Researchers at Loyola University Health System and Loyola University Chicago have determined that costs for hepatitis C virus (HCV) treatment could be cut up to 50 percent if mathematical models are used to predict when patients can stop taking direct-acting antiviral (DAA) drugs, according to the study published in the Journal of Hepatology. The article is titled “HCV kinetic and modeling analyses indicate similar time to cure among sofosbuvir combination regimens with declatasvir, simeprevir or ledipasvir.”
Hepatitis C virus (HCV) is one of the major causes of chronic liver disease, with an estimated 170 million people infected globally. The development and approval of DAAs (direct-acting antiviral agents) has led to a novel approach in the treatment of HCV with high sustained virological response (SVR) rates and the virtual elimination of serious side effects.
“Recent clinical trials of DAAs against HCV suggest that cure of the infection often took place before the end of treatment,” Harel Dahari, Ph.D., assistant professor at Loyola University Chicago Stritch School of Medicine, said in a recent news release.
“Treatment currently is standardized to be given for a set period of time, not tailored to the patient,” said Scott Cotler, M.D., FCO, hepatology division director for Loyola and a professor at Stritch. “In many cases, this may result in the prolonged use of expensive drugs with essentially no additional positive effect.”
In the study, the team of researchers retrospectively evaluated whether early response kinetics could provide the basis to individualize therapy to achieve the best results while reducing duration and cost.
Using more frequent blood testing to determine the levels of HCV, they identified when patients were cured and predicted when therapy could be safely stopped. This modeling could allow for personalized treatment.
“This is the first time this approach has been tested in hepatitis C patients undergoing DAA treatment,” Dahari said. “This initial study is very encouraging.”
In the study, the researchers examined the results of 58 chronic HCV patients who were treated for 12 weeks; 19 with the widely used DAA drug sofosbuvir and simeprevir, 19 with sofosbuvir and daclatasvir, and the rest with sofosbuvil and ledipasvir.
HCV was measured at baseline, day 2, every other week, at the end of the treatment, and 12 weeks post-end of the treatment.
“The use of early viral-kinetic analysis has the potential to individualize duration of DAA therapy with a projected cost savings of 16 to 20 percent per 100 treated persons and up to 50 percent in about 40 percent of patients,” Dahari and colleagues wrote. “Shorter regimens with low pill burdens, and few adverse effects, could improve patient adherence in difficult to treat populations.”
Further studies are needed to confirm these results, but if validated by larger studies, kinetic models of routinely obtained on-treatment HCV RNA measurements to estimate optimal length of treatment could transform the DAA treatment paradigm.