks after the last dose of study drug among participants who completed treatment with HCV RNA \< 12 IU/ml at the end of treatment. |
Outcome results
None listed