A Pilot Study of Treating HCV at a Psychiatrist-staffed Outpatient Addiction Clinic
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|ClinicalTrials.gov Identifier: NCT03235154|
Recruitment Status : Recruiting
First Posted : August 1, 2017
Last Update Posted : October 17, 2018
|Condition or disease||Intervention/treatment||Phase|
|Hepatitis C, Chronic Hepatitis C Opiate Dependence||Drug: sofosbuvir/velpatasvir||Phase 4|
An estimated 3.2 million people in the United States are currently infected with hepatitis C virus (HCV). Since 1990, when the US introduced screening of the blood supply for HCV, injection drug use has been the primary mode of HCV transmission in the United States. It is widely recognized that addressing the HCV epidemic among people who inject drugs (PWID) depends on increasing access to: 1) clean injection equipment; 2) opiate substitution therapy (OST); 3) curative HCV treatment; and 4) assistance with comorbid psychiatric conditions and social issues (Robaeys, C et al, 2013).
Nevertheless, access to HCV treatment among current and former injection drug users is thought to be limited by several factors including: 1) insufficient number of infectious disease and gastroenterology providers and 2) provider and third-party payor concerns about adherence to medication and the risk of reinfection (Aspinall, EJ et al, 2013). Strategies to increase access among current and former injection drug users to direct acting antiviral drugs are urgently needed. The purpose of the current study is to assess the impact of co-treating chronic hepatitis C infection and opiate dependence within the context of an outpatient addiction clinic staffed by psychiatrists. The beneficial impact of co-treating opiate dependence and an infectious illness has been demonstrated in the case of HIV infection. Altice and colleagues conducted an observational study of HIV-infected opiate-dependent patients who were offered OST with buprenorphine/naloxone at 10 different HIV clinics. Subjects initiating buprenorphine/naloxone were more likely to initiate or remain on ART (Altice, 2011).
The Extension for Community Healthcare Outcomes (ECHO) program has demonstrated that with proper training and mentorship, primary care providers with no prior experience in managing HCV are able to treat the disease effectively (Arora et al, 2011). Since the publication of the ECHO study, the treatment of HCV has become considerably less complicated due to the widespread availability of safe, highly effective single tablet regimens, such as Epclusa. The investigators believe that treatment of HCV is now well within the grasp of physicians and other healthcare providers without training in internal or family medicine.
This single arm pilot study will assess HCV treatment with Epclusa at an outpatient addiction clinic staffed by psychiatrists. The investigators hypothesize that with proper training and mentorship, psychiatrists who are also a licensed buprenorphine/naloxone providers will be able to effectively assess liver health and treat chronic hepatitis C infection with Epclusa. Further, the investigators hypothesize that patients with chronic hepatitis C infection on buprenorphine/naloxone maintenance therapy who are treated for HCV by a psychiatrist during regularly scheduled visits to an addiction clinic will have high rates of adherence to HCV treatment and achieve SVR 12.
Given that subjects will receive standard of care evaluation and treatment for their chronic hepatitis C infection, the investigators believe that study participation poses minimal risk. Indeed, The investigators believe that subjects will benefit from improved access to this important treatment which will be provided at a convenient location by a known physician under the guidance of an infectious disease physician with extensive experience treating HCV infection.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Bridging Care to HCV Treatment Among Opiate Dependent Patients on Buprenorphine/Naloxone Maintenance Therapy: A Pilot Study of Treating HCV With Epclusa at a Psychiatrist-staffed Outpatient Addiction Clinic|
|Actual Study Start Date :||October 11, 2017|
|Estimated Primary Completion Date :||August 2019|
|Estimated Study Completion Date :||January 2020|
In this open label, single arm study, all subjects will receive the intervention as prescribed by psychiatrists in the office based opiate addition treatment program.
12 week treatment with once daily sofosbuvir/velpatasivir fixed dose combination therapy. Tablets are formulated with 400mg sofosbuvir and 100mg velpatasvir in pink, diamond-shaped, film coated tablets.
- Percentage of Sustained Virologic Response at 12 Weeks Post Treatment (SVR-12) Achieved by Participants [ Time Frame: This outcome measure will be assessed for each participant 12 weeks after completion of a 12 week course of treatment ]To assess the effectiveness of HCV treatment with velpatasvir/sofosbuvir administered by psychiatrist/licensed buprenorphine/naloxone providers during regularly scheduled visits to an outpatient addiction clinic for buprenorphine/naloxone replacement therapy and mental healthcare, as measured by percentage of patients achieving SVR-12 (defined as HCV RNA < lower limit of quantification (LLOQ) 12 weeks after discontinuation of study treatment),
- Health-Related Quality of Life [ Time Frame: This outcome measure will be assessed for each participant during a 12 week course of study treatment. ]Mean quality of life scores from baseline to the end of treatment will be reported for all participants on buprenorphine/naloxone therapy receiving study treatment.
- Adherence to Study Treatment [ Time Frame: This outcome measure will be assessed for each participant during a 12 week course of study treatment. ]To assess adherence to velpatasvir/sofosbuvir therapy among participants administered treatment in the context of visits to an outpatient addiction clinic for buprenorphine/naloxone replacement therapy and mental health care.
- Psychiatrists Comfort Providing HCV Care [ Time Frame: Approximately 1 year. ]Exploratory analysis describing the psychiatrists' comfort providing HCV care among six areas of counseling, over the course of the study.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03235154
|Contact: Project Managerfirstname.lastname@example.org|
|United States, Massachusetts|
|Cambridge Health Alliance Outpatient Addiction Services||Recruiting|
|Somerville, Massachusetts, United States, 02143|
|Contact: Zev Schuman-Olivier, MD|
|Principal Investigator:||Amy E Colson, MD MPH||Community Research Initiative of New England|