10 results on '"International Network on Hepatitis in Substance Users"'
Search Results
2. Restrictions for reimbursement of interferon-free direct-acting antiviral drugs for HCV infection in Europe
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Marshall, Alison D., Cunningham, Evan B., Nielsen, Stine, Aghemo, Alessio, Alho, Hannu, Backmund, Markus, Bruggmann, Philip, Dalgard, Olav, Seguin-Devaux, Carole, Flisiak, Robert, Foster, Graham R., Gheorghe, Liana, Goldberg, David, Goulis, Ioannis, Hickman, Matthew, Hoffmann, Patrick, Jancorienė, Ligita, Jarcuska, Peter, Kåberg, Martin, Kostrikis, Leondios G., Makara, Mihály, Maimets, Matti, Marinho, Rui Tato, Matičič, Mojca, Norris, Suzanne, Ólafsson, Sigurður, Øvrehus, Anne, Pawlotsky, Jean-Michel, Pocock, James, Robaeys, Geert, Roncero, Carlos, Simonova, Marieta, Sperl, Jan, Tait, Michele, Tolmane, Ieva, Tomaselli, Stefan, van der Valk, Marc, Vince, Adriana, Dore, Gregory J., Lazarus, Jeffrey V., Grebely, Jason, International Network on Hepatitis in Substance Users (INHSU), Kostrikis, Leondios G. [0000-0002-5340-7109], Infectious diseases, AII - Infectious diseases, AII - Amsterdam institute for Infection and Immunity, APH - Digital Health, APH - Personalized Medicine, and APH - Global Health
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hepatitis C virus ,HIV Infections ,chemistry.chemical_compound ,0302 clinical medicine ,Antiviral Agents/economics ,HIV-HCV co-infection ,030212 general & internal medicine ,Reimbursement ,liver fibrosis ,media_common ,Dasabuvir ,Coinfection ,Health Policy ,Gastroenterology ,Hepatitis C ,3. Good health ,Europe ,Hepatitis C, Chronic/complications ,Insurance, Health, Reimbursement ,030211 gastroenterology & hepatology ,Switzerland ,medicine.drug ,medicine.medical_specialty ,HIV Infections/complications ,Antiviral Agents ,Drug Costs ,03 medical and health sciences ,hepatitis C treatment ,medicine ,Humans ,media_common.cataloged_instance ,European Union ,European union ,PWID ,Intensive care medicine ,Hepatitis ,direct-acting antiviral ,Hepatology ,business.industry ,Hepatitis C, Chronic ,alcohol use ,medicine.disease ,reimbursement ,Virology ,Ombitasvir ,chemistry ,Paritaprevir ,Ritonavir ,business ,treatment restrictions - Abstract
All-oral direct-acting antiviral drugs (DAAs) for hepatitis C virus, which have response rates of 95% or more, represent a major clinical advance. However, the high list price of DAAs has led many governments to restrict their reimbursement. We reviewed the availability of, and national criteria for, interferon-free DAA reimbursement among countries in the European Union and European Economic Area, and Switzerland. Reimbursement documentation was reviewed between Nov 18, 2016, and Aug 1, 2017. Primary outcomes were fibrosis stage, drug or alcohol use, prescriber type, and HIV co-infection restrictions. Among the 35 European countries and jurisdictions included, the most commonly reimbursed DAA was ombitasvir, paritaprevir, and ritonavir, with dasabuvir, and with or without ribavirin (33 [94%] countries and jurisdictions). 16 (46%) countries and jurisdictions required patients to have fibrosis at stage F2 or higher, 29 (83%) had no listed restrictions based on drug or alcohol use, 33 (94%) required a specialist prescriber, and 34 (97%) had no additional restrictions for people co-infected with HIV and hepatitis C virus. These findings have implications for meeting WHO targets, with evidence of some countries not following the 2016 hepatitis C virus treatment guidelines by the European Association for the Study of Liver. 3 2 125 133
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- 2018
3. Elimination of hepatitis C virus infection among PWID: The beginning of a new era of interferon-free DAA therapy
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Grebely, Jason, Bruneau, Julie, Bruggmann, Philip, Harris, Magdalena, Hickman, Matthew, Rhodes, Tim, Treloar, Carla, and International Network on Hepatitis in Substance Users
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- 2017
4. Elimination of hepatitis C virus infection among people who use drugs: Ensuring equitable access to prevention, treatment, and care for all.
