Trial Outcomes & Findings for Safety and Efficacy of E/C/F/TDF Versus RTV-Boosted ATV Plus FTC/TDF in HIV-1 Infected, Antiretroviral Treatment-Naive Women (NCT NCT01705574)
NCT ID: NCT01705574
Last Updated: 2019-09-20
Results Overview
The percentage of participants with HIV-1 RNA \< 50 copies/mL at Week 48 of the double-blind phase was analyzed using the snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
583 participants
Primary outcome timeframe
Week 48
Results posted on
2019-09-20
Participant Flow
Participants were enrolled at study sites in North America, Europe, Dominican Republic, Thailand, and Uganda. The first participant was screened on 24 October 2012. The last study visit occurred on 06 September 2018.
810 participants were screened.
Participant milestones
| Measure |
Double-Blind STB to Open-Label STB
Double-Blind (DB) Phase: Stribild® (STB; elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate; E/C/F/TDF) 150/150/200/300 mg fixed-dose combination (FDC) + atazanavir (ATV) placebo + ritonavir (RTV) placebo + Truvada® (TVD; emtricitabine/tenofovir disoproxil fumarate; FTC/TDF) placebo orally once daily with food for 48 weeks
Open-Label Extension (OLE) Phase: After 48 weeks of blinded treatment participants continued on the blinded treatment for 12 weeks and returned for an unblinding visit at Week 60. Participants who were virologically suppressed at Week 48 during the double-blind phase had the option to receive open-label STB FDC orally once daily with food for 48 weeks.
|
Double-Blind ATV+RTV+TVD
Double-Blind Phase: ATV 300 mg + RTV 100 mg + TVD (200/300 mg) FDC + STB placebo orally once daily with food for 48 weeks
|
Double-Blind ATV+RTV+TVD to Open-Label GEN
Double-Blind Phase: ATV 300 mg + RTV 100 mg + TVD (200/300 mg) FDC + STB placebo orally once daily with food for 48 weeks
Open-Label Extension Phase: After 48 weeks of blinded treatment participants continued on the blinded treatment for 12 weeks and returned for an unblinding visit at Week 60. Participants who were virologically suppressed at Week 48 during the double-blind phase had the option to be re-randomized and receive open-label (OL) Genvoya® (GEN; elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide; E/C/F/TAF) 150/150/200/10 mg FDC orally once daily with food for 48 weeks.
|
Double-Blind ATV+RTV+TVD to Open-Label ATV+RTV+TVD
Double-Blind Phase: ATV 300 mg + RTV 100 mg + TVD (200/300 mg) FDC + STB placebo orally once daily with food for 48 weeks
Open-Label Extension Phase: After 48 weeks of blinded treatment participants continued on the blinded treatment for 12 weeks and returned for an unblinding visit at Week 60. Participants who were virologically suppressed at Week 48 during the double-blind phase had the option to be re-randomized and recieve open-label ATV 300 mg + RTV 100 mg + TVD 200/300 mg FDC orally once daily with food for 48 weeks.
|
|---|---|---|---|---|
|
Double-Blind Phase
STARTED
|
293
|
290
|
0
|
0
|
|
Double-Blind Phase
COMPLETED
|
260
|
249
|
0
|
0
|
|
Double-Blind Phase
NOT COMPLETED
|
33
|
41
|
0
|
0
|
|
Open-Label Extension Phase
STARTED
|
246
|
0
|
159
|
53
|
|
Open-Label Extension Phase
COMPLETED
|
231
|
0
|
148
|
48
|
|
Open-Label Extension Phase
NOT COMPLETED
|
15
|
0
|
11
|
5
|
Reasons for withdrawal
| Measure |
Double-Blind STB to Open-Label STB
Double-Blind (DB) Phase: Stribild® (STB; elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate; E/C/F/TDF) 150/150/200/300 mg fixed-dose combination (FDC) + atazanavir (ATV) placebo + ritonavir (RTV) placebo + Truvada® (TVD; emtricitabine/tenofovir disoproxil fumarate; FTC/TDF) placebo orally once daily with food for 48 weeks
Open-Label Extension (OLE) Phase: After 48 weeks of blinded treatment participants continued on the blinded treatment for 12 weeks and returned for an unblinding visit at Week 60. Participants who were virologically suppressed at Week 48 during the double-blind phase had the option to receive open-label STB FDC orally once daily with food for 48 weeks.
|
Double-Blind ATV+RTV+TVD
Double-Blind Phase: ATV 300 mg + RTV 100 mg + TVD (200/300 mg) FDC + STB placebo orally once daily with food for 48 weeks
|
Double-Blind ATV+RTV+TVD to Open-Label GEN
Double-Blind Phase: ATV 300 mg + RTV 100 mg + TVD (200/300 mg) FDC + STB placebo orally once daily with food for 48 weeks
Open-Label Extension Phase: After 48 weeks of blinded treatment participants continued on the blinded treatment for 12 weeks and returned for an unblinding visit at Week 60. Participants who were virologically suppressed at Week 48 during the double-blind phase had the option to be re-randomized and receive open-label (OL) Genvoya® (GEN; elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide; E/C/F/TAF) 150/150/200/10 mg FDC orally once daily with food for 48 weeks.
