Hepatitis C virus DAA treatment adherence patterns and SVR among people who inject drugs treated in opioid agonist therapy programs

Author(s):  
Moonseong Heo ◽  
Irene Pericot-Valverde ◽  
Lior Rennert ◽  
Matthew J Akiyama ◽  
Brianna L Norton ◽  
...  

Abstract Background Adequate medication adherence is critical for achieving sustained viral response (SVR) of hepatitis C virus (HCV) among people who inject drugs (PWID). However, it is less known which patterns of direct-acting antiviral (DAA) treatment adherence are associated with SVR in this population or what factors are associated with each pattern. Methods The randomized three-arm PREVAIL study utilized electronic blister packs to obtain daily time frame adherence data in opiate agonist therapy program settings. Exact logistic regressions were applied to test the associations between SVR and six types of treatment adherence patterns. Results Of the 113 participants treated with combination DAAs, 109 (96.5%) achieved SVR. SVR was significantly associated with all pattern parameters except for number of switches between adherent and missed days: total adherent daily doses (exact AOR=1.12; 95%CI=1.04-1.22), percent total doses (1.09; 1.03-1.16), days on treatment (1.16; 1.05-1.32), maximum consecutive adherent days (1.34; 1.06-2.04), maximum consecutive non-adherent days (.85; .74-.95=.003). SVR was significantly associated with total adherent doses in the first two months of treatment, it was not in the last month. Compared to White participants (30.7±11.8(se)), Black (18.4±7.8) and Hispanic participants (19.2±6.1) had significantly shorter maximum consecutive adherent days. While alcohol intoxication was significantly associated with frequent switches, drug use was not associated with any adherence pattern. Conclusion Consistent maintenance of adequate total dose adherence over the entire course of HCV treatment is important in achieving SVR among PWID. Additional integrative addiction and medical care may be warranted for treating PWID experiencing alcohol intoxication.

2019 ◽  
Vol 70 (12) ◽  
pp. 2695-2702 ◽  
Author(s):  
Matthew J Akiyama ◽  
Daniel Lipsey ◽  
Moonseong Heo ◽  
Linda Agyemang ◽  
Brianna L Norton ◽  
...  

Abstract Background Direct-acting antiviral (DAA) therapy is highly effective in people who inject drugs (PWID); however, rates, specific injection behaviors, and social determinants associated with hepatitis C virus (HCV) reinfection following DAA therapy among PWID on opioid agonist therapy (OAT) are poorly understood. Methods PREVAIL was a randomized controlled trial that assessed models of HCV care for 150 PWID on OAT. Those who achieved sustained virologic response (SVR) (n = 141; 94%) were eligible for this extension study. Interviews and assessments of recurrent HCV viremia occurred at 6-month intervals for up to 24 months following PREVAIL. We used survival analysis to analyze variables associated with time to reinfection. Results Of 141 who achieved SVR, 114 had a least 1 visit in the extension study (62% male; mean age, 52 years). Injection drug use (IDU) was reported by 19% (n = 22) in the extension study. HCV reinfection was observed in 3 participants. Over 246 person-years of follow-up, the incidence of reinfection was 1.22/100 person-years (95% CI, 0.25–3.57). All reinfections occurred among participants reporting ongoing IDU. The incidence of reinfection in participants reporting ongoing IDU (41 person-years of follow-up) was 7.4/100 person-years (95% CI, 1.5–21.6). Reinfection was associated with reporting ongoing IDU in the follow-up period (P < .001), a lack confidence in the ability to avoid contracting HCV (P < .001), homelessness (P = .002), and living with a PWID (P = .007). Conclusions HCV reinfection was low overall, but more common among people with ongoing IDU following DAA therapy on OAT, as well as those who were not confident in the ability to avoid contracting HCV, homeless, or living with a PWID. Interventions to mediate these risk factors following HCV therapy are warranted.


2020 ◽  
Vol 222 (3) ◽  
pp. 488-498 ◽  
Author(s):  
Matthew J Akiyama ◽  
Daniel Lipsey ◽  
Lilia Ganova-Raeva ◽  
Lili T Punkova ◽  
Linda Agyemang ◽  
...  

