As reported in the Journal of Clinical Oncology by Merli et al, the Fondazione Italiana Linfomi phase II BArT study has shown that primary treatment of hepatitis C virus (HCV)-associated indolent non-Hodgkin lymphomas with direct-acting antivirals resulted in sustained virologic response in all patients and lymphoma response in nearly half of patients.
Study Details
In the Italian multicenter trial, 40 untreated HCV-positive patients without criteria for immediate conventional antilymphoma treatment received HCV genotype-appropriate direct-acting antiviral regimens. A total of 27 patients had marginal zone lymphoma and 14 patients had extranodal disease sites. Direct-acting antiviral regimens consisted of ledipasvir/sofosbuvir in 17 patients, sofosbuvir/velpatasvir in 15, and sofosbuvir/ribavirin in 8. The primary outcome measure was sustained virologic response; the main secondary measures were overall response rate of lymphoma and progression-free survival.
Key Findings
Sustained virologic response was achieved in all patients at 12 weeks after completion of direct-acting antiviral treatment.
Lymphoma response at 12 weeks after completion of direct-acting antiviral treatment was observed in 18 patients (45%), with complete response in 8 (20%). Stable disease was observed in 16 (40%) and disease progression was observed in 6 (15%). Response was observed in 48% of patients with marginal zone lymphoma and in 38% of patients with non–marginal zone lymphoma disease. The likelihood of remaining in response at 36 months was 89% (95% confidence interval [CI] = 62%–97%). Among the 14 patients with extranodal sites, 10 had a ≥ 50% reduction in extranodal lesions, including 6 with complete regression. Among the 16 patients with stable disease, only 1 exhibited progression over a median follow-up of 37 months.
Over a median follow-up of 37 months, two patients died and three additional patients had disease progression. All nine patients with disease progression received a conventional lymphoma treatment. At 3 years, overall survival was 93% (95% CI = 74%–98%) and progression-free survival was 76% (95% CI = 57%–87%).
The most common adverse event of any grade was fatigue (20%). One patient had a grade 3 adverse event and one patient had a grade 4 adverse event.
The investigators concluded, “HCV eradication by direct-acting antivirals was achieved in 100% of HCV-positive patients with indolent lymphomas not requiring immediate conventional treatment and resulted in non-negligible rate of lymphoma responses. Treatment with direct-acting antivirals should be considered as the first-line therapy in this setting.”
Luca Arcaini, MD, of the Division of Hematology, Fondazione IRCCS Policlinico San Matteo, Pavia, is the corresponding author for the Journal of Clinical Oncology article.
Disclosure: The study was supported by Gilead Sciences. For full disclosures of the study authors, visit ascopubs.org.
