On Opioid Substitution Therapy Research Articles

A Follow up Study Among Patients on Opioid Substitution Therapy (OST) in Terms of Relapse Rate, Factors Affecting Relapse Rate and HCV Incidence

Background: Many countries are facing a serious problem with opioid dependence. Opioid Substitution Therapy (OST) is prescribed to dependent opioid users to diminish the use and effects of illicitly acquired opioids. The high relapse rate has been affecting the effectiveness of anti-drug work all over the world.Material & Methods:In this study, 200 patients were taken by simple random sampling technique. 100 patient on Buprenorphine substitution therapy and 100 on Methadone maintenance treatment were studied. Patients diagnosed as cases of Opioid dependence as per ICD-10 were selected within the first 3 months and followed up to 1 year at 3, 6 and 9 months. The study was conducted after approval from the institutional ethics and thesis committee. A 14-item questionnaire based on a four-point scale describing the number of times certain events had occurred in the previous week for relapse was used to find factors affecting relapse.Results:The relapse rate among patients in the BPN group at 3, 6 and 9 months relapse was 29.33%, 20.34% and 19.51% while in the Methadone group, it was 24.05%, 15.87% and 12% respectively. The overall HCV Incidence was 75% among patients on Opioid Substitution Therapy. Conclusion:The findings of the study highlight the role of multiple determinants in opioid dependence and relapse. The obtained results showed that HCV infection was an alarming problem among IV opiate drug users in Punjab.

HCV spread among female incarcerated population and treatment pathways to viral elimination in Italian prison settings: clinical perspectives and medico legal aspects

BackgroundHepatitis C virus (HCV) infection is more frequent among incarcerated people than in general population. In the DAAs era, the short schedules and the low risk of adverse reactions, increased the number of HCV treatments. However, the most part of literature reports lack of incarcerated women inclusion in studies on field. Our aim is to assess the screening execution, HCV prevalence, and DAAs treatment among incarcerated women. A focused insight on quick vs standard diagnosis and staging approach will be also provided.MethodsIncarcerated women from 4 Italian regions’ penitentiary institutes were included. HCV screening was executed with HCV saliva test (QuickOral Test®) or phlebotomy. Stage of liver fibrosis was evaluated with FIB-4 value or fibroscan®, based on physicians’ decision. Treatment prescription followed national protocols.ResultsWe included 156 women, 89 (57%) were Italian, mean age was 41 ± 10 years, and 28 (17.9%) were people who inject drugs (PWIDs). Overall, the HCV seroprevalence was 20.5%. Being PWID and on opioid substitution therapy (OST) were significantly associated with serological status (p-value < 0.001). Of them, the 75.5% of patients had active infection, the most frequent genotype was 3a (50%). Among them, 4 (16.6%) and 6 (25%) had psychosis or alcohol abuse history. The 62.5%, 25% and 12.5% had low, intermediate, and advanced fibrosis, respectively. Out of the 24 HCV-RNA positive patients, the 75% underwent to DAAs treatment. The sustained virological response (SVR12) was achieved in 88.8% of cases. When evaluating the influence of quick diagnosis and staging methods vs standard phlebotomy and fibroscan® on SVR12, FIB-4 use showed higher performance for retainment in treatment during prison staying (p = 0.015), while the use of quick saliva test had no influence on the outcome (p = 0.22).ConclusionHCV seroprevalence and active infections are very high among incarcerated women. More tailored interventions should be focused on HCV diagnosis and treatment in female prison population. The use of quick staging methods (FIB-4) is useful to increase SVR12 achievement without delays caused by the fibroscan® awaiting.

