Safety and efficacy of glecaprevir/pibrentasvir in patients with chronic hepatitis C genotypes 1–6 receiving opioid substitution therapy

Grebely, Jason; Dore, Gregory J.; Alami, Negar N.; Conway, Brian; Dillon, John; Gschwantler, Michael; Felizarta, Franco; Hézode, Christophe; Tomasiewicz, Krzysztof; Fredrick, Linda; Dumas, Emily O.; Mensa, Federico

doi:10.1016/j.drugpo.2019.01.011

Cited by 32 publications

(31 citation statements)

References 34 publications

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“…Neither injecting drug use nor use of OST were predictors of non‐adherence to G/P therapy. These findings are in keeping with a previous analysis of G/P, as well as analyses of other DAA regimens which have shown high rates of adherence (≥90%) in PWID and patients on OST; however, recent drug use (within 6 months of study treatment) that, in the opinion of the study investigator, could have precluded adherence to the study protocol was an exclusionary criterion in some of these studies. Patient education on treatment adherence, counselling on harm reduction and peer support should remain an important part of HCV care in the PWID population.…”

Section: Discussionsupporting

confidence: 89%

“…Previous analyses of DAA regimens have demonstrated high adherence to treatment in the overall chronic HCV‐infected patient population, including those who were on opioid substitution therapy (OST) and people who use drugs (≥95% and ≥90% respectively). Some studies have suggested that adherence to DAA therapy decreases with increased treatment duration .…”

Section: Introductionmentioning

confidence: 99%

“…[2][3][4] Adequate adherence to treatment is believed to be a key component of treatment success because non-adherence can potentially result in treatment failure and the emergence of resistant viral variants. 5 Previous analyses of DAA regimens have demonstrated high adherence to treatment in the overall chronic HCV-infected patient population, [6][7][8] including those who were on opioid substitution therapy (OST) and people who use drugs [9][10][11][12][13][14] (≥95% and ≥90% respectively). Some studies have suggested that adherence to DAA therapy decreases with increased treatment duration.…”

Section: Introductionmentioning

confidence: 99%

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Adherence to pan‐genotypic glecaprevir/pibrentasvir and efficacy in HCV‐infected patients: A pooled analysis of clinical trials

Brown

Welzel

Conway

et al. 2019

Liver International

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Background & Aims Adequate adherence to hepatitis C virus (HCV) treatment is believed to be a key component of treatment success because non‐adherence can potentially result in treatment failure and the emergence of resistant viral variants. This analysis assessed factors associated with non‐adherence to glecaprevir/pibrentasvir (G/P) therapy and the impact of non‐adherence on sustained virological response at post‐treatment week 12 (SVR12) rates in HCV genotype (GT) 1‐6‐infected patients. Methods Adherence was calculated by pill counts at study visits during treatment, and defined as having a lowest treatment adherence of ≥80% and ≤120% at each study visit. Exploratory logistic regression modelling assessed predictors of non‐adherence to G/P therapy. SVR12 rates by treatment adherence were assessed in the intent‐to‐treat (ITT) population and modified ITT (mITT) population, which excludes non‐virological failures. Results Overall, 97% (2024/2091) of patients were adherent to G/P therapy at all consecutive study visits. Alcohol use was the only baseline characteristic independently associated with non‐adherence to G/P therapy (OR: 2.38; 95% CI: 1.13‐5.01; P = .022). In the mITT population, overall SVR12 rates were high both in patients who were adherent to G/P therapy and those who were not (99% [1983/2008] and 95% [58/61] respectively; P = .047). Corresponding SVR12 rates in the ITT population were 98% (1983/2024) and 87% (58/67) respectively. Conclusions Most patients adhered to G/P therapy. SVR12 rates were high both in patients who were adherent to G/P treatment and those who were not. Patient education on treatment adherence should remain an important part of HCV treatment. Clinical trials registration NCT02604017, NCT02640482, NCT02640157, NCT02636595, NCT02642432, NCT02651194, NCT02243293, NCT02446717.

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Section: Discussionsupporting

confidence: 89%

Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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Adherence to pan‐genotypic glecaprevir/pibrentasvir and efficacy in HCV‐infected patients: A pooled analysis of clinical trials

Brown

Welzel

Conway

et al. 2019

Liver International

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“…Multidisciplinary projects can improve the cascade of care from diagnosis to treatment in these cases. A policy of not diagnosing vulnerable populations who are considered to be difficult to treat has not been validated in randomized trials and real‐life data, which show that all these at‐risk populations have a cure rate of between 90% and 98% similar to the ‘general’ population …”

Section: Improving Access To Care By Delocalizationmentioning

confidence: 99%

“…A policy of not diagnosing vulnerable populations who are considered to be difficult to treat has not been validated in randomized trials and real-life data, which show that all these at-risk populations have a cure rate of between 90% and 98% similar to the 'general' population. 18 Socio-behavioural features may influence the access to care.…”

Section: Improving Acce Ss To C Are By Deloc Aliz Ationmentioning

confidence: 99%

Micro‐elimination of hepatitis C virus

Hollande

Parlati

Pol

2020

Liver International

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Background & Aims HCV affects about 71 million people worldwide with 1.75 million new infections a year, mainly associated with healthcare, blood transfusion before screening of donors and drug use. Hepatitis C is a systemic disease with hepatic and extrahepatic manifestations resulting in increased morbidity and mortality in HCV‐infected patients compared to cured or uninfected individuals. Results The goal of eliminating hepatitis C by 2030 is based on the following three main actions: strengthening and increasing outreach screening; increasing access to treatment; and improving prevention. Although the tools and the targets of HCV elimination have now been well established, micro‐elimination, a cure in high‐risk populations, is possible, but has not been achieved. These populations are mainly migrants, prisoners, drug users, HIV co‐infected patients and psychiatric patients. New tools must be developed to achieve micro‐elimination, in particular, rapid diagnostic orientation tests for better screening, delocalization of healthcare services to improve access to care, and training physicians to raise awareness of the disease, increase understanding of its pathogenesis and provide information on the availability of safe and effective treatment to cure chronic infection and reverse hepatic and extrahepatic manifestations. Conclusion Thus, while the goal of complete elimination of hepatitis C virus was feasible in Western countries, it was more difficult in high‐prevalence countries where improvement in the detection of chronic infection (with rapid serological and virological diagnostic tests), outsourcing of diagnostic and therapeutic care and access to direct oral antivirals are urgently needed.

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Hepatitis C Virus in the Modern Direct‐Acting Antiviral Era: Where Have All the Special Populations Gone?

Ramers

Trooskin

2018

Clinical Liver Disease

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Safety and efficacy of glecaprevir/pibrentasvir in patients with chronic hepatitis C genotypes 1–6 receiving opioid substitution therapy

Cited by 32 publications

References 34 publications

Adherence to pan‐genotypic glecaprevir/pibrentasvir and efficacy in HCV‐infected patients: A pooled analysis of clinical trials

Adherence to pan‐genotypic glecaprevir/pibrentasvir and efficacy in HCV‐infected patients: A pooled analysis of clinical trials

Micro‐elimination of hepatitis C virus

Hepatitis C Virus in the Modern Direct‐Acting Antiviral Era: Where Have All the Special Populations Gone?

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