Paritaprevir, ritonavir, ombitasvir, and dasabuvir with and without ribavirin in people with HCV genotype 1 and recent injecting drug use or receiving opioid substitution therapy

Grebely, Jason; Conway, Brian; Cunningham, Evan B; Fraser, Chris; Moriggia, Alberto; Gane, Ed; Stedman, Catherine; Cooper, Curtis; Castro, Erika; Schmid, Patrick; Petoumenos, Kathy; Hajarizadeh, Behzad; Marks, Pip; Erratt, Amanda; Dalgård, Olav; Lacombe, Karine; Feld, Jordan J.; Bruneau, Julie; Daulouède, Jean-Pierre; Powis, Jeff; Bruggmann, Philip; Matthews, Gail V.; Kronborg, Ian; Shaw, David R.; Dunlop, Adrian; Hellard, Margaret; Applegate, Tanya; Crawford, Sione; Dore, Gregory J.

doi:10.1016/j.drugpo.2018.10.004

Cited by 22 publications

(11 citation statements)

References 41 publications

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“…It is likely that PWID identified as recent drug users could be those with more disruptive behavior associated with drugs, leading to dropout. This is in contrast with a recently published meta-analysis [26], including more than 3500 patients that demonstrated that people reporting recent drug use achieved similar SVR rates compared to former drug users.…”

Section: Discussioncontrasting

confidence: 97%

Model of Care for Microelimination of Hepatitis C Virus Infection among People Who Inject Drugs

Foschi

Borghi

Grassi

et al. 2021

JCM

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Background: People who inject drugs (PWID) are the largest group at risk for HCV infection. Despite the direct acting antivirals (DAA) advancements, HCV elimination has been hindered by real-life difficulties in PWID. Aims: This study aimed to assess the impact of a multidisciplinary intervention strategy where HCV screening, treatment and follow-up were performed at the same location on efficacy and safety of DAA-therapy in real-life PWID population. Methods: All HCV-infected PWID referred to five specialized outpatient centers for drug addicts (SerDs) in Northern Italy were prospectively enrolled from May 2015 to December 2019. Hepatologists and SerDs healthcare workers collaborated together in the management of PWID inside the SerDs. Sustained virologic response (SVR), safety of treatment, proportion of patients lost to follow-up and reinfection rate were evaluated. Results: A total of 358 PWID started antiviral treatment. About 50% of patients had advanced fibrosis/cirrhosis, 69% received opioid substitution treatment, and 20.7% self-reported recent injecting use. SVR was achieved in 338 (94.4%) patients. Two patients died during treatment; one prematurely discontinued, resulting in a non-responder; twelve were lost during treatment/follow-up; and five relapsed. No serious adverse events were reported. SVR was lower in recent PWID than in former ones (89.2% vs. 95.8%; p = 0.028). Seven reinfections were detected, equating to an incidence of 1.25/100 person-years. Reinfection was associated with recent drug use (OR 11.07, 95%CI 2.10–58.38; p = 0.005). Conclusion: Our embedded treatment model could be appropriate to increase the linkage to care of HCV-infected PWID. In this setting, DAA regimens are well tolerated and highly effective, achieving a lower rate of reinfection.

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Section: Discussioncontrasting

confidence: 97%

Model of Care for Microelimination of Hepatitis C Virus Infection among People Who Inject Drugs

Foschi

Borghi

Grassi

et al. 2021

JCM

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“…The efficacy of LDV/SOF against GT1 was also better compared to the other genotypes, which may be attributed to the small sample size of the latter. In addition, the SVR rate of paritaprevir, ritonavir, ombitasvir and dasabuvir with/out ribavirin was only 71% as opposed to the 91% achieved by boceprevir and telaprevir in drug users with GT1 virus [ 40 , 41 ]. Thus, LDV/SOF is a suitable option for drug users with GT1 HCV.…”

Section: Discussionmentioning

confidence: 99%

Efficacy and safety of ledipasvir/sofosbuvir for hepatitis C among drug users: a systematic review and meta-analysis

