Ignite Creation Date:
2024-05-06 @ 1:37 AM
Last Modification Date:
2024-10-26 @ 11:07 AM
Study NCT ID:
NCT01857245
Status:
COMPLETED
Last Update Posted:
2021-04-01
First Post:
2013-05-16
Brief Title:
Intensive Models of HCV Care for Injection Drug Users
Sponsor:
Prisma Health-Upstate
Organization:
Prisma Health-Upstate
Study Overview
Official Title:
Intensive Models of HCV Care for Injection Drug Users
Status:
COMPLETED
Status Verified Date:
2018-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Injection drug users IDUs constitute 60 of the approximately 5 million people in the US infected with hepatitis C virus HCV HCV treatment leading to sustained viral response SVR is associated with increased survival However IDUs have had poor access to HCV care and their success in HCV treatment has been limited With direct-acting antiviral agents HCV treatment delivered within large clinical trials leads to SVR or cure in over 70 of genotype-1 infected patients compared to 45 with previous therapies However SVR rates are as low as 14 in real-world settings The majority of patients who fail to achieve SVR will develop drug resistance but the optimal adherence level to minimize resistance is unknown If HCV treatment continues to be delivered within current models of care most IDUs will not only fail treatment and develop resistance but may transmit resistant viruses to others We have previously developed a multidisciplinary model of HCV care which integrates on-site primary care substance abuse treatment psychiatric care and HCV-related care within opiate agonist treatment clinics To maximize treatment outcomes we piloted two models of intensive HCV-related care directly observed therapy DOT and concurrent group therapy CGT In our DOT model pegylated interferon is administered once weekly if applicable and one daily dose of oral medication is administered at the methadone window In our CGT model patients initiate HCV treatment within a once weekly treatment group which provides powerful social support to mitigate fears of side effects promote efficient education and deliver weekly injections if applicable It is unknown whether either model is better or more cost-effective than standard on-site care
PREVAIL 1 In the proposed study 150 IDUs with chronic HCV genotype 1 will be recruited from methadone clinics and randomized to one of three models of care DOT concurrent group treatment or standard on-site care Our specific aims are 1 To determine whether either of two intensive on-site HCV treatment models DOT or concurrent group treatment is more efficacious than standard on-site treatment for enhancing adherence and SVR and decreasing drug resistance 2 To determine the incidence and factors associated with the development of drug resistance in IDUs 3 To perform cost and cost-effectiveness analyses of each model 4 To examine the impact of HIV coinfection on adherence and virologic outcomes among HCV-infected IDUs
PREVAIL 2 In the proposed study 60 IDUs with chronic HCV genotypes 1 2 3 and 4 will be recruited from opiate agonist treatment programs and started on HCV treatment Subjects will be offered the choice of model of care either standard on-site DOT or concurrent group treatment Our specific aims are 1 to determine rates of adherence and SVR in a cohort of opiate agonist treatment patients initiating treatment with sofosbuvir-based regimens and 2 to determine adherence rates over time in drug users genotype 3 and genotype 1 IFN-ineligible initiating a 24 week IFN-free regimen
PREVAIL 3 In the proposed study 60 IDUs with chronic HCV genotype 1 and 4 will be recruited from opiate agonist treatment programs and started on HCV treatment Subjects will be offered the choice of model of care either standard on-site DOT or concurrent group treatment Our specific aims are 1 to determine rates of adherence and SVR in a cohort of opiate agonist treatment patients initiating treatment with oral DAA combination of sofosbuvir and simeprevir or fixed dose of sofosbuvir and ledipasvir and 2 to determine adherence rates over time in drug users
PREVAIL 1 In the proposed study 150 IDUs with chronic HCV genotype 1 will be recruited from methadone clinics and randomized to one of three models of care DOT concurrent group treatment or standard on-site care Our specific aims are 1 To determine whether either of two intensive on-site HCV treatment models DOT or concurrent group treatment is more efficacious than standard on-site treatment for enhancing adherence and SVR and decreasing drug resistance 2 To determine the incidence and factors associated with the development of drug resistance in IDUs 3 To perform cost and cost-effectiveness analyses of each model 4 To examine the impact of HIV coinfection on adherence and virologic outcomes among HCV-infected IDUs
