Trial Outcomes & Findings for Efficacy and Safety of Sofosbuvir/Velpatasvir Fixed Dose Combination for 12 Weeks in Adults With Chronic Hepatitis C Virus (HCV) and Human Immunodeficiency Virus (HIV)-1 Coinfection (NCT NCT02480712)
NCT ID: NCT02480712
Last Updated: 2018-11-16
Results Overview
SVR12 was defined as HCV RNA \< the lower limit of quantitation (LLOQ) 12 weeks following the last dose of study drug.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
107 participants
Primary outcome timeframe
Posttreatment Week 12
Results posted on
2018-11-16
Participant Flow
Participants were enrolled at 17 study sites in the United States. The first participant was screened on 01 July 2015. The last study visit occurred on 22 June 2016.
149 participants were screened.
Participant milestones
| Measure |
SOF/VEL 12 Weeks
Sofosbuvir/velpatasvir (SOF/VEL; Epclusa®) (400/100 mg) fixed-dose combination (FDC) tablet orally once daily in HCV treatment-naive and treatment-experienced (including treatment intolerant) participants with chronic HCV infection who were coinfected with HIV-1
|
|---|---|
|
Overall Study
STARTED
|
107
|
|
Overall Study
COMPLETED
|
96
|
|
Overall Study
NOT COMPLETED
|
11
|
Reasons for withdrawal
| Measure |
SOF/VEL 12 Weeks
Sofosbuvir/velpatasvir (SOF/VEL; Epclusa®) (400/100 mg) fixed-dose combination (FDC) tablet orally once daily in HCV treatment-naive and treatment-experienced (including treatment intolerant) participants with chronic HCV infection who were coinfected with HIV-1
|
|---|---|
|
Overall Study
Enrolled but Never Treated
|
1
|
|
Overall Study
Lost to Follow-up
|
5
|
|
Overall Study
Withdrew Consent
|
3
|
|
Overall Study
Death
|
1
|
|
Overall Study
Lack of Efficacy
|
1
|
Baseline Characteristics
Participants in the Safety Analysis Set were analyzed by tenofovir disoproxil fumarate(TDF)-containing antiretroviral therapy (ART) at baseline: * Boosted TDF-containing regimens * Non-boosted TDF-containing regimens * Non TDF-containing regimens
Baseline characteristics by cohort
| Measure |
SOF/VEL 12 Weeks
n=106 Participants
SOF/VEL (400/100 mg) FDC tablet orally once daily in HCV treatment-naive and treatment-experienced (including treatment intolerant) participants with chronic HCV infection who were coinfected with HIV-1
|
|---|---|
|
Age, Continuous
|
54 years
STANDARD_DEVIATION 9.0 • n=106 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=106 Participants
|
|
Sex: Female, Male
Male
|
91 Participants
n=106 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
48 Participants
n=106 Participants
|
|
Race/Ethnicity, Customized
White
|
54 Participants
n=106 Participants
|
|
Race/Ethnicity, Customized
Asian
|
3 Participants
n=106 Participants
|
|
Race/Ethnicity, Customized
Other
|
1 Participants
n=106 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
15 Participants
n=106 Participants
|
|
Race/Ethnicity, Customized
Not Hispanic or Latino
|
91 Participants
n=106 Participants
|
|
IL28b Status
CC
|
24 Participants
n=106 Participants
|
|
IL28b Status
CT
|
52 Participants
n=106 Participants
|
|
IL28b Status
TT
|
30 Participants
n=106 Participants
|
|
HCV RNA
|
6.3 log10 IU/mL
STANDARD_DEVIATION 0.57 • n=106 Participants
|
|
HCV RNA Category
< 800,000 IU/mL
|
28 Participants
n=106 Participants
|
|
HCV RNA Category
≥ 800,000 IU/mL
|
78 Participants
n=106 Participants
|
|
HIV RNA category
Boosted TDF Containing Regimens · HIV RNA < 50 copies/mL
|
55 Participants
n=56 Participants • Participants in the Safety Analysis Set were analyzed by tenofovir disoproxil fumarate(TDF)-containing antiretroviral therapy (ART) at baseline: * Boosted TDF-containing regimens * Non-boosted TDF-containing regimens * Non TDF-containing regimens
|
|
HIV RNA category
Boosted TDF Containing Regimens · HIV RNA ≥ 50 copies/mL
|
1 Participants
n=56 Participants • Participants in the Safety Analysis Set were analyzed by tenofovir disoproxil fumarate(TDF)-containing antiretroviral therapy (ART) at baseline: * Boosted TDF-containing regimens * Non-boosted TDF-containing regimens * Non TDF-containing regimens
|
|
HIV RNA category
Non-Boosted TDF Containing Regimens · HIV RNA < 50 copies/mL
|
35 Participants
n=35 Participants • Participants in the Safety Analysis Set were analyzed by tenofovir disoproxil fumarate(TDF)-containing antiretroviral therapy (ART) at baseline: * Boosted TDF-containing regimens * Non-boosted TDF-containing regimens * Non TDF-containing regimens
