This article is more than 5 years old. Information may no longer be current.

Six weeks of Harvoni may be sufficient in acute HCV

BARCELONA — Six weeks of therapy with sofosbuvir/ledipasvir yielded 100% sustained virologic response by 12 weeks in a small cohort of patients in Germany, according to findings presented at the International Liver Congress.

Katja Deterding, MD, of HepNet Study-House and the Hannover Medical School in Hannover, said there are few data investigating the efficacy, safety and treatment duration of novel direct-acting antiviral therapies for the management of acute HCV.  The current study included 20 patients accrued between November 2014 and October 2015.

The study included 11 patients with genotype 1a disease and 9 patients with genotype 1b. All patients completed 6 weeks of Harvoni (ledipasvir/sofosbuvir, Gilead Sciences) treatment and 12 weeks of follow-up.

“After only 2 weeks of treatment, already nine patients had undetectable HCV RNA,” Deterding said. She added that by week 4 of treatment, HCV RNA was below 15 IU/mL for all 20 patients. “After 6 weeks of treatment, all patients had undetectable HCV RNA.”

Follow-up results indicated that all patients achieved SVR12, according to Deterding. “So 6 weeks of antiviral treatment was enough for all patients to clear the acute HCV infection,” she said. “However, the question is whether there is a correlation between baseline viral load and HCV RNA decline.”

Deterding said that this correlation was not clearly demonstrated. “In the group of patients who already had undetectable HCV RNA at week 2, there were patients who started treatment with a very low baseline viral load,” she said. However, several patients started treatment with a viral load above 100,000 IU/mL. Patients with a higher baseline viral load were still detectable at week 4 of treatment.

The researchers also looked at alanine aminotransferase levels. At week 12 of follow-up, 90% of the cohort had normalized ALT, according to Deterding.

There were 22 drug-related adverse events reported overall. There was only one serious event reported, but that was deemed unrelated to the study drug. The most commonly reported event was gastrointestinal symptoms, reported by four patients (20%). Fatigue and hair loss each occurred in three patients, while two patients each reported headache, skin rash, abdominal pain or psychiatric disorders.

“Treatment of symptomatic acute hepatitis C with sofosbuvir/ledipasvir was safe and well tolerated,” Deterding concluded. “Short treatment of only 6 weeks was highly effective, with an SVR12 rate of 100% in acute HCV genotype 1 monoinfected patients. High baseline viral load was associate with a delayed virological response, which, however, did not lead to treatment failures.”

Deterding suggested that further studies need to be conducted in other HCV genotypes and for other treatment regimens. “Even shorter treatment durations remain to be studied,” she said. “Short-duration treatment of acute hepatitis C may be cost saving compared to treatment of chronic hepatitis C.”

Reference:

Deterding K, et al. Abstract LB08. Presented at: International Liver Congress; April 13-17, 2016; Barcelona.

Disclosures: Deterding reports giving sponsored lectures for AbbVie, Gilead and MSD/Merck.