Trial Outcomes & Findings for Dolutegravir/Rilpivirine, Antiretroviral Efficacy Study Using Real-world Data in Subjects With Human Immunodeficiency Virus (HIV)-1 (NCT NCT03518060)
NCT ID: NCT03518060
Last Updated: 2024-10-16
Results Overview
Virologic suppression (VS) was defined as HIV-RNA less than (\<) 50 copies (c)/mL for at least 6 months or, if between 50-200 c/mL with a subsequent next available measurement (within 120 days) \<50 c/mL at Year 3 follow-up. Any subsequent measurement was accepted as a consecutive measurement as long as measured no later than 120 days after the initial measurement. If no subsequent HIV-RNA measurement was performed within 120 days, this was scored as a confirmed HIV-RNA greater than or equal to (\>=)200 c/mL.
Recruitment status
COMPLETED
Target enrollment
209 participants
Primary outcome timeframe
At Year 3
Results posted on
2024-10-16
Participant Flow
A total of 209 participants were enrolled in the full analysis set (FAS) from which 9 participants were excluded due to not meeting the eligibility criteria. Therefore, 200 participants formed the modified FAS (mFAS).
Participant milestones
| Measure |
Participants Who Received JULUCA
Virologically suppressed HIV positive participants, on a stable antiretroviral regimen, who switched to the 2-Drug Regimen JULUCA (Dolutegravir \[DTG\] / Rilpivirine \[RPV\]) were included in the study. Participants were followed-up for approximately 3 years during routine clinical practice.
|
|---|---|
|
Overall Study
STARTED
|
200
|
|
Overall Study
COMPLETED
|
124
|
|
Overall Study
NOT COMPLETED
|
76
|
Reasons for withdrawal
| Measure |
Participants Who Received JULUCA
Virologically suppressed HIV positive participants, on a stable antiretroviral regimen, who switched to the 2-Drug Regimen JULUCA (Dolutegravir \[DTG\] / Rilpivirine \[RPV\]) were included in the study. Participants were followed-up for approximately 3 years during routine clinical practice.
|
|---|---|
|
Overall Study
Death
|
1
|
|
Overall Study
Poor adherence
|
1
|
|
Overall Study
Withdrawal of informed consent
|
2
|
|
Overall Study
Interaction with comedication or comorbidities
|
4
|
|
Overall Study
Physician Decision
|
7
|
|
Overall Study
Adverse drug reactions
|
23
|
|
Overall Study
Withdrawal by Subject
|
25
|
|
Overall Study
Lost to Follow-up
|
13
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Participants Who Received JULUCA
n=200 Participants
Virologically suppressed HIV positive participants, on a stable antiretroviral regimen, who switched to the 2-Drug Regimen JULUCA (Dolutegravir \[DTG\] / Rilpivirine \[RPV\]) were included in the study. Participants were followed-up for approximately 3 years during routine clinical practice.
|
|---|---|
|
Age, Continuous
|
49.0 Years
n=200 Participants
|
|
Age, Customized
< 50 years
|
104 Participants
n=200 Participants
|
|
Age, Customized
>= 50 years
|
96 Participants
n=200 Participants
|
|
Sex: Female, Male
Female
|
19 Participants
n=200 Participants
|
|
Sex: Female, Male
Male
|
181 Participants
n=200 Participants
|
PRIMARY outcome
Timeframe: At Year 3Population: The analysis was performed on the modified Full Analysis Set (mFAS) which included all eligible participants who did not have any violation of inclusion or exclusion criteria which also included screening failures and major protocol deviations.
Virologic suppression (VS) was defined as HIV-RNA less than (\<) 50 copies (c)/mL for at least 6 months or, if between 50-200 c/mL with a subsequent next available measurement (within 120 days) \<50 c/mL at Year 3 follow-up. Any subsequent measurement was accepted as a consecutive measurement as long as measured no later than 120 days after the initial measurement. If no subsequent HIV-RNA measurement was performed within 120 days, this was scored as a confirmed HIV-RNA greater than or equal to (\>=)200 c/mL.
Outcome measures
| Measure |
Participants Who Received JULUCA
n=200 Participants
Virologically suppressed HIV positive participants, on a stable antiretroviral regimen, who switched to the 2-Drug Regimen JULUCA (Dolutegravir \[DTG\] / Rilpivirine \[RPV\]) were included in the study. Participants were followed-up for approximately 3 years during routine clinical practice.
|
|---|---|
|
Number of Participants With Sustained Virologic Suppression at Year 3
HIV-RNA <50 c/mL
|
119 Participants
|
|
Number of Participants With Sustained Virologic Suppression at Year 3
HIV-RNA 50-200 c/mL and subsequent measurement <50 c/mL
|
2 Participants
|
|
Number of Participants With Sustained Virologic Suppression at Year 3
HIV-RNA 50-200 copies/mL & subsequent measurement >=50 c/mL
|
1 Participants
|
|
Number of Participants With Sustained Virologic Suppression at Year 3
HIV-RNA 50-200 c/mL & missing subsequent measurement
|
1 Participants
|
|
Number of Participants With Sustained Virologic Suppression at Year 3
Discontinuation due to intolerability & LOCF HIV-RNA <50 c/mL
|
23 Participants
|
|
Number of Participants With Sustained Virologic Suppression at Year 3
Discontinuation due to death & LOCF HIV-RNA <50 c/mL
|
1 Participants
|
|
Number of Participants With Sustained Virologic Suppression at Year 3
Discontinuation due to other reasons & LOCF HIV-RNA <50 c/mL
|
35 Participants
|
|
Number of Participants With Sustained Virologic Suppression at Year 3
Discontinuation due to other reasons & LOCF HIV-RNA >=50 c/mL
|
4 Participants
|
|
Number of Participants With Sustained Virologic Suppression at Year 3
Lost to follow-up & LOCF HIV-RNA <50 c/mL
|
13 Participants
|
|
Number of Participants With Sustained Virologic Suppression at Year 3
On drug, but no HIV-RNA in window & LOCF HIV-RNA <50 c/mL
|
1 Participants
|
SECONDARY outcome
Timeframe: At Year 1 and Year 2Population: The analysis was performed on the mFAS which included all eligible participants who did not have any violation of inclusion or exclusion criteria which also included screening failures and major protocol deviations.