|
|
HIV RNA category
Non-Boosted TDF Containing Regimens · HIV RNA ≥ 50 copies/mL
|
0 Participants
n=35 Participants • Participants in the Safety Analysis Set were analyzed by tenofovir disoproxil fumarate(TDF)-containing antiretroviral therapy (ART) at baseline: * Boosted TDF-containing regimens * Non-boosted TDF-containing regimens * Non TDF-containing regimens
|
|
HIV RNA category
Non TDF Containing Regimens · HIV RNA < 50 copies/mL
|
14 Participants
n=15 Participants • Participants in the Safety Analysis Set were analyzed by tenofovir disoproxil fumarate(TDF)-containing antiretroviral therapy (ART) at baseline: * Boosted TDF-containing regimens * Non-boosted TDF-containing regimens * Non TDF-containing regimens
|
|
HIV RNA category
Non TDF Containing Regimens · HIV RNA ≥ 50 copies/mL
|
1 Participants
n=15 Participants • Participants in the Safety Analysis Set were analyzed by tenofovir disoproxil fumarate(TDF)-containing antiretroviral therapy (ART) at baseline: * Boosted TDF-containing regimens * Non-boosted TDF-containing regimens * Non TDF-containing regimens
|
|
Serum Creatinine
Boosted TDF Containing Regimens
|
1.02 mg/dL
STANDARD_DEVIATION 0.194 • n=56 Participants • Participants in the Safety Analysis Set were analyzed by TDF-containing ART at baseline: * Boosted TDF-containing regimens * Non-boosted TDF-containing regimens * Non TDF-containing regimens
|
|
Serum Creatinine
Non-Boosted TDF Containing Regimens
|
0.98 mg/dL
STANDARD_DEVIATION 1.44 • n=35 Participants • Participants in the Safety Analysis Set were analyzed by TDF-containing ART at baseline: * Boosted TDF-containing regimens * Non-boosted TDF-containing regimens * Non TDF-containing regimens
|
|
Serum Creatinine
Non TDF Containing Regimens
|
1.02 mg/dL
STANDARD_DEVIATION 0.255 • n=15 Participants • Participants in the Safety Analysis Set were analyzed by TDF-containing ART at baseline: * Boosted TDF-containing regimens * Non-boosted TDF-containing regimens * Non TDF-containing regimens
|
PRIMARY outcome
Timeframe: Posttreatment Week 12Population: Full Analysis Set: All enrolled participants who received at least one dose of study drug.
SVR12 was defined as HCV RNA \< the lower limit of quantitation (LLOQ) 12 weeks following the last dose of study drug.
Outcome measures
| Measure |
SOF/VEL 12 Weeks
n=106 Participants
SOF/VEL (400/100 mg) FDC tablet orally once daily in HCV treatment-naive and treatment-experienced (including treatment intolerant) participants with chronic HCV infection who were coinfected with HIV-1
|
SOF/VEL 12 Weeks (Non-Boosted TDF Containing Regimens)
SOF/VEL (400/100 mg) FDC tablet orally once daily in HCV treatment-naive and treatment-experienced (including treatment intolerant) participants with chronic HCV infection who were coinfected with HIV-1. Data are summarized for participants who took non-boosted TDF-containing regimens (defined as regimens containing TDF and non-RTV or COBI-boosted PIs or other agents).
|
SOF/VEL 12 Weeks (Non TDF Containing Regimens)
SOF/VEL (400/100 mg) FDC tablet orally once daily in HCV treatment-naive and treatment-experienced (including treatment intolerant) participants with chronic HCV infection who were coinfected with HIV-1. Data are summarized for participants taking regimens that do not contain TDF.
|
|---|---|---|---|
|
Percentage of Participants With Sustained Virologic Response 12 Weeks After Discontinuation of Therapy (SVR12)
|
95.3 percentage of participants
Interval 89.3 to 98.5
|
—
|
—
|
PRIMARY outcome
Timeframe: Up to 12 weeksPopulation: Safety Analysis Set
Outcome measures
| Measure |
SOF/VEL 12 Weeks
n=106 Participants
SOF/VEL (400/100 mg) FDC tablet orally once daily in HCV treatment-naive and treatment-experienced (including treatment intolerant) participants with chronic HCV infection who were coinfected with HIV-1
|
SOF/VEL 12 Weeks (Non-Boosted TDF Containing Regimens)
SOF/VEL (400/100 mg) FDC tablet orally once daily in HCV treatment-naive and treatment-experienced (including treatment intolerant) participants with chronic HCV infection who were coinfected with HIV-1. Data are summarized for participants who took non-boosted TDF-containing regimens (defined as regimens containing TDF and non-RTV or COBI-boosted PIs or other agents).