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Grebely, Jason, Hajarizadeh, Behzad, Lazarus, Jeffrey V., Bruneau, Julie, Treloar, Carla, and International Network on Hepatitis in Substance Users
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HEPATITIS C treatment , *ANTIVIRAL agents , *MEDICAL care , *MIDDLE-income countries - Abstract
There have been major strides towards the World Health Organization goal to eliminate hepatitis C virus (HCV) infection as a global public health threat. The availability of simple, well-tolerated direct-acting antiviral therapies for HCV infection that can achieve a cure in >95% of people has provided an important tool to help achieve the global elimination targets. Encouragingly, therapy is highly effective among people receiving opioid agonist therapy and people who have recently injected drugs. Moving forward, major challenges include ensuring that new infections are prevented from occurring and that people who are living with HCV are tested, linked to care, treated, receive appropriate follow-up, and have equitable access to care. This editorial highlights key themes and articles in a special issue focusing on the elimination of HCV among people who inject drugs. An overarching consideration flowing from this work is how to ensure equitable access to HCV treatment and care for all. This special issue maps the field in relation to: HCV prevention; the cascade of HCV care; strategies to enhance testing, linkage to care, and treatment uptake; and HCV treatment and reinfection. In addition, papers draw attention to the 'risk environments' and socio-ecological determinants of HCV acquisition, barriers to HCV care, the importance of messaging around the side-effects of new direct-acting antiviral therapies, the positive transformative potential of treatment and cure, and the key role of community-based drug user organizations in the HCV response. While this special issue highlights some successful efforts towards HCV elimination among people who inject drugs, it also highlights the relative lack of attention to settings in which resources enabling elimination are scarce, and where elimination hopes and potentials are less clear, such as in many low and middle income countries. Strengthening capacity in areas of the world where resources are more limited will be a critical step towards ensuring equity for all so that global HCV elimination among PWID can be achieved. [ABSTRACT FROM AUTHOR]
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- 2019
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5. Expanding access to prevention, care and treatment for hepatitis C virus infection among people who inject drugs.
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Grebely, Jason, Bruggmann, Philip, Treloar, Carla, Byrne, Jude, Rhodes, Tim, Dore, Gregory J., and International Network for Hepatitis in Substance Users
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HEPATITIS C prevention , *HEPATITIS C treatment , *FLAVIVIRUSES , *HEPATITIS viruses , *HEPATITIS , *INTRAVENOUS drug abusers , *INTRAVENOUS drug abuse , *HEALTH services accessibility , *HEPATITIS C , *COMORBIDITY , *DISEASE complications - Published
- 2015
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6. Strategies for achieving universal access to hepatitis C virus prevention and care for people who inject drugs.
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Grebely, Jason, Bruggmann, Philip, Treloar, Carla, Byrne, Jude, Rhodes, Tim, Dore, Gregory J., and International Network for Hepatitis in Substance Users
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HEPATITIS C , *CARCINOGENS , *PREVENTIVE medicine , *PREVENTIVE health services , *DRUG legalization , *PHARMACOPOEIAS , *HEPATITIS C prevention , *INTRAVENOUS drug abuse , *HEALTH services accessibility , *HEPATITIS viruses , *MEDICAL protocols , *DISEASE complications ,DEVELOPING countries - Published
- 2015
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7. Sofosbuvir and velpatasvir for hepatitis C virus infection in people with recent injection drug use (SIMPLIFY): an open-label, single-arm, phase 4, multicentre trial.
