6 Weeks Of Antiviral Treatment May Be Enough Time To Cure Hepatitis C Patients: Study
The cure for viral disease Hepatitis C (HCV) may need a lot less time to work its mojo than previously expected, suggests new research presented this weekend at The International Liver Congress (ILC) in Barcelona, Spain.
In October 2014, the Food and Drug Administration approved the combination antiviral therapy of sofosbuvir and ledipasvir for the treatment of chronic HCV infection in adults, specifically its genotype 1 variant (there are six major genotypes in total, though genotype 1 is the most common stateside). By February 2016, that approval expanded to genotypes 4, 5 and 6 and also covered HCV patients suffering from other chronic conditions like HIV and cirrhosis. But though the drug combo, branded Harvoni by its manufacturer and pharmaceutical company Gilead Sciences, has proven to be a near-universal cure all when taken for 12 weeks, there have been concerns about the widespread feasibility offered by it and similar HCV drugs.
"Given the high cost of sofosbuvir and ledipasvir, and the associated side effects that occur during treatment, we set out to assess whether shortened treatment duration could be an effective option for acute Hepatitis C patients," said lead author Dr. Katja Deterding in a statement.
The following effort, titled the HepNet Acute HCV IV Study and sponsored by the German Liver Foundation, recruited 20 patients with acute HCV (genotype 1) from various health centers across Germany. Though previous research has shown that a 8 week treatment regimen could be as effective as the full regimen, the researchers gambled even further, and subjected the patients to only 6 weeks of the drug combination.
The patients were then assessed for their HCV status 4 and 12 weeks after treatment. Despite the shorter length, the results proved to be every bit as miraculous as the 12 week version — all 20 patients had undetectable viral loads at 12 weeks as well as normal measurements of overall liver health. There were only one serious adverse event reported during the trial, but it appeared unrelated to the therapy. The most common side effect, reported by 30 percent of the patients, was fatigue.
"Our research demonstrates that not only is the combination of sofosbuvir and ledipasvir safe, well tolerated and effective in acute HCV genotype 1 patients who have severe liver disease with very high liver enzymes, but a shorter treatment duration does not appear to hinder efficacy," said senior author Professor Heiner Wedemeyer.
The success, though only a preliminary trial run, is not only encouraging because it may lower the therapy’s prohibitive costs (nearly $100,000 for a 12-week treatment), but because it might allow doctors to more aggressively combat the viral disease, the authors wrote.
“These exciting findings open up short and cost-effective treatment options that could prevent the spread of HCV in high risk populations," said Professor Frank Tacke, a Governing Board member of the European Association for the Study of the Liver, which organizes the ILC. "We look forward to seeing this pilot study extended so the findings can be validated and then hopefully used as a tool to change clinical practice for the better."
More support for a shorter treatment regimen may arrive soon, with a similar Australian study of 20 HCV patients ongoing right now. Though these patients will also be given their treatment for six weeks, the researchers are using a combination of sofosbuvir and the common HCV drug ribavirin instead.
Elsewhere, other research presented at the ICL this weekend has shown that an once-daily pill developed by AbbVie Inc had the same wonder drug effect across all HCV genotypes in as little as eight weeks of treatment. Unlike Harvoni, though, that drug regimen still awaits approval from regulatory agencies like the FDA.
Source: Deterding K, Spinner C, Schott E, et al. Six Weeks of Sofosbuvir/Ledipasvir (SOF/LDV) are Sufficient to Treat Acute Hepatitis C Virus Genotype 1 Monoinfection: The Hepnet Acute HCV IV Study. ILC 2016. 2016.