VS was defined as HIV-RNA \<50 c/mL for at least 6 months or, if between 50-200 c/mL with a subsequent next available measurement (within 120 days) \<50 c/mL. Any subsequent measurement was accepted as a consecutive measurement as long as measured no later than 120 days after the initial measurement. If no subsequent HIV-RNA measurement was performed within 120 days, this was scored as a confirmed HIV-RNA \>=200 c/mL.
Outcome measures
| Measure |
Participants Who Received JULUCA
n=200 Participants
Virologically suppressed HIV positive participants, on a stable antiretroviral regimen, who switched to the 2-Drug Regimen JULUCA (Dolutegravir \[DTG\] / Rilpivirine \[RPV\]) were included in the study. Participants were followed-up for approximately 3 years during routine clinical practice.
|
|---|---|
|
Number of Participants With Sustained Virologic Suppression at Year 1 and Year 2
HIV-RNA <50 c/mL - at Year 1
|
164 Participants
|
|
Number of Participants With Sustained Virologic Suppression at Year 1 and Year 2
HIV-RNA 50-200 c/mL and subsequent measurement <50 c/mL - at Year 1
|
2 Participants
|
|
Number of Participants With Sustained Virologic Suppression at Year 1 and Year 2
HIV-RNA 50-200 c/mL & subsequent measurement >=50 copies/mL - at Year 1
|
0 Participants
|
|
Number of Participants With Sustained Virologic Suppression at Year 1 and Year 2
HIV-RNA 50-200 c/mL & missing subsequent measurement - at Year 1
|
1 Participants
|
|
Number of Participants With Sustained Virologic Suppression at Year 1 and Year 2
HIV-RNA >=200 copies/mL - at Year 1
|
0 Participants
|
|
Number of Participants With Sustained Virologic Suppression at Year 1 and Year 2
Discontinuation due to intolerability & LOCF HIV-RNA <50 c/mL - at Year 1
|
19 Participants
|
|
Number of Participants With Sustained Virologic Suppression at Year 1 and Year 2
Discontinuation due to death & LOCF HIV-RNA <50 c/mL - at Year 1
|
1 Participants
|
|
Number of Participants With Sustained Virologic Suppression at Year 1 and Year 2
Discontinuation due to other reasons & LOCF HIV-RNA <50 c/mL - at Year 1
|
9 Participants
|
|
Number of Participants With Sustained Virologic Suppression at Year 1 and Year 2
Discontinuation due to other reasons & LOCF HIV-RNA >=50 c/mL - at Year 1
|
0 Participants
|
|
Number of Participants With Sustained Virologic Suppression at Year 1 and Year 2
Lost to follow-up & LOCF HIV-RNA <50 c/mL - at Year 1
|
3 Participants
|
|
Number of Participants With Sustained Virologic Suppression at Year 1 and Year 2
On drug, but no HIV-RNA in window & LOCF HIV-RNA <50 c/mL - at Year 1
|
1 Participants
|
|
Number of Participants With Sustained Virologic Suppression at Year 1 and Year 2
HIV-RNA <50 c/mL - at Year 2
|
143 Participants
|
|
Number of Participants With Sustained Virologic Suppression at Year 1 and Year 2
HIV-RNA 50-200 c/mL and subsequent measurement <50 c/mL - at Year 2
|
3 Participants
|
|
Number of Participants With Sustained Virologic Suppression at Year 1 and Year 2
HIV-RNA 50-200 c/mL & subsequent measurement >=50 copies/mL - at Year 2
|
0 Participants
|
|
Number of Participants With Sustained Virologic Suppression at Year 1 and Year 2
HIV-RNA 50-200 c/mL & missing subsequent measurement - at Year 2
|
0 Participants
|
|
Number of Participants With Sustained Virologic Suppression at Year 1 and Year 2
HIV-RNA >=200 c/mL - at Year 2
|
1 Participants
|
|
Number of Participants With Sustained Virologic Suppression at Year 1 and Year 2
Discontinuation due to intolerability & LOCF HIV-RNA <50 c/mL - at Year 2
|
22 Participants
|
|
Number of Participants With Sustained Virologic Suppression at Year 1 and Year 2
Discontinuation due to death & LOCF HIV-RNA <50 c/mL - at Year 2
|
1 Participants
|
|
Number of Participants With Sustained Virologic Suppression at Year 1 and Year 2
Discontinuation due to other reasons & LOCF HIV-RNA <50 c/mL - at Year 2
|
17 Participants
|
|
Number of Participants With Sustained Virologic Suppression at Year 1 and Year 2
Discontinuation due to other reasons & LOCF HIV-RNA >=50 c/mL - at Year 2
|
3 Participants
|
|
Number of Participants With Sustained Virologic Suppression at Year 1 and Year 2
Lost to follow-up & LOCF HIV-RNA <50 c/mL - at Year 2
|
8 Participants
|
|
Number of Participants With Sustained Virologic Suppression at Year 1 and Year 2
On drug, but no HIV-RNA in window & LOCF HIV-RNA <50 c/mL - at Year 2
|
2 Participants
|
SECONDARY outcome
Timeframe: At Year 1, Year 2 and Year 3Population: The analysis was performed on the mFAS which included all eligible participants who did not have any violation of inclusion or exclusion criteria which also included screening failures and major protocol deviations.
