Theme: Clinical Research Year: 2018
Background: For a long time, drug-addiction strongly limited anti-HCV treatment. Since newer direct-acting antivirals (DAAs) significantly improved tolerability and manageability, we evaluated adherence and efficacy in a drug-users cohort. Methods: Drug users with chronic hepatitis C (n. 106) belonging to Villa Maraini Foundation services and a territorial service for addiction were enrolled from June 2015 to December 2017. Adherence was calculated as percentage of control-visits attended among those scheduled (monthly during treatment and at 12 weeks of follow-up). Fischer test and Mann-Whitney test were used for the statistical analysis. Results: Drug users (n=106, male 83%,) with complex viral, clinical and social features were enrolled. Patients’ cohort (median duration of substance abuse 29 years [IQR 23-35.5]) was so represented: active drug users including chaotic subjects (group A, n=60/106, 56.6%), opioid substitution treatment patients (group B, n=13/106, 12.3%) and rehab patients (group C, n=33/106, 31.1%). Median duration of HCV infection was 22 years [IQR (8-27]), genotype-1a and -3 infections were the most common (52.4% and 35.3%); 81.9% of patients had advanced liver fibrosis (F3-F4) and 26.4% and resistance-associated variants; 10.4% was HIV-coinfected; almost half of the population showed a concomitant occult HBV infection (48.1%); 32.7% had psychiatric comorbidities, 10.4% was arrested. Overall treatment adherence was 94.9%: adherence ≥80% to the scheduled visits was 79.2%, ≤80% was 20.8%. Low rates of adherence emerge analysing only follow-up: 29.2% of drop out during follow up. Per protocol undetectability EOT rate was 100% and SVR12 rate in 64/93 patients who completed treatment at the time of the analysis was 98.4%; four patients discontinued prematurely. Conclusions: Although drug users still face several clinical and social issues, our data indicate that even active drug-users can be highly adherent to DAAs, achieving optimal cure-rates. Treatment adherence rates are very high, while retention in follow up is still a challenge.
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