Real-world study of hepatitis C treatment with direct-acting antivirals in patients with drug abuse and opioid agonist therapy

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.

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A real-world observational study of drug utilization and clinical outcomes of direct-acting antivirals and interferon therapy for hepatitis C treatment in Taiwan

Current Medical Research and Opinion ◽

10.1080/03007995.2020.1857716 ◽

2020 ◽

pp. 1-1

Author(s):

Jia-Hung Chen ◽

Pei-Ning Wu ◽

Sin-Chi Huang ◽

Pao-Ju Hsu ◽

Jason C. Hsu

Keyword(s):

Hepatitis C ◽

Observational Study ◽

Clinical Outcomes ◽

Drug Utilization ◽

Real World ◽

Interferon Therapy ◽

Direct Acting Antivirals ◽

Hepatitis C Treatment ◽

Direct Acting

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Uptake and predictors of direct-acting antiviral treatment for hepatitis C among people receiving opioid agonist therapy in Sweden and Norway: a drug utilization study from 2014 to 2017

Substance Abuse Treatment Prevention and Policy ◽

10.1186/s13011-020-00286-2 ◽

2020 ◽

Vol 15 (1) ◽

Cited By ~ 1

Author(s):

Christer F. Aas ◽

Jørn Henrik Vold ◽

Svetlana Skurtveit ◽

Ingvild Odsbu ◽

Fatemeh Chalabianloo ◽

...

Keyword(s):

Hepatitis C ◽

Drug Utilization ◽

Antiviral Treatment ◽

Agonist Therapy ◽

Drug Utilization Study ◽

Opioid Agonist ◽

Direct Acting Antiviral ◽

Opioid Agonist Therapy ◽

Direct Acting

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Uptake and predictors of direct-acting antiviral treatment for hepatitis C among people receiving opioid agonist therapy in Sweden and Norway: a drug utilization study from 2014 to 2017

10.21203/rs.3.rs-18790/v2 ◽

2020 ◽

Author(s):

Christer F. Aas ◽

Jørn Henrik Vold ◽

Svetlana Skurtveit ◽

Ingvild Odsbu ◽

Fatemeh Chalabianloo ◽

...

Keyword(s):

Hepatitis C ◽

Antiviral Treatment ◽

Prescription Database ◽

Agonist Therapy ◽

Hcv Treatment ◽

Opioid Agonist ◽

Direct Acting Antiviral ◽

Opioid Agonist Therapy ◽

Treatment Uptake ◽

Direct Acting

Abstract Background: Treatment with direct-acting antiviral agents (DAAs) offers an opportunity to eliminate hepatitis C virus (HCV) endemic among people who inject drugs (PWID) and people enrolled in opioid agonist therapy (OAT) programs. The objective of this study was to estimate and to compare HCV treatment uptake after the introduction of DAAs among patients receiving OAT in Sweden and Norway. We also aimed to evaluate predictors of DAAs treatment among OAT patients in both countries.Methods: This observational study was conducted with data from The Swedish Prescribed Drug Register and The Norwegian Prescription Database. We studied dispensed medications to calculate HCV treatment among OAT patients from 2014 to 2017 in Sweden and Norway. HCV prevalence was estimated from primary and secondary sources. Dispensations of medicines from different therapeutic areas, which served as proxy for co-morbidities in 2017, were conditionally adjusted for age, gender, and OAT medications. Logistic regression was used to evaluate these parameters. Results: In total 3,529 individuals were identified with dispensed OAT in the Swedish cohort and 7,739 individuals in the Norwegian cohort. HCV treatment was utilized by 407 persons in Sweden and 920 in Norway during the study period. Annual HCV and DAA treatment uptake increased in both countries. The estimated cumulative HCV treatment uptake at the end of 2017 was 31% in Norway and 28% in Sweden. DAA treatment was associated with increased age (aOR 1.8; 95% CI 1.0-3.2) and the dispensation of drugs used for diabetes (aOR 3.2; 95% CI 1.8-5.7) in Sweden. In Norway, lipid modifying agents and antibacterials were associated with decreased odds (aOR 0.4; 95%CI 0.2-0.9, aOR 0.8; 95%CI 0.6-1.0).Conclusions: An increase in DAA treatment and HCV treatment uptake was observed among Swedish and Norwegian OAT patients whilst introducing new direct-acting antiviral treatment regimens. However, more than two thirds of the OAT population in Norway and Sweden were untreated at the beginning of 2018. A further scale-up is crucial in order to control and eliminate the HCV endemic among OAT patients.