|
Double-Blind ATV+RTV+TVD to Open-Label ATV+RTV+TVD
Double-Blind Phase: ATV 300 mg + RTV 100 mg + TVD (200/300 mg) FDC + STB placebo orally once daily with food for 48 weeks
Open-Label Extension Phase: After 48 weeks of blinded treatment participants continued on the blinded treatment for 12 weeks and returned for an unblinding visit at Week 60. Participants who were virologically suppressed at Week 48 during the double-blind phase had the option to be re-randomized and recieve open-label ATV 300 mg + RTV 100 mg + TVD 200/300 mg FDC orally once daily with food for 48 weeks.
|
|---|---|---|---|---|
|
Double-Blind Phase
Lost to Follow-up
|
12
|
16
|
0
|
0
|
|
Double-Blind Phase
Adverse Event
|
3
|
10
|
0
|
0
|
|
Double-Blind Phase
Withdrew Consent
|
8
|
5
|
0
|
0
|
|
Double-Blind Phase
Non-Compliance with Study Drug
|
4
|
5
|
0
|
0
|
|
Double-Blind Phase
Pregnancy
|
1
|
1
|
0
|
0
|
|
Double-Blind Phase
Protocol Violation
|
1
|
0
|
0
|
0
|
|
Double-Blind Phase
Randomized but Not Treated
|
4
|
4
|
0
|
0
|
|
Open-Label Extension Phase
Lost to Follow-up
|
6
|
0
|
2
|
2
|
|
Open-Label Extension Phase
Withdrew Consent
|
4
|
0
|
4
|
1
|
|
Open-Label Extension Phase
Adverse Event
|
3
|
0
|
0
|
1
|
|
Open-Label Extension Phase
Death
|
2
|
0
|
1
|
0
|
|
Open-Label Extension Phase
Non-Compliance with Study Drug
|
0
|
0
|
1
|
0
|
|
Open-Label Extension Phase
Physician Decision
|
0
|
0
|
2
|
0
|
|
Open-Label Extension Phase
Pregnancy
|
0
|
0
|
1
|
1
|
Baseline Characteristics
Safety and Efficacy of E/C/F/TDF Versus RTV-Boosted ATV Plus FTC/TDF in HIV-1 Infected, Antiretroviral Treatment-Naive Women
Baseline characteristics by cohort
| Measure |
Double-Blind STB to Open-Label STB
n=289 Participants
Double-Blind Phase: STB 150/150/200/300 mg FDC + ATV placebo + RTV placebo + TVD placebo orally once daily with food for 48 weeks
Open-Label Extension Phase: After 48 weeks of blinded treatment participants continued on the blinded treatment for 12 weeks and returned for an unblinding visit at Week 60. Participants who were virologically suppressed at Week 48 during the double-blind phase had the option to receive open-label STB FDC orally once daily with food for 48 weeks.
|
Double-Blind ATV+RTV+TVD to OL GEN or OL ATV+ RTV+TVD
n=286 Participants
Double-Blind Phase: ATV 300 mg + RTV 100 mg + TVD (200/300 mg) FDC + STB placebo orally once daily with food for 48 weeks
Open-Label Extension Phase: After 48 weeks of blinded treatment participants continued on the blinded treatment for 12 weeks and returned for an unblinding visit at Week 60. Participants who were virologically suppressed at Week 48 during the double-blind phase had the option to be re-randomized and either receive open-label GEN 150/150/200/10 mg FDC or open-label ATV 300 mg + RTV 100 mg + TVD 200/300 mg FDC orally once daily with food for 48 weeks.
