Feasibility and Efficacy of Sofosbuvir-Based Regimens for Treatment of HCV-Infection in a Low Threshold Setting

Author: Ulstein K, Backe Ø, Dalgard O

Theme: Clinical Research Year: 2015

The City of Oslo has in collaboration with Akershus University Hospital established a HCV clinic within the premises of the City’s low threshold services for people who inject drugs (PWID). We aim at assessing the feasibility of treating HCV infection in PWID with Sofosbuvir (SOF)-based therapy .

The low threshold HCV clinic is open daily and provides care by a nurse with experience from harm reduction services and is supported by a general practitioner and a specialist in infectious diseases. Consecutive patients seen at the clinic were included if they had received at least one dose of SOF and were scheduled to end treatment within September 2015. HCV RNA positive patients with at least significant liver fibrosis assessed with transient elastography were eligible for treatment. Significant fibrosis was defined as liver stiffness measurement (LSM) ≥ 7 kPa and cirrhosis was defined as LSM ≥ 12.5 kPa.

Nineteen patients, 4 women and 15 men, were included. 16 patients received opiate substitution therapy and 13 had injected drugs within the past 4 weeks. Cirrhosis was present in 14/19 (74%) and of those, 9 had LSM >25 kPa. Among 7 patients with genotype 1, the following regimes were given: SOF/LDV (n=4), SOF+SMV+/-RBV (n=2) and SOF+RBV (n=1). One patient with genotype 2 received SOF+RBV and 10 patients with genotype 3 received SOF/LDV+RBV (n=5), SOF+pegIFN+RBV (n=3) or SOF+DCV (n=2). To date no patients have terminated treatment early but 7 patients have reported missing 1-5 doses. Five patients have completed treatment and all have achieved SVR4. SVR4 results for the remaining 14 will be reported.

Preliminary results show that administration of SOF-based therapy is feasible in a customized street clinic.

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