Low level viremia was defined as a VL greater than (\>) 50 to \<200 c/mL.
Outcome measures
| Measure |
Participants Who Received JULUCA
n=200 Participants
Virologically suppressed HIV positive participants, on a stable antiretroviral regimen, who switched to the 2-Drug Regimen JULUCA (Dolutegravir \[DTG\] / Rilpivirine \[RPV\]) were included in the study. Participants were followed-up for approximately 3 years during routine clinical practice.
|
|---|---|
|
Number of Participants With Low Level Viremia
HIV-RNA 50-200 c/mL and subsequent measurement >=50 c/mL - at Year 1
|
0 Participants
|
|
Number of Participants With Low Level Viremia
mHIV-RNA 50-200 c/mL and subsequent measurement >=50 c/mL - at Year 2
|
0 Participants
|
|
Number of Participants With Low Level Viremia
HIV-RNA 50-200 c/mL and subsequent measurement >=50 c/mL - at Year 3
|
1 Participants
|
SECONDARY outcome
Timeframe: At Year 1, Year 2 and Year 3Population: The analysis was performed on the mFAS which included all eligible participants who did not have any violation of inclusion or exclusion criteria which also included screening failures and major protocol deviations.
Virologic rebound was defined as two consecutive VL measurements of \>=200 c/mL.
Outcome measures
| Measure |
Participants Who Received JULUCA
n=200 Participants
Virologically suppressed HIV positive participants, on a stable antiretroviral regimen, who switched to the 2-Drug Regimen JULUCA (Dolutegravir \[DTG\] / Rilpivirine \[RPV\]) were included in the study. Participants were followed-up for approximately 3 years during routine clinical practice.
|
|---|---|
|
Number of Participants With Virologic Rebound
HIV-RNA >=200 c/mL - at Year 1
|
0 Participants
|
|
Number of Participants With Virologic Rebound
HIV-RNA >=200 c/mL - at Year 2
|
1 Participants
|
|
Number of Participants With Virologic Rebound
HIV-RNA >=200 c/mL - at Year 3
|
0 Participants
|
SECONDARY outcome
Timeframe: At Year 1, Year 2 and Year 3Population: The analysis was performed on the mFAS which included all eligible participants who did not have any violation of inclusion or exclusion criteria which also included screening failures and major protocol deviations.
The treatment switch could have been due to virologic failure (VF) or due to intolerability and last observation carried forward (LOCF) as determined at the discretion of the physician.
Outcome measures
| Measure |
Participants Who Received JULUCA
n=200 Participants
Virologically suppressed HIV positive participants, on a stable antiretroviral regimen, who switched to the 2-Drug Regimen JULUCA (Dolutegravir \[DTG\] / Rilpivirine \[RPV\]) were included in the study. Participants were followed-up for approximately 3 years during routine clinical practice.
|
|---|---|
|
Number of Participants With Treatment Switch
Discontinuation due to intolerability and LOCF HIV-RNA <50 c/mL - at Year 1
|
19 Participants
|
|
Number of Participants With Treatment Switch
Discontinuation due to intolerability and LOCF HIV-RNA <50 c/mL - at Year 2
|
22 Participants
|
|
Number of Participants With Treatment Switch
Discontinuation due to intolerability and LOCF HIV-RNA <50 c/mL - at Year 3
|
23 Participants
|
SECONDARY outcome
Timeframe: Up to Year 3Population: The analysis was performed on the mFAS which included all eligible participants who did not have any violation of inclusion or exclusion criteria which also included screening failures and major protocol deviations.
The HIV monitoring measures included were defined as HIV-RNA measurements, normalized to participant years.
Outcome measures
| Measure |
Participants Who Received JULUCA
n=200 Participants
Virologically suppressed HIV positive participants, on a stable antiretroviral regimen, who switched to the 2-Drug Regimen JULUCA (Dolutegravir \[DTG\] / Rilpivirine \[RPV\]) were included in the study. Participants were followed-up for approximately 3 years during routine clinical practice.
|
|---|---|
|
Number of Monitoring Measures During the 3-year Follow-up
|
4 Measurements per year
Interval 3.6 to 4.4
|
SECONDARY outcome
Timeframe: Up to Year 3Population: The analysis was performed on the safety analysis set (SAS) which included all participants who received at least one dose of DTG+RPV.
An adverse event (AE) was defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE could have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal investigational product, whether or not related to the medicinal investigational product. A SAEs was defined as any adverse event meeting the following criteria: resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in a congenital anomaly in the off-spring of a participant, was medically significant or could have required intervention to prevent the previously stated outcomes.
Outcome measures
| Measure |
Participants Who Received JULUCA
n=200 Participants
Virologically suppressed HIV positive participants, on a stable antiretroviral regimen, who switched to the 2-Drug Regimen JULUCA (Dolutegravir \[DTG\] / Rilpivirine \[RPV\]) were included in the study. Participants were followed-up for approximately 3 years during routine clinical practice.
|
|---|---|
|
Number of Participants With Serious Adverse Events (SAEs)
|
52 Participants
|
SECONDARY outcome
Timeframe: Up to Year 3Population: The analysis was performed on the SAS which included all participants who received at least one dose of DTG+RPV.
