Abstract #FRI-234: Efficacy and safety of Epclusa (sofosbuvir plus velpatasvir) in people with chronic hepatitis C virus infection and recent injecting drug use: The SIMPLIFY study—J. Grebely et. al.
Study Aims and Results: The study was an international study to evaluate the safety and effectiveness of sofosbuvir and velpatasvir in people infected with hepatitis C.
The people in the study included HCV Genotypes 1 (35%); 2 (5%); 3 (58%); 4 (2%), age <40yo 24%, female sex 28%, no opioid substitution therapy, but were injecting drugs 32%; opioid substitution and injecting drugs 42%, minimal/early fibrosis (F0-F1) 62% or early/severe fibrosis (F2-F3) 26%, cirrhosis (F-4) 9%.
The study recruited patients from 19 international sites. There were 114 people recruited for the study; 103 who started treatment. Three patients discontinued treatment who were lost to follow-up and there was one death. There was one case of relapse due to reinfection of hepatitis C. The cure rate was 94% (96 of 102 people).
There were very high cure rates and only one reinfection. The people in this trial will be followed for a period of three years.
The clinical trial validates that people who inject drugs who are on or off opioid substitution therapy can be successfully treated with direct-acting antiviral therapy. We need to treat people everyone with hepatitis C including injection drug users.
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Abstract # THU-225 Four weeks of Ledipasvir/Sofosbuvir + Ribavirin with or without pegylated interferon gives very high and sustained cure rates in difficult to reach but easy to treat injecting drug users with chronic hepatitis C: final results of the 4WIDUC study— A.L.H. Oevrehus et al. by Matthew Zielske
Study Aims and Results: Researchers in this study looked at sustained virologic response (SVR) outcomes of treatment naïve patients on opioid substitution therapy (OST) 12 and 24 weeks after a 4-week treatment cycle. There was an equal number of patients who received Harvoni + Ribavirin with and without interferon. Harvoni is only approved to treat genotypes 1,4, 5 and 6.
Although people with any genotype could be considered for this study, only those who were treatment naïve, on OST, under the age of 50, weighed less than 220lbs and had a viral load under 2 million IU/ml were accepted.
Conclusion: Over the course of a year 32 of 48 people screened began treatment. Of those 32 people, 6 failed to move further into the study because of a high viral load. In the SVR 12 group all but one person with genotype 2 reached SVR. Among those in the SVR 24 population 92% reached SVR when interferon was included and 69% reached SVR when interferon wasn’t included. Causes for failure among those in the SVR 24 group were early relapse, probably reinfection/late relapse, treatment unrelated suicide and dropout before end of treatment.
Editorial Comments: This was a very interesting look at the potential for shortened treatment. Although the number of participants was small, the results of reaching SVR when incorporating pegylated interferon seem to indicate a distinct difference in treatment success. More research needs to be done with a larger group of people, but this is a promising exploration into finding successful ways to treat hard to reach populations. The draw backs to the study are many people do not want to take pegylated interferon and it’s not to be used with people who have mental health issues.
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