Sofosbuvir-Based Direct-Acting Antiviral Therapies for HCV in People Receiving Opioid Substitution Therapy: An Analysis of Phase 3 Studies

Grebely, Jason; Feld, Jordan J.; Wyles, David L.; Sulkowski, Mark S.; Ni, Liyun; Llewellyn, Joe; Mir, Heshaam M.; Sajed, Nika; Stamm, Luisa M.; Hyland, Robert H.; McNally, John; Brainard, Diana M.; Jacobson, Ira M.; Zeuzem, Stefan; Bourlière, Marc; Foster, Graham R.; Afdhal, Nezam H.; Dore, Gregory J.

doi:10.1093/ofid/ofy001

Cited by 38 publications

(34 citation statements)

References 33 publications

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“…In studies that did not provide adherence support, adherence was assessed by pill count (n = 3), a participant‐completed electronic medication diary (n = 1) or an electronic blister back (n = 1) . Fifteen studies reported treatment discontinuation: in recent PWID (n = 5) or OST recipients (n = 10) . Reasons for discontinuation included death, incarceration and loss to follow‐up.…”

Section: Resultsmentioning

confidence: 99%

“…In total 16 studies, were deemed to be of high quality (NOS ≥ 7 or modified NOS ≥ 5). In studies with comparison groups, the most common source of potential bias was a possible difference between the recent PWID or OST group and the comparison group in terms of cirrhosis or other baseline factors such as age or genotype . This was either because of lack of reporting of baseline characteristics by recent PWID or OST group, or reporting of a statistically significant difference between groups.…”

Section: Resultsmentioning

confidence: 99%

“…This was either because of lack of reporting of baseline characteristics by recent PWID or OST group, or reporting of a statistically significant difference between groups. Ten studies were also deemed to be at high risk of bias in terms of the representativeness of the recent PWID or OST group . The most common (n = 6) potential source of bias in this domain was the requirement that participants be on ‘stable OST’ .…”

Section: Resultsmentioning

confidence: 99%

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Staying hepatitis C negative: A systematic review and meta‐analysis of cure and reinfection in people who inject drugs

Latham

Doyle

Palmer

et al. 2019

Liver International

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Background and Aims: Direct-acting antivirals (DAAs) are highly effective in treating hepatitis C. However, there is concern that cure rates may be lower, and reinfection rates higher, among people who inject drugs. We conducted a systematic review of treatment outcomes achieved with DAAs in people who inject drugs (PWID).Hepatitis C (HCV) is a blood-borne virus, which in high-income countries is primarily transmitted amongst people who inject drugs (PWID). 1,2 Curing HCV reduces mortality and improves quality of life. 3,4 Treating PWID also reduces the risk of transmission, and is an essential component of achieving the World Health Organization HCV elimination targets. 5 Despite recommendations that PWID receive treatment, 6-8 this population continues to be excluded; both by individual practitioners, 9 and at a systemic level. 10,11 Our 2013 systematic review of interferon/ribavirin therapy found that PWID receiving treatment had high levels of adherence (82%, 95% CI 74%-89%), low-treatment discontinuation (22%, 95% CI 16%-27%), and similar SVR rates (56%, 95% CI 50%-61%) to non-PWID in realworld settings. 12 A systematic review of treatment outcomes in people reporting recent drug use, including a subgroup of people who inject drugs, found that this population achieves relatively high rates of cure with DAAs. 13 Despite the effectiveness of DAAs, concerns about reinfection in PWID have been raised and may partially account for practitioner unwillingness to prescribe DAA therapy to this population. 9Low rates of reinfection were observed among those PWID treated with interferon-based therapies, 12,14 but this may be different in the DAA era. Indeed, given that DAA treatments are significantly more effective and tolerable than interferon-based therapies, it is possible that the availability of DAA treatment may result in an increase in the number of people with ongoing risk behaviour who achieve cure, and in turn increase the total population at risk of reinfection.Several studies have investigated DAA therapy outcomes amongst PWID, including reinfection, but the number of recent PWID included in each study is small (range: 23-163). [15][16][17][18][19][20][21][22][23][24][25][26][27] We conducted a systematic review and meta-analysis to measure SVR, treatment discontinuation, adherence, and reinfection amongst recent PWID and OST recipients treated with DAAs.Methods: A search strategy was used to identify studies that reported sustained viral response (SVR), treatment discontinuation, adherence or reinfection in recent PWID and/or opioid substitution therapy (OST) recipients. Study quality was assessed using the Newcastle-Ottawa Scale. Meta-analysis of proportions was used to estimate pooled SVR and treatment discontinuation rates. The pooled relative risk of achieving SVR and pooled reinfection rate were calculated using generalized mixed effects linear models. Results:The search identified 8075 references; 26 were eligible for inclusion. The pooled SVR for recent PWID was 88% (95% CI, 83%-92%) and 91% (95% C...

