Olav Dalgard [2] Jason Grebely [2], Brian Conway [3], Evan B. Cunningham [2], Philip Bruggmann [4], Behzad Hajarizadeh [2], Janaki Amin [5], Julie Bruneau [6], Margaret Hellard [7], Alain Litwin [8], Philippa Marks [1], Sophie Quiene [2], Sharmila Siriragavan [2], Tanya L Applegate [2], Tracy Swan [9], Jude Byrne [10], Melanie Lacalamita [11], Adrian Dunlop [12], Gail V. Matthews [2,13], Jeff Powis [14], David Shaw [15], Maria Christine Thurnheer [16], Martin Weltman [17], Ian Kronborg [18], Curtis Cooper [19], Jordan J Feld [20], Chris Fraser [21], John Dillon [22], Phillip Read [23], Ed Gane [24] and Gregory J Dore [2,13] on behalf of the SIMPLIFY Study Group
Affiliates: [1] Akershus University Hospital, Oslo, Norway. [2] The Kirby Institute, UNSW Sydney, Sydney, Australia. [3] Vancouver Infectious Diseases Center, Vancouver, Canada. [4] Arud Centres for Addiction Medicine, Zurich, Switzerland. [5] Faculty of Medicine and Health Sciences, Macquarie University. [6] Centre Hospitalier de l’Université de Montréal, Canada. [7] The Burnet Institute, Melbourne, Australia. [8] Montefiore Medical Centre, New York, United States. [9] International Network on Hepatitis in Substance Users, New York, United States. [10] Australian Injecting & Illicit Drug Users League, Canberra, Australia. [11] Poliklinik für Infektiologie, Inselspital, Bern, Switzerland. [12] Newcastle Pharmacotherapy Service, Newcastle, Australia. [13] St Vincent’s Hospital, Sydney Australia. [14] South Riverdale Community Health Centre, Toronto, Canada. [15] Royal Adelaide Hospital, Adelaide, Australia. [16] Nepean Hospital, Penrith, Australia. [17] Footscray Hospital, Footscray, Australia. [18] Ottawa Hospital Research Institute, Ottawa, Canada. [19] Toronto General Hospital, Toronto. [20] Coolaid Community Health Centre, Victoria, Canada. [21] Ninewells Hospital, Dundee, United Kingdom. [22] Kirketon Road Centre, Sydney, Australia. [23] Auckland Hospital, Auckland, New Zealand.

Access to hepatitis C virus (HCV) therapy is restricted based on recent drug use in many settings.

To evaluate the efficacy of sofosbuvir and velpatasvir in people with recent injecting drug use.

Open-label, single-arm trial Setting: Australia, Canada, New Zealand, Norway, Switzerland, United Kingdom, and United States.

103 treatment-naïve patients with chronic HCV genotypes 1-4 with recent injecting drug use.

Once-daily sofosbuvir and velpatasvir for 12 weeks in a one-week electronic blister pack (records time/date of dose administration). The primary study outcome was sustained virologic response (SVR12, HCV RNA daily in the past month. Treatment completion was observed in 99 of 103 (96%). There were four discontinuations (loss to follow-up, n=3; overdose death, n=1). Overall, SVR was 94% (95% CI, 88%-98%). Two participants with an end of treatment response did not have SVR (loss to follow-up, n=1; reinfection, n=1). Drug use prior to and during treatment did not impact SVR12. One case of HCV reinfection was observed (reinfection rate, 2.7 cases per 100 person-years; 95% CI, 0.1-13.8).

These findings may not be generalizable to PWID with more advanced liver disease.
Conclusions: Patients with HCV infection with recent injecting drug use treated with sofosbuvir and velpatasvir had high rates of SVR12, regardless of ongoing injecting drug use, supporting the removal of drug-use restrictions.