|
Total
n=575 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
36 years
STANDARD_DEVIATION 10.1 • n=5 Participants
|
36 years
STANDARD_DEVIATION 9.7 • n=7 Participants
|
36 years
STANDARD_DEVIATION 9.9 • n=5 Participants
|
|
Sex: Female, Male
Female
|
289 Participants
n=5 Participants
|
286 Participants
n=7 Participants
|
575 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
9 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black
|
143 Participants
n=5 Participants
|
133 Participants
n=7 Participants
|
276 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Pacific Islander
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
128 Participants
n=5 Participants
|
119 Participants
n=7 Participants
|
247 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
9 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Not Permitted
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
20 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
44 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Not Hispanic or Latino
|
269 Participants
n=5 Participants
|
262 Participants
n=7 Participants
|
531 Participants
n=5 Participants
|
|
Region of Enrollment
Russia
|
101 participants
n=5 Participants
|
91 participants
n=7 Participants
|
192 participants
n=5 Participants
|
|
Region of Enrollment
United States
|
59 participants
n=5 Participants
|
60 participants
n=7 Participants
|
119 participants
n=5 Participants
|
|
Region of Enrollment
United Kingdom
|
8 participants
n=5 Participants
|
12 participants
n=7 Participants
|
20 participants
n=5 Participants
|
|
Region of Enrollment
Thailand
|
9 participants
n=5 Participants
|
15 participants
n=7 Participants
|
24 participants
n=5 Participants
|
|
Region of Enrollment
Portugal
|
8 participants
n=5 Participants
|
13 participants
n=7 Participants
|
21 participants
n=5 Participants
|
|
Region of Enrollment
Belgium
|
3 participants
n=5 Participants
|
5 participants
n=7 Participants
|
8 participants
n=5 Participants
|
|
Region of Enrollment
Dominican Republic
|
6 participants
n=5 Participants
|
13 participants
n=7 Participants
|
19 participants
n=5 Participants
|
|
Region of Enrollment
Italy
|
4 participants
n=5 Participants
|
1 participants
n=7 Participants
|
5 participants
n=5 Participants
|
|
Region of Enrollment
Mexico
|
3 participants
n=5 Participants
|
1 participants
n=7 Participants
|
4 participants
n=5 Participants
|
|
Region of Enrollment
Uganda
|
87 participants
n=5 Participants
|
74 participants
n=7 Participants
|
161 participants
n=5 Participants
|
|
Region of Enrollment
France
|
1 participants
n=5 Participants
|
1 participants
n=7 Participants
|
2 participants
n=5 Participants
|
|
CD4 Cell Count
|
376 cells/µL
STANDARD_DEVIATION 199.6 • n=5 Participants
|
385 cells/µL
STANDARD_DEVIATION 210.2 • n=7 Participants
|
381 cells/µL
STANDARD_DEVIATION 204.8 • n=5 Participants
|
|
HIV-1 RNA Category
≤ 100,000 copies/mL
|
220 Participants
n=5 Participants
|
214 Participants
n=7 Participants
|
434 Participants
n=5 Participants
|
|
HIV-1 RNA Category
> 100,000 to ≤400,000 copies/mL
|
44 Participants
n=5 Participants
|
50 Participants
n=7 Participants
|
94 Participants
n=5 Participants
|
|
HIV-1 RNA Category
> 400,000 copies/mL
|
25 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
47 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Week 48Population: Participants in the Intent-to-Treat (ITT) Analysis Set (randomized and received at least one dose of study drug) were analyzed.
The percentage of participants with HIV-1 RNA \< 50 copies/mL at Week 48 of the double-blind phase was analyzed using the snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status.
Outcome measures
| Measure |
Double-Blind STB
n=289 Participants
Double-Blind Phase: STB 150/150/200/300 mg FDC + ATV placebo + RTV placebo + TVD placebo orally once daily with food for 48 weeks
|
Double-Blind ATV+RTV+TVD
n=286 Participants
Double-Blind Phase: ATV 300 mg boosted with RTV 100 mg + TVD (200/300 mg) FDC + E/C/F/TDF placebo once daily for 48 weeks
|
Open-Label ATV + RTV + TVD
Open-Label Extension Phase: After 48 weeks of blinded treatment participants continued on the blinded treatment for 12 weeks and returned for an unblinding visit at Week 60. Participants who were virologically suppressed at Week 48 during the double-blind phase had the option to be re-randomized and receive open-label ATV 300 mg + RTV 100 mg + TVD 200/300 mg FDC orally once daily with food for 48 weeks.
|
|---|---|---|---|
|
Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48 of the Double-Blind Phase as Determined by the US FDA-Defined Snapshot Algorithm
|
87.2 percentage of participants
|
80.8 percentage of participants
|
—
|
SECONDARY outcome
Timeframe: Baseline; Week 48Population: Participants in the ITT Analysis Set with available data were analyzed.
Outcome measures
| Measure |
Double-Blind STB
n=263 Participants
Double-Blind Phase: STB 150/150/200/300 mg FDC + ATV placebo + RTV placebo + TVD placebo orally once daily with food for 48 weeks
|
Double-Blind ATV+RTV+TVD
n=243 Participants
Double-Blind Phase: ATV 300 mg boosted with RTV 100 mg + TVD (200/300 mg) FDC + E/C/F/TDF placebo once daily for 48 weeks
|
Open-Label ATV + RTV + TVD
Open-Label Extension Phase: After 48 weeks of blinded treatment participants continued on the blinded treatment for 12 weeks and returned for an unblinding visit at Week 60. Participants who were virologically suppressed at Week 48 during the double-blind phase had the option to be re-randomized and receive open-label ATV 300 mg + RTV 100 mg + TVD 200/300 mg FDC orally once daily with food for 48 weeks.
|
|---|---|---|---|
|
Change From Baseline in CD4+ Cell Count at Week 48 of the Double-Blind Phase
|
221 cells/μL
Standard Deviation 165.1
|
212 cells/μL
Standard Deviation 176.8
|
—
|
SECONDARY outcome
Timeframe: Week 96Population: Participants in the ITT Analysis Set who received STB through 96 weeks were analyzed.
The percentage of participants with HIV-1 RNA \< 50 copies/mL at Week 96 was analyzed using the snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status.