|
SOF/VEL 12 Weeks (Non TDF Containing Regimens)
SOF/VEL (400/100 mg) FDC tablet orally once daily in HCV treatment-naive and treatment-experienced (including treatment intolerant) participants with chronic HCV infection who were coinfected with HIV-1. Data are summarized for participants taking regimens that do not contain TDF.
|
|---|---|---|---|
|
Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event
|
1.9 percentage of participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Posttreatment Weeks 4 and 24Population: Full Analysis Set
SVR4 and SVR24 were defined as HCV RNA \< LLOQ at 4 and 24 weeks following the last dose of study drug, respectively.
Outcome measures
| Measure |
SOF/VEL 12 Weeks
n=106 Participants
SOF/VEL (400/100 mg) FDC tablet orally once daily in HCV treatment-naive and treatment-experienced (including treatment intolerant) participants with chronic HCV infection who were coinfected with HIV-1
|
SOF/VEL 12 Weeks (Non-Boosted TDF Containing Regimens)
SOF/VEL (400/100 mg) FDC tablet orally once daily in HCV treatment-naive and treatment-experienced (including treatment intolerant) participants with chronic HCV infection who were coinfected with HIV-1. Data are summarized for participants who took non-boosted TDF-containing regimens (defined as regimens containing TDF and non-RTV or COBI-boosted PIs or other agents).
|
SOF/VEL 12 Weeks (Non TDF Containing Regimens)
SOF/VEL (400/100 mg) FDC tablet orally once daily in HCV treatment-naive and treatment-experienced (including treatment intolerant) participants with chronic HCV infection who were coinfected with HIV-1. Data are summarized for participants taking regimens that do not contain TDF.
|
|---|---|---|---|
|
Percentage of Participants With Sustained Virologic Response 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)
SVR4
|
95.3 percentage of participants
Interval 89.3 to 98.5
|
—
|
—
|
|
Percentage of Participants With Sustained Virologic Response 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)
SVR24
|
95.3 percentage of participants
Interval 89.3 to 98.5
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 12 WeeksPopulation: Participants in the Full Analysis Set with available data were analyzed.
Outcome measures
| Measure |
SOF/VEL 12 Weeks
n=106 Participants
SOF/VEL (400/100 mg) FDC tablet orally once daily in HCV treatment-naive and treatment-experienced (including treatment intolerant) participants with chronic HCV infection who were coinfected with HIV-1
|
SOF/VEL 12 Weeks (Non-Boosted TDF Containing Regimens)
SOF/VEL (400/100 mg) FDC tablet orally once daily in HCV treatment-naive and treatment-experienced (including treatment intolerant) participants with chronic HCV infection who were coinfected with HIV-1. Data are summarized for participants who took non-boosted TDF-containing regimens (defined as regimens containing TDF and non-RTV or COBI-boosted PIs or other agents).
|
SOF/VEL 12 Weeks (Non TDF Containing Regimens)
SOF/VEL (400/100 mg) FDC tablet orally once daily in HCV treatment-naive and treatment-experienced (including treatment intolerant) participants with chronic HCV infection who were coinfected with HIV-1. Data are summarized for participants taking regimens that do not contain TDF.
|
|---|---|---|---|
|
Percentage of Participants With HCV RNA < LLOQ on Treatment
Week 1
|
25.7 percentage of participants
Interval 17.7 to 35.2
|
—
|
—
|
|
Percentage of Participants With HCV RNA < LLOQ on Treatment
Week 2
|
68.0 percentage of participants
Interval 58.0 to 76.8
|
—
|
—
|
|
Percentage of Participants With HCV RNA < LLOQ on Treatment
Week 4
|
92.2 percentage of participants
Interval 85.3 to 96.6
|
—
|
—
|
|
Percentage of Participants With HCV RNA < LLOQ on Treatment
Week 6
|
99.0 percentage of participants
Interval 94.7 to 100.0
|
—
|
—
|
|
Percentage of Participants With HCV RNA < LLOQ on Treatment
Week 8
|
100.0 percentage of participants
Interval 96.4 to 100.0
|
—
|
—
|
|
Percentage of Participants With HCV RNA < LLOQ on Treatment
Week 10
|
100.0 percentage of participants
Interval 96.4 to 100.0
|
—
|
—
|
|
Percentage of Participants With HCV RNA < LLOQ on Treatment
Week 12
|
100.0 percentage of participants
Interval 96.4 to 100.0
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline to Week 12Population: Participants in the Full Analysis Set with available data were analyzed.
