<p>Efficacy of direct-acting antiviral therapy for hepatitis C viral infection. Real-life experience in Bahrain</p>

Abstract

Purpose: The introduction of direct-acting antivirals (DAAs) has revolutionized the treatment of chronic hepatitis C viral (HCV) infection. This study aims to establish real-world treatment efficacy of Sofosbuvir-based (SOF-B) and Ombitasvir/Paritaprevir/Ritonavir-based (OPR-B) regimens. Patients and methods: This prospective, non-randomized observational real-life study was conducted in Salmaniya Medical Complex, Bahrain, and included consecutive patients with chronic HCV infection (genotypes 1–4) who were treated with direct-acting antivirals. Sustained virologic response to therapy was assessed at week 12 post end of treatment (SVR12). Results: Of the 167 patients included, 60.5% (n=101) were treated with SOF-B and 39.5% (n=66) with OPR-B regimens for 12 weeks (n=148; 88.6%) or 24 weeks (n=19; 11.4%). SVR12 was achieved in 156 (93.4%) patients, 4 patients failed to achieve SVR despite completion of treatment, and 7 patients discontinued treatment due to non-compliance and were included in the analysis on an intention-to-treat basis. There was no difference between SOF-B and OPR-B regimens (95/101; 94.1%) and (61/66; 92.4%), respectively ( p =0.68). However, SVR12 rates were significantly higher in patients without liver cirrhosis (103/104; 99.0%) compared to patients with cirrhosis (53/63; 84.1%; p <0.001), and in patients who received 12-week-regimen (141/148; 95.3%) compared to those who received 24-week regimen (15/19; 78.9%; p <0.024). However, logistic regression analysis identified cirrhosis at baseline to be the only independent predictor of non-SVR12 (OR: 16.1, 95% confidence interval 1.96–131.91, p =0.01). Apart from Hb, INR, and ALP, all other laboratory parameter improved following treatment ( p <0.05). Conclusion: Both SOF-B and OPR-B regimens achieved high SVR12 rates in this real-life cohort of patients with chronic HCV infection, similar to what is reported in other real-world studies. Cirrhosis was the only independent predictor of poor response.

Genotypes of Hepatitis C Virus and Efficacy of Direct-Acting Antiviral Drugs among Chronic Hepatitis C Patients in a Tertiary Care Hospital

“…Moreover, several review publications and meta-analyses on the distribution of HCV genotypes reported that GT4 predominated in Middle Eastern nations, notably Egypt, Iraq, Saudi Arabia, and Syria, with rates of 86%, 60%, 56%, and 57%, respectively [ 40 , 41 ]. In contrast to our findings, a recent study from Bahrain revealed an increasing tendency of HCV GT1 compared with GT4 in the studied population [ 29 ].…”

“…The introduction of the DAA-based regimens achieved high cure rates with minimal adverse effects, better tolerability, and shorter treatment duration [ 22 , 28 ]. Further, treatment with DAA in patients with chronic HCV infection has a positive effect on the bioelectrical brain activity, with an increase in the amplitude of evoked potentials indicating an improvement in the activity of the cerebral cortex, and this improvement was correlated with the neuroimaging parameters [ 29 , 30 , 31 , 32 , 33 , 34 , 35 ].…”

“…The efficacy of DAAs has been proven by several clinical trials with “ideal” patients, whose characteristics differed from those of patients using these medications in everyday clinical practice. Comorbidities and/or constitutional characteristics might reduce the effectiveness rates of DAAs reported in controlled clinical studies, suggesting that these findings may not reflect the real world [ 29 , 30 ]. Therefore, evaluations of these drugs in real-life settings from various parts of the world are critical.…”

Effectiveness and safety of generic and brand direct acting antivirals for treatment of chronic hepatitis C

“…Moreover, when we restricted our analysis to patients treated with Sofosbuvir-based brand and generic regimens, our study revealed that having cirrhosis and genotype 3 were the independent predictors of not achieving SVR. A previous study in the same setting using brand DAAs for hepatitis C treatment revealed that having cirrhosis at baseline was the only risk factor for not achieving SVR [ 21 ]. The findings of this study indicate that adequate care and attention need to be given during treatment of patients with cirrhosis and genotype 3 HCV in our setting.…”

“…The predominant HCV genotype among Bahraini patients is type 1, followed by genotypes 3 and 4, and the lowest frequency is for genotype 2[ 19 , 20 ]. There is a real-world study of DAAs for hepatitis C treatment in Bahrain[ 21 ], but no study has compared the effectiveness of generic vs brand DAAs for hepatitis C treatment in the country. Therefore, the objective of this study was to compare the efficacy and safety of generic vs brand DAAs for chronic hepatitis C treatment in Bahrain.…”