Restrictions on access to direct-acting antivirals for people who inject drugs: The European Hep-CORE study and the role of patient groups in monitoring national HCV responses

Lazarus, Jeffrey V.; Safreed-Harmon, Kelly; Stumo, Samya R; Jauffret‐Roustide, Marie; Matičič, Mojca; Reic, Tatjana; Schatz, Eberhard; Tallada, Joan; Harris, Magdalena

doi:10.1016/j.drugpo.2017.05.054

Cited by 21 publications

(20 citation statements)

References 17 publications

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“…Restriction primarily was instituted according to fibrosis stage and/or ongoing substance abuse. Seven countries allowed prescription in nonhospital settings, and no single country allowed unrestricted access such as in Australia . Iceland and Georgia were other countries amongst the first to offer unrestricted access to DAA therapy for all patients.…”

Section: Discussionmentioning

confidence: 99%

“…Similarly, real‐world outcomes have consistently demonstrated high efficacy, albeit mostly within the confines of highly selective patient populations, genotypes or treatment regimes . Many countries continue to offer treatment only to those with advanced fibrosis, and often exclude those with ongoing substance abuse or incarceration from accessing therapy despite the long‐term cost‐effectiveness . Current real‐world outcomes have reflected the limitations imposed by systematic rationing and restriction of DAA therapy, with reports often limited to highly selective patient groups.…”

Section: Introductionmentioning

confidence: 99%

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Real‐world outcomes of unrestricted direct‐acting antiviral treatment for hepatitis C in Australia: The South Australian statewide experience

Haridy

Wigg

Muller

et al. 2018

Journal of Viral Hepatitis

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In March 2016, the Australian government offered unrestricted access to direct-acting antiviral (DAA) therapy for chronic hepatitis C virus (HCV) to the entire population. This included prescription by any medical practitioner in consultation with specialists until sufficient experience was attained. We sought to determine the outcomes and experience over the first twelve months for the entire state of South Australia. We performed a prospective, observational study following outcomes of all treatments associated with the state's four main tertiary centres. A total of 1909 subjects initiating DAA therapy were included, representing an estimated 90% of all treatments in the state. Overall, SVR12 was 80.4% in all subjects intended for treatment and 95.7% in those completing treatment and follow-up. 14.2% were lost to follow-up (LTFU) and did not complete SVR12 testing. LTFU was independently associated with community treatment via remote consultation (OR 1.50, 95% CI 1.04-2.18, P = .03), prison-based treatment (OR 2.02, 95% CI 1.08-3.79, P = .03) and younger age (OR 0.98, 95% CI 0.97-0.99, P = .05). Of the 1534 subjects completing treatment and follow-up, decreased likelihood of SVR12 was associated with genotype 2 (OR 0.23, 95% CI 0.07-0.74, P = .01) and genotype 3 (OR 0.23, 95% CI 0.12-0.43, P ≤ .01). A significant decrease in treatment initiation was observed over the twelve-month period in conjunction with a shift from hospital to community-based treatment. Our findings support the high responses observed in clinical trials; however, a significant gap exists in SVR12 in our real-world cohort due to LTFU. A declining treatment initiation rate and shift to community-based treatment highlight the need to explore additional strategies to identify, treat and follow-up remaining patients in order to achieve elimination targets.

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Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Real‐world outcomes of unrestricted direct‐acting antiviral treatment for hepatitis C in Australia: The South Australian statewide experience

Haridy

Wigg

Muller

et al. 2018

Journal of Viral Hepatitis

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“…Prescriber-type restrictions for HCV treatment [62], and lack of access to transient elastography [54] may impact on access to care [20]…”

Section: Health Systems and Regulatory Frameworkmentioning

confidence: 99%

Linkage and retention in HCV care for HIV‐infected populations: early data from the DAA era

