MONDAY, Nov. 3, 2014 (HealthDay News) -- For patients with chronic hepatitis C virus genotype 1 (HCV GT-1) infection who are ineligible for interferon therapy, and who relapsed after sofosbuvir and ribavirin treatment, sofosbuvir plus ledipasvir is a promising new therapy, according to a small study published in the Nov. 4 issue of the Annals of Internal Medicine.
Anu Osinusi, M.D., from the University of Maryland in Baltimore, and colleagues examined the safety and efficacy of sofosbuvir plus ledipasvir in 14 patients with chronic HCV GT-1 who relapsed after 24 weeks of treatment with sofosbuvir plus ribavirin. Patients who relapsed were retreated with sofosbuvir plus ledipasvir for 12 weeks.
The researchers found that all 14 patients achieved a sustained virologic response, including seven patients with advanced liver disease and one with a detectable NS5B S282T mutation after sofosbuvir plus ribavirin therapy. Treatment with sofosbuvir plus ledipasvir was well tolerated. There were four grade 3 events (elevated serum creatinine in a patient with renal insufficiency, hypercholesterolemia, and hypophosphatemia). No grade 4 events or treatment discontinuations were reported.
"The fixed-dose combination of sofosbuvir plus ledipasvir was efficacious in a small cohort of patients with HCV GT-1 [who] relapsed after sofosbuvir plus ribavirin therapy, even in the setting of advanced liver disease," the authors write. "Larger studies are needed to confirm these preliminary efficacy results."
Gilead Sciences funded the study and provided all study medications.
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