Pharmacotherapy Profiles in People with Opioid Use Disorders: Considerations for Relevant Drug–Drug Interactions with Antiviral Treatments for Hepatitis C

People who inject drugs (PWID) are often affected by physical and psychological diseases and prone to co-medication. In Germany, about 50% of PWID are on opioid substitution therapy (OST). Comprehensive data on pharmacotherapy in these patients may help to select antiviral therapy against hepatitis C virus (HCV) infections and avoid drug–drug interactions (DDIs). We compared co-medication profiles based on statutory health insurance prescriptions (IQVIA database) of PWID (n = 16,693), OST (n = 95,023) and treated HCV patients (n = 7886). Potential DDIs with the most widely used HCV direct-acting agents (Sofosbuvir/Velpatasvir, Glecaprevir/Pibrentasvir and Elbasvir/Grazoprevir) were evaluated based on the Liverpool DDI database. Co-medication was present in 57% of PWID, 57% of OST, 44% of patients on HCV therapy and 46% in a subgroup receiving OST+HCV therapy (n = 747 of 1613). For all groups, co-medication belonging to ATC-class N (nervous system) was most commonly prescribed (in 75%, 68%, 41% and 62% of patients, respectively). Contraindications (i.e., DDIs precluding HCV therapy) were infrequent (0.4–2.5% of co-medications); potential DDIs with HCV therapies were shown for 13–19% of co-medications, namely for specific substances including some analgesics, antipsychotics, anticoagulants, lipid lowering drugs and steroids. In conclusion, concomitant pharmacotherapy is common and clinically relevant when treating HCV infection in PWID.

Sexual Dysfunction in Persons Receiving Opioid Substitution Therapy

In the context of a growing opioid epidemic, there is an increased focus on opioid substitution therapy (OST), administered in the forms of methadone maintenance therapy (MMT) and buprenorphine maintenance therapy (BMT). Awareness of the sexual side effects of OST appears to be lacking. Therefore, the goal of this review is to present the pathophysiology of OST and sexual dysfunction, analyze current literature regarding the prevalence of OST and sexual dysfunction, and critically compare MMT and BMT from a sexual medicine perspective. Compared to continued opioid use, OST may improve sexual function. However, there continues to be a high prevalence of sexual dysfunction among those on OST. Specifically, the current literature suggests an association between OST and erectile dysfunction (ED) and hypogonadism for both MMT and BMT. Compared to MMT, BMT appears to have less association with ED and hypogonadism, perhaps due to buprenorphine’s partial opioid receptor agonism mechanism of action. There are no guidelines incorporating sexual side effects as a factor when determining which OST to initiate for patients. Sexual dysfunction is highly prevalent among those on MMT and BMT. BMT is less associated with ED and hypogonadism compared to MMT. Sexual side effects should be discussed during shared decision-making with patients when choosing between MMT or BMT for initiating OST.

Treatment outcomes and costs of a simplified antiviral treatment strategy for hepatitis C among monoinfected and HIV and/or hepatitis B virus-co-infected patients in Myanmar.

Access to hepatitis C virus (HCV) testing and treatment is limited in Myanmar. We assessed an integrated HIV and viral hepatitis testing and HCV treatment strategy. Sofosbuvir/velpatasvir (SOF/VEL) ± weight‐based ribavirin for 12 weeks was provided at three treatment sites in Myanmar and sustained virologic response (SVR) assessed at 12 weeks after treatment. Participants co‐infected with HBV were treated concurrently with tenofovir. Cost estimates in 2018 USD were made at Yangon and Mandalay using standard micro‐costing methods.803 participants initiated SOF/VEL; 4.8% were lost to follow‐up. SVR was achieved in 680/803 (84.6%) by intention‐to‐treat analysis. SVR amongst people who inject drugs (PWID) was 79.7% (381/497), but 92.5% among PWID on opioid substitution therapy (OST) (74/80), and 97.4% among non‐PWID (298/306). Utilizing data from 492 participants, of whom 93% achieved SVR, the estimated average cost of treatment per patient initiated was $1030 (of which 54% were medication costs), with a production cost per successful outcome (SVR) of $1109 and real‐world estimate of $1250. High SVR rates were achieved for non‐PWID and PWID on OST. However, the estimated average cost of the intervention (under the assumption of no genotype testing and reduced real‐world effectiveness) of $1250/patient is unaffordable for a national elimination strategy. Reductions in the cost of antivirals and linkage to social and behavioural health services including substance use disorder treatment to increase retention and adherence to treatment are critical to HCV elimination in this population.

Opioid substitution therapy with buprenorphine-naloxone during COVID-19 outbreak in India: Sharing our experience and interim standard operating procedure.

