In the Journals

Delayed HCV treatment can increase risk for mortality

Delayed treatment for chronic hepatitis C virus infection can be detrimental for patients regardless of fibrosis stage, study data showed.

Mark Sulkowski, MD
Mark S. Sulkowski

“Approximately 3 million people are chronically infected with hepatitis C virus in the U.S.; however, the true burden may be underestimated by at least several hundred thousand,” Infectious Disease News Editorial Board member Mark S. Sulkowski, MD, professor of medicine in the division of infectious diseases at Johns Hopkins School of Medicine, and colleagues wrote. “Treatment with highly efficacious, oral direct-acting antivirals is curative; however, barriers to access exist. Treatment denials are justified by the assumption of no medical consequence to low-stage HCV infection and that liver fibrosis progression can be safely monitored until advanced fibrosis/cirrhosis is detected.”

Sulkowski and colleagues performed transient elastography on 964 patients from the Baltimore area with chronic HCV infection who had a history of injection drug use. The median age was 49 years, and most patients were men (72%) and African American (87%). Slightly more than half (52%) were injecting drugs. About one-third (35%) had HIV coinfections. The researchers evaluated liver stiffness semiannually between 2006 and 2014 using previously validated cutoffs for moderate and severe fibrosis.

Among the total cohort, 62% of patients had baseline measurements suggesting no or mild fibrosis, 23% had moderate fibrosis and 15% had severe fibrosis or cirrhosis. After adjustment for demographics, substance use and HIV status, patients with moderate fibrosis showed elevated all-cause and nonaccidental mortality (adjusted HR = 1.42; 95% CI, 0.96-2.11 for all-cause mortality; HR = 1.66; 95% CI, 1.06-2.59 for nonaccidental mortality). No combination of factors proved useful for predicting the transition from mild to moderate fibrosis with “sufficiently high diagnostic accuracy,” despite the increased risk for mortality in patients with moderate fibrosis.

“In summary, we observed increased mortality among persons with severe and moderate fibrosis and transitions to moderate fibrosis could not be predicted with high accuracy,” the researchers wrote. “These data support the [American Association for the Study of Liver Diseases/Infectious Diseases Society of America] guidelines for treatment of all persons with chronic HCV infection and do not support withholding treatment from those with mild disease.” – by Andy Polhamus

Disclosure: Sulkowski reports research grants from AbbVie, Gilead Sciences, Janssen and Merck; consulting fees from AbbVie, Bristol-Myers Squibb, Cocrystal, Gilead Sciences, Janssen, Merck and Trek; and payment for development of educational presentations from Clinical Care Options, Practice Point and ViralEd. No other researchers report any relevant financial disclosures.

Delayed treatment for chronic hepatitis C virus infection can be detrimental for patients regardless of fibrosis stage, study data showed.

Mark Sulkowski, MD
Mark S. Sulkowski

“Approximately 3 million people are chronically infected with hepatitis C virus in the U.S.; however, the true burden may be underestimated by at least several hundred thousand,” Infectious Disease News Editorial Board member Mark S. Sulkowski, MD, professor of medicine in the division of infectious diseases at Johns Hopkins School of Medicine, and colleagues wrote. “Treatment with highly efficacious, oral direct-acting antivirals is curative; however, barriers to access exist. Treatment denials are justified by the assumption of no medical consequence to low-stage HCV infection and that liver fibrosis progression can be safely monitored until advanced fibrosis/cirrhosis is detected.”

Sulkowski and colleagues performed transient elastography on 964 patients from the Baltimore area with chronic HCV infection who had a history of injection drug use. The median age was 49 years, and most patients were men (72%) and African American (87%). Slightly more than half (52%) were injecting drugs. About one-third (35%) had HIV coinfections. The researchers evaluated liver stiffness semiannually between 2006 and 2014 using previously validated cutoffs for moderate and severe fibrosis.

Among the total cohort, 62% of patients had baseline measurements suggesting no or mild fibrosis, 23% had moderate fibrosis and 15% had severe fibrosis or cirrhosis. After adjustment for demographics, substance use and HIV status, patients with moderate fibrosis showed elevated all-cause and nonaccidental mortality (adjusted HR = 1.42; 95% CI, 0.96-2.11 for all-cause mortality; HR = 1.66; 95% CI, 1.06-2.59 for nonaccidental mortality). No combination of factors proved useful for predicting the transition from mild to moderate fibrosis with “sufficiently high diagnostic accuracy,” despite the increased risk for mortality in patients with moderate fibrosis.

“In summary, we observed increased mortality among persons with severe and moderate fibrosis and transitions to moderate fibrosis could not be predicted with high accuracy,” the researchers wrote. “These data support the [American Association for the Study of Liver Diseases/Infectious Diseases Society of America] guidelines for treatment of all persons with chronic HCV infection and do not support withholding treatment from those with mild disease.” – by Andy Polhamus

Disclosure: Sulkowski reports research grants from AbbVie, Gilead Sciences, Janssen and Merck; consulting fees from AbbVie, Bristol-Myers Squibb, Cocrystal, Gilead Sciences, Janssen, Merck and Trek; and payment for development of educational presentations from Clinical Care Options, Practice Point and ViralEd. No other researchers report any relevant financial disclosures.