Drug Use, Hepatitis C
Conditions
Keywords
PWID
Brief summary
The purpose of this randomized study is to determine whether a community-based test and treat model of hepatitis C (HCV) care delivery will be superior to the usual care practice of referral to specialist clinics for the outcomes of sustained virologic response at 12 weeks after treatment and initiation of HCV treatment for persons who inject drugs (PWID) between ages 18 and 29 who are naïve to HCV treatment
Detailed description
ST&RT is a randomized open-label clinical trial in which 54 HCV infected PWID between ages 18 and 29 will be randomized to either receive the same-day treatment initiation of the FDA-approved fixed dose combination of sofosbuvir 400mg and velpatasvir 100mg (SOF/VEL) with follow up and medical monitoring at a community site (Intervention arm) or to receive referral to an HCV treatment provider's office (Usual Care Arm).
Interventions
OTHERRapid Treatment strategy
The intervention arm receives same-day medical evaluation and treatment for hepatitis C. They receive medical evaluation, laboratory assessment , baseline questionnaire/interview, and distribution of a medication (sofosbuvir/velpatasvir) starter pack on the day of enrollment. Participants who are HCV RNA negative are discontinued from the study. Other participants start medications and receive weekly text messages during 12 weeks of provided sofusbuvir/velpatasvir treatment.
OTHERUsual Care (facilitated referral)
articipants in the control arm will be provided facilitated referral to community HCV providers by an on-site care coordinator already facilitating care at the community site. HCV RNA negative participants will be called to inform them of these results, and then followed separately. HCV RNA positive participants will be asked during the semi-structured interviews as at 12, 24, 36 and 48 week if they engaged in HCV treatment to assess whether their HCV referral has been filled, and to record their current HCV treatment status. They will also receive repeat HCV RNA testing at week 12, 24, and 48. Participants that have started treatment will be asked to sign consent for release of medical records pertaining to HCV-related laboratory testing to determine achievement of treatment response.
Sponsors
Gilead Sciences
Weill Medical College of Cornell University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 29 Years
Healthy volunteers
No
Inclusion criteria
* Persons are eligible for study inclusion if they: (a) are HCV antibody positive, (b) are 18 to 29 years of age, (c) have injected drugs in the past 30 days, (d) are HCV treatment naïve, (e) are English speaking
Exclusion criteria
* Persons excluded from the study will be (a) HIV coinfected persons (b) pregnant women, or women planning on becoming pregnant (c) participants with end-stage renal disease (d) participants with decompensated cirrhosis (c) participants on medications with treatment limiting interactions with sofosbuvir/velpatasvir
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Proportion of Participants Who Achieve Sustained Virologic Response 12 (SVR12) With Rapid Treatment Strategy Compared to Usual Care | Week 48 | The proportion of participants who achieve sustained virologic response defined as an undetectable HCV RNA viral load 12 weeks after the cessation of treatment (SVR12), in the intervention arm compared to the usual care arm by study week 48. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The Proportion of Participants Who Initiate Treatment for HCV | Week 48 | The proportion of participants who initiate treatment for HCV in the intervention arm compared to the usual care arm by study week 48. |
| Presence of Resistance Associated Substitutions (RAS) in Treated Patients With Treatment Failure | 48 wks | — |
| Number of Participants in Both Arms Who Achieve SVR12, or Are RNA Negative at Baseline, That Have HCV Reinfection by Study Week 48 | 48 wks | — |
| Impact of Engagement in HCV Treatment on Frequency of Substance Use or Injection Risk Behaviors | Baseline and 48 weeks | Change in substance use frequency or injection risk behaviors will be defined as percent of participants in each arm that injected alone and the percent of participants who injected with 3 or more individuals |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Baseline RNA-positive Rapid Treatment With Sofosbuvir/Velpatasvir (Intervention Arm) The intervention arm receives same-day medical evaluation and treatment for hepatitis C. They receive medical evaluation, laboratory assessment , baseline questionnaire/interview, and distribution of a medication (sofosbuvir/velpatasvir) starter pack on the day of enrollment. Participants who are HCV RNA negative are discontinued from the study. Other participants start medications and receive weekly text messages during treatment to record adherence. They have follow up visits for laboratory tests, medication distribution, and counseling for prevention of reinfection. They have HCV testing at end of treatment and 12 weeks post treatment, and at 48 weeks to assess for reinfection. Each study visit will include a brief questionnaire and qualitative interview.
