Combination ledipasvir and sofosbuvir effectively treats chronic genotype 1 hepatitis C virus (HCV) infections in a Japanese population, according to a study published in The Lancet.
Compared with other patient populations, Japanese people with chronic genotype 1 HCV tend to be older, have more advanced liver disease, and are more likely to have been previously treated for HCV. In their study, the researchers wanted to test both the safety and efficacy of an all-oral, fixed-dose combination of ledipasvir and sofosbuvir with and without ribavirin for 12 weeks in this patient population.
The study included 341 participants, 171 of whom were randomized to treatment with ledipasvir-sofosbuvir and 170 of whom were randomized to treatment with ledipasvir, sofosbuvir, and ribavirin. After 12 weeks of treatment, patients were followed up for another 24 weeks.
In the ledipasvir-sofosbuvir group, sustained virological response (SVR) was achieved in all 171 (100%) patients, compared with 167 (98%) of 170 patients in the ribavirin group.
Among patients taking ledipasvir-sofosbuvir, the most comment adverse effects were nasopharyngitis (29.2%), headache (7.0%), and malaise (5.3%). In patients taking ledipasvir, sofosbuvir, and ribavirin, the most common adverse effects were nasopharyngitis (23.5%), anemia (13.5%), and headache (8.8%).
Many patients with chronic genotype 1 HCV benefit from existing treatment regimens. However, for patients whose needs are not fulfilled by current treatments, the combination of ledipasvir and sofosbuvir can provide a new, effective treatment option.
Compared with other countries, patients with chronic hepatitis C infection in Japan tend to be older, have more advanced liver disease, and are more likely to have been previously treated for hepatitis C. We aimed to assess the efficacy and safety of an all-oral, fixed-dose combination of the hepatitis C virus NS5A inhibitor ledipasvir and the NS5B nucleotide polymerase inhibitor sofosbuvir with and without ribavirin for 12 weeks in treatment-naive and previously treated Japanese patients with chronic genotype 1 hepatitis C virus infection.