An ADR was defined as a noxious and unintended response to a medicinal investigational product related to any dose where at least a reasonable possibility (i.e. the relationship) cannot be ruled out.
Outcome measures
| Measure |
Participants Who Received JULUCA
n=200 Participants
Virologically suppressed HIV positive participants, on a stable antiretroviral regimen, who switched to the 2-Drug Regimen JULUCA (Dolutegravir \[DTG\] / Rilpivirine \[RPV\]) were included in the study. Participants were followed-up for approximately 3 years during routine clinical practice.
|
|---|---|
|
Number of Participants With Adverse Drug Reactions (ADRs)
|
41 Participants
|
SECONDARY outcome
Timeframe: At Year 1, Year 2 and Year 3Population: The analysis was performed on the mFAS which included all eligible participants who did not have any violation of inclusion or exclusion criteria which also included screening failures and major protocol deviations. This analysis was performed only on the participants from the mFAS who completed the self-assessment questionnaire of adherence.
Adherence to therapy refers to the missed monthly doses. At each follow-up visit, participants were asked to give an estimation of their level of adherence to their antiretroviral therapy (ART).
Outcome measures
| Measure |
Participants Who Received JULUCA
n=174 Participants
Virologically suppressed HIV positive participants, on a stable antiretroviral regimen, who switched to the 2-Drug Regimen JULUCA (Dolutegravir \[DTG\] / Rilpivirine \[RPV\]) were included in the study. Participants were followed-up for approximately 3 years during routine clinical practice.
|
|---|---|
|
Number of Participants With Adherence to Therapy
Year 1
|
111 Participants
|
|
Number of Participants With Adherence to Therapy
Year 2
|
109 Participants
|
|
Number of Participants With Adherence to Therapy
Year 3
|
87 Participants
|
SECONDARY outcome
Timeframe: At Year 1, Year 2 and Year 3Population: The analysis was performed on the mFAS which included all eligible participants who did not have any violation of inclusion or exclusion criteria which also included screening failures and major protocol deviations. This analysis was performed only on the participants from the mFAS who had laboratory parameters data at baseline and at years 1, 2 or 3.
To assess the impact on the lipid metabolism, changes in the following parameters were analyzed: total cholesterol, low-density lipoprotein (LDL) cholesterol, high-density lipoprotein (HDL) cholesterol, triglycerides.
Outcome measures
| Measure |
Participants Who Received JULUCA
n=154 Participants
Virologically suppressed HIV positive participants, on a stable antiretroviral regimen, who switched to the 2-Drug Regimen JULUCA (Dolutegravir \[DTG\] / Rilpivirine \[RPV\]) were included in the study. Participants were followed-up for approximately 3 years during routine clinical practice.
|
|---|---|
|
Change From Baseline (BL) in Lipid Laboratory Values
Change in total cholesterol from BL - at Year 1
|
-2.5 mg/dL
Interval -23.0 to 19.0
|
|
Change From Baseline (BL) in Lipid Laboratory Values
Change in LDL cholesterol from BL - at Year 1
|
1 mg/dL
Interval -13.5 to 18.0
|
|
Change From Baseline (BL) in Lipid Laboratory Values
Change in HDL cholesterol from BL - at Year 1
|
-0.8 mg/dL
Interval -5.8 to 3.1
|
|
Change From Baseline (BL) in Lipid Laboratory Values
Change in triglycerides from BL - at Year 1
|
-1.4 mg/dL
Interval -56.0 to 34.0
|
|
Change From Baseline (BL) in Lipid Laboratory Values
Change in total cholesterol from BL - at Year 2
|
-3 mg/dL
Interval -24.0 to 19.0
|
|
Change From Baseline (BL) in Lipid Laboratory Values
Change in LDL cholesterol from BL - at Year 2
|
7 mg/dL
Interval -17.0 to 21.0
|
|
Change From Baseline (BL) in Lipid Laboratory Values
Change in HDL cholesterol from BL - at Year 2
|
-1.4 mg/dL
Interval -6.0 to 4.0
|
|
Change From Baseline (BL) in Lipid Laboratory Values
Change in triglycerides from BL - at Year 2
|
3.5 mg/dL
Interval -38.5 to 49.3
|
|
Change From Baseline (BL) in Lipid Laboratory Values
Change in total cholesterol from BL - at Year 3
|
-5 mg/dL
Interval -27.0 to 18.0
|
|
Change From Baseline (BL) in Lipid Laboratory Values
Change in LDL cholesterol from BL - at Year 3
|
-1.9 mg/dL
Interval -21.0 to 20.0
|
|
Change From Baseline (BL) in Lipid Laboratory Values
Change in HDL cholesterol from BL - at Year 3
|
-2 mg/dL
Interval -5.8 to 3.9
|
|
Change From Baseline (BL) in Lipid Laboratory Values
Change in triglycerides from BL - at Year 3
|
-1 mg/dL
Interval -46.5 to 47.0
|
SECONDARY outcome
Timeframe: At Year 1, Year 2 and Year 3Population: The analysis was performed on the mFAS which included all eligible participants who did not have any violation of inclusion or exclusion criteria which also included screening failures and major protocol deviations. This analysis was performed only on the participants from the mFAS who completed the HIV TSQs.
