Updated guidelines from the American Association for the Study of Liver Diseases (AASLD) and Infectious Diseases Society of America (IDSA) for the treatment of hepatitis C have identified preferred regimens for patients with decompensated cirrhosis and for other unique populations, such as those with renal impairment.
The recommendations have been divided into a list of variables, including genotype, status of liver function, prior treatment and eligibility for ribavirin (RBV). As with all of the recommendations, bullet point listings are accompanied by a grading of the evidence followed by a detailed analysis of the data on which the recommendation is based.
In a change from the conventional way of preparing clinical recommendations, the guidelines appear on the joint AASLD/IDSA website, www.hcvguidelines.com. The goal is to make current data “accessible to all who are treating HCV,” said Hugo E. Vargas, MD, professor of medicine at Mayo Clinic, in Scottsdale, Ariz.
Consistent With Near-Universal Treatment
Treating hepatitis C virus (HCV) even in patients with severe decompensated cirrhosis is consistent with the position by AASLD/IDSA that essentially everyone infected with HCV should now be considered a candidate for therapy. The major exception is a patient with a life expectancy too short to benefit from HCV treatment. According to Dr. Vargas, one goal of these guidelines is to “minimize barriers” to the benefits of a sustained virologic response (SVR).
Ensuring that all HCV patients obtain access to care “has been a very difficult nut to crack,” Dr. Vargas said. Providing joint AASLD/IDSA recommendations that consolidate and explain the quality of the evidence has been one step toward promoting treatment.
The guidelines for decompensated cirrhosis recommend direct-acting antiviral agents for patients with HCV genotypes 1, 2, 3 and 4. For HCV genotypes 1 and 4, the strongest evidence (class I, level A) supports 12 weeks of 90 mg of ledipasvir (LED) plus 400 mg of sofosbuvir (SOF; Harvoni, Gilead) and RBV, according to the updated recommendations. Slightly weaker evidence supports 60 mg of daclatasvir (DAC; Daklinza, Bristol-Myers Squibb) plus 400 mg of SOF and RBV (class I, level B).
In genotype 2 or 3 HCV patients with decompensated cirrhosis, 60 mg of DAC plus 400 mg of SOF and RBV for 12 weeks (class II, level B) was the only regimen specifically recommended, although the document discusses several alternatives, particularly for those who are not eligible for RBV.
For treating HCV in patients with cirrhosis, the guidelines identify appropriate therapy, but they also specify that these patients “should be referred to a medical practitioner with expertise, ideally in a liver transplant center.” Yet, the new recommendations alert clinicians that advanced liver disease is no longer a contraindication for treatment.
With the recommended therapies, SVR rates in the presence of decompensated cirrhosis have been high, typically exceeding 85% for most of the HCV genotypes even when decompensation is severe. Also important, SVR has been accompanied by improved liver function, whether measured with Model for End-Stage Liver Disease scores or improvement in Child-Turcotte-Pugh class.
The potential for serious adverse events may be why the guidelines recommend referring HCV patients with decompensated cirrhosis to experienced practitioners. In one study, 5% of such patients died over the course of follow-up (Gastroenterology 2015;149:649-659). Although none of the deaths was attributed to antiviral therapy, HCV treatment often is considered in the context of liver transplant, suggesting that complex decisions may be required for stabilizing patients and weighing the benefit–risk ratio of different regimens, particularly those that include RBV.
Read more here: http://www.idse.net/Hepatitis/Article/05-16/New-Hep-C-Recs-Target-Unique-Populations/36321/ses=ogst