PREVAIL 2 In the proposed study 60 IDUs with chronic HCV genotypes 1 2 3 and 4 will be recruited from opiate agonist treatment programs and started on HCV treatment Subjects will be offered the choice of model of care either standard on-site DOT or concurrent group treatment Our specific aims are 1 to determine rates of adherence and SVR in a cohort of opiate agonist treatment patients initiating treatment with sofosbuvir-based regimens and 2 to determine adherence rates over time in drug users genotype 3 and genotype 1 IFN-ineligible initiating a 24 week IFN-free regimen
PREVAIL 3 In the proposed study 60 IDUs with chronic HCV genotype 1 and 4 will be recruited from opiate agonist treatment programs and started on HCV treatment Subjects will be offered the choice of model of care either standard on-site DOT or concurrent group treatment Our specific aims are 1 to determine rates of adherence and SVR in a cohort of opiate agonist treatment patients initiating treatment with oral DAA combination of sofosbuvir and simeprevir or fixed dose of sofosbuvir and ledipasvir and 2 to determine adherence rates over time in drug users
Detailed Description:
PREVAIL 1 In the proposed study 150 IDUs with chronic HCV genotype 1 will be recruited from methadone clinics and randomized to one of three models of care DOT concurrent group treatment or standard on-site care Our specific aims are 1 To determine whether either of two intensive on-site HCV treatment models DOT or concurrent group treatment is more efficacious than standard on-site treatment for enhancing adherence and SVR and decreasing drug resistance 2 To determine the incidence and factors associated with the development of drug resistance in IDUs 3 To perform cost and cost-effectiveness analyses of each model 4 To examine the impact of HIV coinfection on adherence and virologic outcomes among HCV-infected IDUs
PREVAIL 2 In the proposed study 60 IDUs with chronic HCV genotypes 1 2 3 and 4 will be recruited from opiate agonist treatment programs and started on HCV treatment Subjects will be offered the choice of model of care either standard on-site DOT or concurrent group treatment Our specific aims are 1 to determine rates of adherence and SVR in a cohort of opiate agonist treatment patients initiating treatment with sofosbuvir-based regimens and 2 to determine adherence rates over time in drug users genotype 3 and genotype 1 IFN-ineligible initiating a 24 week IFN-free regimen
PREVAIL 3 In the proposed study 60 IDUs with chronic HCV genotype 1 and 4 will be recruited from opiate agonist treatment programs and started on HCV treatment Subjects will be offered the choice of model of care either standard on-site DOT or concurrent group treatment Our specific aims are 1 to determine rates of adherence and SVR in a cohort of opiate agonist treatment patients initiating treatment with oral DAA combination of sofosbuvir and simeprevir or fixed dose of sofosbuvir and ledipasvir and 2 to determine adherence rates over time in drug users
PREVAIL 2 In the proposed study 60 IDUs with chronic HCV genotypes 1 2 3 and 4 will be recruited from opiate agonist treatment programs and started on HCV treatment Subjects will be offered the choice of model of care either standard on-site DOT or concurrent group treatment Our specific aims are 1 to determine rates of adherence and SVR in a cohort of opiate agonist treatment patients initiating treatment with sofosbuvir-based regimens and 2 to determine adherence rates over time in drug users genotype 3 and genotype 1 IFN-ineligible initiating a 24 week IFN-free regimen
PREVAIL 3 In the proposed study 60 IDUs with chronic HCV genotype 1 and 4 will be recruited from opiate agonist treatment programs and started on HCV treatment Subjects will be offered the choice of model of care either standard on-site DOT or concurrent group treatment Our specific aims are 1 to determine rates of adherence and SVR in a cohort of opiate agonist treatment patients initiating treatment with oral DAA combination of sofosbuvir and simeprevir or fixed dose of sofosbuvir and ledipasvir and 2 to determine adherence rates over time in drug users
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 1R01DA034086-01 | NIH | None | httpsreporternihgovquickSearch1R01DA034086-01 |