Meeting News Coverage

EASL releases 2016 HCV recommendations

During a special conference, EASL released its 2016 recommendations for the treatment of hepatitis C. The findings were simultaneously published in the Journal of Hepatology.

“HCV elimination will require national plans together with forecasted budgeting to expedite unrestricted access to treatment,” Jean-Michel Pawlotsky, MD, PhD, professor of medicine at the University of Paris-Est, and member of the recommendations panel, and colleagues wrote. “All treatment-naive and treatment-experienced patients with compensated or decompensated chronic liver disease related to HCV, who are willing to be treated and who have no contraindications to treatment, must be considered for therapy.”

Jean-Michel Pawlotsky
Jean-Michel Pawlotsky

The new recommendations add Epclusa (sofosbuvir/velpatasvir, Gilead Sciences) and Zepatier (grazoprevir/elbasvir, Merck) to the arsenal of treatments recommended in 2015.

Sofosbuvir/velpatasvir fell into recommendations for all genotypes, while grazoprevir/elbasvir was recommended for genotypes 1 and 4.

With these new drugs and the success of previously recommended medications, EASL included recommendations to treat patients awaiting liver transplantation as well as acute HCV.

Though the recommendations suggest treating all patients with MELD scores below 20 and those with scores higher than 20 if their waiting time is greater than 6 months, they warned that long-term impact of treatment and possible delisting is unknown.

“The short-term benefits observed must be balanced with the respective risks of the liver transplantation and of not being transplanted,” the authors wrote.

In acute HCV, treatment is recommended for 8 weeks with a caveat of possibly needing 12 weeks in cases of coinfection or high baseline viral load. Additionally, patients should be retested at 12 and 24 weeks to catch any late relapses.

With the high rates of SVR achieved by most patient populations, these recommendations also looked at follow-up for all patients.

Patients who do not achieve SVR should undergo treatment again, with an interferon-free combination that includes a drug with a significant barrier to resistance, plus one to three other drugs that had no cross-resistance with previously received drugs. Retreatment should be for 12 weeks with ribavirin, or extended to 24 weeks with ribavirin (or without it, if the patient cannot tolerate it) in patients with severe liver disease,  according to Pawlotsky and colleagues.

Patients without cirrhosis who achieve SVR should be retested for HCV RNA 48 weeks after their last treatment. If the RNA or core antigen is still not detected, the patient is cured, researchers wrote. However, patients who have an increased risk for liver disease should be checked periodically. Those patients with cirrhosis who achieve SVR should be monitored for hepatocellular carcinoma every 6 months.

“There remains some concern that reinfection due to recurrent or persistent risk behavior may negate the potential benefit of treatment. Reported rates of reinfection following successful HCV treatment among patients at high-risk, such as [persons who inject drugs] or [men who have sex with men], are in the order of 1–8% per year,” Pawlotsky and colleagues wrote. “The ease of IFN-free therapy may increase the likelihood of reinfection. … In order to maximize the benefit of therapy, the risks of reinfection should be emphasized to patients at risk, and behavioral modifications should be positively reinforced.”

WHO updated its guidelines earlier this year to facilitate HCV treatment in low- to middle-income countries using many of these same methods. The  AASLD/IDSA HCV guidelines have incorporated similar recommendations over the past year. – by Janel Miller

Reference: Pawlotsky J, et al. Presented at: EASL Special Conference: New Perspectives in Hepatitis C Virus Infection — The Roadmap for Cure; Sept. 23-24, 2016; Paris.
Pawlotsky J, et al. J Hepatol. 2016:doi:10.1016/j.jhep.2016.09.001.

Disclosure: Pawlotsky reports receiving grant and research support from AbbVie and Gilead; being on the advisory boards of AbbVie, Bristol-Myers Squibb, Gilead, Janssen, and Merck; and speaking and teaching with AbbVie, Bristol-Myers Squibb, Gilead, Janssen, and Merck. Please see the study for a list of all other researchers’ financial disclosures.

