Overreporting of adherence to hepatitis C direct-acting antiviral therapy and sustained virologic response among people who inject drugs in the HERO study

doi:10.1186/s12879-024-09124-3

. 2024 Feb 23;24(1):251.

doi: 10.1186/s12879-024-09124-3.

Overreporting of adherence to hepatitis C direct-acting antiviral therapy and sustained virologic response among people who inject drugs in the HERO study

Snehal S Lopes¹, Irene Pericot-Valverde², Paula J Lum³, Lynn E Taylor⁴, Shruti H Mehta⁵, Judith I Tsui⁶, Judith Feinberg^{7

8}, Arthur Y Kim^{9

10}, Brianna L Norton^{11

12}, Kimberly Page¹³, Cristina Murray-Krezan¹⁴, Jessica Anderson¹³, Alison Karasz¹⁵, Julia Arnsten^{11

12}, Phillip Moschella^{16

17

18}, Moonseong Heo¹, Alain H Litwin^{19

20

21}

Affiliations

¹ Department of Public Health Sciences, Clemson University, 29634, Clemson, SC, USA.
² Department of Psychology, College of Behavioral, Social, and Health Sciences, Clemson University, 29634, Clemson, SC, USA.
³ Department of Medicine, University of California, San Francisco, 1001 Potrero Ave, 94110, San Francisco, CA, USA.
⁴ Department of Pharmacy Practice and Clinical Research, University of Rhode Island, 7 Greenhouse Road, 02881, Kingston, RI, USA.
⁵ Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, 615 N. Wolfe Street, Room E6546, 21205, Baltimore, MD, USA.
⁶ Department of Medicine, University of Washington, 325 9th Ave, 98104, Seattle, WA, USA.
⁷ Department of Behavioral Medicine and Psychiatry, West Virginia University School of Medicine, 930 Chestnut Ridge Road, 26505, Morgantown, WV, USA.
⁸ Department of Medicine, Section of Infectious Diseases, West Virginia University School of Medicine, 1 Medical Center Drive, 26506, Morgantown, WV, USA.
⁹ Division of Infectious Diseases, Massachusetts General Hospital, 55 Fruit St, 02114, Boston, MA, USA.
¹⁰ Harvard Medical School, 02115, Boston, MA, USA.
¹¹ Albert Einstein College of Medicine, 10461, Bronx, NY, USA.
¹² Department of Medicine, Montefiore Medical Center, 10467, Bronx, NY, USA.
¹³ Department of Internal Medicine, Health Sciences Center, University of New Mexico, University of New Mexico, MSC 10, 5550, 87131, Albuquerque, NM, USA.
¹⁴ Division of General Internal Medicine, Department of Medicine, University of Pittsburgh School of Medicine, 15213, Pittsburgh, PA, USA.
¹⁵ UMass Chan Medical School, University of Massachusetts Medical School, 55 Lake Ave, North, 01605, Worcester, MA, USA.
¹⁶ Department of Emergency Medicine, Prisma Health, Greenville, SC, USA.
¹⁷ School of Health Research, Clemson University, Clemson, SC, USA.
¹⁸ Department of Medicine, University of South Carolina School of Medicine, 876 W Faris Rd, 29605, Greenville, SC, USA.
¹⁹ School of Health Research, Clemson University, Clemson, SC, USA. alain.litwin@prismahealth.org.
²⁰ Department of Medicine, University of South Carolina School of Medicine, 876 W Faris Rd, 29605, Greenville, SC, USA. alain.litwin@prismahealth.org.
²¹ Department of Medicine, Prisma Health, 29605, Greenville, SC, USA. alain.litwin@prismahealth.org.

PMID: 38395747
PMCID: PMC10893697
DOI: 10.1186/s12879-024-09124-3

Overreporting of adherence to hepatitis C direct-acting antiviral therapy and sustained virologic response among people who inject drugs in the HERO study

Snehal S Lopes et al. BMC Infect Dis. 2024.

. 2024 Feb 23;24(1):251.

doi: 10.1186/s12879-024-09124-3.

