Sofosbuvir-Based Therapy in Patients with Chronic Hepatitis C Virus Infection and Malignancies – A Prospective Observational Study of 60 Patients

Background: Sofosbuvir (SOF)-based therapy (SOFBT) is widely used in patients (pts) with Hepatitis C virus (HCV) infection. We evaluated the efficacy and safety of SOFBT in infected pts with various types of malignancies, a population lacking treatment guidelines.

Methods: In this prospective observational study, infected cancer pts who received SOFBT (01/2014-06/2015) were analyzed. Pts were divided into 4 groups [SOF+ peg-interferon (PEG-IFN) + ribavirin (RBV); SOF+ RBV; SOF+ simeprevir (SIM); and SOF/ ledipasvir (LDV)]. Efficacy was assessed by intention-to-treat (ITT) analysis based on sustained virological response 12 weeks after finishing SOFBT (SVR12). A post-hoc per-protocol analysis was performed on pts who completed 12 weeks of follow-up. Poor compliance (>2 missed visits), adverse events (AEs) and clinically significant drug-drug interactions (DDIs) were analyzed.

Results: Sixty pts were enrolled, the majority were men (68%) with genotype 1 (G1, 73%). The most common cancers were hepatocellular carcinoma (10%) and breast cancer (10%). Hematologic cancer was observed in 25 (42%) pts. The overall SVR12 was 87% (52/60) per ITT and 90% (52/58) per-protocol analysis. SVR12 (ITT) were 78% (7/9) for SOF+ PEG-IFN+ RBV, 84% (16/19) for SOF+ RBV, 100% (18/18) for SOF+ SIM and 79% (11/14) for SOF/LDV. SVR12 (per protocol) were 78% (7/9) for SOF+ PEG-IFN+ RBV, 89% (16/18) for SOF+RBV, 100% (18/18) for SOF+ SIM and 85% (11/13) for SOF/LDV. SVR12 (ITT) in G1 pts was 91% (40/44). In pts treated with 8 weeks of SOF/LDV, SVR12 was 100% (6/6). The most common AEs were anemia (27/60; 45%), rash and mood changes (7/60; 12%, each). Most of the AEs (38/60; 63%) were Grade 1. Grade 4 AEs and DDIs were not observed. Two pts died during the study period, both from reasons unrelated to SOFBT. Cancer relapse within 6 months of SOFBT occurred in 2 of the 31 pts (6%) in which malignancies were in complete remission at enrollment. They had marginal zone lymphoma and breast cancer (1pt each). Compared to pts who achieved SVR12, pts who failed SOFBT had more cirrhosis (75% vs 33%, P=.04) and poorer treatment compliance (10% vs 62%, P<.01).

Conclusion: SOF-containing regimens are effective and safe in HCV-infected pts with various types of cancer, with high SVR12 among those with G1 infection.