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Grebely J, Dalgard O, Conway B, Cunningham EB, Bruggmann P, Hajarizadeh B, Amin J, Bruneau J, Hellard M, Litwin AH, Marks P, Quiene S, Siriragavan S, Applegate TL, Swan T, Byrne J, Lacalamita M, Dunlop A, Matthews GV, Powis J, Shaw D, Thurnheer MC, Weltman M, Kronborg I, Cooper C, Feld JJ, Fraser C, Dillon JF, Read P, Gane E, and Dore GJ
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- Administration, Oral, Adult, Antiviral Agents adverse effects, Carbamates adverse effects, Drug Administration Schedule, Drug Packaging, Female, Genotype, Hepacivirus genetics, Hepatitis C, Chronic virology, Heterocyclic Compounds, 4 or More Rings adverse effects, Humans, Male, Medication Adherence, Middle Aged, Recurrence, Risk Factors, Sofosbuvir adverse effects, Sustained Virologic Response, Antiviral Agents therapeutic use, Carbamates therapeutic use, Hepatitis C, Chronic complications, Hepatitis C, Chronic drug therapy, Heterocyclic Compounds, 4 or More Rings therapeutic use, Sofosbuvir therapeutic use, Substance Abuse, Intravenous complications
- Abstract
Background: Despite revised guidelines that no longer exclude people who inject drugs (PWID) from treatment for hepatitis C virus (HCV) infection, many clinicians are reluctant to treat recent PWID. This study aimed to evaluate the efficacy of sofosbuvir and velpatasvir therapy in people with chronic HCV infection and recent injection drug use., Methods: In this open-label, single-arm phase 4 trial (SIMPLIFY), we recruited participants with recent injection drug use (past 6 months) and chronic HCV genotype 1-6 infection from seven countries (19 sites). Participants received oral sofosbuvir (400 mg) and velpatasvir (100 mg) once daily for 12 weeks. Therapy was given in 1-week electronic blister packs to record the time and date of each dose. The primary endpoint was the proportion of patients with sustained virological response 12 weeks after completion of treatment (SVR12; defined as HCV RNA <12 IU/mL), analysed in all patients who received at least one dose. This study is registered with ClinicalTrials.gov, number NCT02336139, and follow-up is ongoing to evaluate the secondary endpoint of HCV reinfection., Findings: Between March 29, and Oct 31, 2016, we enrolled 103 participants; 29 (28%) of whom were female, nine (9%) had cirrhosis, 36 (35%) had HCV genotype 1, five (5%) had genotype 2, 60 (58%) had genotype 3, and two (2%) had genotype 4. 61 (59%) participants were receiving opioid substitution therapy during the study, 76 (74%) injected in the past month, and 27 (26%) injected at least daily in the past month. 100 (97%) of 103 participants completed treatment; two people were lost to follow-up and one person died from an overdose. There were no virological failures. 97 (94%, 95% CI 88-98) of 103 people achieved SVR12. Three participants with an end-of-treatment response did not have a SVR; two were lost to follow-up and one had reinfection. Drug use before and during treatment did not affect SVR12. Treatment-related adverse events were seen in 48 (47%) patients (one grade 3, no grade 4). Seven (7%) patients had at least one serious adverse event; only one such event (rhabdomyolysis, resolved) was possibly related to the therapy. One case of HCV reinfection was observed., Interpretation: HCV treatment should be offered to PWID, irrespective of ongoing drug use. Recent injection drug use should not be used as a reason to withhold reimbursement of HCV therapy., Funding: Gilead Sciences., (Copyright © 2018 Elsevier Ltd. All rights reserved.)
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- 2018
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8. Efficacy of response-guided directly observed pegylated interferon and self-administered ribavirin for people who inject drugs with hepatitis C virus genotype 2/3 infection: The ACTIVATE study.
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Grebely J, Dalgard O, Cunningham EB, Hajarizadeh B, Foster GR, Bruggmann P, Conway B, Backmund M, Robaeys G, Swan T, Amin J, Marks PS, Quiene S, Applegate TL, Weltman M, Shaw D, Dunlop A, Hellard M, Bruneau J, Midgard H, Bourgeois S, Staehelin C, and Dore GJ
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- Adult, Antiviral Agents administration & dosage, Antiviral Agents therapeutic use, Drug Therapy, Combination, Drug Users, Female, Genotype, Hepatitis C, Chronic virology, Humans, Interferon alpha-2, Interferon-alpha administration & dosage, Male, Middle Aged, Opiate Substitution Treatment, Polyethylene Glycols administration & dosage, Recombinant Proteins administration & dosage, Recombinant Proteins therapeutic use, Ribavirin administration & dosage, Self Administration, Substance Abuse, Intravenous virology, Viral Load drug effects, Hepacivirus genetics, Hepatitis C, Chronic complications, Hepatitis C, Chronic drug therapy, Interferon-alpha therapeutic use, Polyethylene Glycols therapeutic use, Ribavirin therapeutic use, Substance Abuse, Intravenous complications
- Abstract
Background: There are few data on treatment for hepatitis C virus (HCV) infection among people with ongoing injecting drug use. This study evaluated the efficacy of response-guided therapy for chronic HCV genotypes 2/3 infection among people with ongoing injecting drug use or receiving opioid substitution therapy (OST). A secondary aim was to identify predictors of HCV treatment response., Methods: ACTIVATE was a multicentre clinical trial recruited between 2012 and 2014. Participants with genotypes 2/3 were treated with directly observed peg-interferon alfa-2b and self-administered ribavirin for 12 (undetectable HCV RNA at week 4) or 24 weeks (detectable HCV RNA at week 4). Participants were recruited from drug treatment clinics, private practices, hospital clinics and community clinics in Australia, Canada, and five countries in Europe. The primary study outcome was sustained virological response (SVR, undetectable HCV RNA >12 weeks post-treatment)., Results: Among 93 people with ongoing injecting drug use or receiving OST treated for HCV genotype 2/3, 59% had recently (past month) injected drugs, 77% were receiving OST and 56% injected drugs during therapy. Overall SVR was 66% (61/93). SVR was 84% in those with undetectable HCV RNA at week 4 (12 weeks) compared to 38% in those without (24 weeks). In adjusted analysis, cirrhosis vs. no/mild fibrosis [adjusted OR (aOR) 0.33, 95% CI 0.13, 0.86] predicted reduced SVR, while response at week 4 was associated with increased SVR [aOR 8.11, 95% CI 2.73, 24.10]. Recent injecting drug use at baseline or during therapy was not associated with SVR., Conclusion: This study demonstrates that people with recent injecting drug use or OST with chronic HCV can achieve responses to interferon-based therapy similar to other populations, despite injecting drugs prior to or during therapy. Cirrhosis was predictive of reduced response to HCV therapy, while response at week 4 (despite shortened therapy) was predictive of improved response., (Copyright © 2017 Elsevier B.V. All rights reserved.)
