Real-world Efficacy of Direct-Acting Antiviral Therapy for HCV Infection Affecting People Who Inject Drugs Delivered in a Multidisciplinary Setting

Alimohammadi, Arshia; Holeksa, Julie; Thiam, Abdoulaye; Truong, David; Conway, Brian

doi:10.1093/ofid/ofy120

Cited by 43 publications

(37 citation statements)

References 23 publications

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“…To this end, a special focus should be given to PWID who are considered HCV core‐transmitters making up the majority of incident (80%) and prevalent (60%) cases . Despite these facts, HCV treatment programmes for PWID have not yet been a major part of the response to the pandemic and PWID remain an underserved population with only one in ten diagnosed patients entering HCV treatment . Of note, a safe and effective pan‐genotypic treatment regimen, particularly with a short duration, could facilitate increased treatment access for PWUDs, a currently underserved patient population .…”

Section: Discussionsupporting

confidence: 93%

“…In addition to health benefits for individual patients, curing HCV infection benefits public health by preventing further transmission. To this end, a special focus should be given to PWID who are considered HCV core‐transmitters making up the majority of incident (80%) and prevalent (60%) cases . Despite these facts, HCV treatment programmes for PWID have not yet been a major part of the response to the pandemic and PWID remain an underserved population with only one in ten diagnosed patients entering HCV treatment .…”

Section: Discussionmentioning

confidence: 99%

See 1 more Smart Citation

Real‐life glecaprevir/pibrentasvir in a large cohort of patients with hepatitis C virus infection: The MISTRAL study

Persico

Aglitti

Milella

et al. 2019

Liver International

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Background and aims:It is paramount to identify predictors of treatment failure with direct antiviral agents in 'field-practice' patients, including people who inject drugs (PWID). Data on the efficacy of glecaprevir/pibrentasvir (GLE/PIB) in a field-practice scenario are scant. The multicentre MISTRAL study enrolled 1177 patients, including PWID, to assess real-life efficacy and safety of GLE/PIB and to identify the predictive factors for this treatment. Methods:This was a prospective, longitudinal study. The outcome variable was the rate of sustained virological response (SVR) at week 12.Results: A total of 123 patients (10%) were infected from hepatitis C virus (HCV) 3.METAVIR fibrosis score was F4 in 104 subjects (9%); 118 patients (10%) were PWID.Overall, 1163/1177 (99%) patients achieved SVR. The baseline clinical factors discriminating between treatment success and treatment failure were age at treatment (P = 0.031) and creatinine level (P = 0.034). SVR rates were not influenced by gender, substance abuse, previous treatment, treatment duration, fibrosis or chronic kidney disease stage. Compared with non-substance users, the 118 PWID exhibited a significantly different genotype pattern distribution (χ 2 < 0.001). A total of 40/118 (33.9%) of substance users were HCV3 compared to 83/1056 (7.9%) non-substance users.Only 6 patients (0.5%) reported a serious adverse event. Conclusions:The MISTRAL study provides evidence of GLE/PIB efficacy in a fieldpractice scenario in a highly epidemic HCV area in southern Italy; it unveiled significant differences in genotype distribution among the most underserved and difficult-to-treat patient subgroups including PWID. K E Y W O R D S cirrhosis, direct-acting antiviral, efficacy, HCV genotype, substance abuse Keypoints • The MISTRAL study shows that glecaprevir/pibrentasvir is effective for the treatment of hepatitis C virus in a field-practice scenario in a highly epidemic area in southern Italy. Handling editor: Alessio Aghemo S U PP O RTI N G I N FO R M ATI O N Additional supporting information may be found online in the Supporting Information section at the end of the article. How to cite this article: Persico M, Aglitti A, Milella M, et al. Real-life glecaprevir/pibrentasvir in a large cohort of patients with hepatitis C virus infection: The MISTRAL study. Liver Int.

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Section: Discussionsupporting

confidence: 93%

Section: Discussionmentioning

confidence: 99%

Real‐life glecaprevir/pibrentasvir in a large cohort of patients with hepatitis C virus infection: The MISTRAL study

Persico

Aglitti

Milella

et al. 2019

Liver International

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“…The efficacy of DAA therapy in PWID with HCV infection has been examined in 2 large prospective studies, in a number of post hoc analyses and in several real world studies [11][12][13]16,17,19,20,[27][28][29]. In the prospective cohorts, ITT SVR12 rates were 94% and 92%, with 3% of the patients being LTFU [13,17].…”

Section: Discussionmentioning

confidence: 99%

“…However, there is a large body of evidence that DAA therapy in PWID offers sustained virological response rates 12 weeks after treatment completion (SVR12) similar to those in non-PWID populations [11][12][13][14][15][16]. A reasonable concern in a marginalized population is compliance with treatment; indeed, although the proportion of patients lost to follow up (LTFU) is small in randomized clinical trials [13,17], data from real-world settings are scanty and conflicting [12,[18][19][20][21].…”