The change in HIV treatment satisfaction was assessed with the help of the HIV Treatment Satisfaction questionnaire (HIVTSQs), which is a 10-item-self-reported scale that measures overall satisfaction with treatment and by specific domains e.g., convenience, flexibility, etc. HIV TSQs total score: unweighted sum of 10 items of the HIV TSQs (range: 0-60; with higher scores indicating greater treatment satisfaction).
Outcome measures
| Measure |
Participants Who Received JULUCA
n=112 Participants
Virologically suppressed HIV positive participants, on a stable antiretroviral regimen, who switched to the 2-Drug Regimen JULUCA (Dolutegravir \[DTG\] / Rilpivirine \[RPV\]) were included in the study. Participants were followed-up for approximately 3 years during routine clinical practice.
|
|---|---|
|
Change in Treatment Satisfaction
Year 1
|
1 Score on a scale
Interval 0.0 to 5.5
|
|
Change in Treatment Satisfaction
Year 2
|
2.5 Score on a scale
Interval 0.0 to 7.0
|
|
Change in Treatment Satisfaction
Year 3
|
3 Score on a scale
Interval 0.0 to 9.0
|
SECONDARY outcome
Timeframe: At Year 1, Year 2 and Year 3Population: The analysis was performed on the mFAS which included all eligible participants who did not have any violation of inclusion or exclusion criteria which also included screening failures and major protocol deviations. This analysis was performed only on the participants from the mFAS who completed the HIV SDM.
The change in HIV symptom distress was assessed with the help of the HIV Symptom Distress Module (SDM); which is a 20-item self-reported measure that addresses the presence and perceived distress linked to symptoms commonly associated with HIV or its treatment. SDM total score: unweighted sum of the 20 items (using a 5-point scale, ranging from 0-4), ranging from 0 to 80. Higher scores indicate higher degrees of symptom distress.
Outcome measures
| Measure |
Participants Who Received JULUCA
n=109 Participants
Virologically suppressed HIV positive participants, on a stable antiretroviral regimen, who switched to the 2-Drug Regimen JULUCA (Dolutegravir \[DTG\] / Rilpivirine \[RPV\]) were included in the study. Participants were followed-up for approximately 3 years during routine clinical practice.
|
|---|---|
|
Change in Symptom Distress
Year 1
|
0 Score on a scale
Interval -6.0 to 4.0
|
|
Change in Symptom Distress
Year 2
|
-1 Score on a scale
Interval -8.0 to 2.0
|
|
Change in Symptom Distress
Year 3
|
-1.5 Score on a scale
Interval -6.0 to 3.5
|
SECONDARY outcome
Timeframe: At Baseline (Day 1)Population: The analysis was performed on the mFAS which included all eligible participants who did not have any violation of inclusion or exclusion criteria which also included screening failures and major protocol deviations.
The primary and secondary reasons for therapy switch were presented.
Outcome measures
| Measure |
Participants Who Received JULUCA
n=200 Participants
Virologically suppressed HIV positive participants, on a stable antiretroviral regimen, who switched to the 2-Drug Regimen JULUCA (Dolutegravir \[DTG\] / Rilpivirine \[RPV\]) were included in the study. Participants were followed-up for approximately 3 years during routine clinical practice.
|
|---|---|
|
Number of Participants by Reasons for Therapy Switch to JULUCA
Side effects of previous ART
|
53 Participants
|
|
Number of Participants by Reasons for Therapy Switch to JULUCA
Potential/real interactions
|
8 Participants
|
|
Number of Participants by Reasons for Therapy Switch to JULUCA
Reduction in number of drugs
|
41 Participants
|
|
Number of Participants by Reasons for Therapy Switch to JULUCA
Non-nucleoside reverse transcriptase inhibitor (NRTI) - free regime
|
9 Participants
|
|
Number of Participants by Reasons for Therapy Switch to JULUCA
Simplification to a single-tablet regimen
|
45 Participants
|
|
Number of Participants by Reasons for Therapy Switch to JULUCA
Patient's preference
|
24 Participants
|
|
Number of Participants by Reasons for Therapy Switch to JULUCA
Other
|
19 Participants
|
|
Number of Participants by Reasons for Therapy Switch to JULUCA
Pill size
|
1 Participants
|
Adverse Events
Participants Who Received JULUCA
Serious events: 52 serious events
Other events: 41 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Participants Who Received JULUCA
n=200 participants at risk
Virologically suppressed HIV positive participants, on a stable antiretroviral regimen, who switched to the 2-Drug Regimen JULUCA (Dolutegravir \[DTG\] / Rilpivirine \[RPV\]) were included in the study. Participants were followed-up for approximately 3 years during routine clinical practice.
|
|---|---|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
1.0%
2/200 • Number of events 2 • Serious Adverse Events (SAEs), Adverse Drug Reactions (ADRs) and All-Cause Mortality were collected from Day 1 up to maximum Year 3.
|
|
Cardiac disorders
Angina pectoris
|
0.50%
1/200 • Number of events 1 • Serious Adverse Events (SAEs), Adverse Drug Reactions (ADRs) and All-Cause Mortality were collected from Day 1 up to maximum Year 3.
|
|
Cardiac disorders
Atrial fibrillation
|
1.5%
3/200 • Number of events 3 • Serious Adverse Events (SAEs), Adverse Drug Reactions (ADRs) and All-Cause Mortality were collected from Day 1 up to maximum Year 3.
|
|
Cardiac disorders
Atrial flutter
|
0.50%
1/200 • Number of events 1 • Serious Adverse Events (SAEs), Adverse Drug Reactions (ADRs) and All-Cause Mortality were collected from Day 1 up to maximum Year 3.