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- 2017
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9. Elimination of HCV as a public health concern among people who inject drugs by 2030 - What will it take to get there?
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Grebely J, Dore GJ, Morin S, Rockstroh JK, and Klein MB
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- Government Programs, Harm Reduction, Hepatitis C epidemiology, Hepatitis C etiology, Humans, Incidence, Opiate Substitution Treatment, Public Health, Substance Abuse, Intravenous drug therapy, Disease Eradication, Hepatitis C prevention & control, Substance Abuse, Intravenous complications
- Abstract
Introduction: Globally, there is a considerable burden of HCV and HIV infections among people who inject drugs (PWID) and transmission of both infections continues. Needle and syringe programme (NSP) and opioid substitution therapy (OST) coverage remains low, despite evidence demonstrating their prevention benefit. Direct-acting antiviral therapies (DAA) with HCV cure >95% among PWID provide an opportunity to reverse rising trends in HCV-related morbidity and mortality and reduce incidence. However, HCV testing, linkage to care, and treatment remain low due to health system, provider, societal, and patient barriers. Between 2015 and 2030, WHO targets include reducing new HCV infections by 80% and HCV deaths by 65%, and increasing HCV diagnoses from <5% to 90% and number of eligible persons receiving HCV treatment from <1% to 80%. This commentary discusses why PWID should be considered as a priority population in these efforts, reasons why this goal could be attainable among PWID, challenges that need to be overcome, and key recommendations for action., Discussion: Challenges to HCV elimination as a global health concern among PWID include poor global coverage of harm reduction services, restrictive drug policies and criminalization of drug use, poor access to health services, low HCV testing, linkage to care and treatment, restrictions for accessing DAA therapy, and the lack of national strategies and government investment to support WHO elimination goals. Key recommendations for action include reforming drug policies (decriminalization of drug use and/or possession, or providing alternatives to imprisonment for PWID; decriminalization of the use and provision of sterile needles-syringes; and legalization of OST for people who are opioid dependent), scaling up and improving funding for harm reduction services, making health services accessible for PWID, supporting community empowerment and community-based programmes, improving access to affordable diagnostics and medicines, and eliminating stigma, discrimination, and violence against PWID., Conclusions: The ambitious targets for HCV elimination set by WHO are achievable in many countries, but will require researchers, healthcare providers, policy makers, affected communities, advocates, the pharmaceutical and diagnostics industries, and governments around the world to work together to make this happen., Competing Interests: JG is a consultant/advisor and has received research grants from Abbvie, Cepheid, Bristol Myers Squibb, Gilead Sciences and Merck/MSD. GD is a consultant/advisor and has received research grants from Abbvie, Bristol Myers Squibb, Gilead, Merck, Janssen and Roche. JKR has received honoraria for consulting or speaking at educational events from Abbott, Abbvie, Bionor, BMS, Cipla, Gilead, Janssen, Merck and ViiV. MBK received research grants for investigator initiated trials from Merck and ViiV Healthcare; consulting fees from ViiV Healthcare, Bristol-Meyers Squibb, Merck, Gilead and AbbVie.
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- 2017
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10. Contradictory advice for people who inject drugs in the 2016 EASL Recommendations on Treatment of Hepatitis C.
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Grebely J, Swan T, Hickman M, Bruneau J, Bruggmann P, Dalgard O, Litwin A, Backmund M, and Dore GJ
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- Hepacivirus, Humans, Hepatitis C, Substance Abuse, Intravenous
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- 2017
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