Sofosbuvir-based therapy in patients with chronic hepatitis C virus infection and malignancies: A prospective study of 143 patients.

Abstract

e18152 Background: Data on the management of chronic hepatitis C virus (HCV) infection in cancer patients (pts) are sparse with many of them excluded from cancer clinical trials (CCT). We evaluated the efficacy and safety of sofosbuvir-based therapy (SOFBT) in such pts. Methods: Consecutiveptstreated with SOFBT at MD Anderson (1/2014-2/2017) were included in a prospective observational study. Efficacy (sustained virological response 12 weeks [SVR12] after SOFBT) was assessed based on intention to treat (ITT) analysis. A posthoc per-protocol analysis (PPA) was performed on pts with 12 weeks of follow-up post SOFBT. Adverse events (AEs) and drug-drug interactions (DDIs) were evaluated. Results: Of the 143 pts studied, the majority were men (102; 89%), white (89; 62%) and had genotype 1 (103; 72%). The most common cancers were non-Hodgkin lymphoma (NHL), hepatocellular carcinoma (HCC) (24; 17%, each) and breast cancer (11; 8%). Of the 31 infected pts excluded from CCTs, 27 (87%) were granted access after SVR. The overall SVR12 were 90% ITT (129/143) and 91% PPA (118/130). SVR12 ITT were 80% (8/10) for SOF+peg-interferon+ ribavirin, 86% (24/28) for SOF+ ribavirin, 95% (20/21) for SOF+simeprevir, 90% (64/71) for SOF/ledipasvir, 100% (8/8) for SOF+daclatasvir and 100% (5/5) for SOF/velpatasvir. The most common AEs were grade 1 (50; 35%), predominantly anemia (22%). DDIs or grade 4 AEs did not occur. Two pts died during the study period, both from reasons unrelated to SOFBT. In 3 pts with HCV-associated NHL, SOFBT was used alone without chemotherapy. Two of them had splenic marginal zone NHL and achieved complete remission (CR); the remaining pt had follicular lymphoma with stable cancer (SC) after SOFBT. No cases of de novo HCC occurred within 6 months of SOFBT. In the same period, 10% (4/40) of pts with SC had progression (acute leukemia, breast cancer, HCC and NHL in 1 each) and 5% (4/75) of pts with CR developed relapse (acute leukemia in 3, NHL in 1). More pts who failed SOFBT had cirrhosis (77% vs 27%, P = .001) and poorer adherence (≥ 2 missed appointments) (43% vs 4%, P = .001) than those with SVR. Conclusions: SOFBT is effective and safe in cancer pts; it improves access to CCT and may induce CR in selected NHL pts.