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Adherence to Once-daily and Twice-daily Direct-acting Antiviral Therapy for Hepatitis C Infection Among People With Recent Injection Drug Use or Current Opioid Agonist Therapy

Clinical Infectious Diseases ◽

10.1093/cid/ciz1089 ◽

2019 ◽

Vol 71 (7) ◽

pp. e115-e124 ◽

Cited By ~ 6

Author(s):

Evan B Cunningham ◽

Behzad Hajarizadeh ◽

Janaki Amin ◽

Alain H Litwin ◽

Edward Gane ◽

...

Keyword(s):

Hepatitis C ◽

Drug Use ◽

Injection Drug Use ◽

Injection Drug ◽

Agonist Therapy ◽

Opioid Agonist ◽

Once Daily ◽

Direct Acting Antiviral ◽

Opioid Agonist Therapy ◽

Direct Acting

Abstract Background This study investigated adherence and associated factors among people with recent injection drug use (IDU) or current opioid agonist therapy (OAT) and compared once-daily to twice-daily hepatitis C virus (HCV) direct-acting antiviral (DAA) therapy. Methods SIMPLIFY and D3FEAT are international, multicenter studies that recruited participants with recent IDU (previous 6 months; SIMPLIFY, D3FEAT) or current OAT (D3FEAT) between March 2016 and February 2017 in 8 countries. Participants received sofosbuvir/velpatasvir (once daily; SIMPLIFY) or paritaprevir/ritonavir/ombitasvir, dasabuvir (twice daily) ± ribavirin (D3FEAT) for 12 weeks administered in electronic blister packs. We evaluated overall adherence (proportion of prescribed doses taken) and nonadherence (<90% adherent) between dosing patterns. Results Of 190 participants, 184 (97%) completed treatment. Median adherence was 92%, with higher adherence among those receiving once-daily vs twice-daily therapy (94% vs 87%, P = .005). Overall, 40% of participants (n = 76) were nonadherent (<90% adherent). Recent stimulant injecting (odds ratio [OR], 2.48 [95% confidence interval {CI}, 1.28–4.82]), unstable housing (OR, 2.18 [95% CI, 1.01–4.70]), and twice-daily dosing (OR, 2.81 [95% CI, 1.47–5.36]) were associated with nonadherence. Adherence decreased during therapy. Sustained virologic response was high in nonadherent (89%) and adherent populations (95%, P = .174), with no difference in SVR between those who did and did not miss 7 consecutive doses (92% vs 93%, P = .897). Conclusions This study demonstrated high adherence to once- and twice-daily DAA therapy among people with recent IDU or currently receiving OAT. Nonadherence described did not impact treatment outcomes, suggesting forgiveness to nonadherence.

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Uptake and predictors of direct-acting antiviral treatment for hepatitis C among people receiving opioid agonist therapy in Sweden and Norway: a drug utilization study from 2014 to 2017

10.21203/rs.2.21198/v1 ◽

2020 ◽

Author(s):

Christer frode Aas ◽

Jørn Henrik Vold ◽

Svetlana Skurtveit ◽

Ingvild Odsbu ◽

Fatemeh Chalabianloo ◽

...