Outcome measures
| Measure |
Double-Blind STB
n=278 Participants
Double-Blind Phase: STB 150/150/200/300 mg FDC + ATV placebo + RTV placebo + TVD placebo orally once daily with food for 48 weeks
|
Double-Blind ATV+RTV+TVD
Double-Blind Phase: ATV 300 mg boosted with RTV 100 mg + TVD (200/300 mg) FDC + E/C/F/TDF placebo once daily for 48 weeks
|
Open-Label ATV + RTV + TVD
Open-Label Extension Phase: After 48 weeks of blinded treatment participants continued on the blinded treatment for 12 weeks and returned for an unblinding visit at Week 60. Participants who were virologically suppressed at Week 48 during the double-blind phase had the option to be re-randomized and receive open-label ATV 300 mg + RTV 100 mg + TVD 200/300 mg FDC orally once daily with food for 48 weeks.
|
|---|---|---|---|
|
Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 96 for the STB Group as Determined by the US FDA-Defined Snapshot Algorithm
|
84.5 Percentage of participants
Interval 79.7 to 88.6
|
—
|
—
|
SECONDARY outcome
Timeframe: Open-Label Extension Week 48Population: Participants in the OLE ITT Analysis Set were analyzed.
The percentage of participants with HIV-1 RNA \< 50 copies/mL at Week 48 of the open-label phase was analyzed using the snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status.
Outcome measures
| Measure |
Double-Blind STB
n=159 Participants
Double-Blind Phase: STB 150/150/200/300 mg FDC + ATV placebo + RTV placebo + TVD placebo orally once daily with food for 48 weeks
|
Double-Blind ATV+RTV+TVD
n=53 Participants
Double-Blind Phase: ATV 300 mg boosted with RTV 100 mg + TVD (200/300 mg) FDC + E/C/F/TDF placebo once daily for 48 weeks
|
Open-Label ATV + RTV + TVD
Open-Label Extension Phase: After 48 weeks of blinded treatment participants continued on the blinded treatment for 12 weeks and returned for an unblinding visit at Week 60. Participants who were virologically suppressed at Week 48 during the double-blind phase had the option to be re-randomized and receive open-label ATV 300 mg + RTV 100 mg + TVD 200/300 mg FDC orally once daily with food for 48 weeks.
|
|---|---|---|---|
|
Percentage of Participants Receiving STB or ATV+RTV+TVD With HIV-1 RNA < 50 Copies/mL at Week 48 of the Open-Label Extension Phase
|
94.3 Percentage of participants
|
86.8 Percentage of participants
|
—
|
SECONDARY outcome
Timeframe: Baseline; Open-Label Extension Week 48Population: Participants in the OLE ITT Analysis Set with available on-treatment data were analyzed.
Outcome measures
| Measure |
Double-Blind STB
n=239 Participants
Double-Blind Phase: STB 150/150/200/300 mg FDC + ATV placebo + RTV placebo + TVD placebo orally once daily with food for 48 weeks
|
Double-Blind ATV+RTV+TVD
n=151 Participants
Double-Blind Phase: ATV 300 mg boosted with RTV 100 mg + TVD (200/300 mg) FDC + E/C/F/TDF placebo once daily for 48 weeks
|
Open-Label ATV + RTV + TVD
n=49 Participants
Open-Label Extension Phase: After 48 weeks of blinded treatment participants continued on the blinded treatment for 12 weeks and returned for an unblinding visit at Week 60. Participants who were virologically suppressed at Week 48 during the double-blind phase had the option to be re-randomized and receive open-label ATV 300 mg + RTV 100 mg + TVD 200/300 mg FDC orally once daily with food for 48 weeks.
|
|---|---|---|---|
|
Change in CD4+ Cell Count at Week 48 of the Open-Label Extension Phase
|
265 cells/uL
Standard Deviation 190.4
|
35 cells/uL
Standard Deviation 137.5
|
49 cells/uL
Standard Deviation 204.8
|
Adverse Events
Double-Blind: STB
Serious events: 25 serious events
Other events: 176 other events
Deaths: 0 deaths
Double-Blind: ATV+RTV+TVD
Serious events: 29 serious events
Other events: 194 other events
Deaths: 0 deaths
DB STB to OL STB
Serious events: 13 serious events
Other events: 118 other events
Deaths: 0 deaths
DB ATV+RTV+TVD to OL GEN
Serious events: 12 serious events
Other events: 68 other events
Deaths: 0 deaths
DB ATV+RTV+TVD to OL ATV+RTV+TVD
Serious events: 4 serious events
Other events: 20 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Double-Blind: STB
n=289 participants at risk
Double-Blind Phase: STB 150/150/200/300 mg FDC + ATV placebo + RTV placebo + TVD placebo orally once daily with food for 48 weeks
|
Double-Blind: ATV+RTV+TVD
n=286 participants at risk
Double-Blind Phase: ATV 300 mg + RTV 100 mg + TVD (200/300 mg) FDC + STB placebo orally once daily with food for 48 weeks
|
DB STB to OL STB
n=246 participants at risk
Open-Label Extension Phase: After 48 weeks of blinded treatment participants continued on the blinded treatment for 12 weeks and returned for an unblinding visit at Week 60. Participants who were virologically suppressed at Week 48 during the double-blind phase had the option to receive open-label STB FDC orally once daily with food for 48 weeks.
