BOSTON, MA—At The Liver Meeting® 2016, scientists reported that treatment with ledipasvir/sofosbuvir (LDV/SOF) for 6 weeks was well tolerated and highly effective in patients with acute hepatitis C virus (HCV) genotype 1 infection.
For patients with acute HCV infection, early treatment initiation with interferon alfa monotherapy has proven to be highly effective but also has been associated with frequent adverse effects. “There is no fully published study yet exploring the safety, efficacy and required treatment duration of interferon-free treatment of acute HCV monoinfection,” explained Dr. Katja Deterding, from the Hannover Medical School, Hannover, Germany. Early literature has suggested LDV/SOF treatment to be effective in HCV but relapses were seen in patients co-infected with HIV after 6 weeks of treatment.
The single-arm, prospective multicenter pilot study (German HepNet Acute HCV IV Study) was designed to assess the safety and efficacy of LDV/SOF for 6 weeks without ribavirin in patients with acute HCV genotype 1 monoinfection. The researchers, led by Dr. Deterding, presented data on the final 24 weeks post-treatment. Data from 10 centers including 20 patients were included: 11 with HCV genotype 1a and 9 with HCV genotype 1b.
Prior to treatment initiation, median ALT and bilirubin levels were 225U/L and 13.6µmol/L, respectively. During treatment, ALT levels decreased quickly and normalized values were observed by Week 2 in 9 patients and by Week 4 in 17 patients, the authors noted.
HCV RNA was undetectable by the AmpliPrep/COBAS TaqMan HCV Test v2.0 by Week 2 for 8 patients, by Week 4 in 13 patients, and by Week 6 in 20 patients. SVR12 was reported to be 100%. Having a high baseline viral load was associated with delayed virological response but it did not result in treatment failures.
In general, “a rapid improvement in biochemical disease activity was observed during therapy,” concluded Dr. Deterding. “Short-duration treatment of acute hepatitis C may be cost saving as compared to treatment of chronic hepatitis C, could prevent the spread of HCV in high-risk populations, and rapidly improve symptoms of acute hepatitis.”
Further research is needed to confirm the efficacy of the 6-week treatment duration (or even shorter) for other HCV genotypes and other treatment regimens, the authors concluded.