Keyword(s):

Hepatitis C ◽

Prescription Database ◽

Cumulative Frequency ◽

Agonist Therapy ◽

Hcv Treatment ◽

Opioid Agonist ◽

Direct Acting Antiviral ◽

Opioid Agonist Therapy ◽

Treatment Uptake ◽

Direct Acting

Abstract Background Treatment with direct-acting antiviral agents (DAAs) offers an opportunity to eliminate hepatitis C virus (HCV) endemic among people who inject drugs (PWID) and people enrolled in opioid agonist therapy (OAT) programs. The objective of this study was to estimate and to compare HCV treatment uptake after the introduction of DAAs among patients receiving OAT in Sweden and Norway. We also aimed to evaluate predictors of DAAs treatment among OAT patients in both countries. Methods This observational study was conducted with data from The Swedish Prescribed Drug Register and The Norwegian Prescription Database. We studied dispensed medications to calculate cumulative frequency of HCV treatment among OAT patients from 2014 to 2017 in Sweden and Norway. Dispensations of medicines from different therapeutic areas, which served as proxy for co-morbidities in 2017, were adjusted for age, gender, and OAT medications and studied in a logistic regression model. Results In total 3,529 individuals were identified with dispensed OAT in the Swedish cohort and 7,739 individuals in the Norwegian cohort. HCV treatment was utilized by 407 persons in Sweden and 920 in Norway during the study period. Annual HCV treatment uptake increased in both countries, giving a cumulative frequency of around one-third in both countries at the end of the study period. DAA treatment was associated with increased age (aOR 1.8; 95% CI 1.0-3.2) and dispensation of drugs used for diabetes (aOR 3.2; 95% CI 1.8-5.7) in Sweden. In Norway, lipid modifying agents and antibacterials were associated with decreased odds (aOR 0.4; 95%CI 0.2-0.9, aOR 0.8; 95%CI 0.6-1.0). Conclusions An increase in DAA treatment and HCV treatment uptake was observed among Swedish and Norwegian OAT patients during the introduction period of new direct-acting treatment regimens. However, a further scale-up is crucial to be able to control and eliminate the HCV endemic among OAT patients.

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Clinical and Patient-Reported Outcomes of Direct-Acting Antivirals for the Treatment of Chronic Hepatitis C Among Patients on Opioid Agonist Treatment: A Real-world Prospective Cohort Study

Open Forum Infectious Diseases ◽

10.1093/ofid/ofaa317 ◽

2020 ◽

Vol 7 (8) ◽

Author(s):

Bernd Schulte ◽

Christiane S Schmidt ◽

Jakob Manthey ◽

Lisa Strada ◽

Stefan Christensen ◽

...

Keyword(s):

Cohort Study ◽

Hepatitis C ◽

Real World ◽

Patient Reported Outcomes ◽

Direct Acting Antivirals ◽

Hcv Treatment ◽

Opioid Agonist ◽

Patient Reported ◽

Direct Acting ◽

Over Time

Abstract Background Patient-reported outcomes (PROs) can help to reduce uncertainties about hepatitis C virus (HCV) treatment with direct-acting antivirals (DAAs) among people who inject drugs and increase treatment uptake in this high-risk group. Besides clinical data, this study analyzed for the first time PROs in a real-world sample of patients on opioid agonist treatment (OAT) and HCV treatment with DAAs. Methods HCV treatment data including virological response, adherence, safety, and PROs of 328 German patients on OAT were analyzed in a pragmatic prospective cohort study conducted from 2016 to 2018. Clinical effectiveness was defined as sustained virological response (SVR) at week 12 after end of treatment and calculated in per-protocol (PP) and intention-to-treat (ITT) analyses. Changes over time in PROs on health-related quality of life, physical and mental health, functioning, medication tolerability, fatigue, concentration, and memory were analyzed by repeated-measures analyses of variances (ANOVAs). Results We found high adherence and treatment completion rates, a low number of mainly mild adverse events, and high SVR rates (PP: 97.5% [n = 285]; ITT: 84.5% [n = 328]). Missing SVR data in the ITT sample were mainly caused by patients lost to follow-up after treatment completion. Most PROs showed statistically significant but modest improvements over time, with more pronounced improvements in highly impaired patients. Conclusions This real-world study confirms that DAA treatment among OAT patients is feasible, safe, and effective. PROs show that all patients, but particularly those with higher somatic, mental, and social burden, benefit from DAA treatment.

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