Preliminary clinical outcome data among patients with hepatitis C virus infection receiving direct-acting antiviral therapy in the Chronic Hepatitis Cohort Study, 2014-2015
Spradling PR, Xing J, Rupp LB, Moorman AC, Gordon SC, Lu M, Teshale EH, Boscarino JA, Daida Y, Schmidt MA, Holmberg SD. Preliminary clinical outcome data among patients with hepatitis C virus infection receiving direct-acting antiviral therapy in the Chronic Hepatitis Cohort Study, 2014-2015. Hepatology 2016; 64(Suppl 1):487A-488A.
Background: Data describing clinical outcomes of direct-acting antiviral (DAA) therapy among patients infected with hepatitis C virus (HCV) in general healthcare settings are limited. We examined DAA-associated outcomes among HCV-infected patients in the Chronic Hepatitis Cohort Study (CHeCS), an observational study conducted at 4 US healthcare organizations. Methods: Patients who began a DAA regimen from January 2014 − August 2015 were included in the analysis. We examined frequency of treatment completion and of sustained viral response (SVR) 12 weeks post-treatment vs. no SVR by sociodemographic, clinical, and treatment-related factors, and conducted multivariable analysis to identify factors independently associated with SVR. Results: Of 613 patients who began an initial DAA regimen during the study period, 212 (48%) were treatment experienced, 210 (54%) had cirrhosis, 81 (18%) were of black race, and 24 (5%) were HIV-coinfected: 280 (46%) had HCV genotype 1a (G1a); 136 (22%) had G1b; 107 (17%) had G2; 68 (11%) had G3; 5 (1%) had G4-6; and 17 (3%) had mixed genotype infection. Overall, 401 (65%) patients received a sofosbuvir (SOF) regimen without ledipasvir (LDV) (i.e., SOF ± simeprevir or daclatasvir ± ribavirin [RBV]) and 211 (34%) received SOF with LDV ± RBV. No patients received an ombitasvir-containing regimen. Of 545 (89% of 613) patients with available SVR data, 463 (85%) achieved SVR. Among patients with G1a, frequencies of SVR ranged from 77% (SOF without LDV and no RBV) to 96% (SOF with LDV ± RBV); among those with G1b, 70% (SOF regimen without LDV + RBV) to 98% (SOF with LDV ± RBV). The frequency of SVR was 83%, 80% and 75% among patients with G2, G3, and G4-6 infection, respectively. In multivariable analysis controlling for all variables, the sole factor independently associated with SVR was receipt of SOF with LDV ± RBV (aOR 6.1 vs. SOF regimen without LDV and no RBV). Neither age, sex, race/ethnicity, previous treatment status, presence of cirrhosis, genotype, comorbidity score, body mass index, or HIV coinfection were associated with SVR. Of the 613 patients who initiated treatment, 68 (11%) either had completed treatment but did not yet have SVR data available (n=32), were still receiving treatment at the close of the study period (n=22), or stopped treatment early (n=14). Conclusions: Among patients who received DAAs in these general healthcare settings, half of whom had cirrhosis and previous treatment, the frequency of treatment completion and SVR was high. Receipt of a regimen other than SOF with LDV was associated with a lower likelihood of achieving SVR.