Authors

Affiliations

¹ Department of Public Health Sciences, Clemson University, 29634, Clemson, SC, USA.
² Department of Psychology, College of Behavioral, Social, and Health Sciences, Clemson University, 29634, Clemson, SC, USA.
³ Department of Medicine, University of California, San Francisco, 1001 Potrero Ave, 94110, San Francisco, CA, USA.
⁴ Department of Pharmacy Practice and Clinical Research, University of Rhode Island, 7 Greenhouse Road, 02881, Kingston, RI, USA.
⁵ Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, 615 N. Wolfe Street, Room E6546, 21205, Baltimore, MD, USA.
⁶ Department of Medicine, University of Washington, 325 9th Ave, 98104, Seattle, WA, USA.
⁷ Department of Behavioral Medicine and Psychiatry, West Virginia University School of Medicine, 930 Chestnut Ridge Road, 26505, Morgantown, WV, USA.
⁸ Department of Medicine, Section of Infectious Diseases, West Virginia University School of Medicine, 1 Medical Center Drive, 26506, Morgantown, WV, USA.
⁹ Division of Infectious Diseases, Massachusetts General Hospital, 55 Fruit St, 02114, Boston, MA, USA.
¹⁰ Harvard Medical School, 02115, Boston, MA, USA.
¹¹ Albert Einstein College of Medicine, 10461, Bronx, NY, USA.
¹² Department of Medicine, Montefiore Medical Center, 10467, Bronx, NY, USA.
¹³ Department of Internal Medicine, Health Sciences Center, University of New Mexico, University of New Mexico, MSC 10, 5550, 87131, Albuquerque, NM, USA.
¹⁴ Division of General Internal Medicine, Department of Medicine, University of Pittsburgh School of Medicine, 15213, Pittsburgh, PA, USA.
¹⁵ UMass Chan Medical School, University of Massachusetts Medical School, 55 Lake Ave, North, 01605, Worcester, MA, USA.
¹⁶ Department of Emergency Medicine, Prisma Health, Greenville, SC, USA.
¹⁷ School of Health Research, Clemson University, Clemson, SC, USA.
¹⁸ Department of Medicine, University of South Carolina School of Medicine, 876 W Faris Rd, 29605, Greenville, SC, USA.
¹⁹ School of Health Research, Clemson University, Clemson, SC, USA. alain.litwin@prismahealth.org.
²⁰ Department of Medicine, University of South Carolina School of Medicine, 876 W Faris Rd, 29605, Greenville, SC, USA. alain.litwin@prismahealth.org.
²¹ Department of Medicine, Prisma Health, 29605, Greenville, SC, USA. alain.litwin@prismahealth.org.

PMID: 38395747
PMCID: PMC10893697
DOI: 10.1186/s12879-024-09124-3

Abstract

Background: Self-reported adherence to direct-acting antivirals (DAAs) to treat hepatitis C virus (HCV) among persons who inject drugs (PWID) is often an overreport of objectively measured adherence. The association of such overreporting with sustained virologic response (SVR) is understudied. This study among PWID aimed to determine a threshold of overreporting adherence that optimally predicts lower SVR rates, and to explore correlates of the optimal overreporting threshold.

Methods: This study analyzed per-protocol data of participants with adherence data (N = 493) from the HERO (Hepatitis C Real Options) study. Self-reported and objective adherence to a 12-week DAA regimen were measured using visual analogue scales and electronic blister packs, respectively. The difference (Δ) between self-reported and objectively measured adherence was calculated. We used the Youden index based on receiver operating characteristic (ROC) curve analysis to identify an optimal threshold of overreporting for predicting lower SVR rates. Factors associated with the optimal threshold of overreporting were identified by comparing baseline characteristics between participants at/above versus those below the threshold.

Results: The self-reported, objective, and Δ adherence averages were 95.1% (SD = 8.9), 75.9% (SD = 16.3), and 19.2% (SD = 15.2), respectively. The ≥ 25% overreporting threshold was determined to be optimal. The SVR rate was lower for ≥ 25% vs. < 25% overreporting (86.7% vs. 95.8%, p <.001). The factors associated with ≥ 25% Δ adherence were unemployment; higher number of days and times/day of injecting drugs; higher proportion of positive urine drug screening for amphetamine, methamphetamine, and oxycodone, and negative urine screening for THC (tetrahydrocannabinol)/cannabis.

Conclusions: Self-reported DAA adherence was significantly greater than objectively measured adherence among PWID by 19.2%. Having ≥ 25% overreported adherence was associated with optimal prediction of lower SVR rates. PWID with risk factors for high overreporting may need to be more intensively managed to promote actual adherence.

Keywords: Adherence; Electronic blister pack; HCV DAA; Objective measure; Overreporting; Persons who inject drugs; SVR; Self-report; Visual analog scale.

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Conflict of interest statement

JF has received research grant support from Gilead Sciences. AYK has served on advisory boards for Biomarin. AHL has served on advisory boards for Gilead Sciences and Merck Pharmaceuticals and received research funding from Gilead Sciences. SHM has received speaker fees from Gilead Sciences. All other authors declare no competing interests.

