Real-World Effectiveness of Simeprevir-containing Regimens Among Patients With Chronic Hepatitis C Virus: The SONET Study

Abstract

Background.The Simeprevir ObservatioNal Effectiveness across practice seTtings (SONET) study evaluated the real-world effectiveness of simeprevir-based treatment for hepatitis C virus (HCV) infection.Methods.The SONET study was a phase 4, prospective, observational, United States–based study enrolling patients ≥18 years of age with chronic genotype 1 HCV infection. The primary endpoint was the proportion of patients who achieved sustained virologic response 12 weeks after the end of treatment (SVR12), defined as HCV ribonucleic acid undetectable ≥12 weeks after the end of all HCV treatments.Results.Of 315 patients (intent-to-treat [ITT] population), 275 (87.3%) completed the study. Overall, 291 were treated with simeprevir + sofosbuvir, 17 with simeprevir + sofosbuvir + ribavirin, and 7 with simeprevir + peginterferon + ribavirin. The majority of patients were male (63.2%) and white (60.6%); median age was 58 years, 71.7% had genotype/subtype 1a, and 39.4% had cirrhosis. The SVR12 was achieved by 81.2% (255 of 314) of ITT patients (analysis excluded 1 patient who completed the study but was missing SVR12 data); 2 had viral breakthrough and 18 had viral relapse. The SVR12 was achieved by 92.4% (255 of 276) of patients in the modified ITT (mITT) population, which excluded patients who discontinued treatment for nonvirologic reasons before the SVR12 time point or were missing SVR12 assessment data. Among mITT patients, higher SVR12 rates were associated with factors including age ≥65 years, non-Hispanic/Latino ethnicity, and employment status, but not genotype/subtype nor presence of cirrhosis. Simeprevir-based treatment was well tolerated; no serious adverse events were considered related to simeprevir.Conclusions.In the real-world setting, simeprevir + sofosbuvir treatment was common and 92% of mITT patients achieved SVR12. Simeprevir-based treatment was effective and well tolerated in this cohort, including patients with cirrhosis.

Sofosbuvir based regimens in the treatment of chronic hepatitis C genotype 1 infection in African–American patients: a community-based retrospective cohort study

“…SOF-based DAAs included in our study were generally well tolerated and AEs are consistent with other DAA-based studies in the literature 13 – 17 . Common adverse effects were fatigue, headache, nausea, arthralgia, and rash.…”

“…Similar findings were also reflected in a real-world. The SONET study where overall response rate was 92% and AA females had higher SVR rates (97%) compared with AA males (90%) 17 .…”

“…Our study meets this criterion, as it provides real-world data on safety, efficacy, and tolerability of DAAs in an inner-city community hospital setting with a high AA population. Existing clinical studies have shown an excellent response to DAAS in HCV GT-1 infection 13 – 17 .…”

Sofosbuvir in combination with daclatasvir or simeprevir for 12 weeks in noncirrhotic subjects chronically infected with hepatitis C virus genotype 1: a randomized clinical trial

“…Different SVR rates (80.6e97%) were reported in noncirrhotic patients with chronic HCV genotype 1 infection treated for 12 weeks with the SOF þ SMV regimen [10e16]. In this study, an SVR rate of 93% was experienced with SOF þ SMV, which is in agreement with previously reported SVR rates in the COSMOS (93%) [15], OPTIMIST-2 (93%) [14] and SONET (93.5%) studies [12]. Considering that the virus response to the SOF þ SMV regimen depends on host and virus baseline characteristics, our results may be relevant to a limited geographical area.…”

Clinical impact of pharmacokinetic interactions between the HCV protease inhibitor simeprevir and frequently used concomitant medications

“…Studies selected for this analysis were Janssen-sponsored clinical trials evaluating interferon-free combinations of SMV in combination with sofosbuvir (SOF) and/or daclatasvir (DCV) with or without ribavirin (RBV) ( Table 1) [14][15][16][17][18][19][20][21][22]. All studies were conducted in accordance with the 1975 Declaration of Helsinki, approved by independent ethics committees and registered with www.clinicaltrials.…”