Yang¹,

Tang²,

Xu³

et al. 2021

Virol J

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Background and aims Limited data is available on the efficacy of direct acting anti-viral drugs on hepatitis C in drug users. The aim of this meta-analysis was to comprehensively analyze the efficacy and safety of LDV/SOF in drug users infected with the hepatitis C virus (HCV). Methods The PubMed, Cochrane library, Embase and Web of Science databases were searched for articles published till April 2021 on HCV-positive drug users who were treated with ledipasvir/sofosbuvir (LDV/SOF). The primary endpoint was pooled sustained virological response at 12 weeks (SVR12) with 95% confidence interval (95% CI). Funnel plots and Egger’s test were used to assess the publication bias. Results A total of 12 studies and 711 subjects treated with LDV/SOF-based regimen for HCV were included, and the pooled SVR12 rate was 89.8% (95% CI 85.9–92.7). The pooled SVR12 rate of genotype 1 drug users was 92.4% (95% CI 88.6–95.0). Subgroup analysis showed that pooled SVR12 rates of patients treated with LDV/SOF and LDV/SOF ± RBV were 89.2% (95% CI 83.4–93.1), 90.4% (95% CI 83.6–94.5) respectively. In addition, the SVR12 rates were 88% (95% CI 70.7–95.7) for 8 weeks, 89.9% (95% CI 81.0–94.9) for 12 weeks and 82.2% (95% CI 24.9–98.5) for 24 weeks of treatment. Conclusion LDV/SOF is a safe and relatively effective treatment for hepatitis C in drug users.

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“…In fact, one of the most important concerns of prescribers is the compliance of patients to treatment. However, a recent analysis [24] of the data reported for two multicenter phase 4 trials enrolling subjects with recent injection drug use or receiving opioid agonist therapy, who were treated with velpatasvir-sofosbuvir (SIMPLIFY-1) [10] or paritaprevir-ombitasvir-ritonavir plus dasabuvir (D3FEAT) [25], demonstrated that 184 of the 190 patients included (97%) completed the treatment, with a median adherence rate of 92%; recent stimulant injecting, unstable housing, and twice-daily regimens were associated with lower compliance. However, some clinicians may argue that it would be difficult to replicate the results derived from trials to clinical practice.…”

Section: Discussionmentioning

confidence: 99%

Directly Acting Antiviral-Based Treatment for HCV-Infected Persons Who Inject Drugs: A Multicenter Real-Life Study

Messina

Onorato

Caprio

et al. 2020

Life

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Background: We aimed to evaluate the factors associated with a virological response in a cohort of Hepatitis C virus (HCV)-infected people who inject drugs (PWID) treated with direct acting antivirals (DAAs). Methods: We conducted a multicenter retrospective cohort study enrolling HCV-infected PWID treated with DAAs. The primary outcome evaluated was the sustained virological response (SVR12) rate. Results: Five hundred and twenty HCV-infected PWID treated with all-oral DAA-based regimens were enrolled; a total of 168 (32.3%) patients presented genotype 1a, 109 (21.0%) genotype 1b, and 174 (33.5%) genotype 3; a total 152 of the 520 subjects (29.2%) were cirrhotics; a total 118 (22.7%) and 373 (71.7%) were treated with DAA regimens of second and third generation, respectively; a total 169 (33.6%) patients were receiving an opioid agonist at the start of antiviral therapy. Only 11 subjects (2.1%) did not show an SVR12. A significant correlation was found between treatment with opioid substitution therapy (p < 0.001), Human Immunodeficiency Virus (HIV) coinfection (p = 0.002), and treatment with first- or second-generation regimens (p = 0.0015) and HCV failure. Upon multivariate analysis, treatment with a first- or second-generation DAA was the only factor independently associated with failure (OR 10.4, 95% CI: 1.43 to 76.1, p = 0.02). Conclusions: Treatment with DAAs led to a high SVR12 rate (97.9%) in a large cohort of HCV-infected PWID. The only predictor of viral failure found in our analysis was treatment with first- and second-generation DAA.

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Paritaprevir, ritonavir, ombitasvir, and dasabuvir with and without ribavirin in people with HCV genotype 1 and recent injecting drug use or receiving opioid substitution therapy

Cited by 22 publications

References 41 publications

Model of Care for Microelimination of Hepatitis C Virus Infection among People Who Inject Drugs

Model of Care for Microelimination of Hepatitis C Virus Infection among People Who Inject Drugs

Efficacy and safety of ledipasvir/sofosbuvir for hepatitis C among drug users: a systematic review and meta-analysis

Directly Acting Antiviral-Based Treatment for HCV-Infected Persons Who Inject Drugs: A Multicenter Real-Life Study

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