Figures

**Fig. 1**
The plot for overall objective adherence by overall self-reported adherence

**Fig. 2**
The plot for Δ adherence by overall self-reported adherence

See this image and copyright information in PMC

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References

1. Bruggmann P, Grebely J. Prevention, treatment and care of hepatitis C virus infection among people who inject drugs. Int J Drug Policy. 2015;26:22–S6. doi: 10.1016/j.drugpo.2014.08.014. - DOI - PubMed
1. Centers for Disease Control and Prevention. Viral Hepatitis Surveillance Report– United States, 2020 2022, September [cited 2023 6/27/2023]. Available from: https://www.cdc.gov/hepatitis/statistics/2020surveillance/hepatitis-c.htm.
1. Degenhardt L, Peacock A, Colledge S, Leung J, Grebely J, Vickerman P, et al. Global prevalence of injecting drug use and sociodemographic characteristics and prevalence of HIV, HBV, and HCV in people who inject drugs: a multistage systematic review. Lancet Global Health. 2017;5(12):E1192–E207. doi: 10.1016/S2214-109X(17)30375-3. - DOI - PMC - PubMed
1. Macias J, Morano L, Tellez F, Granados R, Rivero-Juarez A, Palacios R, et al. Response to direct-acting antiviral therapy among ongoing drug users and people receiving opioid substitution therapy. J Hepatol. 2019;71(1):45–51. doi: 10.1016/j.jhep.2019.02.018. - DOI - PubMed
1. Litwin AH, Lum PJ, Taylor LE, Mehta SH, Tsui JI, Feinberg J, et al. Patient-centred models of hepatitis C treatment for people who inject drugs: a multicentre, pragmatic randomised trial. Lancet Gastroenterol Hepatol. 2022;7(12):1112–27. doi: 10.1016/S2468-1253(22)00275-8. - DOI - PubMed

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[1] Bruggmann P, Grebely J. Prevention, treatment and care of hepatitis C virus infection among people who inject drugs. Int J Drug Policy. 2015;26:22–S6. doi: 10.1016/j.drugpo.2014.08.014. - DOI - PubMed

[2] Bruggmann P, Grebely J. Prevention, treatment and care of hepatitis C virus infection among people who inject drugs. Int J Drug Policy. 2015;26:22–S6. doi: 10.1016/j.drugpo.2014.08.014. - DOI - PubMed

[3] Centers for Disease Control and Prevention. Viral Hepatitis Surveillance Report– United States, 2020 2022, September [cited 2023 6/27/2023]. Available from: https://www.cdc.gov/hepatitis/statistics/2020surveillance/hepatitis-c.htm.

[4] Centers for Disease Control and Prevention. Viral Hepatitis Surveillance Report– United States, 2020 2022, September [cited 2023 6/27/2023]. Available from: https://www.cdc.gov/hepatitis/statistics/2020surveillance/hepatitis-c.htm.

[5] Degenhardt L, Peacock A, Colledge S, Leung J, Grebely J, Vickerman P, et al. Global prevalence of injecting drug use and sociodemographic characteristics and prevalence of HIV, HBV, and HCV in people who inject drugs: a multistage systematic review. Lancet Global Health. 2017;5(12):E1192–E207. doi: 10.1016/S2214-109X(17)30375-3. - DOI - PMC - PubMed

[6] Degenhardt L, Peacock A, Colledge S, Leung J, Grebely J, Vickerman P, et al. Global prevalence of injecting drug use and sociodemographic characteristics and prevalence of HIV, HBV, and HCV in people who inject drugs: a multistage systematic review. Lancet Global Health. 2017;5(12):E1192–E207. doi: 10.1016/S2214-109X(17)30375-3. - DOI - PMC - PubMed

[7] Macias J, Morano L, Tellez F, Granados R, Rivero-Juarez A, Palacios R, et al. Response to direct-acting antiviral therapy among ongoing drug users and people receiving opioid substitution therapy. J Hepatol. 2019;71(1):45–51. doi: 10.1016/j.jhep.2019.02.018. - DOI - PubMed

[8] Macias J, Morano L, Tellez F, Granados R, Rivero-Juarez A, Palacios R, et al. Response to direct-acting antiviral therapy among ongoing drug users and people receiving opioid substitution therapy. J Hepatol. 2019;71(1):45–51. doi: 10.1016/j.jhep.2019.02.018. - DOI - PubMed

[9] Litwin AH, Lum PJ, Taylor LE, Mehta SH, Tsui JI, Feinberg J, et al. Patient-centred models of hepatitis C treatment for people who inject drugs: a multicentre, pragmatic randomised trial. Lancet Gastroenterol Hepatol. 2022;7(12):1112–27. doi: 10.1016/S2468-1253(22)00275-8. - DOI - PubMed

[10] Litwin AH, Lum PJ, Taylor LE, Mehta SH, Tsui JI, Feinberg J, et al. Patient-centred models of hepatitis C treatment for people who inject drugs: a multicentre, pragmatic randomised trial. Lancet Gastroenterol Hepatol. 2022;7(12):1112–27. doi: 10.1016/S2468-1253(22)00275-8. - DOI - PubMed

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Overreporting of adherence to hepatitis C direct-acting antiviral therapy and sustained virologic response among people who inject drugs in the HERO study

Affiliations

Overreporting of adherence to hepatitis C direct-acting antiviral therapy and sustained virologic response among people who inject drugs in the HERO study

Authors

Affiliations

Abstract

Conflict of interest statement

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