A Pilot Study of Treating HCV at a Psychiatrist-staffed Outpatient Addiction Clinic

NCT03235154 | Completed Phase 4 Results FDA Drug

• 1 other identifier: 15-05
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

Brief Summary

The main purpose of this pilot study is to investigate the safety, effectiveness and tolerability of the study medication in the treatment of people with chronic hepatitis C virus infection who regularly attend a psychiatrist-staffed clinic for opiate addiction treatment.

Conditions

Hepatitis C, Chronic; Hepatitis C; Opiate Dependence

Keywords

HCV; Suboxone; Epclusa; psychiatrist

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants With Sustained Virologic Response at 12 Weeks Post Treatment (SVR-12)

  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),

  This outcome measure will be assessed for each participant 12 weeks after completion of a 12 week course of treatment

Secondary Outcomes (2)

• Health-Related Quality of Life

  Baseline and 12 weeks post treatment

• Adherence to Study Treatment

  This outcome measure will be assessed for each participant during a 12 week course of study treatment.

Study Arms (1)

Treatment Arm

OTHER

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.

Drug: sofosbuvir/velpatasvir

Interventions

sofosbuvir/velpatasvir DRUG

12 week treatment with once daily sofosbuvir/velpatasvir fixed dose combination therapy. Tablets are formulated with 400mg sofosbuvir and 100mg velpatasvir in pink, diamond-shaped, film coated tablets.

Treatment Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Willing and able to provide written informed consent
• Age ≥ 18 years
• Confirmation of chronic HCV infection as documented by a positive HCV antibody test at least 6 months prior to the Baseline/Day 1 visit and positive HCV RNA test at screening
• HCV genotype 1, 2, 3, 4, 5 or 6
• In stable remission from opiate use on buprenorphine/naloxone for at least 12 weeks
• Within the following laboratory parameters as assessed at the screening visit:
• HCV RNA quantifiable
• Screening rhythm strip without bradycardia (heart rate \> 60 or, if on beta blocker, \> 55 BPM)
• Alanine Aminotransferase (ALT) ≤ 10 x ULN (upper limit of normal)
• Aspartate Aminotransferase (AST) ≤ 10 x ULN
• Direct bilirubin ≤ 1.5 x ULN
• Platelets \> 60,000
• Hemoglobin A1C (HbA1c) ≤ 10%
• Creatinine clearance ≥ 30 mL/min, as calculated by the Cockcroft-Gault equation
• Albumin ≥ 3g/dL

You may not qualify if:

• Presence of decompensated cirrhosis as defined by encephalopathy, ascites, or a history of a variceal bleed
• Prior treatment with direct acting antiviral hepatitis C medications
• Positive urine drug toxicity test at screening (except for cannabinoids and prescribed medications)
• Absence of buprenorphine in urine sample at screening
• Currently pregnant or breastfeeding female
• Detectable HIV RNA \> 50 copies/ml (co-infected subjects with suppressed viral load are eligible for participation)
• Use of any prohibited concomitant medication within 28 days prior to day 1
• Chronic use of systemically administered immunosuppressive agents
• Difficulty with blood collection or poor venous access
• History of solid organ transplantation
• Known significant allergy to sofosbuvir or velpatasvir
• Current chronic liver disease of a non-HCV etiology (including hemochromatosis, Wilson's disease, alfa-1 antitrypsin deficiency)
• Active Hepatitis B virus (HBV) infection defined as either a positive HBV surface antigen test or a positive test for HBV DNA. (Subjects who are positive for HBV core antibody but negative for Hepatitis B surface antibody, surface antigen, and DNA ARE eligible)

Sponsors & Collaborators

• Community Research Initiative of New England: lead
• Gilead Sciences: collaborator

Study Sites (1)

Cambridge Health Alliance Outpatient Addiction Services

Somerville, Massachusetts, 02143, United States

Location

Related Publications (4)

• Altice FL, Bruce RD, Lucas GM, Lum PJ, Korthuis PT, Flanigan TP, Cunningham CO, Sullivan LE, Vergara-Rodriguez P, Fiellin DA, Cajina A, Botsko M, Nandi V, Gourevitch MN, Finkelstein R; BHIVES Collaborative. HIV treatment outcomes among HIV-infected, opioid-dependent patients receiving buprenorphine/naloxone treatment within HIV clinical care settings: results from a multisite study. J Acquir Immune Defic Syndr. 2011 Mar 1;56 Suppl 1(Suppl 1):S22-32. doi: 10.1097/QAI.0b013e318209751e.

  PMID: 21317590 BACKGROUND

• Arora S, Thornton K, Murata G, Deming P, Kalishman S, Dion D, Parish B, Burke T, Pak W, Dunkelberg J, Kistin M, Brown J, Jenkusky S, Komaromy M, Qualls C. Outcomes of treatment for hepatitis C virus infection by primary care providers. N Engl J Med. 2011 Jun 9;364(23):2199-207. doi: 10.1056/NEJMoa1009370. Epub 2011 Jun 1.

  PMID: 21631316 BACKGROUND

• Robaeys G, Grebely J, Mauss S, Bruggmann P, Moussalli J, De Gottardi A, Swan T, Arain A, Kautz A, Stover H, Wedemeyer H, Schaefer M, Taylor L, Backmund M, Dalgard O, Prins M, Dore GJ; International Network on Hepatitis in Substance Users. Recommendations for the management of hepatitis C virus infection among people who inject drugs. Clin Infect Dis. 2013 Aug;57 Suppl 2:S129-37. doi: 10.1093/cid/cit302.

  PMID: 23884061 BACKGROUND

• Aspinall EJ, Corson S, Doyle JS, Grebely J, Hutchinson SJ, Dore GJ, Goldberg DJ, Hellard ME. Treatment of hepatitis C virus infection among people who are actively injecting drugs: a systematic review and meta-analysis. Clin Infect Dis. 2013 Aug;57 Suppl 2:S80-9. doi: 10.1093/cid/cit306.

  PMID: 23884071 BACKGROUND

MeSH Terms

Conditions

Hepatitis C, Chronic; Hepatitis C; Opioid-Related Disorders

Interventions

sofosbuvir-velpatasvir drug combination

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis, Chronic; Hepatitis; Liver Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Limitations and Caveats

Small number of subjects analyzed

Results Point of Contact

• Title: Amy E. Colson, MD
• Organization: Community Research Initiative of New England

acolson@crine.org

6175021700

Study Officials

• Amy E Colson, MD MPH

  Community Research Initiative of New England

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 27, 2017
• First Posted: August 1, 2017
• Study Start: October 11, 2017
• Primary Completion: September 26, 2019
• Study Completion: September 26, 2019
• Last Updated: May 13, 2021
• Results First Posted: May 13, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)