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

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.

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

Clinical Infectious Diseases ◽

10.1093/cid/ciy899 ◽

2018 ◽

Vol 69 (2) ◽

pp. 323-331 ◽

Cited By ~ 15

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.

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Implementing a Low-threshold Audio-only Telehealth Model for Medication-assisted Treatment of Opioid Use Disorder at a Community-based Non-profit Organization in Washington, D.C.

10.21203/rs.3.rs-915722/v1 ◽

2021 ◽

Author(s):

Ellis Jaewon Yeo ◽

Hannah Kralles ◽

David Sternberg ◽

Dana McCullough ◽

Ajetha Nadanasabesan ◽

...

Keyword(s):

Patient Characteristics ◽

The United States ◽

Opioid Use Disorder ◽

Retention Rates ◽

People Who Use Drugs ◽

Opioid Use ◽

Treatment Access ◽

Community Based ◽

Medication Assisted Treatment ◽

Low Threshold

Abstract BackgroundThe COVID-19 pandemic has had especially devastating effects on people who use drugs. Due to pandemic protocols in the United States, medication-assisted treatment (MAT) regulations became more flexible, permitting our community-based nonprofit organization to transition its low-threshold MAT clinic to an audio-only telehealth model of care in 2020. Case PresentationThis case study describes our transition from a low-threshold community-based in-person MAT clinic to an audio-only telehealth model. We extracted data from electronic health records to describe patient characteristics and to calculate treatment retention rates. We measure the success of our intervention relative to published retention rates, both overall as well as for in-person and telehealth care. ConclusionsLow-threshold medication-assisted treatment in the care of people with opioid use disorder is essential to increasing treatment access and continuity. We found that an audio-only telehealth model was viable. Although we had decreased retention rates following the transition to an audio-only telehealth model, our rates remained excellent compared to published values for in-person MAT care. We call for advocacy and regulations to support continued use of telehealth services throughout and beyond the COVID-19 pandemic.

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Concurrent Initiation of Hepatitis C and Opioid Use Disorder Treatment in People Who Inject Drugs

Clinical Infectious Diseases ◽

10.1093/cid/ciaa105 ◽

2020 ◽

Vol 71 (7) ◽

pp. 1715-1722 ◽

Cited By ~ 5

Author(s):

Elana S Rosenthal ◽

Rachel Silk ◽

Poonam Mathur ◽

Chloe Gross ◽

Rahwa Eyasu ◽

...

Keyword(s):

Hepatitis C ◽

Drug Use ◽

People Who Inject Drugs ◽

Opioid Use Disorder ◽

Opioid Use ◽

Agonist Therapy ◽

Hcv Treatment ◽

Opioid Agonist ◽

Opioid Agonist Therapy ◽

The Impact

Abstract Background People who inject drugs have a high prevalence of hepatitis C virus (HCV) and significant disease associated with drug use; however, HCV treatment often occurs in absence of interventions to address opioid use disorder and drug use–related harms. The impact of concurrent initiation of opioid agonist therapy (OAT) on HCV treatment and drug use outcomes is unknown. Methods In this prospective, open-label, observational trial at a harm reduction organization’s drop-in center in Washington, DC, 100 patients with chronic HCV infection, opioid use disorder, and ongoing injection drug use were treated with sofosbuvir-velpatasvir for 12-weeks and offered buprenorphine initiation. The primary end point was sustained virologic response (SVR), and secondary end points included uptake of and retention in OAT, change in risk behavior, and determinants of SVR. Results Eighty-two patients (82%) achieved SVR, which was not associated with baseline OAT status (P = .33), on-treatment drug use (P >.99), or imperfect daily adherence (P = .35) but was significantly associated with completing 2 or more 28-pill bottles of sofosbuvir-velpatasvir (P < .001) and receiving OAT at week 24 (P = .01). Of 67 patients not already receiving OAT at baseline, 53 (79%) started OAT. At week 24, 68 (68%) patients were receiving OAT. Receipt of OAT was associated with fewer opiate-positive urine drug screens (P = .003), lower human immunodeficiency virus risk-taking behavior scores (P < .001), and lower rates of opioid overdose (P = .04). Conclusions The Novel Model of Hepatitis C Treatment as an Anchor to Prevent HIV, Initiate Opioid Agonist Therapy, and Reduce Risky Behavior study demonstrates high uptake of buprenorphine collocated with HCV treatment, and it shows that concurrent initiation of OAT with HCV treatment can result in high rates of SVR while reducing risks associated with drug use. Clinical Trials Registration NCT03221309.