et al. 2018

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IntroductionThere is currently no published data on the effectiveness of DAA treatment for elimination of HCV infection in HIV‐infected populations at a population level. However, a number of relevant studies and initiatives are emerging. This research aims to report cascade of care data for emerging HCV elimination initiatives and studies that are currently being evaluated in HIV/HCV co‐infected populations in the context of implementation science theory.Methods HCV elimination initiatives and studies in HIV co‐infected populations that are currently underway were identified. Context, intervention characteristics and cascade of care data were synthesized in the context of implementation science frameworks.ResultsSeven HCV elimination initiatives and studies were identified in HIV co‐infected populations, mainly operating in high‐income countries. Four were focused mainly on HCV elimination in HIV‐infected gay and bisexual men (GBM), and three included a combination of people who inject drugs (PWID), GBM and other HIV‐infected populations. None were evaluating treatment delivery in incarcerated populations. Overall, HCV RNA was detected in 4894 HIV‐infected participants (range within studies: 297 to 994): 48% of these initiated HCV treatment (range: 21% to 85%; within studies from a period where DAAs were broadly available the total is 57%, range: 36% to 74%). Among studies with treatment completion data, 96% of 1109 initiating treatment completed treatment (range: 94% to 99%). Among those who could be assessed for sustained virological response at 12 weeks (SVR12), 1631 of 1757 attained SVR12 (93%, range: 86% to 98%).ConclusionsEarly results from emerging research on HCV elimination in HIV‐infected populations suggest that HCV treatment uptake is higher than reported levels prior to DAA treatment availability, but approximately half of patients remain untreated. These results are among diagnosed populations and additional effort is required to increase diagnosis rates. Among those who have initiated treatment, completion and SVR rates are promising. More data are required in order to evaluate the effectiveness of these elimination programmes in the long term, assess which intervention components are effective, and whether they need to be tailored to particular population groups.

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“…1,2 DAA regimens have produced sustained virological response (SVR) rates in excess of 90% for patients with compensated cirrhosis, more than twice the rate achieved by interferon-based regimens. 3 Given initial clinical guidelines and practice involving treatment prioritization for those with advanced fibrosis, 4,5 an appreciable proportion of the 5 million people treated with DAAs globally to date will have had compensated cirrhosis. 6 Despite this, there remains relatively little evidence regarding the impact of IFN-free therapy for patients with compensated cirrhosis on important clinical outcomes, such as progression to decompensated cirrhosis (DC), development of HCC and mortality There is robust and compelling evidence from the interferon treatment era that patients achieving SVR have significantly reduced risk of severe liver complications and all-cause mortality compared with non-SVR.…”

Section: Introductionmentioning

confidence: 99%

Real‐world impact following initiation of interferon‐free hepatitis C regimens on liver‐related outcomes and all‐cause mortality among patients with compensated cirrhosis

McDonald

Pollock

Barclay

et al. 2019

Journal of Viral Hepatitis

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Few studies have investigated clinical outcomes among patients with cirrhosis who were treated with interferon (IFN)‐free direct‐acting antiviral (DAA). We aimed to quantify treatment impact on first decompensated cirrhosis hospital admission, first hepatocellular carcinoma (HCC) admission, liver‐related mortality and all‐cause mortality among a national cohort of cirrhotic patients. Through record linkage between Scotland's HCV Clinical Database and inpatient/day‐case hospitalization and deaths records, a study population comprising chronic HCV‐infected patients with compensated cirrhosis and initiated on IFN‐free DAA between 1 March 2013 and 31 March 2018 was analysed. Cox regression evaluated the association of each clinical outcome with time‐dependent treatment status (on treatment, responder, nonresponder or noncompliant), adjusting for patient factors including Child‐Pugh class. Among the study population (n = 1073) involving 1809 years of follow‐up, 75 (7.0%) died (39 from liver‐related causes), 47 progressed to decompensated cirrhosis, and 28 developed HCC. Compared with nonresponders, treatment response (96% among those attending their 12 weeks post‐treatment SVR test) was associated with a reduced relative risk of decompensated cirrhosis (hazard ratio [HR] = 0.14; 95% CI: 0.05‐0.39), HCC (HR = 0.17; 95% CI: 0.04‐0.79), liver‐related death (HR = 0.13; 95% CI: 0.05‐0.34) and all‐cause mortality (HR = 0.30; 95% CI: 0.12‐0.76). Compared with responders, noncompliant patients had an increased risk of liver‐related (HR = 6.73; 95% CI: 2.99‐15.1) and all‐cause (HR = 5.45; 95% CI: 3.07‐9.68) mortality. For HCV patients with cirrhosis, a treatment response was associated with a lower risk of severe liver complications and improved survival. Our findings suggest additional effort is warranted to address the higher mortality among the minority of cirrhotic patients who do not comply with DAA treatment or associated RNA testing.

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Restrictions on access to direct-acting antivirals for people who inject drugs: The European Hep-CORE study and the role of patient groups in monitoring national HCV responses

Cited by 21 publications

References 17 publications

Real‐world outcomes of unrestricted direct‐acting antiviral treatment for hepatitis C in Australia: The South Australian statewide experience

Real‐world outcomes of unrestricted direct‐acting antiviral treatment for hepatitis C in Australia: The South Australian statewide experience

Linkage and retention in HCV care for HIV‐infected populations: early data from the DAA era

Real‐world impact following initiation of interferon‐free hepatitis C regimens on liver‐related outcomes and all‐cause mortality among patients with compensated cirrhosis

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