Coronavirus disease 2019 (COVID-19) has been declared as a pandemic by the World Health Organization on March 11, 2020. It has affected most countries of the world, including India. Both the disease and the unavoidable national response to it have posed unique challenges to our health-care system. A particular vulnerable group of patients is those with opioid dependence maintained on opioid substitution therapy (OST). These patients are pharmacologically dependent on the OST medication (buprenorphine, buprenorphine-naloxone combination [BNX], and methadone) for their healthy functioning and recovery. COVID-19 outbreak, lock-down, and difficult access to medical care, all are likely to induce stress and withdrawal, which is a potential risk for relapse among individuals with opioid dependence, who are anyway more vulnerable due to social, housing, living, and medical conditions. In this context, it is essential to re-strategize the existing OST services to adapt to the challenging circumstances. In this communication, we share our experience and formulate interim standard operating procedures (SOPs) for running a hospital-based OST service utilizing take-home BNX. The challenges, principles to meet the challenges, and interim SOPs are shared as being currently practiced in our center. Individual institutes, agencies, hospitals, and clinics running OST service with BNX can adapt these SOPs according to their characteristics, needs, demand, and resources; so long as, the basic principles are adhered to.

Efficacy of Direct-acting Antivirals for Chronic Hepatitis C Virus Infection in People Who Inject Drugs or Receive Opioid Substitution Therapy: A Systematic Review and Meta-analysis.

Treatment uptake for hepatitis C virus (HCV) infection in people who inject drugs (PWID) and patients on opioid substitution therapy (OST) is still low despite treatment guidelines that advocate the use of direct-acting antivirals (DAAs) in all patients. Our aim in this review was to investigate treatment outcomes among PWID and patients on OST in comparison to control cohorts. A search of Embase, Medline, PubMed, and Web of Science (from October 2010 to March 2018) was conducted to assess sustained virologic response (SVR), discontinuation rates, adherence, and HCV reinfection in PWID and patients on OST. We identified 11 primary articles and 12 conference abstracts comprising 1702 patients on OST, 538 PWID, and 19 723 patients who served as controls. Among patients on OST, the pooled SVR was 90% (95% confidence interval [CI], 87% to 93%) and pooled treatment discontinuation rate was 7% (95% CI, 4% to 11%). Similarly, the pooled SVR was 88% (95% CI, 80% to 93%) in PWID and the pooled treatment discontinuation rate was 9% (95% CI, 5% to 15%). There was no significant difference regarding pooled rates of SVR, adherence, and discontinuation between patients on OST and controls as well as between PWID and controls. HCV reinfection rates among patients on OST ranged from 0.0 to 12.5 per 100 person-years. HCV treatment outcomes in PWID and patients on OST are similar to those in patients without a history of injecting drugs, supporting current guideline recommendations to treat HCV in these patient populations.

Safety and efficacy of glecaprevir/pibrentasvir in patients with chronic hepatitis C genotypes 1–6 receiving opioid substitution therapy

BackgroundInternational guidelines recommend treatment of hepatitis C virus (HCV) infection in people who inject drugs (PWID), including those on opioid substitution therapy (OST). The pangenotypic combination of glecaprevir and pibrentasvir has shown high sustained virologic response at post-treatment Week 12 (SVR12) in clinical trials. Herein, we evaluate the safety and efficacy of glecaprevir/pibrentasvir in patients receiving OST. MethodsPooled data from patients with HCV genotypes 1–6 who were treated with glecaprevir/pibrentasvir for 8, 12, or 16 weeks in eight Phase 2 and 3 trials were categorized by use of OST. Treatment completion, treatment adherence, SVR12, adverse events (AEs), and laboratory abnormalities were evaluated for patients receiving and not receiving OST. ResultsAmong 2256 patients, 157 (7%) were receiving OST. Compared with patients not receiving OST, OST patients were younger (mean age, 46.8 vs 52.8 years), male (69% vs 54%), white (93% vs 80%), HCV treatment-naïve (86% vs 72%), had HCV genotype 3 (60% vs 26%), and had a history of depression or bipolar disorder (43% vs 19%). Most patients completed (OST: 98% [n/N = 154/157]; non-OST: 99% [n/N = 2070/2099]) and were adherent (received ≥90% of study drug doses) to glecaprevir/pibrentasvir treatment (OST: 98% [n/N = 121/123]; non-OST: 99% [n/N = 1884/1905] among patients with available data). In the intention-to-treat population, SVR12 rates in OST and non-OST patients were 96.2% (n/N = 151/157; 95% CI 93.2–99.2) and 97.9% (n/N = 2055/2099; 95% CI 97.3–98.5), respectively. For OST patients, reasons for nonresponse included virologic relapse (<1%; n = 1), premature study drug discontinuation (<1%; n = 1), and loss to follow-up (3%; n = 4). AEs occurring in ≥10% of OST patients were headache, fatigue, and nausea. Drug-related serious AEs, AEs leading to study drug discontinuation, and Grade 3 or higher laboratory abnormalities were infrequent in both groups (<1%). No HCV reinfections occurred through post-treatment Week 12. ConclusionGlecaprevir/pibrentasvir is highly efficacious and well tolerated in HCV-infected patients receiving OST.

