Trial Outcomes & Findings for HCV Seek, Test and Rapid Treatment for Young PWID (NCT NCT03627546)
NCT ID: NCT03627546
Last Updated: 2024-04-29
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
39 participants
Primary outcome timeframe
Week 48
Results posted on
2024-04-29
Participant Flow
Participant milestones
| Measure |
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,
|
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.
|
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.
|
|---|---|---|---|
|
Overall Study
STARTED
|
15
|
11
|
13
|
|
Overall Study
COMPLETED
|
14
|
11
|
0
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
13
|
Reasons for withdrawal
| Measure |
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,
|
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.
|
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.
|
|---|---|---|---|
|
Overall Study
Deemed ineligible after ransdomization
|
1
|
0
|
0
|
|
Overall Study
HCV RNA Negative (protocol pre-specified)
|
0
|
0
|
13
|
Baseline Characteristics
HCV Seek, Test and Rapid Treatment for Young PWID
Baseline characteristics by cohort
| Measure |
Baseline RNA-positive Rapid Treatment With Sofosbuvir/Velpatasvir (Intervention Arm)
n=14 Participants
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,
|
Baseline RNA-positive Usual Care (Control Arm)
n=11 Participants
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.
|
Baseline RNA Negative
n=13 Participants
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.
|
Total
n=38 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
26.07 years
STANDARD_DEVIATION 3.54 • n=5 Participants
|
25.36 years
STANDARD_DEVIATION 2.66 • n=7 Participants
|
26.92 years
STANDARD_DEVIATION 2.87 • n=5 Participants
|
26.16 years
STANDARD_DEVIATION 3.06 • n=4 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
28 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Race/ethnicity · Non-Hispanic White
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
21 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Race/ethnicity · Non-Hispanic Black
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Race/ethnicity · Hispanic
|
6 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
13 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Race/ethnicity · Other
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
14 participants
n=5 Participants
|
11 participants
n=7 Participants
|
13 participants
n=5 Participants
|
38 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Week 48Population: 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.
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.
Outcome measures
| Measure |
Rapid Treatment With Sofosbuvir/Velpatasvir (Intervention Arm)
n=14 Participants
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,
|
Usual Care (Control Arm)
n=11 Participants
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.
|
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.
|
|---|---|---|---|
|
The Proportion of Participants Who Achieve Sustained Virologic Response 12 (SVR12) With Rapid Treatment Strategy Compared to Usual Care
|
9 Participants
|
1 Participants
|
—
|
SECONDARY outcome
Timeframe: Week 48Population: 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.
The proportion of participants who initiate treatment for HCV in the intervention arm compared to the usual care arm by study week 48.
Outcome measures
| Measure |
Rapid Treatment With Sofosbuvir/Velpatasvir (Intervention Arm)
n=14 Participants
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,
|
Usual Care (Control Arm)
n=11 Participants
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.
|
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.
|
|---|---|---|---|
|
The Proportion of Participants Who Initiate Treatment for HCV
|
13 Participants
|
3 Participants
|
—
|
SECONDARY outcome
Timeframe: 48 wksPopulation: Resistance testing data was not collected.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 48 wksOutcome measures
| Measure |
Rapid Treatment With Sofosbuvir/Velpatasvir (Intervention Arm)
n=14 Participants
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,
|
Usual Care (Control Arm)
n=11 Participants
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.
|
Baseline RNA Negative
n=13 Participants
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.
|
|---|---|---|---|
|
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
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Baseline and 48 weeksPopulation: 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.
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
Outcome measures
| Measure |
Rapid Treatment With Sofosbuvir/Velpatasvir (Intervention Arm)
n=14 Participants
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,
|
Usual Care (Control Arm)
n=11 Participants
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.
|
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.
|
|---|---|---|---|
|
Impact of Engagement in HCV Treatment on Frequency of Substance Use or Injection Risk Behaviors
Week 48 · Injected with 1-2 indivuduals
|
3 Participants
|
4 Participants
|
—
|
|
Impact of Engagement in HCV Treatment on Frequency of Substance Use or Injection Risk Behaviors
Entry · Injected with 3 or more individuals
|
3 Participants
|
2 Participants
|
—
|
|
Impact of Engagement in HCV Treatment on Frequency of Substance Use or Injection Risk Behaviors
Entry · Injected with 1-2 indivuduals
|
10 Participants
|
5 Participants
|
—
|
|
Impact of Engagement in HCV Treatment on Frequency of Substance Use or Injection Risk Behaviors
Entry · Injected alone
|
1 Participants
|
4 Participants
|
—
|
|
Impact of Engagement in HCV Treatment on Frequency of Substance Use or Injection Risk Behaviors
Entry · Did not inject
|
0 Participants
|
0 Participants
|
—
|
|
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
|
1 Participants
|
—
|
|
Impact of Engagement in HCV Treatment on Frequency of Substance Use or Injection Risk Behaviors
Week 48 · Injected alone
|
1 Participants
|
0 Participants
|
—
|
|
Impact of Engagement in HCV Treatment on Frequency of Substance Use or Injection Risk Behaviors
Week 48 · Did not inject
|
5 Participants
|
2 Participants
|
—
|
Adverse Events
Rapid Treatment With Sofosbuvir/Velpatasvir (Intervention Arm)
Serious events: 6 serious events
Other events: 0 other events
Deaths: 0 deaths
Usual Care (Control Arm)
Serious events: 5 serious events
Other events: 0 other events
Deaths: 0 deaths
Baseline RNA Negative
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Rapid Treatment With Sofosbuvir/Velpatasvir (Intervention Arm)
n=14 participants at risk
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,
|
Usual Care (Control Arm)
n=11 participants at risk
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.
