Patients with hepatitis C genotype 4 had high sustained virologic response rates with Harvoni over 8 weeks in treatment-naive cases without cirrhosis and over 12 weeks with ribavirin regardless of cirrhosis or treatment experience, according to recently published data from a phase 3 study in Egypt.
“Given the high prevalence of HCV in Egypt and the heterogeneity of the HCV-infected population with respect to age, comorbidities and prior HCV therapy, there is a need in Egypt for a highly efficacious, well-tolerated, single-tablet regimen with simple monitoring,” Gamal Shiha, MD, PhD, from the Liver Research Institute and Hospital in Egypt, and colleagues wrote. “With the widespread use of sofosbuvir, an efficacious treatment for those who have failed treatment with a sofosbuvir-based regimen would also be highly desirable.”
The study included one cohort of treatment-naive patients who received Harvoni (ledipasvir/sofosbuvir, Gilead Sciences) with or without ribavirin for 8 weeks or 12 weeks (n = 170), one cohort of ledipasvir/sofosbuvir- or sofosbuvir-experienced patients treated again with the addition of ribavirin for 12 weeks (n = 74), and one cohort of interferon-experienced patients treated with ledipasvir/sofosbuvir with or without ribavirin for 12 weeks (n = 11).
Among treatment-naive patients who received 8 weeks of ledipasvir/sofosbuvir, the SVR rates were 90% with ribavirin, 95% without ribavirin, and 94% among those with cirrhosis (91% with ribavirin vs. 97% without).
The SVR rates among treatment-naive patients treated for 12 weeks was 98% with or without ribavirin.
All 11 ledipasvir/sofosbuvir- or sofosbuvir-experienced patients retreated with ribavirin for 12 weeks achieved SVR.
The SVR rates among interferon-experienced patients were 100% with ribavirin and 94% without ribavirin. One patient in this group experienced virological relapse after 12 weeks.
Three serious adverse events occurred, although none were related to treatment. Overall rates of adverse events were higher among patients who received ribavirin with treatment at both 8 weeks (52% vs. 37%) and 12 weeks (63% vs. 41%).
“The SVR rates observed in some baseline subgroups, such as the treatment-naive patients without cirrhosis, should be interpreted somewhat with caution due to relatively low patient numbers and lack of study power,” the researchers wrote. “These results are in line with data previously reported in HCV genotype 1 patients who failed treatment with a sofosbuvir-based regimen and were retreated with ledipasvir–sofosbuvir plus ribavirin for 12 weeks.” – by Talitha Bennett
Disclosure: Shiha reports he has served as a principal investigator for AbbVie and Gilead. Please see the full study for the other authors’ relevant financial disclosures.