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Triple therapy found to be efficacious and reduces treatment duration in HCV patients

In a study published in the Journal of Viral Hepatitis, triple therapy with simeprevir, pegylated interferon and ribavirin was safe and effective among patients with hepatitis C virus infection and reduced response-guided therapy vs. patients not treated with simeprevir.

Researchers, including Jane Scott, PhD, of Janssen Global Services Inc., analyzed data of patients with HCV from three randomized clinical trials dosed with either simeprevir for 12 weeks and pegylated interferon plus ribavirin (PR; n = 768) for 24 or 48 weeks or placebo with PR (n = 393) for 48 weeks. The patients’ rate of fatigue according to the Fatigue Severity Scale (FSS), depressive symptoms assessed by the Center for Epidemiologic Studies Depression scale (CES-D) and functional impairment via the Work Productivity and Activity Impairment (WPAI) questionnaire were all evaluated at baseline and throughout treatment in all three trials.

Overall, 86.5% of patients who received simeprevir completed treatment through 24 weeks (n = 664). More than half of the patients were male in each cohort (59.8% in the simeprevir group and 57.9% in the placebo group) and the median age was 49 years for both groups.

Analyses showed the mean patient-reported outcome (PRO) scores worsened from baseline to 4 weeks for both groups of patients. However, these scores improved after 24 weeks for patients who received simeprevir and after 48 weeks for patients who received placebo.

Analyses showed that patients in the simeprevir group had a significantly lower area under the curve of 60 and “fewer weeks with clinically important worsening” of scores at any time point, according to the research. Patients who received simeprevir experienced less time with increased fatigue according to FSS scores (6.9 weeks less; P < .001), impairment in WPAI Productivity scores (6 weeks), impairment in WPAI Daily Activities (6.1 weeks) and worsened CES-D score (6.8 weeks) compared with patients who received placebo.

In the PRO score subgroup analysis, patients who met the criteria for response-guided therapy or achieved sustained virologic response 12 weeks post-treatment had better outcomes. Differences in mean PRO scores were found to be associated with fibrosis level among the patients who received placebo.

Both groups experienced similar rates of fatigue and anemia for adverse events (AEs). However, a greater efficacy of simeprevir enabled reduced treatment duration and reduced time with PR-related AEs without adding to AE severity, according to the research.

“There was a significant within-group change in FSS total score from baseline to end of treatment (P < .001),” the researchers wrote. “The between-groups difference was also statistically significant for anemia and fatigue AEs.”

“This analysis confirms the value of [simeprevir] triple therapy based on pooled data from three clinical trials and the use of validated PRO measures with consistent findings,” the researchers concluded. “[Response-guided therapy] reduced time on PR therapy for most patients in the [simeprevir/PR] group compared with [placebo/PR]. AE results showed overall comparable safety for [both groups], but PRO endpoints complement our understanding of the safety and tolerability of [simeprevir/PR] treatment.”

Simeprevir is marketed as Olysio in the U.S and was approved by the FDA in November 2014 to treat HCV in combination with Sovaldi. – by Melinda Stevens

Disclosures: Scott reports being employed by Janssen and owning stock in Janssen’s parent company, Johnson & Johnson. Please see the full study for a list of all other authors’ relevant financial disclosures.