Integrated, Co-located, Telemedicine-based Treatment Approaches for Hepatitis C Virus Management in Opioid Use Disorder Patients on Methadone

2018 ◽  
Vol 69 (2) ◽  
pp. 323-331 ◽  
Author(s):  
Andrew H Talal ◽  
Phyllis Andrews ◽  
Anthony Mcleod ◽  
Yang Chen ◽  
Clewert Sylvester ◽  
...  
Keyword(s):  
Hepatitis C Virus ◽  
Hepatitis C ◽  
Multiple Correspondence Analysis ◽  
Opioid Use Disorder ◽  
Hcv Rna ◽  
Directly Observed Therapy ◽  
Opioid Use ◽  
Hcv Treatment ◽  
Opioid Substitution Therapy ◽  
Direct Acting

Abstract Background Despite high hepatitis C virus (HCV) prevalence, opioid use disorder (OUD) patients on methadone rarely engage in HCV treatment. We investigated the effectiveness of HCV management via telemedicine in an opioid substitution therapy (OST) program. Methods OUD patients on methadone underwent biweekly telemedicine sessions between a hepatologist and physician assistant during the entire HCV treatment course. All pretreatment labs (HCV RNA, genotype, and noninvasive fibrosis assessments) were obtained onsite and direct-acting antivirals were coadministered with methadone using modified directly observed therapy. We used multiple correspondence analysis, least absolute shrinkage and selection operator, and logistic regression to identify variables associated with pursuit of HCV care. Results Sixty-two HCV RNA–positive patients (24% human immunodeficiency virus [HIV] infected, 61% male, 61% African American, 25.8% Hispanic) were evaluated. All patients were stabilized on methadone and all except 4 were HCV genotype 1 infected. Advanced fibrosis/cirrhosis was present in 34.5% of patients. Of the 45 treated patients, 42 (93.3%) achieved viral eradication. Of 17 evaluated patients who were not treated, 5 were discontinued from the drug treatment program or did not follow up after the evaluation, 2 had HIV adherence issues, and 10 had insurance authorization issues. Marriage and a mental health diagnosis other than depression were the strongest positive predictors of treatment pursuit, whereas being divorced, separated, or widowed was the strongest negative predictor. Conclusions HCV management via telemedicine integrated into an OST program is a feasible model with excellent virologic effectiveness. Psychosocial and demographic variables can assist in identification of subgroups with a propensity or aversion to pursue HCV treatment.

scholarly journals Efficacy and Safety of Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir With or Without Ribavirin in Patients With Chronic Hepatitis C Virus Genotype 1 Infection Receiving Opioid Substitution Therapy: A Post Hoc Analysis of 12 Clinical Trials

2018 ◽  
Vol 5 (11) ◽  
Author(s):  
Jason Grebely ◽  
Massimo Puoti ◽  
Heiner Wedemeyer ◽  
Curtis Cooper ◽  
Mark S Sulkowski ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Hepatitis C ◽  
Treatment Adherence ◽  
Efficacy And Safety ◽  
Substitution Therapy ◽  
Hcv Treatment ◽  
Opioid Substitution Therapy ◽  
Direct Acting Antiviral ◽  
Direct Acting ◽  
Opioid Substitution