Sofosbuvir and Velpatasvir: Sofosbuvir/velpatasvir (Epclusa) is an FDA-approved treatment for HCV. It is provided in the intervention arm as part of a rapid treatment strategy, | 14 |
| Baseline RNA-positive Usual Care (Control Arm) Participants in the control arm will be provided facilitated referral to community HCV providers by an on-site care coordinator already facilitating care at the community site. HCV RNA negative participants will be called to inform them of these results, and then discontinued from the study. HCV RNA positive participants will be asked during the semi-structured interviews as at 12, 24, 36 and 48 week if they engaged in HCV treatment to assess whether their HCV referral has been filled, and to record their current HCV treatment status. They will also receive repeat HCV RNA testing at week 12, 24, and 48. Participants that have started treatment will be asked to sign consent for release of medical records pertaining to HCV-related laboratory testing to determine achievement of treatment response. | 11 |
| Baseline RNA Negative Participants assigned to either group who were found to be HCV RNA-negative at entry. They are not eligible for treatment and thus not part of the analysis. They were asked to return the treatment starter pack. They are followed with HCV RNA measured at Week 24 and 48. | 13 |
| Total | 38 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Deemed ineligible after ransdomization | 1 | 0 | 0 |
| Overall Study | HCV RNA Negative (protocol pre-specified) | 0 | 0 | 13 |
Baseline characteristics
| Characteristic | Baseline RNA-positive Rapid Treatment With Sofosbuvir/Velpatasvir (Intervention Arm) | Baseline RNA-positive Usual Care (Control Arm) | Baseline RNA Negative | Total |
|---|---|---|---|---|
| Age, Continuous | 26.07 years STANDARD_DEVIATION 3.54 | 25.36 years STANDARD_DEVIATION 2.66 | 26.92 years STANDARD_DEVIATION 2.87 | 26.16 years STANDARD_DEVIATION 3.06 |
| Race/Ethnicity, Customized Race/ethnicity Hispanic | 6 Participants | 3 Participants | 4 Participants | 13 Participants |
| Race/Ethnicity, Customized Race/ethnicity Non-Hispanic Black | 1 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Race/ethnicity Non-Hispanic White | 6 Participants | 6 Participants | 9 Participants | 21 Participants |
| Race/Ethnicity, Customized Race/ethnicity Other | 1 Participants | 2 Participants | 0 Participants | 3 Participants |
| Region of Enrollment United States | 14 participants | 11 participants | 13 participants | 38 participants |
| Sex: Female, Male Female | 3 Participants | 3 Participants | 4 Participants | 10 Participants |
| Sex: Female, Male Male | 11 Participants | 8 Participants | 9 Participants | 28 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 14 | 0 / 11 | 0 / 0 |
| other Total, other adverse events | 0 / 14 | 0 / 11 | 0 / 0 |
| serious Total, serious adverse events | 6 / 14 | 5 / 11 | 0 / 0 |
Outcome results
Primary
The Proportion of Participants Who Achieve Sustained Virologic Response 12 (SVR12) With Rapid Treatment Strategy Compared to Usual Care
The proportion of participants who achieve sustained virologic response defined as an undetectable HCV RNA viral load 12 weeks after the cessation of treatment (SVR12), in the intervention arm compared to the usual care arm by study week 48.
Time frame: Week 48
Population: Thirteen participants who were HCV-RNA negative at baseline excluded from analysis since they do not have hepatitis C and are not eligible for treatment. One participant in the intervention arm was deemed ineligible after randomization and was not included in analysis.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Rapid Treatment With Sofosbuvir/Velpatasvir (Intervention Arm) | The Proportion of Participants Who Achieve Sustained Virologic Response 12 (SVR12) With Rapid Treatment Strategy Compared to Usual Care | 9 Participants |
| Usual Care (Control Arm) | The Proportion of Participants Who Achieve Sustained Virologic Response 12 (SVR12) With Rapid Treatment Strategy Compared to Usual Care | 1 Participants |
p-value: 0.01Chi-squared
Secondary
Impact of Engagement in HCV Treatment on Frequency of Substance Use or Injection Risk Behaviors
Change in substance use frequency or injection risk behaviors will be defined as percent of participants in each arm that injected alone and the percent of participants who injected with 3 or more individuals
Time frame: Baseline and 48 weeks
Population: Thirteen participants who were HCV-RNA negative at baseline excluded from analysis since they do not have hepatitis C and are not eligible for treatment. Not all participants completed the survey at Week 48.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Rapid Treatment With Sofosbuvir/Velpatasvir (Intervention Arm) | Impact of Engagement in HCV Treatment on Frequency of Substance Use or Injection Risk Behaviors | Entry | Injected with 3 or more individuals | 3 Participants |
