Determinants of Hepatitis C Virus Treatment Completion and Efficacy in Drug Users Assessed by Meta-analysis

Dimova, Rositsa B.; Zeremski, Marija; Jacobson, Ira M.; Hagan, Holly; Jarlais, Don C. Des; Talal, Andrew H.

doi:10.1093/cid/cis1007

Cited by 127 publications

(120 citation statements)

References 50 publications

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“…The comparable SVR12 outcomes in this post hoc analysis are consistent with previous data of interferon-based HCV therapy [7][8][9] and interferon-free DAA therapy for chronic HCV G1 among people receiving OST [10][11][12]. However, this study adds considerably to the literature, given that almost all studies of DAA therapy among people receiving OST are restricted to people with HCV G1, G4, or G6.…”

Section: Discussionsupporting

confidence: 89%

Efficacy and Safety of Sofosbuvir/Velpatasvir in Patients With Chronic Hepatitis C Virus Infection Receiving Opioid Substitution Therapy: Analysis of Phase 3 ASTRAL Trials

et al. 2016

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In this analysis of the ASTRAL trials (non-opioid substitution therapy [OST], n = 984; OST, n = 51) evaluating the once-daily, pan-genotypic regimen of sofosbuvir/velpatasvir for hepatitis C virus infection, OST did not impact completion, adherence, sustained virologic response (SVR12), or safety. SVR12 was 96% (95% confidence interval, 87%, >99%) in those receiving OST.Keywords. HCV; OST; PWID; sofosbuvir; velpatasvir.People who inject drugs (PWID) are disproportionately affected by hepatitis C virus (HCV) infection [1]. People with a history of injection drug use include those who have stopped injecting, those with recent injecting, and those receiving opioid substitution therapy (OST; eg, methadone or buprenorphine), some of whom may also have recently injected drugs. Data are lacking on HCV treatment outcomes with interferon-free direct-acting antiviral agents (DAAs) among people receiving OST, particularly people with genotypes (G) other than HCV G1. The phase 3 ASTRAL 1-3 trials evaluated the efficacy and safety of sofosbuvir/velpatasvir in patients with chronic HCV genotypes 1-6 [2, 3]. People receiving stable OST were eligible for inclusion, but people with clinically relevant illicit drug use within 12 months or a positive urine drug test at screening were excluded. No drug screens were performed during or following treatment. These clinical trial populations are highly selected, included people on stable OST, excluded people with recent drug use, and may not be representative of recent PWID populations. However, there are little data on interferon-free DAA therapy among people receiving OST.The aim of this post hoc analysis was to evaluate treatment completion, adherence, sustained virologic response (SVR), and safety of sofosbuvir/velpatasvir in people receiving OST without drug use at screening. METHODS Study Participants and DesignFrom 18 July 2014 to 19 December 2014 participants were enrolled in 3 international, multicenter, randomized open-label trials, including ASTRAL 1-3 (ClinicalTrials.gov: NCT02201940, NCT02220998, and NCT02201953) [2,3]. A fixed-dose combination tablet of sofosbuvir/velpatasvir 400 mg/100 mg was administered for 12 weeks in patients with chronic HCV genotypes 1-6. These studies have been described previously [2,3].Participants receiving OST were eligible for inclusion in the ASTRAL studies. Patients were excluded if they had clinically significant drug use within 12 months of screening (as assessed by the investigator) or a noncannabinoid detected by a positive urine drug test during the screening phase not explained by a prescription medication. No drug screens were performed during or following treatment. Study EndpointsIn this analysis, endpoints included treatment completion, adherence (≥90% of doses), SVR12, safety (adverse events [AEs] and serious AEs), and reinfection. The analysis population included all randomized patients who received at least 1 dose of sofosbuvir/velpatasvir. Adherence was calculated by dividing the number of total doses received during therapy...

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Section: Discussionsupporting

confidence: 89%

Efficacy and Safety of Sofosbuvir/Velpatasvir in Patients With Chronic Hepatitis C Virus Infection Receiving Opioid Substitution Therapy: Analysis of Phase 3 ASTRAL Trials

et al. 2016

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“…Although interferon-based HCV therapy is safe and effective among PWID (Aspinall, et al, 2013;Dimova, et al, 2013;Hellard, Sacks-Davis, & Gold, 2009), patient, provider, health system, structural, and societal barriers (Grebely, Oser, Taylor, & Dore, 2013;Harris & Rhodes, 2013;Wolfe, et al, 2015) have led to low diagnosis and treatment for HCV infection in the interferon-era (Alavi, et al, 2014;Iversen, et al, 2014). The availability of tolerable and simple direct-acting antiviral (DAA) therapies for HCV infection with cure rates >95% represents one of the greatest medical advances in decades FaladeNwulia, et al, 2017).…”

Section: Hcv Treatment For Pwidmentioning

confidence: 99%

“…Interferon-based therapy is safe and effective among PWID (Aspinall, et al, 2013;Dimova, et al, 2013;Hellard, et al, 2009). In this issue, Grebely et al present the results from the first international clinical trial from the ACTIVATE Network, which was a trial to evaluate response-guided interferon-based HCV therapy for participants with HCV genotypes 2/3 and recent injecting (previous 6 months) or receiving OST, prior to the availability of DAA therapy between 2012 and 2014 (Grebely THIS ISSUE).…”

Section: Hcv Treatment For Pwidmentioning

confidence: 99%

Elimination of hepatitis C virus infection among PWID: The beginning of a new era of interferon-free DAA therapy

Grebely

Bruneau

Bruggmann

et al. 2017

International Journal of Drug Policy

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“…There is now compelling evidence that interferon-based HCV treatment is safe and effective for PWID (Aspinall et al, 2013;Dimova et al, 2013;Hellard, Sacks-Davis, & Gold, 2009;Robaeys et al, 2013). In two systematic reviews of interferon-based studies assessing treatment for PWID (one specifically focusing on those with recent injecting at the time of treatment initiation), the overall sustained virological response (SVR) was 56% (Aspinall et al, 2013;Dimova et al, 2013).…”

Section: Epidemiology and Prevention Of Hcv Infection Among Pwidmentioning

confidence: 99%

“…In two systematic reviews of interferon-based studies assessing treatment for PWID (one specifically focusing on those with recent injecting at the time of treatment initiation), the overall sustained virological response (SVR) was 56% (Aspinall et al, 2013;Dimova et al, 2013). These response rates are comparable to responses in non-drug using populations in large randomized controlled trials of interferon-based treatment (Manns, Wedemeyer, & Cornberg, 2006).…”

Section: Epidemiology and Prevention Of Hcv Infection Among Pwidmentioning

confidence: 99%

Expanding access to prevention, care and treatment for hepatitis C virus infection among people who inject drugs

Grebely

Bruggmann

Treloar

et al. 2015

International Journal of Drug Policy

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Determinants of Hepatitis C Virus Treatment Completion and Efficacy in Drug Users Assessed by Meta-analysis

Cited by 127 publications

References 50 publications

Efficacy and Safety of Sofosbuvir/Velpatasvir in Patients With Chronic Hepatitis C Virus Infection Receiving Opioid Substitution Therapy: Analysis of Phase 3 ASTRAL Trials

Efficacy and Safety of Sofosbuvir/Velpatasvir in Patients With Chronic Hepatitis C Virus Infection Receiving Opioid Substitution Therapy: Analysis of Phase 3 ASTRAL Trials

Elimination of hepatitis C virus infection among PWID: The beginning of a new era of interferon-free DAA therapy

Expanding access to prevention, care and treatment for hepatitis C virus infection among people who inject drugs

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