|
DB ATV+RTV+TVD to OL GEN
n=159 participants at risk
Open-Label Extension Phase: After 48 weeks of blinded treatment participants continued on the blinded treatment for 12 weeks and returned for an unblinding visit at Week 60. Participants who were virologically suppressed at Week 48 during the double-blind phase had the option to be re-randomized and receive open-label GEN 150/150/200/10 mg FDC orally once daily with food for 48 weeks.
|
DB ATV+RTV+TVD to OL ATV+RTV+TVD
n=53 participants at risk
Open-Label Extension Phase: After 48 weeks of blinded treatment participants continued on the blinded treatment for 12 weeks and returned for an unblinding visit at Week 60. Participants who were virologically suppressed at Week 48 during the double-blind phase had the option to be re-randomized and recieve open-label ATV 300 mg + RTV 100 mg + TVD (200/300 mg) FDC orally once daily with food for 48 weeks.
|
|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/289 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
0.35%
1/286 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
0.41%
1/246 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
0.00%
0/159 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
0.00%
0/53 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
|
Blood and lymphatic system disorders
Haemorrhagic anaemia
|
0.00%
0/289 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
0.35%
1/286 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
0.00%
0/246 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
0.00%
0/159 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
0.00%
0/53 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
0.00%
0/289 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
0.35%
1/286 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
0.00%
0/246 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
0.00%
0/159 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
0.00%
0/53 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
|
Cardiac disorders
Acute coronary syndrome
|
0.00%
0/289 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
0.00%
0/286 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
0.41%
1/246 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
0.00%
0/159 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
0.00%
0/53 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
|
Cardiac disorders
Angina unstable
|
0.35%
1/289 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
0.00%
0/286 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
0.00%
0/246 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
0.00%
0/159 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
0.00%
0/53 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
|
Cardiac disorders
Cardiomegaly
|
0.00%
0/289 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
0.35%
1/286 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
0.00%
0/246 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
0.00%
0/159 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
0.00%
0/53 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
|
Cardiac disorders
Coronary artery occlusion
|
0.00%
0/289 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
0.00%
0/286 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
0.00%
0/246 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
0.63%
1/159 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
0.00%
0/53 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
|
Eye disorders
Chalazion
|
0.00%
0/289 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
0.35%
1/286 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
0.00%
0/246 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
0.00%
0/159 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
0.00%
0/53 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/289 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
0.35%
1/286 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
0.41%
1/246 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
0.00%
0/159 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
1.9%
1/53 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
|
Gastrointestinal disorders
Gastritis
|
0.35%
1/289 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
0.00%
0/286 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
0.00%
0/246 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
0.00%
0/159 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
0.00%
0/53 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/289 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
0.00%
0/286 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
0.41%
1/246 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
0.63%
1/159 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
0.00%
0/53 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.35%
1/289 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
0.00%
0/286 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
0.00%
0/246 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
0.00%
0/159 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
0.00%
0/53 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/289 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
0.00%
0/286 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
0.41%
1/246 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
0.00%
0/159 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
0.00%
0/53 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
|
General disorders
Chest pain
|
0.00%
0/289 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
0.00%
0/286 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
0.41%
1/246 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
0.63%
1/159 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
0.00%
0/53 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
|
General disorders
Death
|
0.00%
0/289 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
0.00%
0/286 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
0.41%
1/246 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
0.00%
0/159 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
0.00%
0/53 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
|
General disorders
Malaise
|
0.35%
1/289 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
0.00%
0/286 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
0.00%
0/246 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
0.00%
0/159 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
0.00%
0/53 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.35%
1/289 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
0.00%
0/286 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
0.00%
0/246 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
0.00%
0/159 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
0.00%
0/53 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.00%
0/289 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
0.35%
1/286 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
0.00%
0/246 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
0.00%
0/159 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
0.00%
0/53 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/289 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
0.00%
0/286 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
0.00%
0/246 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
0.63%
1/159 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
0.00%
0/53 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
|
Hepatobiliary disorders
Chronic hepatitis
|
0.35%
1/289 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
0.00%
0/286 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
0.00%
0/246 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
0.00%
0/159 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
0.00%
0/53 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
|
Hepatobiliary disorders
Drug-induced liver injury
|
0.00%
0/289 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
0.35%
1/286 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
0.00%
0/246 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
0.00%
0/159 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
0.00%
0/53 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
|
Infections and infestations
Arthritis bacterial
|
0.35%
1/289 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
0.00%
0/286 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
0.00%
0/246 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
0.00%
0/159 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
0.00%
0/53 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
|
Infections and infestations
Bone tuberculosis
|
0.00%
0/289 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
0.00%
0/286 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
0.41%
1/246 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
0.00%
0/159 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
0.00%
0/53 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
|
Infections and infestations
Breast abscess
|
0.00%
0/289 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
0.00%
0/286 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
0.41%
1/246 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
0.00%
0/159 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
0.00%
0/53 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
|
Infections and infestations
Catheter site infection
|
0.35%
1/289 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
0.00%
0/286 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
0.00%
0/246 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
0.00%
0/159 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
0.00%
0/53 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/289 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
0.35%
1/286 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
0.00%
0/246 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
0.00%
0/159 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
0.00%