Alcohol and Cannabis Consumption Does Not Diminish Cure Rates in a Real-World Cohort of Chronic Hepatitis C Virus Infected Patients on Opioid Substitution Therapy-Data From the German Hepatitis C-Registry (DHC-R).

Background:The importance of alcohol and cannabis consumption for the effectiveness of treatment of chronic hepatitis C virus (HCV) infection with direct acting antivirals (DAAs) in people on opioid substitution therapy (OST) has not been investigated in detail.Methods:We investigated sustained virological response (SVR) rates and proportion of lost to follow-up (LTFU) between OST (n = 739) and non-OST patients (n = 7008) in the German Hepatitis C-Registry (Deutsches Hepatitis C-Register, DHC-R), which is a national multicenter prospective non-interventional real-world registry. Non-OST patients comprised patients with former/current drug use (non-OST/DU; n = 1500) and patients never consuming drugs (non-OST/NDU; n = 5508).Findings:SVR 12/24 rates (intention to treat [ITT]) in patients consuming no or less than 30 g/day (women) or 40 g/day (men) were significantly higher in non-OST/NDU (range 91%-92%) vs OST patients (range 83%-86%), mainly due to significantly higher LTFU rates in OST (range 11%-12%) compared with non-OST/NDU (range 2%-3%). In non-OST/NDU with high alcohol consumption of more than 30/40 g/day, SVR 12/24 rates (ITT) were lower (85%) but did not differ to OST (85%) with high alcohol consumption. No significant differences could be seen for SVR 12/24 in per-protocol (PP) analysis independent of alcohol consumption or amount of alcohol intake. Cannabis use did not significantly influence SVR 12/24 in ITT or PP or LTFU.Conclusions:High SVR rates could be achieved in both OST and non-OST patients irrespective of alcohol or cannabis consumption. However, LTFU is more likely in patients with current or former drug use than in patients without drug history and in patients with high alcohol consumption but occurred mainly after end of antiviral treatment (EOT), leaving a high chance for HCV elimination in these patients.

Asymptomatic Screening of Clients on Opioid Substitution Therapy for Tuberculosis: An Experience from India

Clients on Opioid Substitution Therapy (OST) may be at risk of TB. We screened for tuberculosis in asymptomatic OST clients using Chest-X-ray (CXR) and sputum from those with CXR suggestive of TB were tested using Xpert MTB/Rif. Among 472 who underwent CXR, 1% had CXR suggestive of TB. The number needed to screen was 118 clients for one CXR suggestive of TB. All four clients with CXR suggestive of TB underwent MTB/Rif assay and one was diagnosed with TB. The TB patient was asymptomatic and could have been missed through the passive approach. We recommend further studies to explore ACF among OST clients.

1981. Real-World Data on Safety and Effectiveness of Glecaprevir/Pibrentasvir for the Treatment of Patients With Chronic Hepatitis C Virus Infection on Opioid Substitution Therapy: Latest Results from the German Hepatitis C-Registry

