Direct-Acting Drugs Show Promise in Acute HCV – MedPage Today

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BARCELONA — People with acute hepatitis C can be cured with a shortened course of the antivirals used to treat the chronic form of the disease, a researcher said here.

In a single-arm prospective pilot study, 6 weeks of the antiviral combination of sofosbuvir and ledipasvir (Harvoni) cured 100% of patients, Heiner Wedemeyer, MD, of Hannover Medical School in Germany, reported.

That’s markedly cheaper than waiting until patients develop chronic disease and then treating them for 12 weeks with the same drugs, Wedemeyer told reporters at the International Liver Congress.

“These are really amazing data,” commented Frank Tacke, MD, PhD, of the University Hospital Aachen in Germany and a member of the scientific committee of the European Association of the Study of the Liver (EASL),which organizes the meeting.

It’s good news that “6 weeks of treatment [can cure] this severely affected population of patients,” said Tacke, who moderated a media briefing at which some of the data was presented, noting that’s half the time needed to treat most patients with chronic disease.

But he asked whether the cheaper treatment cost was the sole rationale for the study.

Not at all, Wedemeyer replied. Acute HCV is “a relatively rare condition,” he said, “but some patients are severely affected.”

He noted that many people take antivirals for influenza that merely shorten the symptomatic period from about 7 to 5 days. While many people with acute HCV have no symptoms, Wedemeyer said those that do usually have them for several weeks. The symptoms include jaundice, nausea, and abdominal pain.

“These people are ill for months and we need to offer them something,” he said.

Wedemeyer added that people with acute disease are infectious, so effective and rapid treatment would prevent further transmission.

Between 10% and 15% of people with acute disease will clear the infection without intervention, but the remainder will go on to develop chronic disease, which is more difficult and costly to treat.

Acute HCV can be successfully treated with regimens based on interferon — an immune stimulant that is associated with unpleasant and dangerous adverse effects — but the efficacy of novel interferon-free regimens has not been well studied.

To begin to fill that gap, Wedemeyer and colleagues enrolled 20 patients with known or suspected exposure to HCV within the preceding 4 months, confirmed antibodies against HCV, and/or a level of alanine aminotransferase of more than 10 times upper the limit of normal.

Participants had to be adults with detectable plasma HCV RNA (of genotype 1) and no worse than compensated liver disease. They were ruled out of the study if they had HIV, hepatitis A or B, or ongoing drug abuse.

Wedemeyer noted that the incidence of acute HCV has been falling, but cases still occur. Importantly, while sexual transmission is generally regarded as rare, in this study it was involved in 55% of the cases, while medical procedures caused another 25%.

All patients were treated with the fixed-dose, single-pill combination. Wedemeyer said most patients had plasma HCV RNA levels below 15 IU/mL after 2 weeks of treatment, and all had undetectable HCV by the end of 6 weeks. All remained without evidence of the virus 12 weeks later.

“We cured all the patients,” Wedemeyer said, where a cure was defined as no detectable HCV 12 weeks after the end of therapy (SVR12). “This is really spectacular,” he stated.

A high baseline viral load delayed the response, but did not affect the eventual outcome.

The regimen was also safe and well tolerated, he said. The most common adverse event possibly or probably related to the study drug, measured until the end of the 12-week follow-up, was fatigue, followed by gastrointestinal symptoms, reported by six and four of the 20 patients, respectively.

There was one serious adverse event — a skiing accident — that was not related to the study drug, he said.

The regimen “was absolutely safe,” Wedemeyer said.

Gilead Sciences supplied the study drug and some financing.

Wedemeyer disclosed relevant relationships with AbbVie, Abbott, Bristol Myers Squibb, Gilead, and Merck/Schering-Plough.

Tacke disclosed no relevant relationships with industry.

  • Reviewed by
    F. Perry Wilson, MD, MSCE Assistant Professor, Section of Nephrology, Yale School of Medicine and Dorothy Caputo, MA, BSN, RN, Nurse Planner

last updated 04.18.2016

Direct-Acting Drugs Show Promise in Acute HCV – MedPage Today