During a special conference, EASL released its 2016 recommendations for the treatment of hepatitis C. The findings were simultaneously published in the Journal of Hepatology.

“HCV elimination will require national plans together with forecasted budgeting to expedite unrestricted access to treatment,” Jean-Michel Pawlotsky, MD, PhD, professor of medicine at the University of Paris-Est, and member of the recommendations panel, and colleagues wrote. “All treatment-naive and treatment-experienced patients with compensated or decompensated chronic liver disease related to HCV, who are willing to be treated and who have no contraindications to treatment, must be considered for therapy.”

Jean-Michel Pawlotsky
Jean-Michel Pawlotsky

The new recommendations add Epclusa (sofosbuvir/velpatasvir, Gilead Sciences) and Zepatier (grazoprevir/elbasvir, Merck) to the arsenal of treatments recommended in 2015.

Sofosbuvir/velpatasvir fell into recommendations for all genotypes, while grazoprevir/elbasvir was recommended for genotypes 1 and 4.

With these new drugs and the success of previously recommended medications, EASL included recommendations to treat patients awaiting liver transplantation as well as acute HCV.

Though the recommendations suggest treating all patients with MELD scores below 20 and those with scores higher than 20 if their waiting time is greater than 6 months, they warned that long-term impact of treatment and possible delisting is unknown.

“The short-term benefits observed must be balanced with the respective risks of the liver transplantation and of not being transplanted,” the authors wrote.

In acute HCV, treatment is recommended for 8 weeks with a caveat of possibly needing 12 weeks in cases of coinfection or high baseline viral load. Additionally, patients should be retested at 12 and 24 weeks to catch any late relapses.

With the high rates of SVR achieved by most patient populations, these recommendations also looked at follow-up for all patients.

Patients who do not achieve SVR should undergo treatment again, with an interferon-free combination that includes a drug with a significant barrier to resistance, plus one to three other drugs that had no cross-resistance with previously received drugs. Retreatment should be for 12 weeks with ribavirin, or extended to 24 weeks with ribavirin (or without it, if the patient cannot tolerate it) in patients with severe liver disease,  according to Pawlotsky and colleagues.

Patients without cirrhosis who achieve SVR should be retested for HCV RNA 48 weeks after their last treatment. If the RNA or core antigen is still not detected, the patient is cured, researchers wrote. However, patients who have an increased risk for liver disease should be checked periodically. Those patients with cirrhosis who achieve SVR should be monitored for hepatocellular carcinoma every 6 months.

“There remains some concern that reinfection due to recurrent or persistent risk behavior may negate the potential benefit of treatment. Reported rates of reinfection following successful HCV treatment among patients at high-risk, such as [persons who inject drugs] or [men who have sex with men], are in the order of 1–8% per year,” Pawlotsky and colleagues wrote. “The ease of IFN-free therapy may increase the likelihood of reinfection. … In order to maximize the benefit of therapy, the risks of reinfection should be emphasized to patients at risk, and behavioral modifications should be positively reinforced.”

WHO updated its guidelines earlier this year to facilitate HCV treatment in low- to middle-income countries using many of these same methods. The  AASLD/IDSA HCV guidelines have incorporated similar recommendations over the past year. – by Janel Miller

Reference: Pawlotsky J, et al. Presented at: EASL Special Conference: New Perspectives in Hepatitis C Virus Infection — The Roadmap for Cure; Sept. 23-24, 2016; Paris.
Pawlotsky J, et al. J Hepatol. 2016:doi:10.1016/j.jhep.2016.09.001.

Disclosure: Pawlotsky reports receiving grant and research support from AbbVie and Gilead; being on the advisory boards of AbbVie, Bristol-Myers Squibb, Gilead, Janssen, and Merck; and speaking and teaching with AbbVie, Bristol-Myers Squibb, Gilead, Janssen, and Merck. Please see the study for a list of all other researchers’ financial disclosures.