High success rates for the use of ombitasvir/paritaprevir/ritonavir containing regimens in treatment of naïve and experienced chronic hepatitis C genotype 4: Real world results

Abstract

Introduction and Aims: Treatment of hepatitis C virus (HCV) genotype 4 patient with fixed dose combination of ombitasvir-paritaprevir-ritonavir plus ribavirin (OBV/rPTV/RBV) has been proven efficacy and safety in many clinical trials. The current study reports the efficacy and safety of OBV/rPTV/RBV (for treatmentnaïve), and OBV/rPTV/RBV/sofosbuvir (SOF) (for treatment-experienced), in chronic HCV genotype 4 patients in real life settings.Methods: Prospective cohort study including all adult chronic HCV genotype 4 patients who were scheduled to receive OBV/rPTV/RBV ± SOF for 12 or 24 weeks in New Cairo Viral Hepatitis Treatment Center. The primary efficacy endpoint was a virologic response at posttreatment week 12 (SVR12). Changes in hematological parameters, liver biochemical profile and fibrosis-4 index (FIB-4), as well as clinical and laboratory adverse events (AEs) across follow up visits (week 4, end of treatment [EOT], and SVR12), were recorded.Results: Our study included 325 patients (age; 47.63 ± 12.63 years, 55.38% [n = 180] men). Most of the included patients (89.85%, n = 292) were treatment naïve and only 7% (n = 23) had liver cirrhosis. Overall, SVR12 was attained by 98.44% (316 of 321) of the patients; 97.15% (307 of 316) of patients who received 12 weeks of OBV/rPTV/ RBV ± SOF and 100% (9 of 9) of patients who received 24 weeks of OBV/rPTV/RBV as assessed by modified intention to treat analysis. There was a significant improvement of baseline alanine aminotransferase, aspartate aminotransferase, hemoglobin, FIB-4 at SVR12 (P < 0.05). The most common reported AEs were anemia (n = 106), fatigue (n = 41) and elevated indirect bilirubin (n = 37). Conclusion:OBV/rPTV/RBV (±SOF) is a highly effective therapy for chronic HCV patients in real life settings.

Effectiveness and safety of ombitasvir/paritaprevir/ritonavir in treatment of chronic hepatitis C Egyptian hemodialysis patients, case-control study

“…The study by El Kassas et al [10] observed high rates for the use of ombitasvir/paritaprevir/ritonavir containing regimens study which included 325 patients (age, 47.63 ± 12.63 years); SVR12 was attained by 100% of patients who received OBV/rPTV/RBV as assessed by modified intention to treat analysis. In concordance with the present study, they found that there was a significant improvement of baseline alanine aminotransferase and aspartate aminotransferase.…”

Three regimens for re-treatment failure of Sofosbuvir-based therapy for chronic hepatitis-C genotype-4: a cohort study

“…HCV DAAs combination regimens issued by the Egyptian National Committee for Control of Viral Hepatitis (NCCVH) for retreatment of non-responders was selected to provide the highest efficacy considering the use of drugs with a different mechanism and higher barrier of resistance than the previously-used combinations for the same patient 9 . Previously, the available retreatment options were limited to prolongation of treatment duration, the addition of RBV or novel combinations of approved DAAs (if available) until the SOF/VEL/VOX combination was approved by the Food and Drug Administration (FDA) in July 2017 20 , 21 .…”

“…Combining SOF with OMB, PAR and RIT ± RBV has shown adequate efficacy and safety for the treatment of naïve patients with HCV genotype-4 9 . This combination was also used for treatment-experienced patients.…”

“…El Kassas et al . 9 reported an SVR-12 of 100% in patients who were re-treated with the SOF/DCV/RBV combination. In our study, the response rate to this regimen was 96.2%.…”

“…Real-world experiences are still needed for this combination 8 . Unfortunately, current salvage therapies are not accessible in many regions and there are limited data available about the efficacy of different retreatment regimens 9 .…”