Prior to the approval of direct-acting antivirals (DAA), uptake of curative hepatitis C virus (HCV) treatment was low, particularly for HIV/HCV co-infected patients. DAA offers >95% sustained virologic response (SVR) for the vast majority of HCV-infected patients, regardless of HIV-1 infection. Although safety and efficacy of HCV therapies have improved, challenges have emerged including high rates of insurance denials and drug interactions between antiretrovirals (ARV) and DAA.
Using the Duke Enterprise Data Unified Content Explorer, we identified all HIV/HCV co-infected and HCV mono-infected patients engaged (at least one appointment in the system during the study period) in the healthcare system from 2011-2015, reflecting the DAA era. Prescriptions for DAA were queried to determine the treatment numbers. Demographic and clinical data were extracted by database and supplemented by manual record review. We describe the proportion of patients receiving DAA therapy per year of the study. Comparisons among cohorts employed the Fisher’s exact test, the chi-square test, and Student’s t-test as appropriate.
We identified 9,960 patients with HCV mono-infection and 715 with HIV/HCV co-infection seen at least annually. The description of the HCV mono-infected versus HIV-HCV co-infected patients is as follows: for gender, 60.9% and 69.9% of patients were male; for race, 38.4% and 71.7% were black; 30.6% and 23.9% had cirrhosis; 10.2% and 18.6% had hepatitis B virus co-infection. During the study period, 323/9960 (3.2%) patients with HCV mono-infection were prescribed an interferon-based regimen, compared to 22/715 (2.9%) of HIV/HCV co-infected patients (Figure 1). Comparatively, 970/9960 (9.7%) of HCV mono-infected versus 125/715 (17.4%) of HIV/HCV co-infected patients were prescribed interferon-free DAA regimens (p<0.0001). Patients with HIV/HCV achieved high SVR 12 weeks after therapy completion, with rates of 9/22 (40.9%) compared to 123/125 (98.4%) in the DAA-interferon versus DAA-only era, respectively (p<0.0001). ARV regimens were switched in 21 of 125 (17%) HIV-HCV co-infected patients prior to initiation of DAA.
The introduction of DAA therapy has significantly improved access to HCV treatment and SVR is high in HIV/HCV co-infected patients. Meanwhile <20% of all HCV-infected patients at Duke have received therapy. More studies are needed to understand the barriers to access and how these barriers can be addressed.