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2897. Collocated Buprenorphine Is Associated with Improved HCV Visit Adherence in People Who Inject Drugs (PWID): Data From the ANCHOR Study

Open Forum Infectious Diseases ◽

10.1093/ofid/ofz359.175 ◽

2019 ◽

Vol 6 (Supplement_2) ◽

pp. S82-S82

Author(s):

Elana S Rosenthal ◽

Rachel Silk ◽

Poonam Mathur ◽

Rahwa Eyasu ◽

Laura Nussdorf ◽

...

Keyword(s):

Opioid Use Disorder ◽

People Who Use Drugs ◽

High Risk Population ◽

Opioid Use ◽

Hcv Treatment ◽

Opioid Agonist ◽

Opioid Agonist Therapy ◽

Visit Adherence ◽

Chronic Hcv

Abstract Background Engaging PWID in HCV treatment and monitoring for reinfection is critical to eliminate HCV and improve health in people who use drugs. However, PWID are often marginalized and can be difficult to engage and retain in care. The collocation of HCV treatment with buprenorphine to treat opioid use disorder (OUD) may improve visit adherence in this population. Methods ANCHOR is a single-center study evaluating treatment of HCV in PWID with chronic HCV, OUD, and IDU. Participants receive sofosbuvir/velpatasvir x12 weeks and are offered collocated buprenorphine. HCV visits occur at weeks 4, 12, 24, 48, 72 and 96. Results At screening, the 100 enrolled patients were predominantly male (76%), black (93%), middle-aged (median 57years), injected opioids daily or more (58%), and were not on OAT (67%). Fifty-five (55%) patients were initiated on collocated buprenorphine at some point after day 0. Being on collocated buprenorphine at the time of HCV visit was associated with increased likelihood of visit attendance at weeks 12 (P = 0.002), 24 (P = 0.01), 48 (P = 0.02), 72 (P = 0.003), and 96 (P = 0.04). For patients who attended study visits, being on collocated buprenorphine was associated with a shorter time between planned visit and actual visit at weeks 12 (P = 0.03), 24 (P = 0.04), and 48 (P = 0.04). When looking at patients not on collocated buprenorphine, being on noncollocated opioid agonist therapy vs. not being on OUD treatment did not impact visit adherence. Conclusion Evidence-based treatment of HCV and OUD are critical to improving health in PWID. The collocation of HCV treatment with office-based buprenorphine may improve adherence to visits and visit timing, especially in long-term follow-up. Infectious disease providers should offer collocated buprenorphine as a tool to improve long-term outcomes and engagement in this high-risk population. Disclosures All Authors: No reported Disclosures.

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Highly Successful Hepatitis C Virus (HCV) Treatment Outcomes in Human Immunodeficiency Virus/HCV-Coinfected Patients at a Large, Urban, Ryan White Clinic

Open Forum Infectious Diseases ◽

10.1093/ofid/ofx062 ◽

2017 ◽

Vol 4 (2) ◽

Cited By ~ 13

Author(s):

Manish Patel ◽

Saira Rab ◽

Aley G. Kalapila ◽

Alison Kyle ◽

Ike Solomon Okosun ◽

...

