Positive drug testing has led to HCV treatment denial in some settings despite the lack of data demonstrating
reduced safety or efficacy in these individuals. The impact of recreational drug use, including cannabinoids, on
treatment outcome with IFN-free regimens has not been assessed. This analysis assessed the point prevalence
of on-treatment positive drug tests and the impact on treatment outcome among patients treated with ledipasvir/
sofosbuvir (LDV/SOF) ± ribavirin(RBV) in a Phase 3 clinical trial (ION-1).
Patients were excluded from ION-1 if they had clinically significant drug use as assessed by the investigator or
a positive urine drug test at screening unexplained by a prescribed medication. Serum samples from treatment
naïve HCV genotype 1(GT 1)-infected patients enrolled in the ION-1 study were retrospectively tested for drugs
(amphetamines/methamphetamine, barbiturates, benzodiazepines, cocaine, methadone, opiates, oxycodone,
phencyclidine, propoxyphene and cannabinoids) by Enzyme-Linked Immunosorbent Assay (ELISA) at Weeks 8
and 12 of treatment. SVR12 rates were compared between those with positive and negative drug test results.
Of the 865 patients treated with LDV/SOF±RBV in ION-1, 853 patients had Week 8 or Week 12 frozen serum
samples available for testing.. Demographics were similar across the two groups. Overall, 30% (n=259) tested
positive for recreational drugs at either Week 8 or 12. Of 259 patients, 73% (188/259) had positive results at both
time points; the 170/188 (66%) were positive for cannabinoids. The SVR and the overall virologic failure rates
were comparable between these two groups (97% vs 100%; 0 vs <1%).
Conclusions: Active recreational drug use among treatment-naïve chronic HCV GT1 patients was common but
did not impact the treatment outcome with LDV/SOF with or without RBV despite slightly higher rates of becoming
lost to follow up.
CHU Brabois, Nancy