0/53 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
|
Infections and infestations
Furuncle
|
0.00%
0/289 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
0.35%
1/286 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
0.00%
0/246 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
0.00%
0/159 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
0.00%
0/53 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
|
Infections and infestations
Gastroenteritis
|
0.35%
1/289 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
0.00%
0/286 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
0.41%
1/246 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
0.00%
0/159 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
0.00%
0/53 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
|
Infections and infestations
Gastroenteritis viral
|
0.00%
0/289 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
0.35%
1/286 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
0.00%
0/246 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
0.00%
0/159 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
0.00%
0/53 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
|
Infections and infestations
Malaria
|
0.35%
1/289 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
0.00%
0/286 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
0.00%
0/246 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
0.00%
0/159 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
0.00%
0/53 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
|
Infections and infestations
Ophthalmic herpes zoster
|
0.00%
0/289 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
0.35%
1/286 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
0.00%
0/246 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
0.00%
0/159 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
0.00%
0/53 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
|
Infections and infestations
Pelvic inflammatory disease
|
0.35%
1/289 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
0.00%
0/286 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
0.00%
0/246 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
0.00%
0/159 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
0.00%
0/53 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
|
Infections and infestations
Peritonitis
|
0.35%
1/289 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
0.35%
1/286 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
0.00%
0/246 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
0.00%
0/159 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
0.00%
0/53 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
|
Infections and infestations
Pneumonia
|
0.69%
2/289 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
0.35%
1/286 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
0.41%
1/246 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
0.00%
0/159 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
0.00%
0/53 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
|
Infections and infestations
Pulmonary tuberculosis
|
0.35%
1/289 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
0.00%
0/286 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
0.00%
0/246 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
0.00%
0/159 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
0.00%
0/53 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
|
Infections and infestations
Subcutaneous abscess
|
0.35%
1/289 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
0.00%
0/286 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
0.00%
0/246 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
0.00%
0/159 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
0.00%
0/53 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
|
Infections and infestations
Syphilis
|
0.00%
0/289 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
0.35%
1/286 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
0.00%
0/246 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
0.00%
0/159 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
0.00%
0/53 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/289 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
0.35%
1/286 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
0.00%
0/246 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
0.00%
0/159 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
0.00%
0/53 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.35%
1/289 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
0.00%
0/286 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
0.00%
0/246 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
0.00%
0/159 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
0.00%
0/53 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
|
Investigations
Electrocardiogram T wave inversion
|
0.00%
0/289 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
0.00%
0/286 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
0.41%
1/246 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
0.00%
0/159 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
0.00%
0/53 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.35%
1/289 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
0.00%
0/286 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
0.41%
1/246 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
0.00%
0/159 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
0.00%
0/53 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.35%
1/289 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
0.00%
0/286 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
0.00%
0/246 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
0.00%
0/159 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
0.00%
0/53 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/289 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
0.35%
1/286 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
0.00%
0/246 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
0.00%
0/159 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
0.00%
0/53 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.35%
1/289 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
0.00%
0/286 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
0.00%
0/246 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
0.00%
0/159 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
0.00%
0/53 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.35%
1/289 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
0.00%
0/286 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
0.00%
0/246 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
0.00%
0/159 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
0.00%
0/53 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/289 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
0.70%
2/286 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
0.00%
0/246 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
0.00%
0/159 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
0.00%
0/53 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cervix carcinoma
|
0.35%
1/289 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
0.00%
0/286 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
0.41%
1/246 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
0.00%
0/159 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
0.00%
0/53 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Fibroadenoma of breast
|
0.00%
0/289 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
0.00%
0/286 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
0.41%
1/246 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
0.00%
0/159 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
0.00%
0/53 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Thyroid cancer
|
0.00%
0/289 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
0.00%
0/286 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
0.41%
1/246 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
0.00%
0/159 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
0.00%
0/53 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine leiomyoma
|
0.00%
0/289 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
0.00%
0/286 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
0.00%
0/246 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
0.63%
1/159 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
0.00%
0/53 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/289 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
0.00%
0/286 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
0.00%
0/246 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
0.63%
1/159 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
0.00%
0/53 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
|
Nervous system disorders
Headache
|
0.35%
1/289 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
0.00%
0/286 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
0.00%
0/246 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
0.00%
0/159 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
0.00%
0/53 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
|
Pregnancy, puerperium and perinatal conditions
Abortion spontaneous
|
0.69%
2/289 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
0.70%
2/286 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
0.41%
1/246 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
1.9%
3/159 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
3.8%
2/53 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
|
Pregnancy, puerperium and perinatal conditions
Ectopic pregnancy
|
0.35%
1/289 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
0.00%
0/286 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
0.00%
0/246 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
0.00%
0/159 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
1.9%
1/53 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
|
Pregnancy, puerperium and perinatal conditions