Outcome measures
| Measure |
SOF/VEL 12 Weeks
n=106 Participants
SOF/VEL (400/100 mg) FDC tablet orally once daily in HCV treatment-naive and treatment-experienced (including treatment intolerant) participants with chronic HCV infection who were coinfected with HIV-1
|
SOF/VEL 12 Weeks (Non-Boosted TDF Containing Regimens)
SOF/VEL (400/100 mg) FDC tablet orally once daily in HCV treatment-naive and treatment-experienced (including treatment intolerant) participants with chronic HCV infection who were coinfected with HIV-1. Data are summarized for participants who took non-boosted TDF-containing regimens (defined as regimens containing TDF and non-RTV or COBI-boosted PIs or other agents).
|
SOF/VEL 12 Weeks (Non TDF Containing Regimens)
SOF/VEL (400/100 mg) FDC tablet orally once daily in HCV treatment-naive and treatment-experienced (including treatment intolerant) participants with chronic HCV infection who were coinfected with HIV-1. Data are summarized for participants taking regimens that do not contain TDF.
|
|---|---|---|---|
|
HCV RNA Change From Baseline/Day 1
Change at Week 8
|
-5.17 log10 IU/mL
Standard Deviation 0.575
|
—
|
—
|
|
HCV RNA Change From Baseline/Day 1
Change at Week 1
|
-4.47 log10 IU/mL
Standard Deviation 0.606
|
—
|
—
|
|
HCV RNA Change From Baseline/Day 1
Change at Week 2
|
-4.97 log10 IU/mL
Standard Deviation 0.577
|
—
|
—
|
|
HCV RNA Change From Baseline/Day 1
Change at Week 4
|
-5.15 log10 IU/mL
Standard Deviation 0.560
|
—
|
—
|
|
HCV RNA Change From Baseline/Day 1
Change at Week 6
|
-5.18 log10 IU/mL
Standard Deviation 0.572
|
—
|
—
|
|
HCV RNA Change From Baseline/Day 1
Change at Week 10
|
-5.17 log10 IU/mL
Standard Deviation 0.575
|
—
|
—
|
|
HCV RNA Change From Baseline/Day 1
Change at Week 12
|
-5.17 log10 IU/mL
Standard Deviation 0.575
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to Posttreatment Week 24Population: Full Analysis Set
Virologic failure was defined as: * On-treatment virologic failure: * Breakthrough (confirmed HCV RNA ≥ LLOQ after having previously had HCV RNA \< LLOQ while on treatment), or * Rebound (confirmed \> 1 log10 IU/mL increase in HCV RNA from nadir while on treatment), or * Non-response (HCV RNA persistently ≥ LLOQ through 8 weeks of treatment) * Virologic relapse: * Confirmed HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA \< LLOQ at last on-treatment visit
Outcome measures
| Measure |
SOF/VEL 12 Weeks
n=106 Participants
SOF/VEL (400/100 mg) FDC tablet orally once daily in HCV treatment-naive and treatment-experienced (including treatment intolerant) participants with chronic HCV infection who were coinfected with HIV-1
|
SOF/VEL 12 Weeks (Non-Boosted TDF Containing Regimens)
SOF/VEL (400/100 mg) FDC tablet orally once daily in HCV treatment-naive and treatment-experienced (including treatment intolerant) participants with chronic HCV infection who were coinfected with HIV-1. Data are summarized for participants who took non-boosted TDF-containing regimens (defined as regimens containing TDF and non-RTV or COBI-boosted PIs or other agents).
|
SOF/VEL 12 Weeks (Non TDF Containing Regimens)
SOF/VEL (400/100 mg) FDC tablet orally once daily in HCV treatment-naive and treatment-experienced (including treatment intolerant) participants with chronic HCV infection who were coinfected with HIV-1. Data are summarized for participants taking regimens that do not contain TDF.
