Reported Safety of Hepatitis C Virus Direct-Acting Antivirals With Opioids: 2017 to 2021

Abstract Introduction: Due to concerns over potential interactions between some hepatitis C direct-acting antivirals (DAAs) and opioids, we describe adverse event (AE) reports of concomitant use of opioids and DAAs. Methods: AEs reported (July 28, 2017 to December 31, 2021) with the administration of the DAAs glecaprevir/pibrentasvir, sofosbuvir/velpatasvir, ledipasvir/sofosbuvir, sofosbuvir/velpatasvir/voxilaprevir, and elbasvir/grazoprevir as suspect products were downloaded from the US Food and Drug Administration AE Reporting System Public Dashboard. The number of AE reports containing opioids (fentanyl, hydrocodone, oxycodone) as co-suspect products/concomitant products were counted and summarized by severity, reporting country and whether an outcome of death was reported. Overdose AEs were counted irrespective of opioid use, and changes over time were assessed. Results: In total 40 AEs were reported for DAAs and concomitant fentanyl use, 25 were in the USA, 14 resulted in death and 13 were considered serious; and 626 were reported with concomitant oxycodone/hydrocodone use, 596 were in the USA, 28 resulted in death an 296 were considered serious. There were 196 overdose AEs (32 deaths) declining from 2018 (N=56) to 2021 (N=29). Conclusions: Treating people with HCV infection who use drugs is key to achieving HCV elimination. Low numbers of DAA AE reports with opioids may provide reassurance to prioritize HCV treatment in this population.