Preliminary clinical outcome data among patients with hepatitis C virus infection receiving direct-acting antiviral therapy in the Chronic Hepatitis Cohort Study, 2014-2015

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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.




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