|
|---|---|---|---|
|
Percentage of Participants With Virologic Failure
|
1.9 percentage of participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 12 WeeksPopulation: Participants in the Safety Analysis Set with available data were analyzed by TDF-containing ART at baseline: * Boosted TDF-containing regimens * Non-boosted TDF-containing regimens * Non TDF-containing regimens
Outcome measures
| Measure |
SOF/VEL 12 Weeks
n=56 Participants
SOF/VEL (400/100 mg) FDC tablet orally once daily in HCV treatment-naive and treatment-experienced (including treatment intolerant) participants with chronic HCV infection who were coinfected with HIV-1
|
SOF/VEL 12 Weeks (Non-Boosted TDF Containing Regimens)
n=35 Participants
SOF/VEL (400/100 mg) FDC tablet orally once daily in HCV treatment-naive and treatment-experienced (including treatment intolerant) participants with chronic HCV infection who were coinfected with HIV-1. Data are summarized for participants who took non-boosted TDF-containing regimens (defined as regimens containing TDF and non-RTV or COBI-boosted PIs or other agents).
|
SOF/VEL 12 Weeks (Non TDF Containing Regimens)
n=15 Participants
SOF/VEL (400/100 mg) FDC tablet orally once daily in HCV treatment-naive and treatment-experienced (including treatment intolerant) participants with chronic HCV infection who were coinfected with HIV-1. Data are summarized for participants taking regimens that do not contain TDF.
|
|---|---|---|---|
|
Percentage of Participants That Maintained HIV-1 RNA < 50 Copies/mL While On HCV Treatment
Week 4
|
94.4 percentage of participants
|
97.1 percentage of participants
|
100 percentage of participants
|
|
Percentage of Participants That Maintained HIV-1 RNA < 50 Copies/mL While On HCV Treatment
Week 8
|
96.3 percentage of participants
|
97.1 percentage of participants
|
100 percentage of participants
|
|
Percentage of Participants That Maintained HIV-1 RNA < 50 Copies/mL While On HCV Treatment
Week 12
|
96.2 percentage of participants
|
100 percentage of participants
|
92.9 percentage of participants
|
SECONDARY outcome
Timeframe: Week 12; Posttreatment Week 12Population: Participants in the Safety Analysis Set with available data were analyzed by TDF-containing ART at baseline: * Boosted TDF-containing regimens * Non-boosted TDF-containing regimens * Non TDF-containing regimens
Outcome measures
| Measure |
SOF/VEL 12 Weeks
n=56 Participants
SOF/VEL (400/100 mg) FDC tablet orally once daily in HCV treatment-naive and treatment-experienced (including treatment intolerant) participants with chronic HCV infection who were coinfected with HIV-1
|
SOF/VEL 12 Weeks (Non-Boosted TDF Containing Regimens)
n=35 Participants
SOF/VEL (400/100 mg) FDC tablet orally once daily in HCV treatment-naive and treatment-experienced (including treatment intolerant) participants with chronic HCV infection who were coinfected with HIV-1. Data are summarized for participants who took non-boosted TDF-containing regimens (defined as regimens containing TDF and non-RTV or COBI-boosted PIs or other agents).
|
SOF/VEL 12 Weeks (Non TDF Containing Regimens)
n=15 Participants
SOF/VEL (400/100 mg) FDC tablet orally once daily in HCV treatment-naive and treatment-experienced (including treatment intolerant) participants with chronic HCV infection who were coinfected with HIV-1. Data are summarized for participants taking regimens that do not contain TDF.
|
|---|---|---|---|
|
Serum Creatinine Change From Baseline At the End of Treatment and At Posttreatment Week 12
Change at Week 12
|
0.09 mg/dL
Standard Deviation 0.196
|
0.04 mg/dL
Standard Deviation 0.107
|
0.00 mg/dL
Standard Deviation 0.083
|
|
Serum Creatinine Change From Baseline At the End of Treatment and At Posttreatment Week 12
Change at Posttreatment Week 12
|
0.04 mg/dL
Standard Deviation 0.153
|
0.02 mg/dL
Standard Deviation 0.142
|
-0.06 mg/dL
Standard Deviation 0.204
|
Adverse Events
SOF/VEL 12 Weeks (Boosted TDF Containing Regimens)
Serious events: 2 serious events
Other events: 34 other events
Deaths: 0 deaths
SOF/VEL 12 Weeks (Non-Boosted TDF Containing Regimens)
Serious events: 0 serious events
Other events: 19 other events
Deaths: 0 deaths
SOF/VEL 12 Weeks (Non TDF Containing Regimens)
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
SOF/VEL 12 Weeks (Boosted TDF Containing Regimens)
n=56 participants at risk
SOF/VEL (400/100 mg) FDC tablet orally once daily in HCV treatment-naive and treatment-experienced (including treatment intolerant) participants with chronic HCV infection who were coinfected with HIV-1. Data for participants who took boosted TDF-containing regimens (defined as regimens containing TDF and RTV or COBI-boosted PIs or other agents (eg, EVG/COBI)) are summarized in this group.
