In the Journals Plus

Patients on opioid substitutes have better outcomes with interferon-free HCV regimens

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January 9, 2018

Photo of Zobair Younossi
Zobair M. Younossi

In patients with hepatitis C virus infection who were receiving opioid substitutes, interferon-free drug regimens yielded better outcomes compared with regimens containing interferon, according to researchers.

Regimens that contain neither interferon (IFN) nor ribavirin (RBV) were most effective among patients receiving opioid substitute therapy (OST) in an analysis of drug trials, they wrote in The Journal of Infectious Diseases.

“Both SVR rates and [patient-reported outcome (PRO)] improvements in OST patients treated with IFN-free regimens are noninferior or superior to those seen in the rest of HCV population,” researcher Zobair M. Younossi, MD, chairman of the department of medicine at Inova Fairfax Hospital and vice president for research at Inova Health System in Falls Church, Va., and colleagues wrote. “Given that, we propose that the use of interferon in this vulnerable HCV population may not be appropriate. Rather, it is IFN-free, RBV-free [direct-acting antiviral (DAA)]-based treatment that provides substantial advantages for patients on OST, including the highest rates of treatment adherence and SVR, and the best patient experience during treatment.”

The researchers assessed data from 21 multicenter, phase 3 trials of DAA regimens containing sofosbuvir (SOF), which is sold under the brand name Sovaldi (Gilead Sciences) in the United States. The trials were conducted between 2013 and 2017 in the U.S., Puerto Rico, Canada, Australia, New Zealand, Europe and China.

Specifically, they examined data from 8,450 patients involved in the trials, 407 of whom were on OST. Of the patients on OST, 17 received IFN+RBV+SOF, 154 received IFN-free regimens with RBV, and 226 received regimens with neither IFN nor RBV. For each of those regimens, the researchers compared outcomes among patients on OST with those among patients not receiving OST.

The study outcomes included SVR and PROs like depression, clinically overt fatigue, type 2 diabetes, anxiety, cirrhosis and others. The researchers assigned scores for the various PROs.

Younossi and colleagues said that SVR12 rates associated with any of the regimens were not significantly different between patients on OST and those who were not on OST.

At baseline, patients on OST had significantly lower PRO scores than those who were not on OST, with score deficits ranging from 3.5% to 15.6%.

By the end of treatment, patients who received IFN+RBV+SOF experienced significant decreases in PRO scores regardless of OST use, the researchers said, but the worsening of PROs was “more pronounced and long-lasting in patients on OST in comparison to other patients.”

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The researchers also observed smaller score decreases related to treatment with IFN-free, RBV-containing regimens, and the data were again similar between the two patient groups.

However, patients in both groups who were treated with INF- and RBV-free regimens experienced improvements in PRO scores as early as 4 weeks after the start of treatment, with increases among patients on OST ranging from 2.7% to 12.6%. Some increases among patients on OST were greater in comparison to those seen among patients not on OST — by 2.2% to 4.5%, the researchers said. The increases in PRO scores among patients on OST at the end of treatment, regardless of duration, ranged from 3% to 15.2%.

Ponni V. Perumalswami
Andrew H. Talal
Andrew H. Talal

In a related editorial, Ponni V. Perumalswami, MD, an assistant professor of medicine at the Icahn School of Medicine at Mount Sinai, and Andrew H. Talal, MD, MPH, professor of medicine and director of the Center for Clinical Care and Research in Liver Disease at the Jacobs School of Medicine and Biomedical Sciences at the University at Buffalo in New York, wrote that DAA efficacy should encourage people with substance use disorders (PWSUD) to seek HCV treatment.

“HCV treatment-induced improvements to outcomes among opioid substitution-treated and untreated PWSUD could increase their willingness to pursue HCV care,” they wrote. “Indeed, many such patients cite stigmatization over drug use as a reason to avoid HCV treatment engagement. DAA prescription to PWSUDs removes the need for injection required with older regimens, a potential treatment obstacle due to recall of memories of drug use and stigmatization.” – by Joe Green

Disclosures: Perumalswami reports no relevant financial disclosures. Talal reports receiving research grants from AbbVie, Merck, Gilead Sciences, Intercept, Conatus and Abbott Laboratories, and has served as an advisor to AbbVie, Merck and Abbott Laboratories. Stepanova reports no relevant financial disclosures. Please see the study for all other authors’ relevant financial disclosures.