BackgroundThe coformulated direct-acting antivirals glecaprevir/pibrentasvir (G/P) are approved to treat chronic hepatitis C virus (HCV) genotype 1–6 infection. In clinical trials, G/P demonstrated high efficacy, but real-world data in patients on opioid substitution therapy (OST), a population for which antiviral treatment is critical for HCV elimination, are limited. Here we report the first real-world data on the effectiveness and safety of G/P for OST patients within the German Hepatitis C-Registry (DHC-R).MethodsThe DHC-R is an ongoing, noninterventional, multicenter, prospective, monitored registry study. Data were collected between July 28, 2017 and February 9, 2018 from 104 sites in Germany. The analysis included adult HCV-infected patients who were treated with G/P according to the European Medicines Agency label. The primary endpoint was sustained virologic response at post-treatment week 12 (SVR12). Safety and tolerability were assessed in patients that completed treatment.ResultsAs of February 9, 2018, 638 patients had initiated on-label treatment with G/P and are included in the baseline analysis. Patients on OST comprised 26% (168/638) of the baseline population, of which most patients were treatment-naive, without cirrhosis and had HCV genotype 1a or 3. Among patients with available SVR12 data, 96% (27/28) of OST patients and 97% (66/68) of non-OST patients achieved SVR12. There were no virologic failures: of three early discontinuations, one OST patient was lost to follow-up and two non-OST patients discontinued treatment due to adverse events (AE). In the modified intention-to-treat population which excluded non-virologic failures, SVR12 was 100% for both OST and non-OST patients. The safety population included 321 patients in total. Among OST patients, 2% (2/84) experienced serious AEs (SAE) without any treatment discontinuations due to AE/SAE.ConclusionIn this real-world analysis, G/P treatment yielded favorable effectiveness and safety results in patients on OST. Updated data and SVR12 results will be presented.Disclosures J. Reimer, AbbVie, Bristol-Myers Squibb, Gilead, Janssen-Cilag, MSD: Board Member and Scientific Advisor, Educational grant and Speaker honorarium. A. Stoehr, AbbVie, Gilead, Janssen, MSD, ViiV: Consultant and Scientific Advisor, Consulting fee and Speaker honorarium. U. Naumann, AbbVie, Bristol-Myers Squibb, Gilead Sciences, Janssen, Mundipharma, MSD, Roche, ViiV: Board Member, Scientific Advisor and Speaker’s Bureau, Consulting fee and Speaker honorarium. G. Teuber,: AbbVie, BMS, Janssen, Gilead, MSD: Consultant and Scientific Advisor, Consulting fee and Speaker honorarium. C. Zamani, AbbVie Inc.: Board Member and Scientific Advisor, Consulting fee. S. Mauss, AbbVie, Gilead, Falk, Janssen, MSD: Scientific Advisor and Speaker’s Bureau, Consulting fee and Speaker honorarium. N. Qurishi, AbbVie, Gilead, Janssen, MSD, ViiV, Mundipharma, Hexal: Consultant and Scientific Advisor, Consulting fee and Speaker honorarium. K. Lohmann, AbbVie Inc.: Employee and Shareholder, Salary and Stock and/or options. H. Kleine, AbbVie Inc.: Employee and Shareholder, Salary and Stock and/or options. A. Pangerl, AbbVie Inc.: Employee and Shareholder, Salary and Stock and/or options. S. Christensen, AbbVie, Gilead, Indivior, Janssen-Cilag, MSD, ViiV: Consultant and Scientific Advisor, Consulting fee and Speaker honorarium.

PS-036 - Scaling up HCV-DAA treatment in patients on opioid substitution therapy (OST) – does alcohol and cannabis diminish cure rates? Data from the German Hepatitis C-Registry (DHC-R)

PS-036 - Scaling up HCV-DAA treatment in patients on opioid substitution therapy (OST) – does alcohol and cannabis diminish cure rates? Data from the German Hepatitis C-Registry (DHC-R)

Direct-acting antiviral treatment of chronic HCV-infected patients on opioid substitution therapy: Still a concern in clinical practice?