|
SOF/VEL 12 Weeks (Non-Boosted TDF Containing Regimens)
n=35 participants at risk
SOF/VEL (400/100 mg) FDC tablet orally once daily in HCV treatment-naive and treatment-experienced (including treatment intolerant) participants with chronic HCV infection who were coinfected with HIV-1. Data are summarized for participants who took non-boosted TDF-containing regimens (defined as regimens containing TDF and non-RTV or COBI-boosted PIs or other agents).
|
SOF/VEL 12 Weeks (Non TDF Containing Regimens)
n=15 participants at risk
SOF/VEL (400/100 mg) FDC tablet orally once daily in HCV treatment-naive and treatment-experienced (including treatment intolerant) participants with chronic HCV infection who were coinfected with HIV-1. Data are summarized for participants taking regimens that do not contain TDF.
|
|---|---|---|---|
|
Infections and infestations
Localised infection
|
1.8%
1/56 • Up to 12 Weeks Plus 30 Days
Safety Analysis Set
|
0.00%
0/35 • Up to 12 Weeks Plus 30 Days
Safety Analysis Set
|
0.00%
0/15 • Up to 12 Weeks Plus 30 Days
Safety Analysis Set
|
|
Infections and infestations
Sepsis
|
1.8%
1/56 • Up to 12 Weeks Plus 30 Days
Safety Analysis Set
|
0.00%
0/35 • Up to 12 Weeks Plus 30 Days
Safety Analysis Set
|
0.00%
0/15 • Up to 12 Weeks Plus 30 Days
Safety Analysis Set
|
|
Infections and infestations
Urinary tract infection bacterial
|
1.8%
1/56 • Up to 12 Weeks Plus 30 Days
Safety Analysis Set
|
0.00%
0/35 • Up to 12 Weeks Plus 30 Days
Safety Analysis Set
|
0.00%
0/15 • Up to 12 Weeks Plus 30 Days
Safety Analysis Set
|
|
Nervous system disorders
Radial nerve palsy
|
1.8%
1/56 • Up to 12 Weeks Plus 30 Days
Safety Analysis Set
|
0.00%
0/35 • Up to 12 Weeks Plus 30 Days
Safety Analysis Set
|
0.00%
0/15 • Up to 12 Weeks Plus 30 Days
Safety Analysis Set
|
Other adverse events
| Measure |
SOF/VEL 12 Weeks (Boosted TDF Containing Regimens)
n=56 participants at risk
SOF/VEL (400/100 mg) FDC tablet orally once daily in HCV treatment-naive and treatment-experienced (including treatment intolerant) participants with chronic HCV infection who were coinfected with HIV-1. Data for participants who took boosted TDF-containing regimens (defined as regimens containing TDF and RTV or COBI-boosted PIs or other agents (eg, EVG/COBI)) are summarized in this group.
|
SOF/VEL 12 Weeks (Non-Boosted TDF Containing Regimens)
n=35 participants at risk
SOF/VEL (400/100 mg) FDC tablet orally once daily in HCV treatment-naive and treatment-experienced (including treatment intolerant) participants with chronic HCV infection who were coinfected with HIV-1. Data are summarized for participants who took non-boosted TDF-containing regimens (defined as regimens containing TDF and non-RTV or COBI-boosted PIs or other agents).
|
SOF/VEL 12 Weeks (Non TDF Containing Regimens)
n=15 participants at risk
SOF/VEL (400/100 mg) FDC tablet orally once daily in HCV treatment-naive and treatment-experienced (including treatment intolerant) participants with chronic HCV infection who were coinfected with HIV-1. Data are summarized for participants taking regimens that do not contain TDF.