Gestational hypertension
|
0.35%
1/289 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
0.00%
0/286 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
0.00%
0/246 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
0.00%
0/159 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
0.00%
0/53 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
|
Pregnancy, puerperium and perinatal conditions
Imminent abortion
|
0.00%
0/289 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
0.35%
1/286 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
0.00%
0/246 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
0.00%
0/159 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
0.00%
0/53 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
|
Pregnancy, puerperium and perinatal conditions
Ruptured ectopic pregnancy
|
0.00%
0/289 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
0.00%
0/286 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
0.00%
0/246 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
0.00%
0/159 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
1.9%
1/53 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
|
Pregnancy, puerperium and perinatal conditions
Uterine hypertonus
|
0.00%
0/289 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
0.00%
0/286 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
0.00%
0/246 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
0.63%
1/159 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
0.00%
0/53 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/289 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
0.00%
0/286 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
0.00%
0/246 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
0.63%
1/159 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
0.00%
0/53 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
|
Psychiatric disorders
Conversion disorder
|
0.00%
0/289 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
0.00%
0/286 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
0.00%
0/246 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
0.63%
1/159 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
0.00%
0/53 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
|
Psychiatric disorders
Depression
|
0.69%
2/289 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
0.35%
1/286 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
0.00%
0/246 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
0.00%
0/159 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
0.00%
0/53 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
|
Psychiatric disorders
Depression suicidal
|
0.35%
1/289 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
0.00%
0/286 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
0.00%
0/246 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
0.00%
0/159 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
0.00%
0/53 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
|
Psychiatric disorders
Major depression
|
0.35%
1/289 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
0.00%
0/286 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
0.00%
0/246 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
0.00%
0/159 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
0.00%
0/53 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
|
Psychiatric disorders
Stress
|
0.35%
1/289 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
0.00%
0/286 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
0.00%
0/246 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
0.00%
0/159 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
0.00%
0/53 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
|
Psychiatric disorders
Substance abuse
|
0.00%
0/289 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
0.35%
1/286 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
0.00%
0/246 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
0.00%
0/159 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
0.00%
0/53 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
|
Psychiatric disorders
Suicidal ideation
|
0.00%
0/289 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
0.35%
1/286 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
0.00%
0/246 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
0.00%
0/159 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
0.00%
0/53 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
|
Psychiatric disorders
Suicide attempt
|
0.00%
0/289 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
0.35%
1/286 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
0.00%
0/246 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
0.00%
0/159 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
0.00%
0/53 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/289 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
0.70%
2/286 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
0.00%
0/246 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
0.00%
0/159 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
0.00%
0/53 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
|
Reproductive system and breast disorders
Cervical dysplasia
|
0.35%
1/289 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
0.00%
0/286 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
0.00%
0/246 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
0.00%
0/159 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
0.00%
0/53 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
|
Reproductive system and breast disorders
Ovarian cyst
|
0.00%
0/289 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
0.00%
0/286 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
0.00%
0/246 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
0.63%
1/159 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
0.00%
0/53 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
|
Reproductive system and breast disorders
Uterine haemorrhage
|
0.00%
0/289 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
0.35%
1/286 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
0.00%
0/246 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
0.00%
0/159 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
0.00%
0/53 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
0.35%
1/289 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
0.35%
1/286 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
0.00%
0/246 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
0.00%
0/159 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
0.00%
0/53 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.69%
2/289 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
0.00%
0/286 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
0.00%
0/246 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
0.00%
0/159 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
0.00%
0/53 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
|
Respiratory, thoracic and mediastinal disorders
Neonatal respiratory distress
|
0.00%
0/289 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
0.35%
1/286 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
0.00%
0/246 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
0.00%
0/159 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
0.00%
0/53 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
|
Respiratory, thoracic and mediastinal disorders
Pleurisy
|
0.00%
0/289 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
0.35%
1/286 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
0.00%
0/246 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
0.00%
0/159 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
0.00%
0/53 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
|
Skin and subcutaneous tissue disorders
Erythema multiforme
|
0.00%
0/289 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
0.35%
1/286 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
0.00%
0/246 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
0.00%
0/159 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
0.00%
0/53 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
|
Skin and subcutaneous tissue disorders
Stevens-Johnson syndrome
|
0.35%
1/289 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
0.35%
1/286 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
0.00%
0/246 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
0.00%
0/159 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
0.00%
0/53 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
|
Vascular disorders
Hypertension
|
0.00%
0/289 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
0.00%
0/286 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
0.41%
1/246 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
0.00%
0/159 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
0.00%
0/53 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
|
Vascular disorders
Hypotension
|
0.35%
1/289 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
0.00%
0/286 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
0.00%
0/246 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
0.00%
0/159 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
0.00%
0/53 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
Other adverse events
| Measure |
Double-Blind: STB
n=289 participants at risk
Double-Blind Phase: STB 150/150/200/300 mg FDC + ATV placebo + RTV placebo + TVD placebo orally once daily with food for 48 weeks
|
Double-Blind: ATV+RTV+TVD
n=286 participants at risk
Double-Blind Phase: ATV 300 mg + RTV 100 mg + TVD (200/300 mg) FDC + STB placebo orally once daily with food for 48 weeks
|
DB STB to OL STB
n=246 participants at risk
Open-Label Extension Phase: After 48 weeks of blinded treatment participants continued on the blinded treatment for 12 weeks and returned for an unblinding visit at Week 60. Participants who were virologically suppressed at Week 48 during the double-blind phase had the option to receive open-label STB FDC orally once daily with food for 48 weeks.