Abstract Background We evaluated the impact of opioid substitution therapy (OST) on the completion, adherence, efficacy, and safety of the 3-direct-acting antiviral regimen of ombitasvir, paritaprevir (identified by AbbVie and Enanta) co-dosed with ritonavir, and dasabuvir ± ribavirin among patients infected with hepatitis C virus (HCV) genotype (GT) 1, with or without compensated cirrhosis. Methods Data were pooled from GT1-infected patients enrolled in 12 phase II/III/IIIb clinical trials and categorized by use of OST. Patients with ongoing drug use were excluded. HCV treatment completion, treatment adherence (≥90%), sustained virologic response at post-treatment week 12 (SVR12), and adverse events were assessed. Results Of 4747 patients, 3% (n = 149) received OST. Among patients receiving OST vs those not receiving OST, 82% (n = 122) vs 52% (n = 2409) had GT1a infection; 76% (n = 113) vs 61% (n = 2792) were treatment naïve; and 17% (n = 25) vs 18% (n = 830) had cirrhosis, respectively. The proportion of patients completing HCV treatment did not differ between those receiving and not receiving OST (97% [n = 144] vs 98% [n = 4510], respectively), whereas adherence to treatment was reduced in patients receiving vs those not receiving OST (88% [n = 105] vs 97% [n = 4057], respectively). SVR12 was similar between patients receiving and not receiving OST (94% [n = 140] vs 96% [n = 4405], respectively; P = .273). Treatment was well tolerated. Conclusions Although treatment adherence was lower in patients receiving OST vs those not receiving OST, treatment completion and SVR12 were similar between groups. These data support the use of direct-acting antiviral therapies in patients receiving OST.

scholarly journals Hepatitis C Virus Treatment Access Among Human Immunodeficiency Virus and Hepatitis C Virus (HCV)-Coinfected People Who Inject Drugs in Guangzhou, China: Implications for HCV Treatment Expansion

2016 ◽  
Vol 3 (2) ◽  
Author(s):  
Carissa E. Chu ◽  
Feng Wu ◽  
Xi He ◽  
Kali Zhou ◽  
Yu Cheng ◽  
...  
Keyword(s):  
Hepatitis C Virus ◽  
Hepatitis C ◽  
Social Workers ◽  
People Who Inject Drugs ◽  
Hiv Treatment ◽  
Direct Acting Antivirals ◽  
Hcv Treatment ◽  
Treatment Access ◽  
Immunodeficiency Virus ◽  
Direct Acting

Abstract Background.  Hepatitis C virus (HCV) treatment access among human immunodeficiency virus (HIV)/HCV-coinfected people who inject drugs is poor, despite a high burden of disease in this population. Understanding barriers and facilitators to HCV treatment uptake is critical to the implementation of new direct-acting antivirals. Methods.  We conducted in-depth interviews with patients, physicians, and social workers at an HIV treatment facility and methadone maintenance treatment centers in Guangzhou, China to identify barriers and facilitators to HCV treatment. We included patients who were in various stages of HCV treatment and those who were not treated. We used standard qualitative methods and organized data into themes. Results.  Interview data from 29 patients, 8 physicians, and 3 social workers were analyzed. Facilitators and barriers were organized according to a modified Consolidated Framework for Implementation Research schematic. Facilitators included patient trust in physicians, hope for a cure, peer networks, and social support. Barriers included ongoing drug use, low HCV disease knowledge, fragmented reimbursement systems, HIV exceptionalism, and stigma. Conclusions.  Expanding existing harm reduction programs, HIV treatment programs, and social services may facilitate scale-up of direct-acting antivirals globally. Improving integration of ancillary social and mental health services within existing HIV care systems may facilitate HCV treatment access.

scholarly journals Cross-Genotypic Examination of Hepatitis C Virus Polymerase Inhibitors Reveals a Novel Mechanism of Action for Thumb Binders

2014 ◽  
Vol 58 (12) ◽  
pp. 7215-7224 ◽  
Author(s):  
Auda A. Eltahla ◽  
Enoch Tay ◽  
Mark W. Douglas ◽  
Peter A. White
Keyword(s):  
Hepatitis C Virus ◽  
Hepatitis C ◽  
De Novo ◽  
Hcv Rna ◽  
Amino Acid Residues ◽  
Recombinant Enzymes ◽  
Polymerase Inhibitors ◽  
Binding Pockets ◽  
Direct Acting

