VIENNA — Delaying treatment for hepatitis C virus infection until an increased fibrosis-4 score is reached negatively impacted the efficacy of the treatment among veterans, according to data presented at the 2015 International Liver Congress.
Jeffrey S. Mc Combs, PhD, associate professor at the University of Southern California School of Pharmacy, Los Angeles, Calif., and colleagues, analyzed data of 187,860 veterans with HCV from the electronic medical records at Veteran Affairs between 1999 and 2010. The patients selected for analysis had one or more reported fibrosis-4 (FIB-4) values, which the researchers looked at to estimate the impact on patient risk of treatment initiation before and after the patient’s FIB-4 values increased, and to conclude whether or not treatment can or should be delayed.
Jeffrey S. Mc Combs
The impact of time to treatment initiation and time to three different definitions of an elevated FIB-4 level were estimated using a time-dependent Cox proportional hazards models, according to the research.
“What we have done is go back and look at the treatment of VA patients over a 10-year period ending in 2010 before the new medications and ask questions about what we can learn about the way treatment proceeded prior to new drugs,” Mc Combs said during his presentation. “We are building a story about essential need for new medications. It grew into an analysis [where we asked] can we come up with ways of allocating the scarce resources in a way that we can all get through this crisis and arrive at a point where we can eradicate this disease and not break the bank, so to speak.”
According to the results, beginning HCV therapy prior to a patient reaching a FIB-4 value greater than 1.00 reduced morbidity by 41% and mortality by 36%. Beginning treatment after FIB-4 reached 1.00 was effective, but decreased the reduced morbidity risk to 30%. However, this did not occur if treatment initiation was delayed until after reaching a FIB-4 value greater than 3.25.
The risk reductions associated with treatment initiation before reaching a FIB-4 of more than 3.25 were 34% for the composite event and 45% for mortality. However, if treatment was initiated after a FIB-4 value of over 3.25 was attained, these risks decreased to 11% and 25%, respectively.
These adverse effects of delaying treatment until after reaching a FIB-4 value greater than 3.25 were because patients already treated would have viral load suppression and a reduced impact of viral load suppression on morbidity, according to Mc Combs presentation.
“We’re trying to provide information [so] you can go to your peers and argue that if we’re going to have some sort of a system where we will delay therapy to patients at most risk, which is essentially trying to get around a cash flow problem, how do you do it? What do you watch? How long do you wait?” Mc Combs said. – by Melinda Stevens
Mc Combs JS, et al. Abstract O003. Presented at: International Liver Congress; April 22-26, 2015; Vienna.
Disclosures: The researchers report no relevant financial disclosures.