Abstract Background Understanding hepatitis C virus (HCV) transmission among people who inject drugs (PWID) is essential for HCV elimination. We aimed to differentiate reinfections from treatment failures and to identify transmission linkages and associated factors in a cohort of PWID receiving opioid agonist therapy (OAT). Methods We analyzed baseline and follow-up specimens from 150 PWID from 3 OAT clinics in the Bronx, New York. Next-generation sequencing data from the hypervariable region 1 of HCV were analyzed using Global Hepatitis Outbreak and Surveillance Technology. Results There were 3 transmission linkages between study participants. Sustained virologic response (SVR) was not achieved in 9 participants: 7 had follow-up specimens with similar sequences to baseline, and 2 died. In 4 additional participants, SVR was achieved but the participants were viremic at later follow-up: 2 were reinfected with different strains, 1 had a late treatment failure, and 1 was transiently viremic 17 months after treatment. All transmission linkages were from the same OAT clinic and involved spousal or common-law partnerships. Conclusion This study highlights the use of next-generation sequencing as an important tool for identifying viral transmission and to help distinguish relapse and reinfection among PWID. Results reinforce the need for harm reduction interventions among couples and those who report ongoing risk factors after SVR.


2019 ◽  
Vol 160 (22) ◽  
pp. 846-853
Author(s):  
Evelin Berta ◽  
Anna Egresi ◽  
Anna Bacsárdi ◽  
Zsófia Gáspár ◽  
Gabriella Lengyel ◽  
...  

Abstract: Hepatitis C virus infection causes approximately 4 million new infections worldwide, and 399 000 deaths due to its complications, cirrhosis and hepatocellular carcinoma (HCC). Microenvironmental changes, chronic inflammation, oxidative stress, endoplasmic reticulum stress caused by HCV infection, via genetic and epigenetic changes can result in primary liver cancer during decades. The direct oncogenic property of HCV is wellknown. The transforming effect of four HCV proteins (core, NS3, NS4B, NS5A) has been proven. Effective antiviral therapy, sustained viral response decreases the HCV-related general and liver-related mortality. Interferon-based therapy reduces the risk of HCC development. Shorter therapy with direct acting antiviral agents (DAA) has higher efficacy, fewer side-effects. Publications have reported the unexpected effects of DAA. The authors review the articles focusing on the occurrence of HCC in connection with DAA therapies. There is a need for prospective, multicentric studies with longer follow-up to examine the risk of HCC formation. After antiviral therapy, HCC surveillance is of high importance which means abdominal ultrasound every 3–6–12 months in sustained viral response patients as well. Orv Hetil. 2019; 160(22): 846–853.


2020 ◽  
Vol 7 (10) ◽  
Author(s):  
Jackie Habchi ◽  
Aurielle M Thomas ◽  
Sophie Sprecht-Walsh ◽  
Elenita Arias ◽  
Jeffrey Bratberg ◽  
...  

Abstract Background A minority of patients with opioid use disorder are treated for hepatitis C virus infection (HCV). While colocated HCV and opioid agonist therapy (OAT) along with harm reduction can facilitate prevention and cascade to cure, there are few real-world examples of such embedded care models in the United States in the direct-acting antiviral (DAA) era. Methods We conducted a retrospective chart review to determine sustained virologic response (SVR) and reinfection rates during the first 5-year period of DAA availability among individuals tested and treated on-site at Rhode Island’s only nonprofit methadone maintenance program. Results Of 275 who initiated DAAs, the mean age (range) was 43 (22–71) years, 34.5% were female, 57.5% had genotype 1a, 23.3% had cirrhosis, and 92% were Medicaid recipients. SVR was 85.0% (232/273), while modified intent-to-treat SVR was 93.2% (232/249); 17 patients did not achieve SVR, 2 awaited SVR 12 weeks post-end-of-treatment, and 24 were lost to follow-up. Thirty reinfections were identified over 375.5 person-years of follow-up (rate, 7.99/100 person-years). The median time to first reinfection (interquartile range) was 128 (85.25–202.5) days. Before July 1, 2018, 72 patients accessed DAAs over 3.7 years; after Medicaid DAA restrictions were lifted, 109 patients accessed DAAs over 1.3 years. The Prior Authorization (PA) process requires many steps, differing across 11 RI insurers, taking 45–120 minutes per patient. Conclusions DAA treatment was effective among a marginalized population in an urban colocated OAT/HCV program. Removing DAA restrictions facilitates treatment initiation. The PA process remains a modifiable barrier to expanding capacity in the United States.


2019 ◽  
Vol 170 (9) ◽  
pp. 594 ◽  
Author(s):  
Matthew J. Akiyama ◽  
Brianna L. Norton ◽  
Julia H. Arnsten ◽  
Linda Agyemang ◽  
Moonseong Heo ◽  
...  

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