|
|
Cardiac disorders
Mitral valve incompetence
|
0.50%
1/200 • Number of events 1 • Serious Adverse Events (SAEs), Adverse Drug Reactions (ADRs) and All-Cause Mortality were collected from Day 1 up to maximum Year 3.
|
|
Cardiac disorders
Myopericarditis
|
0.50%
1/200 • Number of events 1 • Serious Adverse Events (SAEs), Adverse Drug Reactions (ADRs) and All-Cause Mortality were collected from Day 1 up to maximum Year 3.
|
|
Cardiac disorders
Palpitations
|
0.50%
1/200 • Number of events 1 • Serious Adverse Events (SAEs), Adverse Drug Reactions (ADRs) and All-Cause Mortality were collected from Day 1 up to maximum Year 3.
|
|
Congenital, familial and genetic disorders
Atrial septal defect
|
0.50%
1/200 • Number of events 1 • Serious Adverse Events (SAEs), Adverse Drug Reactions (ADRs) and All-Cause Mortality were collected from Day 1 up to maximum Year 3.
|
|
Eye disorders
Retinal detachment
|
0.50%
1/200 • Number of events 1 • Serious Adverse Events (SAEs), Adverse Drug Reactions (ADRs) and All-Cause Mortality were collected from Day 1 up to maximum Year 3.
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.50%
1/200 • Number of events 1 • Serious Adverse Events (SAEs), Adverse Drug Reactions (ADRs) and All-Cause Mortality were collected from Day 1 up to maximum Year 3.
|
|
Gastrointestinal disorders
Diverticulum intestinal haemorrhagic
|
0.50%
1/200 • Number of events 1 • Serious Adverse Events (SAEs), Adverse Drug Reactions (ADRs) and All-Cause Mortality were collected from Day 1 up to maximum Year 3.
|
|
General disorders
Chest pain
|
0.50%
1/200 • Number of events 1 • Serious Adverse Events (SAEs), Adverse Drug Reactions (ADRs) and All-Cause Mortality were collected from Day 1 up to maximum Year 3.
|
|
General disorders
Drug ineffective
|
0.50%
1/200 • Number of events 1 • Serious Adverse Events (SAEs), Adverse Drug Reactions (ADRs) and All-Cause Mortality were collected from Day 1 up to maximum Year 3.
|
|
General disorders
Multiple organ dysfunction syndrome
|
0.50%
1/200 • Number of events 1 • Serious Adverse Events (SAEs), Adverse Drug Reactions (ADRs) and All-Cause Mortality were collected from Day 1 up to maximum Year 3.
|
|
Infections and infestations
Acute hepatitis B
|
0.50%
1/200 • Number of events 1 • Serious Adverse Events (SAEs), Adverse Drug Reactions (ADRs) and All-Cause Mortality were collected from Day 1 up to maximum Year 3.
|
|
Infections and infestations
Diverticulitis
|
0.50%
1/200 • Number of events 1 • Serious Adverse Events (SAEs), Adverse Drug Reactions (ADRs) and All-Cause Mortality were collected from Day 1 up to maximum Year 3.
|
|
Infections and infestations
Urinary tract infection
|
0.50%
1/200 • Number of events 1 • Serious Adverse Events (SAEs), Adverse Drug Reactions (ADRs) and All-Cause Mortality were collected from Day 1 up to maximum Year 3.
|
|
Injury, poisoning and procedural complications
Fibula fracture
|
0.50%
1/200 • Number of events 1 • Serious Adverse Events (SAEs), Adverse Drug Reactions (ADRs) and All-Cause Mortality were collected from Day 1 up to maximum Year 3.
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
1.0%
2/200 • Number of events 2 • Serious Adverse Events (SAEs), Adverse Drug Reactions (ADRs) and All-Cause Mortality were collected from Day 1 up to maximum Year 3.
|
|
Injury, poisoning and procedural complications
Upper limb fracture
|
0.50%
1/200 • Number of events 1 • Serious Adverse Events (SAEs), Adverse Drug Reactions (ADRs) and All-Cause Mortality were collected from Day 1 up to maximum Year 3.
|
|
Investigations
Angiogram
|
0.50%
1/200 • Number of events 1 • Serious Adverse Events (SAEs), Adverse Drug Reactions (ADRs) and All-Cause Mortality were collected from Day 1 up to maximum Year 3.
|
|
Investigations
Continuous glucose monitoring
|
0.50%
1/200 • Number of events 1 • Serious Adverse Events (SAEs), Adverse Drug Reactions (ADRs) and All-Cause Mortality were collected from Day 1 up to maximum Year 3.
|
|
Investigations
Nitrite urine
|
0.50%
1/200 • Number of events 1 • Serious Adverse Events (SAEs), Adverse Drug Reactions (ADRs) and All-Cause Mortality were collected from Day 1 up to maximum Year 3.