|
DB ATV+RTV+TVD to OL GEN
n=159 participants at risk
Open-Label Extension Phase: After 48 weeks of blinded treatment participants continued on the blinded treatment for 12 weeks and returned for an unblinding visit at Week 60. Participants who were virologically suppressed at Week 48 during the double-blind phase had the option to be re-randomized and receive open-label GEN 150/150/200/10 mg FDC orally once daily with food for 48 weeks.
|
DB ATV+RTV+TVD to OL ATV+RTV+TVD
n=53 participants at risk
Open-Label Extension Phase: After 48 weeks of blinded treatment participants continued on the blinded treatment for 12 weeks and returned for an unblinding visit at Week 60. Participants who were virologically suppressed at Week 48 during the double-blind phase had the option to be re-randomized and recieve open-label ATV 300 mg + RTV 100 mg + TVD (200/300 mg) FDC orally once daily with food for 48 weeks.
|
|---|---|---|---|---|---|
|
Gastrointestinal disorders
Dyspepsia
|
4.5%
13/289 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
5.2%
15/286 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
1.6%
4/246 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
1.9%
3/159 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
0.00%
0/53 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
|
Gastrointestinal disorders
Nausea
|
14.9%
43/289 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
14.3%
41/286 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
2.4%
6/246 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
4.4%
7/159 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
3.8%
2/53 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
|
Gastrointestinal disorders
Vomiting
|
9.7%
28/289 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
5.9%
17/286 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
1.2%
3/246 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
2.5%
4/159 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
0.00%
0/53 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
|
Blood and lymphatic system disorders
Anaemia
|
3.8%
11/289 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
4.9%
14/286 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
7.3%
18/246 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
2.5%
4/159 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
0.00%
0/53 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
|
Gastrointestinal disorders
Abdominal pain
|
5.9%
17/289 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
3.1%
9/286 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
0.41%
1/246 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
1.9%
3/159 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
3.8%
2/53 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
|
Gastrointestinal disorders
Diarrhoea
|
5.2%
15/289 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
6.6%
19/286 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
2.4%
6/246 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
3.1%
5/159 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
1.9%
1/53 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
|
General disorders
Fatigue
|
2.8%
8/289 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
5.2%
15/286 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
0.81%
2/246 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
1.9%
3/159 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
3.8%
2/53 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
|
Hepatobiliary disorders
Jaundice
|
0.35%
1/289 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
10.5%
30/286 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
0.00%
0/246 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
0.00%
0/159 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
1.9%
1/53 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
|
Hepatobiliary disorders
Ocular icterus
|
0.35%
1/289 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
11.9%
34/286 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
0.00%
0/246 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
0.00%
0/159 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
0.00%
0/53 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
|
Infections and infestations
Influenza
|
6.9%
20/289 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
7.0%
20/286 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
5.7%
14/246 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
7.5%
12/159 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
1.9%
1/53 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
|
Infections and infestations
Malaria
|
11.8%
34/289 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
8.7%
25/286 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
5.7%
14/246 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
5.0%
8/159 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
1.9%
1/53 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
|
Infections and infestations
Nasopharyngitis
|
5.2%
15/289 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
4.9%
14/286 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
3.3%
8/246 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
3.8%
6/159 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
0.00%
0/53 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
|
Infections and infestations
Upper respiratory tract infection
|
17.3%
50/289 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
15.7%
45/286 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
14.6%
36/246 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
14.5%
23/159 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
18.9%
10/53 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
|
Infections and infestations
Urinary tract infection
|
7.6%
22/289 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
8.0%
23/286 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
6.1%
15/246 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
5.7%
9/159 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
0.00%
0/53 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
|
Infections and infestations
Vulvovaginal candidiasis
|
7.3%
21/289 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
7.0%
20/286 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
6.1%
15/246 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
3.8%
6/159 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
7.5%
4/53 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
5.2%
15/289 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
4.9%
14/286 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
1.2%
3/246 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
0.00%
0/159 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
1.9%
1/53 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
3.5%
10/289 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
7.3%
21/286 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
3.7%
9/246 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
3.1%
5/159 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
1.9%
1/53 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
6.9%
20/289 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
5.9%
17/286 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
5.3%
13/246 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
8.8%
14/159 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
1.9%
1/53 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
|
Nervous system disorders
Dizziness
|
5.9%
17/289 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
3.5%
10/286 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
2.8%
7/246 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
0.00%
0/159 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
1.9%
1/53 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
|
Nervous system disorders
Headache
|
17.0%
49/289 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
15.4%
44/286 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
11.0%
27/246 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
12.6%
20/159 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
9.4%
5/53 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
|
Nervous system disorders
Neuropathy peripheral
|
7.3%
21/289 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
7.0%
20/286 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
4.9%
12/246 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
6.3%
10/159 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
13.2%
7/53 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
6.9%
20/289 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
6.3%
18/286 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
4.9%
12/246 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
5.7%
9/159 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
3.8%
2/53 • First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
|
Additional Information
Gilead Clinical Study Information Center
Gilead Sciences
Phone: 1-833-445-3230 (GILEAD-0)
Email: [email protected]
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