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Adherence, SVR unaffected by drug use in patients with HCV

AMSTERDAM — Adherence to treatment and subsequent sustained virologic response were unaffected by drug use in a study of patients enrolled in an opioid agonist treatment program, according to a presenter at the International Liver Congress.

“Importantly, drug use was not associated with poor adherence or SVR12,” Alain H. Litwin, MD, professor in the department of medicine and the department of psychiatry and behavioral sciences at Albert Einstein College of Medicine, said during his presentation. “Data demonstrate support for treating active injection drug users receiving opiate agonist therapy.”

In this randomized, controlled trial, Litwin and colleagues initiated HCV treatment in 150 participants with genotype 1 disease. From October 2013 to May 2016, they randomized participants to either directly observed treatment (n = 51), group medical therapy (n = 48) or self-administered individual treatment (n = 51). Of these participants, 27% had cirrhosis, 14% were coinfected with HIV, 25% had depression and 65.3% used drugs within 6 months of initiating their HCV treatment. Baseline data indicated that 51.3% had a positive urine screening before initiating therapy. Approximately 75% were injection drug users and 44.7% had a psychiatric comorbidity.

Participants received a variety of treatments ranging from telaprevir, interferon and ribavirin to Harvoni (ledipasvir/sofosbuvir, Gilead Sciences).

Overall, 94% (95% CI, 89%-97%) achieved SVR12. There was no significant difference between the treatment groups, with directly-observed patients reaching 98% SVR12, group therapy reaching 93.8% and individuals reaching 90.2%.

Adherence was higher in the directly observed treatment group vs. the individual group (82.8% vs. 74.4%, respectively; P = .007), though all three groups self-reported around 95% adherence. Individual adherence was monitored with electronic blister packs. Still, treatment completion was higher than 95% in all three groups with an overall completion rate of 96.7% (95% CI, 92%-99%).

Neither recent drug use, any drug use at baseline or any drug use during HCV treatment had a significant effect on adherence, Litwin showed. He added that only alcohol intoxication was predictive of poor adherence.

Litwin said that none of the following factors significantly impacted SVR12: race, sex, psychiatric illness, injection drug use, any drug use, HIV coinfection, cirrhosis or choice of treatment.

“We did indeed find that adherence is significantly associated with SVR12,” Litwin said.

Adherence was associated with SVR12 in that every 10% increase in adherence measure, the OR for SVR12 was 1.62 (95% CI, 1.12-2.34), and for the same increase as measured by daily window adherence, the OR for SVR12 was 1.82 (95% CI, 1.2-2.75). No other factors, even ongoing drug use, affected SVR12, Litwin said.

References:

Litwin AH. PS-130. Presented at: International Liver Congress; April 19-24, 2017; Amsterdam.

Disclosures: Litwin reports receiving grants from Gilead Sciences and Merck, and serving as a consultant for AbbVie, Bristol-Myers Squibb, Gilead Sciences, Janssen and Merck.