|
|
Metabolism and nutrition disorders
Type 2 diabetes mellitus
|
0.50%
1/200 • Number of events 1 • Serious Adverse Events (SAEs), Adverse Drug Reactions (ADRs) and All-Cause Mortality were collected from Day 1 up to maximum Year 3.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gallbladder cancer
|
0.50%
1/200 • Number of events 1 • Serious Adverse Events (SAEs), Adverse Drug Reactions (ADRs) and All-Cause Mortality were collected from Day 1 up to maximum Year 3.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hypopharyngeal cancer
|
0.50%
1/200 • Number of events 1 • Serious Adverse Events (SAEs), Adverse Drug Reactions (ADRs) and All-Cause Mortality were collected from Day 1 up to maximum Year 3.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma
|
0.50%
1/200 • Number of events 1 • Serious Adverse Events (SAEs), Adverse Drug Reactions (ADRs) and All-Cause Mortality were collected from Day 1 up to maximum Year 3.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant peritoneal neoplasm
|
0.50%
1/200 • Number of events 1 • Serious Adverse Events (SAEs), Adverse Drug Reactions (ADRs) and All-Cause Mortality were collected from Day 1 up to maximum Year 3.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal cancer
|
0.50%
1/200 • Number of events 1 • Serious Adverse Events (SAEs), Adverse Drug Reactions (ADRs) and All-Cause Mortality were collected from Day 1 up to maximum Year 3.
|
|
Nervous system disorders
Aphasia
|
0.50%
1/200 • Number of events 1 • Serious Adverse Events (SAEs), Adverse Drug Reactions (ADRs) and All-Cause Mortality were collected from Day 1 up to maximum Year 3.
|
|
Nervous system disorders
Cerebellar stroke
|
0.50%
1/200 • Number of events 1 • Serious Adverse Events (SAEs), Adverse Drug Reactions (ADRs) and All-Cause Mortality were collected from Day 1 up to maximum Year 3.
|
|
Nervous system disorders
Cerebral infarction
|
0.50%
1/200 • Number of events 1 • Serious Adverse Events (SAEs), Adverse Drug Reactions (ADRs) and All-Cause Mortality were collected from Day 1 up to maximum Year 3.
|
|
Nervous system disorders
Generalised tonic-clonic seizure
|
0.50%
1/200 • Number of events 1 • Serious Adverse Events (SAEs), Adverse Drug Reactions (ADRs) and All-Cause Mortality were collected from Day 1 up to maximum Year 3.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.50%
1/200 • Number of events 1 • Serious Adverse Events (SAEs), Adverse Drug Reactions (ADRs) and All-Cause Mortality were collected from Day 1 up to maximum Year 3.
|
|
Psychiatric disorders
Acute stress disorder
|
0.50%
1/200 • Number of events 1 • Serious Adverse Events (SAEs), Adverse Drug Reactions (ADRs) and All-Cause Mortality were collected from Day 1 up to maximum Year 3.
|
|
Psychiatric disorders
Drug abuse
|
0.50%
1/200 • Number of events 1 • Serious Adverse Events (SAEs), Adverse Drug Reactions (ADRs) and All-Cause Mortality were collected from Day 1 up to maximum Year 3.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.50%
1/200 • Number of events 1 • Serious Adverse Events (SAEs), Adverse Drug Reactions (ADRs) and All-Cause Mortality were collected from Day 1 up to maximum Year 3.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
1.5%
3/200 • Number of events 3 • Serious Adverse Events (SAEs), Adverse Drug Reactions (ADRs) and All-Cause Mortality were collected from Day 1 up to maximum Year 3.
|
|
Surgical and medical procedures
Abdominal cavity drainage
|
0.50%
1/200 • Number of events 1 • Serious Adverse Events (SAEs), Adverse Drug Reactions (ADRs) and All-Cause Mortality were collected from Day 1 up to maximum Year 3.
|
|
Surgical and medical procedures
Cardioversion
|
0.50%
1/200 • Number of events 1 • Serious Adverse Events (SAEs), Adverse Drug Reactions (ADRs) and All-Cause Mortality were collected from Day 1 up to maximum Year 3.
|
|
Surgical and medical procedures
Chemotherapy
|
0.50%
1/200 • Number of events 1 • Serious Adverse Events (SAEs), Adverse Drug Reactions (ADRs) and All-Cause Mortality were collected from Day 1 up to maximum Year 3.
|
|
Surgical and medical procedures
Cholecystectomy
|
0.50%
1/200 • Number of events 1 • Serious Adverse Events (SAEs), Adverse Drug Reactions (ADRs) and All-Cause Mortality were collected from Day 1 up to maximum Year 3.
|
|
Surgical and medical procedures
Mitral valve repair
|
1.0%
2/200 • Number of events 2 • Serious Adverse Events (SAEs), Adverse Drug Reactions (ADRs) and All-Cause Mortality were collected from Day 1 up to maximum Year 3.
|
|
Surgical and medical procedures
Shoulder operation
|
0.50%
1/200 • Number of events 1 • Serious Adverse Events (SAEs), Adverse Drug Reactions (ADRs) and All-Cause Mortality were collected from Day 1 up to maximum Year 3.
|
|
Vascular disorders
Shock haemorrhagic
|
0.50%
1/200 • Number of events 1 • Serious Adverse Events (SAEs), Adverse Drug Reactions (ADRs) and All-Cause Mortality were collected from Day 1 up to maximum Year 3.
|
Other adverse events
| Measure |
Participants Who Received JULUCA
n=200 participants at risk
Virologically suppressed HIV positive participants, on a stable antiretroviral regimen, who switched to the 2-Drug Regimen JULUCA (Dolutegravir \[DTG\] / Rilpivirine \[RPV\]) were included in the study. Participants were followed-up for approximately 3 years during routine clinical practice.
|
|---|---|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.50%
1/200 • Number of events 1 • Serious Adverse Events (SAEs), Adverse Drug Reactions (ADRs) and All-Cause Mortality were collected from Day 1 up to maximum Year 3.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.50%
1/200 • Number of events 1 • Serious Adverse Events (SAEs), Adverse Drug Reactions (ADRs) and All-Cause Mortality were collected from Day 1 up to maximum Year 3.
