Sofosbuvir-based DAAs effective for most genotypes in Chinese patients
Sofosbuvir plus ribavirin with or without pegylated interferon was safe and effective in Chinese patients with hepatitis C genotypes 1, 2, 3 and 6, regardless of treatment experience, according to recently published data.
“Both sofosbuvir plus peginterferon/ribavirin for 12 weeks and all-oral sofosbuvir plus ribavirin for 12 to 24 weeks would represent, in China, a clinically significant improvement compared with the current standard of care of peginterferon/ribavirin,” Lai Wei, MD, from the Peking University People’s Hospital, China, and colleagues wrote.
The study comprised 389 patients with HCV. Patients with genotype 1 and those with genotype 6 received combination sofosbuvir (Sovaldi, Gilead Sciences) plus ribavirin for 24 weeks or the combination with PEG-IFN for 12 weeks. Patients with genotype 2 received the sofosbuvir combination for 12 weeks and those with genotype 3 received the combination for 24 weeks.
Patients with genotype 1 achieved a sustained virologic response rate of 95% without PEG-IFN and 94% with PEG-IFN. Patients with genotype 6 had the highest SVR of 100% in those who received combination therapy with PEG-IFN and 97% among those treated without PEG-IFN. Those with genotype 2 achieved a rate of 92% and those with genotype 3 achieved a rate of 95%.
Twenty patients experienced relapse within 12 weeks; however, no patients experienced viral breakthrough during treatment.
Subgroup analysis showed that patients achieved an SVR of 86% or higher regardless of baseline characteristics, including IL28B genotype, baseline HCV-RNA levels and treatment experience. Patients with cirrhosis who received PEG-IFN during treatment had a lower rate of SVR.
The most common adverse events included reticulocyte count (n = 63), pyrexia (n = 60) and anemia (n = 55), which occurred more often among patients treated with PEG-IFN for 12 weeks (94% vs. 84%) and for 24 weeks (94% vs. 78%) than those treated without PEG-IFN. The researchers considered one case of angle closure glaucoma and one case of gastritis to be treatment-related.
“Besides lack of efficacy, the reasons for treatment failure [with PEG-IFN] include discontinuation of treatment due to unmanaged or unmanageable side effects and problems with the monitoring of patients in rural areas,” the researchers wrote. “Overall, sofosbuvir-based therapy resulted in high SVR rates of 92% [or higher].” – by Talitha Bennett
Disclosure: Wei reports he received research grants from AbbVie, Bristol-Myers Squibb and Roche; has served on advisory boards for AbbVie, Allergan, Ascletis, Bristol-Myers Squibb, Galmed, Gilead and Trek; and has served on the speakers bureaus of Abbott, AbbVie, Ascletis, Bristol-Myers Squibb, Gilead, Johnson & Johnson and Merck Sharp & Dohme. Please see the full study for the other authors’ relevant financial disclosures.