Real World Adherence To Direct-Acting Antivirals In A Cohort Of People Who Use Drugs In Rome, Italy

Author: Teti E, Foroghi Biland L, Malagnino V, De Masi, Campogiani L, Compagno M, Coppola L, Malerba G, Gentile A, Ferrari L, Spalliera I, Pellegrino M, Cento V, Masci D, Rodoquino G, Patti M, Rossi E, Barra M, Sarmati L, Andreoni M

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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