|
|
Gastrointestinal disorders
Diarrhoea
|
1.5%
3/200 • Number of events 3 • Serious Adverse Events (SAEs), Adverse Drug Reactions (ADRs) and All-Cause Mortality were collected from Day 1 up to maximum Year 3.
|
|
Gastrointestinal disorders
Flatulence
|
1.0%
2/200 • Number of events 2 • Serious Adverse Events (SAEs), Adverse Drug Reactions (ADRs) and All-Cause Mortality were collected from Day 1 up to maximum Year 3.
|
|
Gastrointestinal disorders
Gastrointestinal disorder
|
0.50%
1/200 • Number of events 1 • Serious Adverse Events (SAEs), Adverse Drug Reactions (ADRs) and All-Cause Mortality were collected from Day 1 up to maximum Year 3.
|
|
Gastrointestinal disorders
Nausea
|
0.50%
1/200 • Number of events 1 • Serious Adverse Events (SAEs), Adverse Drug Reactions (ADRs) and All-Cause Mortality were collected from Day 1 up to maximum Year 3.
|
|
Gastrointestinal disorders
Vomiting
|
1.0%
2/200 • Number of events 2 • Serious Adverse Events (SAEs), Adverse Drug Reactions (ADRs) and All-Cause Mortality were collected from Day 1 up to maximum Year 3.
|
|
General disorders
Fatigue
|
0.50%
1/200 • Number of events 1 • Serious Adverse Events (SAEs), Adverse Drug Reactions (ADRs) and All-Cause Mortality were collected from Day 1 up to maximum Year 3.
|
|
General disorders
Influenza like illness
|
0.50%
1/200 • Number of events 1 • Serious Adverse Events (SAEs), Adverse Drug Reactions (ADRs) and All-Cause Mortality were collected from Day 1 up to maximum Year 3.
|
|
Investigations
CD4 lymphocytes decreased
|
0.50%
1/200 • Number of events 1 • Serious Adverse Events (SAEs), Adverse Drug Reactions (ADRs) and All-Cause Mortality were collected from Day 1 up to maximum Year 3.
|
|
Investigations
Weight increased
|
0.50%
1/200 • Number of events 1 • Serious Adverse Events (SAEs), Adverse Drug Reactions (ADRs) and All-Cause Mortality were collected from Day 1 up to maximum Year 3.
|
|
Investigations
White blood cell count decreased
|
0.50%
1/200 • Number of events 1 • Serious Adverse Events (SAEs), Adverse Drug Reactions (ADRs) and All-Cause Mortality were collected from Day 1 up to maximum Year 3.
|
|
Metabolism and nutrition disorders
Increased appetite
|
0.50%
1/200 • Number of events 1 • Serious Adverse Events (SAEs), Adverse Drug Reactions (ADRs) and All-Cause Mortality were collected from Day 1 up to maximum Year 3.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.50%
1/200 • Number of events 1 • Serious Adverse Events (SAEs), Adverse Drug Reactions (ADRs) and All-Cause Mortality were collected from Day 1 up to maximum Year 3.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
1.0%
2/200 • Number of events 2 • Serious Adverse Events (SAEs), Adverse Drug Reactions (ADRs) and All-Cause Mortality were collected from Day 1 up to maximum Year 3.
|
|
Nervous system disorders
Dizziness
|
0.50%
1/200 • Number of events 1 • Serious Adverse Events (SAEs), Adverse Drug Reactions (ADRs) and All-Cause Mortality were collected from Day 1 up to maximum Year 3.
|
|
Nervous system disorders
Headache
|
0.50%
1/200 • Number of events 1 • Serious Adverse Events (SAEs), Adverse Drug Reactions (ADRs) and All-Cause Mortality were collected from Day 1 up to maximum Year 3.
|
|
Nervous system disorders
Nervous system disorder
|
1.0%
2/200 • Number of events 2 • Serious Adverse Events (SAEs), Adverse Drug Reactions (ADRs) and All-Cause Mortality were collected from Day 1 up to maximum Year 3.
|
|
Psychiatric disorders
Abnormal dreams
|
0.50%
1/200 • Number of events 1 • Serious Adverse Events (SAEs), Adverse Drug Reactions (ADRs) and All-Cause Mortality were collected from Day 1 up to maximum Year 3.
|
|
Psychiatric disorders
Depression
|
2.0%
4/200 • Number of events 4 • Serious Adverse Events (SAEs), Adverse Drug Reactions (ADRs) and All-Cause Mortality were collected from Day 1 up to maximum Year 3.
|
|
Psychiatric disorders
Sleep disorder
|
4.5%
9/200 • Number of events 9 • Serious Adverse Events (SAEs), Adverse Drug Reactions (ADRs) and All-Cause Mortality were collected from Day 1 up to maximum Year 3.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.50%
1/200 • Number of events 1 • Serious Adverse Events (SAEs), Adverse Drug Reactions (ADRs) and All-Cause Mortality were collected from Day 1 up to maximum Year 3.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.50%
1/200 • Number of events 1 • Serious Adverse Events (SAEs), Adverse Drug Reactions (ADRs) and All-Cause Mortality were collected from Day 1 up to maximum Year 3.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.50%
1/200 • Number of events 1 • Serious Adverse Events (SAEs), Adverse Drug Reactions (ADRs) and All-Cause Mortality were collected from Day 1 up to maximum Year 3.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single site data not precede the primary publication of the entire clinical trial.
- Publication restrictions are in place
Restriction type: OTHER