There is limited real-world information on the effectiveness of antiviral treatment of chronic hepatitis C virus (HCV) infection with direct-acting antivirals (DAA) in people on opioid substitution therapy (OST). This study compared sustained virological response (SVR) rates and proportion of lost to follow-up (LTFU) between OST and non-OST patients in the German Hepatitis C-Registry (DHC-R). National multi-centre prospective real-world registry (German Hepatitis C-Registry, DHC-R). Non-OST patients comprised patients with former/current drug use (non-OST/DU) and patients never consuming drugs (non-OST/NDU). A total of 254 medical centres in Germany, including 123 centres providing OST. A total of 7747 chronic HCV patients started DAA therapy (739 OST and 7008 non-OST; 1500 non-OST/DU; 5508 non-OST/NDU) patients. Five hundred and twenty-eight OST and 5582 non-OST patients had completed antiviral therapy and at least one follow-up documentation [intention-to-treat (ITT) population]. Study outcomes were SVR, proportion of LTFU and safety of treatment. SVR (ITT) was documented in 85% (450 of 528) OST patients versus 86% (969 of 1126) in non-OST/DU (P=0.651) and 92% (4113 of 4456) non-OST/NDU (P<0.001) patients. Independent predictors for SVR (P<0.01 in multivariate analysis) included HCV genotype non-3 [adjusted odds ratio (aOR)=1.11; 95% confidence interval (CI)=1.07-1.15], female sex (aOR=1.59; CI=1.30-1.94), platelet counts >90×109/l (aOR=1.51, CI=1.14-2.01), cirrhosis (aOR=0.77; CI=0.62-0.96) and patient group (OST/DI (aOR=0.58; CI=0.42-0.78); non-OST/DU (OR: 0.63; CI=0.50-0.78). In per-protocol analysis (PP), SVR rates were ≥94% in all patient groups. In OST the proportion of LTFU was higher (10.2%) than in non-OST/DU (8.5%) and non-OST/NDU (3.2%, P<0.001) patients. Independent factors for LTFU (P<0.01) were HCV genotype non-3 (aOR=0.92; CI=0.88-0.96), female sex (aOR: 0.7; CI=0.53-0.92), pre-treatment (aOR=0.64; CI=0.50-0.82), OST/DI (aOR=3.35; CI=2.35-4.78) and non-OST/DU (aOR=2.38; CI=1.80-3.14). In Germany, direct-acting antiviral treatment of former or current drug users with or without opioid substitution therapy can achieve equally high sustained virological response rates as in patients with no history of drug use.

Conspicuous by their abstinence: The limited engagement of heroin users in English and Welsh Drug Recovery Wings

BackgroundIn recent years, an abstinence-focused, ‘recovery’ agenda has emerged in UK drug policy, largely in response to the perception that many opioid users had been ‘parked indefinitely’ on opioid substitution therapy (OST). The introduction of ten pilot ‘Drug Recovery Wings’ (DRWs) in 2011 represents the application of this recovery agenda to prisons. This paper describes the DRWs’ operational models, the place of opiate dependent prisoners within them, and the challenges of delivering ‘recovery’ in prison. MethodsIn 2013, the implementation and operational models of all ten pilot DRWs were rapidly assessed. Up to three days were spent in each DRW, undertaking semi-structured interviews with a sample of 94 DRW staff and 102 DRW residents. Interviews were fully transcribed, and coded using grounded theory. Findings from the nine adult prisons are presented here. ResultsFour types of DRW were identified, distinguished by their size and selection criteria. Strikingly, no mid- or large-sized units regularly supported OST recipients through detoxification. Type A were large units whose residents were mostly on OST with long criminal records and few social or personal resources. Detoxification was rare, and medication reduction slow. Type B's mid-sized DRW was developed as a psychosocial support service for OST clients seeking detoxification. However, staff struggled to find such prisoners, and detoxification again proved rare. Type C DRWs focused on abstinence from all drugs, including OST. Though OST clients were not intentionally excluded, very few applied to these wings. Only Type D DRWs, offering intensive treatment on very small wings, regularly recruited OST recipients into abstinence-focused interventions. ConclusionPrison units wishing to support OST recipients in making greater progress towards abstinence may need to be small, intensive and take a stepped approach based on preparatory motivational work and extensive preparation for release. However, concerns about post-release deaths will remain.

German cohort on Sofosbuvir based therapy for HIV/HCV- and HCV-infection (GECCO) – Patients on opioid substitution therapy (OST) respond as well as non-OST patients

Background: Sofosbuvir (SOF) was approved in Europe in January 2014. However, outcomes of SOF based therapy in patients on OST in comparison to NON-OST were not systematically studied. Here, we present corresponding real-life data on SOF-based treatments from Germany.