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