The hepatitis C (HCV) care cascade in the US is limited by the number of specialists able to treat HCV. Given the advent of directly acting antiviral therapy, we conducted a large-scale, longitudinal trial to evaluate the efficacy and safety of primary care driven HCV treatment
In this multi-center, open label, phase IV clinical trial, chronic HCV-infected patients of community health centers in Washington DC were identified by their providers, consented, and distributed in a non-randomized manner to receive treatment from either a specialist (ID/Hepatology), primary care physician (PCP), or nurse practitioner (NP). Providers underwent uniform training on IDSA-AALSD therapeutic guidelines. Patients were treated with ledipasvir and sofosbuvir (LDV/SOF) as per label. The primary outcome was defined as unquantifiable HCV RNA viral load 12 weeks after completion of therapy (SVR12). Adherence to visits at 4, 8, and 12 weeks (all -7 to +14 days), were categorized by a composite score of attendance. Statistical analysis included chi-squared or Fisher’s exact test and logistic regression using SAS, version 9.3
600 patients began treatment with LDV/SOF from May to November 2015, with follow up ongoing. 14 patients discontinued treatment early, including 4 due to adverse events and 1 death unrelated to study participation. Patients were predominantly black (96%) and genotype 1a (72%); 24% were HIV/HCV-coinfected, 18% were treatment experienced, and 20% were CPA cirrhotic, with comparable baseline characteristics between provider groups. Of 181 patients with available results, 169 achieved SVR12 (93.4% per protocol; 86.7% intention-to-treat including early discontinued). Of 12 patients with virologic failure, 1 had breakthrough and 11 had relapse. There was no significant difference (p=0.67) between per protocol SVR12 and provider type: NPs (47/49;95.9%), PCPs (36/38;94.7%), and specialists (86/94;91.5%). HIV status had no impact on SVR12 or SVR12 by provider type. Of 419 patients who completed 12 weeks of therapy, composite adherence was significantly associated with provider type: 50% in NPs, 41% in PCPs, and 19% in specialists (P<0.001)
For the first time, we demonstrate that HCV treatment administered independently by PCPs and NPs is safe and effective, inclusive of challenging subpopulations of the epidemic, and within the largest African-American cohort described to date. Community-based non-specialist providers could significantly expand the scale of HCV therapy