|
|---|---|---|---|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
3.6%
2/56 • Up to 12 Weeks Plus 30 Days
Safety Analysis Set
|
2.9%
1/35 • Up to 12 Weeks Plus 30 Days
Safety Analysis Set
|
6.7%
1/15 • Up to 12 Weeks Plus 30 Days
Safety Analysis Set
|
|
Nervous system disorders
Headache
|
12.5%
7/56 • Up to 12 Weeks Plus 30 Days
Safety Analysis Set
|
17.1%
6/35 • Up to 12 Weeks Plus 30 Days
Safety Analysis Set
|
6.7%
1/15 • Up to 12 Weeks Plus 30 Days
Safety Analysis Set
|
|
Psychiatric disorders
Abnormal dreams
|
5.4%
3/56 • Up to 12 Weeks Plus 30 Days
Safety Analysis Set
|
2.9%
1/35 • Up to 12 Weeks Plus 30 Days
Safety Analysis Set
|
0.00%
0/15 • Up to 12 Weeks Plus 30 Days
Safety Analysis Set
|
|
Psychiatric disorders
Depression
|
5.4%
3/56 • Up to 12 Weeks Plus 30 Days
Safety Analysis Set
|
2.9%
1/35 • Up to 12 Weeks Plus 30 Days
Safety Analysis Set
|
0.00%
0/15 • Up to 12 Weeks Plus 30 Days
Safety Analysis Set
|
|
Psychiatric disorders
Insomnia
|
7.1%
4/56 • Up to 12 Weeks Plus 30 Days
Safety Analysis Set
|
8.6%
3/35 • Up to 12 Weeks Plus 30 Days
Safety Analysis Set
|
0.00%
0/15 • Up to 12 Weeks Plus 30 Days
Safety Analysis Set
|
|
Psychiatric disorders
Nervousness
|
0.00%
0/56 • Up to 12 Weeks Plus 30 Days
Safety Analysis Set
|
0.00%
0/35 • Up to 12 Weeks Plus 30 Days
Safety Analysis Set
|
6.7%
1/15 • Up to 12 Weeks Plus 30 Days
Safety Analysis Set
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
1.8%
1/56 • Up to 12 Weeks Plus 30 Days
Safety Analysis Set
|
5.7%
2/35 • Up to 12 Weeks Plus 30 Days
Safety Analysis Set
|
0.00%
0/15 • Up to 12 Weeks Plus 30 Days
Safety Analysis Set
|
|
Gastrointestinal disorders
Abdominal distension
|
5.4%
3/56 • Up to 12 Weeks Plus 30 Days
Safety Analysis Set
|
5.7%
2/35 • Up to 12 Weeks Plus 30 Days
Safety Analysis Set
|
0.00%
0/15 • Up to 12 Weeks Plus 30 Days
Safety Analysis Set
|
|
Gastrointestinal disorders
Constipation
|
3.6%
2/56 • Up to 12 Weeks Plus 30 Days
Safety Analysis Set
|
5.7%
2/35 • Up to 12 Weeks Plus 30 Days
Safety Analysis Set
|
0.00%
0/15 • Up to 12 Weeks Plus 30 Days
Safety Analysis Set
|
|
Gastrointestinal disorders
Diarrhoea
|
10.7%
6/56 • Up to 12 Weeks Plus 30 Days
Safety Analysis Set
|
5.7%
2/35 • Up to 12 Weeks Plus 30 Days
Safety Analysis Set
|
0.00%
0/15 • Up to 12 Weeks Plus 30 Days
Safety Analysis Set
|
|
Gastrointestinal disorders
Nausea
|
7.1%
4/56 • Up to 12 Weeks Plus 30 Days
Safety Analysis Set
|
5.7%
2/35 • Up to 12 Weeks Plus 30 Days
Safety Analysis Set
|
6.7%
1/15 • Up to 12 Weeks Plus 30 Days
Safety Analysis Set
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/56 • Up to 12 Weeks Plus 30 Days
Safety Analysis Set
|
0.00%
0/35 • Up to 12 Weeks Plus 30 Days
Safety Analysis Set
|
6.7%
1/15 • Up to 12 Weeks Plus 30 Days
Safety Analysis Set
|
|
Gastrointestinal disorders
Vomiting
|
1.8%
1/56 • Up to 12 Weeks Plus 30 Days
Safety Analysis Set
|
2.9%
1/35 • Up to 12 Weeks Plus 30 Days
Safety Analysis Set
|
6.7%
1/15 • Up to 12 Weeks Plus 30 Days
Safety Analysis Set
|
|
General disorders
Chest discomfort
|
0.00%
0/56 • Up to 12 Weeks Plus 30 Days
Safety Analysis Set
|
2.9%
1/35 • Up to 12 Weeks Plus 30 Days
Safety Analysis Set
|
6.7%
1/15 • Up to 12 Weeks Plus 30 Days
Safety Analysis Set
|
|
General disorders
Fatigue
|
28.6%
16/56 • Up to 12 Weeks Plus 30 Days
Safety Analysis Set
|
20.0%
7/35 • Up to 12 Weeks Plus 30 Days
Safety Analysis Set
|
20.0%
3/15 • Up to 12 Weeks Plus 30 Days
Safety Analysis Set
|
|
Immune system disorders
Seasonal allergy
|
0.00%
0/56 • Up to 12 Weeks Plus 30 Days
Safety Analysis Set
|
5.7%
2/35 • Up to 12 Weeks Plus 30 Days
Safety Analysis Set
|
0.00%
0/15 • Up to 12 Weeks Plus 30 Days
Safety Analysis Set