ABSTRACTDirect-acting antivirals (DAAs) targeting proteins encoded by the hepatitis C virus (HCV) genome have great potential for the treatment of HCV infections. However, the efficacy of DAAs designed to target genotype 1 (G1) HCV against non-G1 viruses has not been characterized fully. In this study, we investigated the inhibitory activities of nonnucleoside inhibitors (NNIs) against the HCV RNA-dependent RNA polymerase (RdRp). We examined the ability of six NNIs to inhibit G1b, G2a, and G3a subgenomic replicons in cell culture, as well asin vitrotranscription by G1b and G3a recombinant RdRps. Of the six G1 NNIs, only the palm II binder nesbuvir demonstrated activity against G1, G2, and G3 HCV, in both replicon and recombinant enzyme models. The thumb I binder JTK-109 also inhibited G1b and G3a replicons and recombinant enzymes but was 41-fold less active against the G2a replicon. The four other NNIs, which included a palm I binder (setrobuvir), two thumb II binders (lomibuvir and filibuvir), and a palm β-hairpin binder (tegobuvir), all showed at least 40-fold decreases in potency against G2a and G3a replicons and the G3a enzyme. This antiviral resistance was largely conferred by naturally occurring amino acid residues in the G2a and G3a RdRps that are associated with G1 resistance. Lomibuvir and filibuvir (thumb II binders) inhibited primer-dependent but notde novoactivity of the G1b polymerase. Surprisingly, these compounds instead specifically enhanced thede novoactivity at concentrations of ≥100 nM. These findings highlight a potential differential mode of RdRp inhibition for HCV NNIs, depending on their prospective binding pockets, and also demonstrate a surprising enhancement ofde novoactivity for thumb RdRp binders. These results also provide a better understanding of the antiviral coverage for these polymerase inhibitors, which will likely be used in future combinational interferon-free therapies.

scholarly journals Predicting Treatment Failure for Initiators of Hepatitis C Virus Treatment in the era of Direct-Acting Antiviral Therapy

2020 ◽  
Vol 11 ◽  
Author(s):  
Nadia A. Nabulsi ◽  
Michelle T. Martin ◽  
Lisa K. Sharp ◽  
David E. Koren ◽  
Robyn Teply ◽  
...  
Keyword(s):  
Hepatitis C Virus ◽  
Hepatitis C ◽  
Treatment Failure ◽  
Antiviral Therapy ◽  
Characteristic Curve ◽  
Predictive Ability ◽  
Predictive Performance ◽  
Hcv Treatment ◽  
Direct Acting Antiviral ◽  
Direct Acting

Introduction: Hepatitis C virus (HCV), the leading cause of advanced liver disease, has enormous economic burden. Identification of patients at risk of treatment failure could lead to interventions that improve cure rates.Objectives: Our goal was to develop and evaluate a prediction model for HCV treatment failure.Methods: We analyzed HCV patients initiating direct-acting antiviral therapy at four United States institutions. Treatment failure was determined by lack of sustained virologic response (SVR) 12 weeks after treatment completion. From 20 patient-level variables collected before treatment initiation, we identified a subset associated with treatment failure in bivariate analyses. In a derivation set, separate predictive models were developed from 100 bootstrap samples using logistic regression. From the 100 models, variables were ranked by frequency of selection as predictors to create four final candidate models, using cutoffs of ≥80%, ≥50%, ≥40%, and all variables. In a validation set, predictive performance was compared across models using area under the receiver operating characteristic curve.Results: In 1,253 HCV patients, overall SVR rate was 86.1% (95% CI = 84.1%, 88.0%). The AUCs of the four final candidate models were: ≥80% = 0.576; ≥50% = 0.605; ≥40% = 0.684; all = 0.681. The best performing model (≥40%) had significantly better predictive ability than the ≥50% (p = 0.03) and ≥80% models (p = 0.02). Strongest predictors of treatment failure were older age, history of hepatocellular carcinoma, and private (vs. government) insurance.Conclusion: This study highlighted baseline factors associated with HCV treatment failure. Treatment failure prediction may facilitate development of data-driven clinical tools to identify patients who would benefit from interventions to improve SVR rates.

