LONDON — The European Association for the Study of the Liver has introduced new online recommendations for the management of HCV. The recommendations were issued in response to expanded use of three new direct-acting antiviral agents that have gained or will gain approval by the European Medicines Agency in 2014.
Alessio Aghemo, MD, PhD, an EASL Governing Board member and panelist for the recommendations, discussed reasons for updating the guidelines: “We have seen an incredible increase in sustained virologic response rates,” he said. “All of these changes and improvements were essentially looked at and described by the previous clinical practice guidelines by EASL in 2011 and 2013. But something has changed since the 2013 clinical practice guidelines.”
Sofosbuvir (Sovaldi, Gilead) was approved by the European Medicines Agency in January. The approval of simeprevir (Olysio, Janssen) is anticipated in May and daclastavir (Bristol-Myers Squibb) will likely be approved in August or September, according to an EASL press release.
The online recommendations will contain information on the use of these drugs with or without interferon.
The three direct-acting antivirals (DAAs) have an effect on genotypes that were not acted upon by interferon, telaprevir and boceprevir, according to Aghemo.
“By combining them you can get effective treatment in most patients,” he said. “The rationale that pushed us to give this recommendation was easy. We wanted to support and assist physicians in clinical practice. We also wanted health care providers and patients to understand the best currently available treatment options.”
The guideline panel’s second aim was to help guide reimbursement for the clinical community, Aghemo said. EASL wanted patients in all countries in Europe to have as much access to these drugs as possible.
“In Europe, HCV is heterogeneous not just in terms of epidemiology,” Aghemo said. “But there are different rules in terms of reimbursement and screening policies, so we wanted to have guidelines that are homogeneous to push all European countries to have similar access to treatments.”
The recommendations will cover indications for which patients should be treated with the drugs that reach the market by the end of 2014. Guidelines for monitoring HCV therapy and measures to improve adherence to medications will be included, along with recommendations for following up with patients who achieve SVR. Clinicians may also find information on the retreatment of nonresponders and the treatment of patients with severe liver disease or other comorbidities.
“There are guidelines for six treatment options for genotype 1, six options for genotype 4, and [fewer] options for genotypes 2 and 3,” Aghemo said. “We will provide a preferred option for each genotype, but we will offer other options in terms of efficacy, safety, correct dosing and drug interaction issues.”
Aghemo added that the guidelines will address the so-called special populations. “Most importantly, we wanted to show that patients coinfected with HIV should not be looked at as a special population anymore,” he said. “These patients have shown exactly the same SVR rates as monoinfected patients with no drug interactions with HIV antiviral therapy.”
Another key message in terms of special populations was that patients with cirrhosis or those who have or will undergo liver transplantation should receive treatments that are interferon-free. “My last point is that we have no data for hemodialysis patients,” Aghemo said. “This is a group that needs treatment. We hope to have data in the future, but currently we are very cautious in our approach.” – by Rob Volansky
Disclosure: Aghemo serves on the EASL governing board and on the scientific committee. He reports receiving speaker fees for Gilead Sciences, AbbVie, Janssen, Merck and Roche.