|
|
Infections and infestations
Bronchitis
|
5.4%
3/56 • Up to 12 Weeks Plus 30 Days
Safety Analysis Set
|
0.00%
0/35 • Up to 12 Weeks Plus 30 Days
Safety Analysis Set
|
0.00%
0/15 • Up to 12 Weeks Plus 30 Days
Safety Analysis Set
|
|
Infections and infestations
Fungal infection
|
0.00%
0/56 • Up to 12 Weeks Plus 30 Days
Safety Analysis Set
|
0.00%
0/35 • Up to 12 Weeks Plus 30 Days
Safety Analysis Set
|
6.7%
1/15 • Up to 12 Weeks Plus 30 Days
Safety Analysis Set
|
|
Infections and infestations
Nasopharyngitis
|
5.4%
3/56 • Up to 12 Weeks Plus 30 Days
Safety Analysis Set
|
5.7%
2/35 • Up to 12 Weeks Plus 30 Days
Safety Analysis Set
|
0.00%
0/15 • Up to 12 Weeks Plus 30 Days
Safety Analysis Set
|
|
Infections and infestations
Upper respiratory tract infection
|
14.3%
8/56 • Up to 12 Weeks Plus 30 Days
Safety Analysis Set
|
2.9%
1/35 • Up to 12 Weeks Plus 30 Days
Safety Analysis Set
|
0.00%
0/15 • Up to 12 Weeks Plus 30 Days
Safety Analysis Set
|
|
Infections and infestations
Urinary tract infection
|
3.6%
2/56 • Up to 12 Weeks Plus 30 Days
Safety Analysis Set
|
0.00%
0/35 • Up to 12 Weeks Plus 30 Days
Safety Analysis Set
|
13.3%
2/15 • Up to 12 Weeks Plus 30 Days
Safety Analysis Set
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
10.7%
6/56 • Up to 12 Weeks Plus 30 Days
Safety Analysis Set
|
2.9%
1/35 • Up to 12 Weeks Plus 30 Days
Safety Analysis Set
|
6.7%
1/15 • Up to 12 Weeks Plus 30 Days
Safety Analysis Set
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/56 • Up to 12 Weeks Plus 30 Days
Safety Analysis Set
|
5.7%
2/35 • Up to 12 Weeks Plus 30 Days
Safety Analysis Set
|
0.00%
0/15 • Up to 12 Weeks Plus 30 Days
Safety Analysis Set
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/56 • Up to 12 Weeks Plus 30 Days
Safety Analysis Set
|
0.00%
0/35 • Up to 12 Weeks Plus 30 Days
Safety Analysis Set
|
6.7%
1/15 • Up to 12 Weeks Plus 30 Days
Safety Analysis Set
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
1.8%
1/56 • Up to 12 Weeks Plus 30 Days
Safety Analysis Set
|
0.00%
0/35 • Up to 12 Weeks Plus 30 Days
Safety Analysis Set
|
6.7%
1/15 • Up to 12 Weeks Plus 30 Days
Safety Analysis Set
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/56 • Up to 12 Weeks Plus 30 Days
Safety Analysis Set
|
0.00%
0/35 • Up to 12 Weeks Plus 30 Days
Safety Analysis Set
|
6.7%
1/15 • Up to 12 Weeks Plus 30 Days
Safety Analysis Set
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
3.6%
2/56 • Up to 12 Weeks Plus 30 Days
Safety Analysis Set
|
5.7%
2/35 • Up to 12 Weeks Plus 30 Days
Safety Analysis Set
|
0.00%
0/15 • Up to 12 Weeks Plus 30 Days
Safety Analysis Set
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
3.6%
2/56 • Up to 12 Weeks Plus 30 Days
Safety Analysis Set
|
0.00%
0/35 • Up to 12 Weeks Plus 30 Days
Safety Analysis Set
|
6.7%
1/15 • Up to 12 Weeks Plus 30 Days
Safety Analysis Set
|
|
Skin and subcutaneous tissue disorders
Rash
|
1.8%
1/56 • Up to 12 Weeks Plus 30 Days
Safety Analysis Set
|
0.00%
0/35 • Up to 12 Weeks Plus 30 Days
Safety Analysis Set
|
6.7%
1/15 • Up to 12 Weeks Plus 30 Days
Safety Analysis Set
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee After conclusion of the study and without prior written approval from Gilead, investigators in this study may communicate, orally present, or publish in scientific journals or other media only after the following conditions have been met: * The results of the study in their entirety have been publicly disclosed by or with the consent of Gilead in an abstract, manuscript, or presentation form; or * The study has been completed at all study sites for at least 2 years
- Publication restrictions are in place
Restriction type: OTHER