scholarly journals Successful Treatment of Hepatitis C Virus by Ledipasvir/Sofosbuvir in a Cirrhotic Patient with Sickle Cell Disease and Thalassemia Minor

2018 ◽  
Vol 12 (3) ◽  
pp. 629-632 ◽  
Author(s):  
Hassan Al Moussawi ◽  
Abhishek D. Polavarapu ◽  
Divya Asti ◽  
Zainab Awada ◽  
Stephen  Mulrooney
Keyword(s):  
Hepatitis C Virus ◽  
Hepatitis C ◽  
Sickle Cell Disease ◽  
Sickle Cell ◽  
Cirrhotic Patient ◽  
Cell Disease ◽  
Hcv Treatment ◽  
Direct Acting Antiviral ◽  
Thalassemia Minor ◽  
Direct Acting

Around 8% of patients diagnosed with sickle cell disease (SCD) are hepatitis C virus (HCV) carriers. Previously, HCV treatment was seldom considered in SCD patients, as the ribavirin-induced hemolysis and interferon-induced cytopenias could lead to more profound anemia. Nowadays, several oral direct-acting antiviral drugs have been developed and approved by the FDA for hepatitis C treatment. While direct-acting antivirals mitigate many of these risks, their safety and efficacy in SCD patients remains insufficiently explored. Here, we report on successfully treating HCV with ledipasvir/sofosbuvir in a compensated cirrhotic patient with SCD and thalassemia minor.

Amino acid substitutions in the hepatitis C virus core region predict hepatocarcinogenesis following eradication of HCV RNA by all-oral direct-acting antiviral regimens

2018 ◽  
Vol 90 (6) ◽  
pp. 1087-1093 ◽  
Author(s):  
Fumihiro Ogata ◽  
Norio Akuta ◽  
Masahiro Kobayashi ◽  
Shunichiro Fujiyama ◽  
Yusuke Kawamura ◽  
...  
Keyword(s):  
Hepatitis C Virus ◽  
Hepatitis C ◽  
Amino Acid ◽  
Core Region ◽  
Hcv Rna ◽  
Amino Acid Substitutions ◽  
Direct Acting Antiviral ◽  
Virus Core ◽  
Direct Acting

scholarly journals Treatment as prevention for hepatitis C virus in Pakistan: mathematical modelling projections

BMJ Open ◽  
2019 ◽  
Vol 9 (5) ◽  
pp. e026600 ◽  
Author(s):  
Houssein H Ayoub ◽  
Laith J Abu-Raddad
Keyword(s):  
Hepatitis C Virus ◽  
Hepatitis C ◽  
Incidence Rate ◽  
Treatment As Prevention ◽  
Treatment Programme ◽  
Annual Incidence Rate ◽  
Rate Reduction ◽  
Hcv Treatment ◽  
Age Structured ◽  
Direct Acting

ObjectiveDirect-acting antivirals have opened an opportunity for controlling hepatitis C virus (HCV) infection in Pakistan, where 10% of the global infection burden is found. We aimed to evaluate the implications of five treatment programme scenarios for HCV treatment as prevention (HCV-TasP) in Pakistan.DesignAn age-structured mathematical model was used to evaluate programme impact using epidemiological and programme indicators.SettingTotal Pakistan population.ParticipantsTotal Pakistan HCV-infected population.InterventionsHCV treatment programme scenarios from 2018 up to 2030.ResultsBy 2030 across the five HCV-TasP scenarios, 0.6–7.3 million treatments were administered, treatment coverage reached between 3.7% and 98.7%, prevalence of chronic infection reached 2.4%–0.03%, incidence reduction ranged between 41% and 99%, program-attributed reduction in incidence rate ranged between 7.2% and 98.5% and number of averted infections ranged between 126 221 and 750 547. Annual incidence rate reduction in the first decade of the programme was around 6%–18%. Number of treatments needed to prevent one new infection ranged between 4.7–9.8, at a drug cost of about US$900. Cost of the programme by 2030, in the most ambitious elimination scenario, reached US$708 million. Stipulated WHO target for 2030 cannot be accomplished without scaling up treatment to 490 000 per year, and maintaining it for a decade.ConclusionHCV-TasP is a highly impactful and potent approach to control Pakistan’s HCV epidemic and achieve elimination by 2030.