| Rapid Treatment With Sofosbuvir/Velpatasvir (Intervention Arm) | Impact of Engagement in HCV Treatment on Frequency of Substance Use or Injection Risk Behaviors | Entry | Injected with 1-2 indivuduals | 10 Participants |
| Rapid Treatment With Sofosbuvir/Velpatasvir (Intervention Arm) | Impact of Engagement in HCV Treatment on Frequency of Substance Use or Injection Risk Behaviors | Entry | Injected alone | 1 Participants |
| Rapid Treatment With Sofosbuvir/Velpatasvir (Intervention Arm) | Impact of Engagement in HCV Treatment on Frequency of Substance Use or Injection Risk Behaviors | Entry | Did not inject | 0 Participants |
| Rapid Treatment With Sofosbuvir/Velpatasvir (Intervention Arm) | Impact of Engagement in HCV Treatment on Frequency of Substance Use or Injection Risk Behaviors | Week 48 | Injected with 3 or more individuals | 1 Participants |
| Rapid Treatment With Sofosbuvir/Velpatasvir (Intervention Arm) | Impact of Engagement in HCV Treatment on Frequency of Substance Use or Injection Risk Behaviors | Week 48 | Injected with 1-2 indivuduals | 3 Participants |
| Rapid Treatment With Sofosbuvir/Velpatasvir (Intervention Arm) | Impact of Engagement in HCV Treatment on Frequency of Substance Use or Injection Risk Behaviors | Week 48 | Injected alone | 1 Participants |
| Rapid Treatment With Sofosbuvir/Velpatasvir (Intervention Arm) | Impact of Engagement in HCV Treatment on Frequency of Substance Use or Injection Risk Behaviors | Week 48 | Did not inject | 5 Participants |
| Usual Care (Control Arm) | Impact of Engagement in HCV Treatment on Frequency of Substance Use or Injection Risk Behaviors | Week 48 | Did not inject | 2 Participants |
| Usual Care (Control Arm) | Impact of Engagement in HCV Treatment on Frequency of Substance Use or Injection Risk Behaviors | Entry | Injected with 3 or more individuals | 2 Participants |
| Usual Care (Control Arm) | Impact of Engagement in HCV Treatment on Frequency of Substance Use or Injection Risk Behaviors | Week 48 | Injected with 3 or more individuals | 1 Participants |
| Usual Care (Control Arm) | Impact of Engagement in HCV Treatment on Frequency of Substance Use or Injection Risk Behaviors | Entry | Injected with 1-2 indivuduals | 5 Participants |
| Usual Care (Control Arm) | Impact of Engagement in HCV Treatment on Frequency of Substance Use or Injection Risk Behaviors | Week 48 | Injected alone | 0 Participants |
| Usual Care (Control Arm) | Impact of Engagement in HCV Treatment on Frequency of Substance Use or Injection Risk Behaviors | Entry | Injected alone | 4 Participants |
| Usual Care (Control Arm) | Impact of Engagement in HCV Treatment on Frequency of Substance Use or Injection Risk Behaviors | Week 48 | Injected with 1-2 indivuduals | 4 Participants |
| Usual Care (Control Arm) | Impact of Engagement in HCV Treatment on Frequency of Substance Use or Injection Risk Behaviors | Entry | Did not inject | 0 Participants |
Secondary
Number of Participants in Both Arms Who Achieve SVR12, or Are RNA Negative at Baseline, That Have HCV Reinfection by Study Week 48
Time frame: 48 wks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Rapid Treatment With Sofosbuvir/Velpatasvir (Intervention Arm) | Number of Participants in Both Arms Who Achieve SVR12, or Are RNA Negative at Baseline, That Have HCV Reinfection by Study Week 48 | 1 Participants |
| Usual Care (Control Arm) | Number of Participants in Both Arms Who Achieve SVR12, or Are RNA Negative at Baseline, That Have HCV Reinfection by Study Week 48 | 0 Participants |
| Baseline RNA Negative | Number of Participants in Both Arms Who Achieve SVR12, or Are RNA Negative at Baseline, That Have HCV Reinfection by Study Week 48 | 1 Participants |
Secondary
Presence of Resistance Associated Substitutions (RAS) in Treated Patients With Treatment Failure
Time frame: 48 wks
Population: Resistance testing data was not collected.
Secondary
The Proportion of Participants Who Initiate Treatment for HCV
The proportion of participants who initiate treatment for HCV in the intervention arm compared to the usual care arm by study week 48.
Time frame: Week 48
Population: Thirteen participants who were HCV-RNA negative at baseline excluded from analysis since they do not have hepatitis C and are not eligible for treatment. One participant in the intervention arm was deemed ineligible after randomization and was not included in analysis.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Rapid Treatment With Sofosbuvir/Velpatasvir (Intervention Arm) | The Proportion of Participants Who Initiate Treatment for HCV | 13 Participants |
| Usual Care (Control Arm) | The Proportion of Participants Who Initiate Treatment for HCV | 3 Participants |
p-value: 0.0007Chi-squared