Keyword(s):

Adverse Effect ◽

Human Immunodeficiency Virus ◽

Hepatitis C Virus ◽

Hepatitis C ◽

Treatment Outcomes ◽

Real World ◽

Hcv Treatment ◽

Real World Data ◽

Immunodeficiency Virus ◽

Ryan White

Abstract Background The introduction of direct-acting antivirals (DAAs) created a major paradigm shift in the treatment of chronic hepatitis C. Currently, there is little “real-world” data regarding hepatitis C virus (HCV) treatment outcomes in the human immunodeficiency virus (HIV)/HCV-coinfected population. Methods This retrospective cohort study examined HCV treatment outcomes of HIV/HCV-coinfected patients at a large, urban, Ryan White-funded clinic caring for an underserved population. All HIV patients initiating HCV treatment from January 1, 2013 to November 30, 2015 were included in the analysis. The primary end point was sustained virologic response 12 weeks after the end of therapy (SVR12). Results A total of 172 patients initiated HCV treatment within the study period: 79% were male, 83% were black, 95% were HCV genotype 1, 79% were HCV treatment naive, and 16% had cirrhosis. At baseline, median CD4 was 494 cells/μL (interquartile range, 316–722) and 92% had HIV ribonucleic acid less than 40 copies/mL. The most common DAA initiated was ledipasvir/sofosbuvir (LDV/SOF) (85%), with 92% receiving 12 weeks of treatment. Overall, SVR12 was 93% by intention-to-treat analysis and 98% by per-protocol analysis. The majority of patients on LDV/SOF did not report any adverse effect. One patient in the ribavirin plus SOF group discontinued treatment due to adverse effect. Conclusions In a cohort of mainly black, male, HIV/HCV-coinfected patients at a large, urban, Ryan White clinic, HCV treatment with DAAs resulted in high SVR12 rates and was well tolerated despite real-world challenges including medication access barriers and drug interaction concerns.

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Implementing a low-threshold audio-only telehealth model for medication-assisted treatment of opioid use disorder at a community-based non-profit organization in Washington, D.C.

Harm Reduction Journal ◽

10.1186/s12954-021-00578-1 ◽

2021 ◽

Vol 18 (1) ◽

Author(s):

Ellis Jaewon Yeo ◽

Hannah Kralles ◽

David Sternberg ◽

Dana McCullough ◽

Ajetha Nadanasabesan ◽

...

Keyword(s):

Behavioral Health Care ◽

Opioid Use Disorder ◽

Lessons Learned ◽

Retention Rates ◽

People Who Use Drugs ◽

Opioid Use ◽

Treatment Access ◽

Community Based ◽

Medication Assisted Treatment ◽

Low Threshold

Abstract Background The COVID-19 pandemic has had especially devastating effects on people who use drugs. Due to pandemic protocols in the USA, medication-assisted treatment (MAT) regulations became more flexible, permitting our community-based nonprofit organization to transition its low-threshold MAT clinic to an audio-only telehealth model of care in 2020. Lessons learned have the potential to improve MAT delivery to people with OUD. Case presentation This case study describes our transition from a low-threshold community-based in-person MAT clinic to an audio-only telehealth model. We extracted data from electronic health records to describe patient characteristics and to calculate treatment retention rates. Patients were predominantly male (74.4%) and black (90.6%). The mean age was 53 years old with more than half of the clients aged 55 or older. Less than half (42.3%) of the patients lived in stable housing. Patients commonly had self-reported comorbid conditions such as hypertension (35.4%), hepatitis C (23.5%), diabetes (11.9%), human immunodeficiency virus (HIV) (7.2%). A majority of patients (68.6%) reported engagement with behavioral health care. We measure the success of our intervention relative to published retention rates, both overall as well as for in-person and telehealth care. In-person retention rates at 90- and 180-days were substantially higher than telehealth retention rates (93.9% vs 68.4% and 91.5% vs 51.9%, respectively). Conclusions Low-threshold medication-assisted treatment in the care of people with opioid use disorder is essential to increasing treatment access and continuity. We found that an audio-only telehealth model was viable. Although we had decreased retention rates following the transition to an audio-only telehealth model, our rates remained excellent compared to published values for in-person MAT care. We call for advocacy and regulations to support continued use of telehealth services throughout and beyond the COVID-19 pandemic.

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