Avinash Prabhakar

Impact of completing chronic hepatitis C (CHC) treatment on post-therapy healthcare cost.

Abstract Background: Chronic hepatitis C (CHC) is associated with significant economic burden. This study evaluated the healthcare cost alleviation associated with treatment of CHC. Methods: Health insurance claims from 60 self-insured US companies were analyzed (01/2001–03/2012). Adult patients with ≥1 CHC diagnosis (ICD-9-CM: 070.44, 070.54), initiating interferon, and with ≥2 dispensings and with ≥48 weeks of follow-up were selected. Patients diagnosed with HIV or who completed only 24 weeks of interferon therapy (a surrogate for CHC genotypes 2 and 3) were excluded from the study. Interferon users were categorized into complete and discontinued therapy cohorts. During the post–48-week treatment period, cohorts were compared for healthcare resource utilization using rate ratios (RRs), as well as healthcare costs using per-patient per-year (PPPY) cost differences. Results: A total of 1017 patients who completed and 953 patients who discontinued interferon therapy were identified. Relative to the discontinued therapy cohort, the completed therapy cohort had significantly fewer hospitalizations (RR [95% CI] = 0.74 [0.68, 0.81], p < 0.001), outpatient visits (RR [95% CI] = 0.92 [0.91, 0.93], p < 0.001), and ER visits (RR [95% CI] = 0.93 [0.87, 1.00], p = 0.039), which translated into significantly lower total healthcare costs PPPY (cost difference [95% CI] = 

Efficacy and safety of simeprevir and sofosbuvir with and without ribavirin in subjects with recurrent genotype 1 hepatitis C postorthotopic liver transplant: the randomized GALAXY study

4540 [1570, 7680], p = 0.004) and hospitalization costs (cost difference [95% CI] = 

Predictors of high healthcare resource utilization and liver disease progression among patients with chronic hepatitis C

3039 [1140, 5248], p = 0.002). Non–CHC-related costs accounted for 55% and CHC-related costs for 45% of the all-cause cost difference between cohorts. Limitations: Claims data may have contained inaccuracies, and genotypes of patients with CHC could not be confirmed. The study consisted of privately insured individuals and may not be generalizable to the entire CHC population. Conclusion: Compared to discontinued therapy patients, CHC patients who completed interferon therapy and presumably had a higher rate of achieving SVR were found to have lower levels of healthcare resource utilization and costs post-therapy. The reduction was primarily in costs associated with non–HCV-related comorbidities.

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

This prospective, randomized, phase 2 study in subjects with recurrent hepatitis C virus (HCV) genotype 1 postorthotopic liver transplant evaluated once‐daily simeprevir 150 mg + sofosbuvir 400 mg, with and without ribavirin 1000 mg. Primary endpoint was proportion of subjects with week 12 sustained virologic response (SVR12). Thirty‐three subjects without cirrhosis were randomized 1:1:1 into three arms (stratified by genotype/subtype and Q80K): Arm 1, simeprevir + sofosbuvir + ribavirin, 12 weeks; Arm 2, simeprevir + sofosbuvir, 12 weeks; Arm 3, simeprevir + sofosbuvir, 24 weeks; 13 additional subjects (two with cirrhosis, 11 without cirrhosis) entered Arm 3. All 46 subjects received at least one dose of study drug; median age, 60 years; 73.9% male; 80.4% White; 71.7% genotype/subtype 1a [12 (36.4%) of these had Q80K]; median 4.5 years post‐transplant. Among randomized subjects, SVR12 was achieved by 81.8% in Arm 1, 100% in Arm 2, and 93.9% in Arm 3; two subjects did not achieve SVR12: one viral relapse (follow‐up week 4; Arm 1) and one missing follow‐up week 12 data. In total, five subjects had a serious adverse event, considered unrelated to treatment per investigator. Simeprevir exposure was increased relative to the nontransplant setting, but not considered clinically relevant. Simeprevir + sofosbuvir treatment, with or without ribavirin, was efficacious and well tolerated (ClinicalTrials.gov Identifier: NCT02165189).

Effectiveness of Simeprevir-Containing Regimens among Patients with Chronic Hepatitis C Virus in Various Us Practice Settings: The Sonet Study

Abstract Background: Since hepatitis C virus therapy is typically prioritized for patients with more advanced disease, predicting which patients will progress could help direct scarce resources to those likely to benefit most. This study aims to identify demographics and clinical characteristics associated with high healthcare resource utilization (HRU) and liver disease progression among CHC patients. Methods: Using health insurance claims (January 2001–March 2013), adult patients with ≥2 CHC claims (ICD-9-CM: 070.44 or 070.54), and ≥6 months of continuous insurance coverage before and ≥36 months after the first CHC diagnosis were included. Patients with human immunodeficiency virus were excluded. Generalized estimating equations were used to identify the demographic and clinical characteristics of being in the 20% of patients with the highest HRU. Factors predicting liver disease progression were also identified. Results: In the study population (n = 4898), liver disease severity and both CHC- and non–CHC-related comorbidities and conditions were strong predictors of high healthcare costs, with odds ratios (ORs; 95% confidence interval [CI]) for ≥2 CHC-related and ≥2 non-CHC-related comorbidities/conditions of 2.78 (2.48–3.12) and 2.19 (1.76–2.72), respectively. CHC- and non-CHC-related comorbidities and conditions were also strong predictors of liver disease progression with ORs (95% CI) for ≥2 CHC-related and ≥2 non-CHC-related comorbidities and conditions of 2.18 (1.83–2.60) and 1.50 (1.14–1.97), respectively. Limitations: Potential inaccuracies in claims data, information or classification bias, and findings based on a privately insured population. Conclusion: This study suggests that CHC patients with high healthcare resource utilization have a high level of comorbidity at baseline and also that non-CHC comorbidities and conditions are strong predictors of high HRU. Non-cirrhotic CHC patients with one or more comorbidities are at high risk of progressing to cirrhosis or end-stage liver disease.

Efficacy and Safety of Simeprevir and Sofosbuvir with and without Ribavirin for 12 Weeks in Subjects with Recurrent Genotype 1 Hepatitis C Post-Orthotopic Liver Transplant: The Galaxy 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.

Direct And Indirect Cost Burden Of Chronic Hepatitis C Infection In Privately-Insured Patients, Stratified By Liver Disease Severity

EFFECTIVENESS OF SIMEPREVIR-CONTAINING REGIMENS AMONG PATIENTS WITH CHRONIC HEPATITIS C VIRUS IN VARIOUS US PRACTICE SETTINGS: THE SONET STUDY I. Alam, K. Brown, C. Donovan, J. Forlenza, K. Lauwers, M.A. Mah’moud, R. Manch, S.R. Mohanty, A. Prabhakar, R. Reindollar, G. Sawyerr, J. Slim, N. Tandon, S. Villadiego, S. Naggie. Austin Hepatitis Center, Austin, TX; Janssen Scientific Affairs, Titusville, NJ, United States; Janssen Research & Development, Beerse, Belgium; Duke University School of Medicine/Boice-Willis Clinic, Rocky Mount, NC; St. Joseph’s Hospital & Medical Center, Phoenix, AZ; New York Methodist Hospital, Brooklyn, NY; Piedmont Healthcare, Gastroenterology and Hepatology, Statesville, NC; Saint Michael’s Medical Center, Newark, NJ; DurhamVAMedical Center/Duke University School of Medicine, Durham, NC, United States E-mail: dralam@austin.rr.com