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. 2023 Oct 1;20(1):142.
doi: 10.1186/s12954-023-00874-y.

Reported adverse events related to use of hepatitis C virus direct-acting antivirals with opioids: 2017-2021

Anthony Martinez  1 , Tipu Khan  2 , Douglas E Dylla  3 , John Marcinak  4 , Michelle Collins  5 , Brad Saget  6 , Brian Conway  7   8
Affiliations

Reported adverse events related to use of hepatitis C virus direct-acting antivirals with opioids: 2017-2021

Anthony Martinez et al. Harm Reduct J. .

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-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 (62.5%) were in the USA, 35 (87.5%) were considered serious, and 14 (35.0%) resulted in death; and 626 were reported with concomitant oxycodone/hydrocodone use, 596 (95.2%) were in the USA, 296 (47.3%) were considered serious, and 28 (4.5%) resulted in death. There were 196 overdose AEs (32 [16%] deaths) declining from 2018 (N = 56) to 2021 (N = 29).

Conclusions: Treating people with hepatitis C virus (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. These data contribute to evidence supporting the continued scale-up of DAA treatment among people who use drugs to achieve HCV elimination goals.

Keywords: Addiction; Clinical populations; Hepatitis; Safety; Substance abuse.

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Conflict of interest statement

AM has served as a speaker, a consultant and an advisory board member for Gilead, Intercept, Eisai, Salix, Bayer, BMS, Antios and AbbVie, and has received research funding from AbbVie, Gilead, Merck, Tobira, and Intercept. TK has served as a speaker, a consultant and an advisory board member for AbbVie, Indivior, and Alkermes. BC has received grants, honoraria, consultant fees and or/travel support from AbbVie, Gilead, Indivior, Merck, Sanofi Pasteur and ViiV Heathcare. DED, JM, MC, BS are full-time employees of AbbVie and may hold AbbVie stock and/or stock options.

Figures

Fig. 1
Fig. 1
FAERS AE reports. FAERS AE reports for A concomitant fentanyl and DAA use B concomitant oxycodone/hydrocodone and DAA use C overdose AEs and deaths irrespective of concomitant opioid use. AEs, adverse events; DAA, direct-acting antiviral; EBR/GZR, elbasvir/grazoprevir; FAERS, US Food and Drug Administration Adverse Event Reporting System; G/P, glecaprevir/pibrentasvir; LDV/SOF, ledipasvir/sofosbuvir; SOF/VEL, sofosbuvir/velpatasvir; SOF/VEL/VOX, sofosbuvir/velpatasvir/voxilaprevir
Fig. 2
Fig. 2
Number of overdose AEs by year in people with a DAA listed as the suspect product. AEs, adverse events; DAA, direct-acting antiviral
See this image and copyright information in PMC

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