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Section: Resultsmentioning

confidence: 99%

Section: Resultsmentioning

confidence: 99%

Section: Resultsmentioning

confidence: 99%

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Staying hepatitis C negative: A systematic review and meta‐analysis of cure and reinfection in people who inject drugs

Latham

Doyle

Palmer

et al. 2019

Liver International

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“…Hence, OST and active drug use should not be regarded as exclusion for treatment . DAA treatment in OST patients and PWID, show that SVR rates of >95% can be reached . Furthermore, low reinfection rates of 2‐6 per 100 person‐years (PY) have been reported .…”

Section: Introductionmentioning

confidence: 99%

Incidence and spontaneous clearance of hepatitis C virus (HCV) in people who inject drugs at the Stockholm Needle Exchange—Importance for HCV elimination

Kåberg

Navér

Hammarberg

et al. 2018

Journal of Viral Hepatitis

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The major transmission route for hepatitis C virus (HCV) is through sharing of unsterile injection equipment among people who inject drugs (PWID). The WHO strategy for HCV elimination by 2030 proposes increased efforts to treat PWID populations that drive the HCV epidemic. Among participants in the Stockholm needle exchange programme (NEP), the HCV prevalence is 60%. We aimed to study HCV incidence, spontaneous HCV clearance rate, and predictors associated with new HCV infections and reinfections in NEP participants. All 2320 patients enrolled in the programme between 8 April 2013 and 23 September 2016 were tested for HCV at baseline, and responded to a questionnaire regarding sociodemographic data and injection risk behaviour. Tests for HCV were repeated at an interval of 3-6 months. The anti-HCV prevalence in the NEP participants at baseline was 77%, and the prevalence of HCV RNA was 57%. 24% of the anti-HCV positive were HCV RNA negative with a spontaneously cleared HCV infection. The overall HCV incidence rate was 22/100 PY. The HCV incidence rate in the HCV naive group was 26/100 PY, and in the spontaneously cleared group 19/100. Although there were no significant differences in becoming HCV infected between the two groups (31% vs 29%), the rate of spontaneous HCV clearance was significantly lower in the HCV naive group, 20% vs 44%, (P < 0.05). A high HCV incidence rate was noted among the PWID indicating that treatment needs to be scaled up in conjunction with harm reduction measures to achieve HCV elimination goals set by WHO. This includes high coverage needle exchange programmes and effective addiction treatment for substance users, including opiate substitution treatment.

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“…However, studies have now clearly demonstrated that neither mental health concerns nor substance use greatly affect treatment outcomes. Multiple studies have shown high treatment completion and SVR rates among individuals receiving opiate agonist therapy (26,27). More recently, a multicentre study enrolled 103 participants who were actively injecting, of whom 100 completed therapy with 94% SVR (28).…”

Section: Treat Where Identified: Cure Among Current or Former People mentioning

confidence: 99%

Hepatitis C models of care: approaches to elimination

Biondi

Feld

2020

CanLivJ

Self Cite

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Hepatitis C direct-acting antivirals (DAAs) have an efficacy of 95% or greater, with pangenotypic options. Many regions in Canada have recently abolished the need to demonstrate fibrosis before treatment with DAAs, and several combination therapies are available under public and private insurance coverage. As a result, efforts to increase treatment are largely focused on engaging specific populations and providers. With minimal side effects and decreased need for monitoring, hepatitis C screening, linkage, and treatment can largely be done in a single setting. In this article, we highlight both Canadian and international examples of the specialist's ongoing role and discuss the task shifting of hepatitis C treatment to primary care; specialized community clinics; and mental health, corrections, addictions, and opioid substitution therapy settings. Although specialists continue to support most models of care described in the literature, we highlight the potential for non-specialist care in working toward the elimination of hepatitis C in Canada.

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Sofosbuvir-Based Direct-Acting Antiviral Therapies for HCV in People Receiving Opioid Substitution Therapy: An Analysis of Phase 3 Studies

Cited by 38 publications

References 33 publications

Staying hepatitis C negative: A systematic review and meta‐analysis of cure and reinfection in people who inject drugs

Staying hepatitis C negative: A systematic review and meta‐analysis of cure and reinfection in people who inject drugs

Incidence and spontaneous clearance of hepatitis C virus (HCV) in people who inject drugs at the Stockholm Needle Exchange—Importance for HCV elimination

Hepatitis C models of care: approaches to elimination

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