|
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. All-Cause Mortality, Serious, and Other (Not Including Serious) Adverse Events were not monitored/assessed in the "Baseline RNA Negative" Arm/Group
|
|---|---|---|---|
|
Injury, poisoning and procedural complications
Drug overdose
|
14.3%
2/14 • Number of events 2 • 12 months
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. All-Cause Mortality, Serious, and Other (Not Including Serious) Adverse Events were not monitored/assessed in the "Baseline RNA Negative" Arm/Group
|
36.4%
4/11 • Number of events 6 • 12 months
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. All-Cause Mortality, Serious, and Other (Not Including Serious) Adverse Events were not monitored/assessed in the "Baseline RNA Negative" Arm/Group
|
—
0/0 • 12 months
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. All-Cause Mortality, Serious, and Other (Not Including Serious) Adverse Events were not monitored/assessed in the "Baseline RNA Negative" Arm/Group
|
|
Infections and infestations
Skin/soft tissue infection
|
21.4%
3/14 • Number of events 3 • 12 months
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. All-Cause Mortality, Serious, and Other (Not Including Serious) Adverse Events were not monitored/assessed in the "Baseline RNA Negative" Arm/Group
|
0.00%
0/11 • 12 months
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. All-Cause Mortality, Serious, and Other (Not Including Serious) Adverse Events were not monitored/assessed in the "Baseline RNA Negative" Arm/Group
|
—
0/0 • 12 months
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. All-Cause Mortality, Serious, and Other (Not Including Serious) Adverse Events were not monitored/assessed in the "Baseline RNA Negative" Arm/Group
|
|
Infections and infestations
pneumonia
|
7.1%
1/14 • Number of events 1 • 12 months
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. All-Cause Mortality, Serious, and Other (Not Including Serious) Adverse Events were not monitored/assessed in the "Baseline RNA Negative" Arm/Group
|
0.00%
0/11 • 12 months
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. All-Cause Mortality, Serious, and Other (Not Including Serious) Adverse Events were not monitored/assessed in the "Baseline RNA Negative" Arm/Group
|
—
0/0 • 12 months
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. All-Cause Mortality, Serious, and Other (Not Including Serious) Adverse Events were not monitored/assessed in the "Baseline RNA Negative" Arm/Group
|
|
Pregnancy, puerperium and perinatal conditions
miscarriage
|
7.1%
1/14 • Number of events 1 • 12 months
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. All-Cause Mortality, Serious, and Other (Not Including Serious) Adverse Events were not monitored/assessed in the "Baseline RNA Negative" Arm/Group
|
0.00%
0/11 • 12 months
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. All-Cause Mortality, Serious, and Other (Not Including Serious) Adverse Events were not monitored/assessed in the "Baseline RNA Negative" Arm/Group
|
—
0/0 • 12 months
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. All-Cause Mortality, Serious, and Other (Not Including Serious) Adverse Events were not monitored/assessed in the "Baseline RNA Negative" Arm/Group
|
|
Injury, poisoning and procedural complications
Spleen laceration
|
7.1%
1/14 • Number of events 1 • 12 months
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. All-Cause Mortality, Serious, and Other (Not Including Serious) Adverse Events were not monitored/assessed in the "Baseline RNA Negative" Arm/Group
|
0.00%
0/11 • 12 months
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. All-Cause Mortality, Serious, and Other (Not Including Serious) Adverse Events were not monitored/assessed in the "Baseline RNA Negative" Arm/Group
|
—
0/0 • 12 months
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. All-Cause Mortality, Serious, and Other (Not Including Serious) Adverse Events were not monitored/assessed in the "Baseline RNA Negative" Arm/Group
|
|
Nervous system disorders
Seizure from withdrawal
|
0.00%
0/14 • 12 months
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. All-Cause Mortality, Serious, and Other (Not Including Serious) Adverse Events were not monitored/assessed in the "Baseline RNA Negative" Arm/Group
|
9.1%
1/11 • Number of events 2 • 12 months
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. All-Cause Mortality, Serious, and Other (Not Including Serious) Adverse Events were not monitored/assessed in the "Baseline RNA Negative" Arm/Group
|
—
0/0 • 12 months
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. All-Cause Mortality, Serious, and Other (Not Including Serious) Adverse Events were not monitored/assessed in the "Baseline RNA Negative" Arm/Group
|
|
Gastrointestinal disorders
GI bleed
|
0.00%
0/14 • 12 months
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. All-Cause Mortality, Serious, and Other (Not Including Serious) Adverse Events were not monitored/assessed in the "Baseline RNA Negative" Arm/Group
|
9.1%
1/11 • Number of events 1 • 12 months
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. All-Cause Mortality, Serious, and Other (Not Including Serious) Adverse Events were not monitored/assessed in the "Baseline RNA Negative" Arm/Group
|
—
0/0 • 12 months
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. All-Cause Mortality, Serious, and Other (Not Including Serious) Adverse Events were not monitored/assessed in the "Baseline RNA Negative" Arm/Group
|
|
Infections and infestations
Sepsis
|
0.00%
0/14 • 12 months
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. All-Cause Mortality, Serious, and Other (Not Including Serious) Adverse Events were not monitored/assessed in the "Baseline RNA Negative" Arm/Group
|
9.1%
1/11 • Number of events 1 • 12 months
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. All-Cause Mortality, Serious, and Other (Not Including Serious) Adverse Events were not monitored/assessed in the "Baseline RNA Negative" Arm/Group
|
—
0/0 • 12 months
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. All-Cause Mortality, Serious, and Other (Not Including Serious) Adverse Events were not monitored/assessed in the "Baseline RNA Negative" Arm/Group
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place