Article: Late relapse versus HCV reinfection in patients with sustained virologic response after sofosbuvir-based therapies—Sarrazin et. al
Source: Clin Infect Dis. first published online October 12, 2016 doi:10.1093/cid/ciw676
Study Aims and Results: The aim of the study was to determine the number of people who relapsed after achieving a cure on sofosbuvir-based therapies. The study evaluated eleven phase 3 studies that included ledipasvir plus sofosbuvir (Harvoni) and sofosbuvir-based treatment trials. The studies included 3,004 patients who were cured (12-week post-treatment sustained virological response). The blood samples of the people who relapsed were sequenced looking for variances in the structure of the hepatitis C virus.
Conclusion: Twelve people were found to have relapsed. But it was determined that 7 of the 12 people who relapsed had different genetic strains indicating reinfection. This means that of the 3,004 successfully cured patients that only 5 people relapsed—a relapse rate of .01%.
Editorial Comments: In another study that was presented at the 2016 International Liver Congress—Long-Term Follow-up of Patients With Chronic HCV Infection Following Treatment With Direct-Acting Antiviral Regimens: Maintenance of SVR, Persistence of Resistance Mutations, and Clinical Outcomes presented by Eric Lawitz concluded that 99.7% (5414 of 5433 people) as of October 2015 maintained their cure. Of the people who relapsed, 6 were late relapses and 12 were reinfected. There were also low rates of liver cancers and low rates of treatment-emergent RAVs (resistant associated variants). It will be interesting to follow this study. To view the presentation visit: http://www.natap.org/2016/EASL/EASL_18.htm
The studies confirm important information about long-term cure rates. The Sarrazin study is a fairly large study and will add to the growing body of evidence that direct-acting antiviral medications have high cure rates that have long-term durability.Share This Page