Section: Introductionmentioning

confidence: 99%

Direct-acting antiviral treatment for chronic hepatitis C in people who use drugs in a real-world setting

Koustenis

Anagnostou

Kranidioti

et al. 2020

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Background Direct-acting antivirals (DAAs) offer high cure rates in people who inject drugs (PWID) with hepatitis C virus (HCV) infection. There are concerns regarding lower response rates among PWID in real life. We evaluated the outcome of DAA therapy in PWID in a real-world setting and the factors that affect it. Methods We performed a retrospective analysis of 174 PWID with chronic hepatitis C who started DAAs in a Greek liver clinic in collaboration with an addiction program. Patients who did not return for reassessment were considered as lost to follow up (LTFU). A logistic regression model was used to assess factors associated with a sustained virological response 12 weeks after treatment completion (SVR12) and LTFU. Results Patients' mean age was 48±9.2 years and 91/174 (52.3%) were attending opioid substitution treatment programs. Overall, 144/174 (82.8%) patients completed therapy and presented for SVR12 testing, 8/174 (4.6%) did not complete treatment and 22/174 (12.6%) were LTFU. Overall SVR12 was 79.9% (139/174). For those with an available SVR12 test the response rate reached 96.5% (139/144). Regression analysis did not indicate any significant association between patient characteristics and SVR12. Age <45 years and genotype 3 were independent predictors of LTFU. Parallel use was found to have a trend towards LTFU. Conclusions HCV treatment by hepatologists and addiction specialists is feasible, effective and safe in a real-world setting. However, as 12% of patients appear to be LTFU, more emphasis should be placed on interventions guaranteeing follow up for SVR testing and general care. Keywords Direct-acting antivirals, hepatitis C virus infection, people who inject drugs, sustained virological response, lost to follow up

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“…In the former group, intolerance of treatment, and in the latter group, lack of accessible services, structural barriers and stigma in healthcare settings may contribute to LTF. In addition to unrestricted DAA access for individuals with IDU, a multidisciplinary approach targeting social, mental health and medical needs of this frequently marginalized population is required to achieve optimal treatment benefits . On the other hand, patients with cirrhosis were mainly older and about 99% had Elixhauser index ≥1, which may lead to polypharmacy and consequently, treatment intolerance and LTF.…”

Section: Discussionmentioning

confidence: 99%

Loss to follow‐up: A significant barrier in the treatment cascade with direct‐acting therapies

Darvishian

Wong

Binka

et al. 2019

Journal of Viral Hepatitis

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Effectiveness of direct‐acting antiviral (DAA) therapies could be influenced by patient characteristics such as comorbid conditions, which could lead to premature treatment discontinuation and/or irregular medical follow‐ups. Here, we evaluate loss to follow‐up and treatment effectiveness of sofosbuvir/ledipasvir ± ribavirin (SOF/LDV ± RBV), ombitasvir/paritaprevir/ritonavir + dasabuvir ± ribavirin (OBV/PTV/r + DSV ± RBV) for hepatitis C virus (HCV) genotype 1 (GT1) and sofosbuvir + ribavirin (SOF + RBV) for genotype 3 (GT3) in British Columbia Canada: The British Columbia Hepatitis Testers Cohort includes data on individuals tested for HCV since 1992, integrated with medical visit, hospitalization and prescription drug data. HCV‐positive individuals who initiated DAA regimens, irrespective of treatment completion, for GT1 and GT3 until 31 December, 2017 were included. Factors associated with sustained virological response (SVR) and loss to follow‐up were assessed by using multivariable logistic regression models. In total 4477 individuals initiated DAAs. The most common prescribed DAA was SOF/LDV ± RBV with SVR of 95%. The highest SVR of 99.5% was observed among OBV/PTV/r + DSV‐treated patients. Overall, 453 (10.1%) individuals were lost to follow‐up. Higher loss to follow‐up was observed among GT1 patients treated with OBV (17.8%) and GT3 patients (15.7%). The loss to follow‐up rate was significantly higher among individuals aged <60 years, those with a history of injection drug use (IDU), on opioid substitution therapy and with cirrhosis. Our findings indicate that loss to follow‐up exceeds viral failure in HCV DAA therapy and its rate varies significantly by genotype and treatment regimen. Depending on the aetiology of lost to follow‐up, personalized case management for those with medical complications and supporting services among IDU are needed to achieve the full benefits of effective treatments.

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Real-world Efficacy of Direct-Acting Antiviral Therapy for HCV Infection Affecting People Who Inject Drugs Delivered in a Multidisciplinary Setting

Cited by 43 publications

References 23 publications

Real‐life glecaprevir/pibrentasvir in a large cohort of patients with hepatitis C virus infection: The MISTRAL study

Real‐life glecaprevir/pibrentasvir in a large cohort of patients with hepatitis C virus infection: The MISTRAL study

Direct-acting antiviral treatment for chronic hepatitis C in people who use drugs in a real-world setting

Loss to follow‐up: A significant barrier in the treatment cascade with direct‐acting therapies

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