Patients with chronic hepatitis C virus (HCV) infection without cirrhosis have a high rate of sustained viral response at 12 weeks with use of 3-week triple direct-acting antiviral therapy, according to a study published in the Lancet Gastroenterology & Hepatology.
Researchers examined the antiviral efficacy and safety of 3 weeks of response-guided therapy with an NS3 protease inhibitor and dual NS5A inhibitor–NS5B nucleotide analogue in the open-label, phase 2a study. Patients with chronic HCV genotype 1b infection without cirrhosis were randomly assigned to 1 of 3 treatment groups (sofosbuvir, ledipasvir, and asunaprevir; sofosbuvir, daclatasvir, and simeprevir; or sofosbuvir, daclatasvir, and asunaprevir) until 6 patients in each group achieved an ultrarapid virologic response (plasma HCV RNA <500 IU/mL by day 2).
Patients who had an ultrarapid virologic response received 3 weeks of therapy, and those who did not achieve an ultrarapid response were switched to sofosbuvir and ledipasvir for either 8 weeks or 12 weeks. The primary endpoint was the proportion of patients who had a sustained virologic response at 12 weeks (SVR12) after treatment completion.
A total of 26 patients were included in the analysis—12 received sofosbuvir, ledipasvir, and asunaprevir; 6 received sofosbuvir, daclatasvir, and simeprevir; and 8 received sofosbuvir, daclatasvir, and asunaprevir. Six patients in each group (69%) achieved an ultrarapid virologic response. All patients who had an ultrarapid virologic response and were given 3 weeks of triple therapy achieved SVR12. The most common adverse events were fatigue (4 patients) and headache (3 patients). No serious adverse events were observed.
“Although our study is small, we showed high rates of sustained viral response at 12 weeks with use of the 3-week triple direct-acting antiviral therapy, which supports the possibility that this ultrashort regimen might be effective for some patients infected with HCV,” reported George Lau, MD, from the Humanity and Health Medical Center in Hong Kong, and colleagues.
“By shortening the duration of therapy from the currently recommended 12 weeks to 3 weeks, we could drastically reduce the cost of therapy and the rate of adverse events,” the investigators concluded.
- Lau G, Benhamou Y, Chen G, et al. Efficacy and safety of 3-week response-guided triple direct-acting antiviral therapy for chronic hepatitis C infection: a phase 2, open-label, proof-of-concept study. Lancet Gastroenterol Hepatol. 2016;1(2):97-104. DOI: 10.1016/S2468-1253(16)30015-2.