scholarly journals Hepatitis C Treatment Among People Who Use Drugs in an Office-Based Opioid Treatment Program Versus a Syringe Exchange Program: A Real-World Prospective Clinical Trial

2021 ◽  
Vol 21 (8) ◽  
Author(s):  
Andrew Seaman ◽  
Wren Ronan ◽  
Lauren Myers ◽  
Haven Wheelock ◽  
Melinda Butler ◽  
...  
Keyword(s):  
Hepatitis C ◽  
Treatment Outcomes ◽  
Real World ◽  
Treatment Completion ◽  
Opioid Use Disorder ◽  
People Who Use Drugs ◽  
Opioid Use ◽  
Hcv Treatment ◽  
Treatment Access ◽  
Open Label

Background: Hepatitis C Virus (HCV) treatment in people who inject drugs (PWID) is a key component of elimination models but PWID face substantial barriers to treatment access. Despite data showing treatment outcomes among PWID on medications for opioid use disorder (MOUD) are similar to non-PWID outcomes, few studies examine PWID treatment outcomes with only syringe services support. Objectives: To evaluate the effect of recruitment for HCV treatment with elbasvir/grazoprevir (E/G) in a syringe services program (SSP) as compared to an MOUD program for people with opioid use disorder. Methods: This real-world, multi-site prospective open-label pilot study compares treatment of PWID with aspartate aminotransferase to platelet ratio (APRI) < 0.7 and genotype 1a, 1b, and 4 HCV with E/G, engaged in MOUD (n = 25) or an SSP (n = 25). The MOUD arm was enrolled through a federally qualified community health center and SSP arm through a nearby SSP. Prospective arms were compared to an academic hepatology clinic group (n = 50). Sustained virologic response at 12 weeks (SVR12), medication adherence, and treatment discontinuation were evaluated. Results: In the MOUD vs SSP arms, substance use throughout treatment was found in 36% (9/25) vs 100% (25/25); good adherence (> 90% pills taken) in 100% (25/25) vs 68% (17/25); treatment completion 100% (25/25) vs 64% (16/25); and SVR12 rates were 96% (24/25) vs 60% (15/25). In the community standard comparison group, SVR12 was achieved in 94% (47/50). There were two virologic failures or re-infections in the SSP group; all other non-responders were due to missing SVR12 data. Conclusions: While recruitment and follow-up are challenging in SSPs, preliminary data suggests adherence, treatment completion, and SVR12 are high in PWID treated with E/G engaging in SSP or MOUD. All metrics are comparable to community standards for non-PWID for treatment of HCV with direct-antiviral drugs.

scholarly journals Crushing and Splitting Direct-Acting Antivirals for Hepatitis C Virus Treatment: A Case Series and Literature Review

2021 ◽  
Vol 8 (11) ◽  
Author(s):  
Kristen Whelchel ◽  
Autumn D Zuckerman ◽  
David E Koren ◽  
Caroline Derrick ◽  
Jeannette Bouchard ◽  
...  
Keyword(s):  
Hepatitis C Virus ◽  
Hepatitis C ◽  
Literature Review ◽  
Case Series ◽  
Direct Acting Antivirals ◽  
Limited Data ◽  
Hcv Treatment ◽  
Direct Acting

Abstract Limited data exist regarding the use of direct-acting antivirals (DAAs) for hepatitis C virus (HCV) in patients who are unable to swallow tablets. This case series describes HCV treatment in patients requiring tablet manipulation, providing evidence for safety and effectiveness of HCV DAA tablet manipulation.

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