Dolutegravir (DTG) is a well-tolerated 2nd generation integrase strand transfer inhibitor (INSTI); rilpivirine (RPV) is a well-tolerated non- nucleoside reverse transcriptase inhibitors (NNRTI) and lamivudine (3TC) is a nucleoside reverse transcriptase inhibitors (NRTIs). This study aims to gather the real-world evidence to evaluate effectiveness of the two-drug regimen (2DR). This is a multi-site observational study in subjects who have started and/or who plan to initiate 2DR with an integrase inhibitor plus a reverse transcriptase inhibitor. The study does not require any changes to the routine standard of care that subjects receive. Approximately 500 eligible subjects will be included from potential investigational sites across Europe and data from them will be collected either retrospectively or prospectively.
Study Type
OBSERVATIONAL
Enrollment
774
DTG is a 2nd generation integrase strand transfer inhibitor. Subjects receiving DTG as a part of 2DR treatment will be included in the study.
3TC is a nucleoside reverse transcriptase inhibitor. Subjects receiving 3TC as a part of 2DR treatment will be included in the study.
RPV is a non-nucleoside reverse transcriptase inhibitor. Subjects receiving RPV as part of 2DR treatment will be included in the study.
GSK Investigational Site
Barcelona, Spain
Number of Treatment-naïve Participants With Human Immunodeficiency Virus Ribonucleic Acid (HIV-RNA) Levels Less Than (<)50 Copies/Milliliter (c/mL) at 24 Weeks After 2DR (Two-drug Regimen) Initiation
Time frame: At Week 24
Number of Treatment-naïve Participants With HIV-RNA Levels <50 c/mL at 48 Weeks After 2DR Initiation
Time frame: At Week 48
Number of Treatment-naïve Participants With HIV-RNA Levels <50 c/mL at 96 Weeks After 2DR Initiation
Time frame: At Week 96
Number of Treatment-experienced Viremic Participants With HIV-RNA Levels <50 c/mL at Week 24
Time frame: At Week 24
Number of Treatment-experienced Viremic Participants With HIV-RNA Levels <50 c/mL at Week 48
Time frame: At Week 48
Number of Treatment-experienced Viremic Participants With HIV-RNA Levels <50 c/mL at Week 96
Time frame: At Week 96
Number of Treatment-naïve Participants Experiencing Virologic Failure (VF) [Up to 24 Weeks]
VF was defined as virologic rebound (after achieving suppression, 2 consecutive HIV RNA level greater than or equal to \[\>=\] 50 copies/mL or 1 HIV RNA level \>=50 copies/mL followed by study treatment discontinuation) or virologic non-response (2 consecutive VL\>=200 copies/mL after at least 24 weeks of treatment).
Time frame: Up to 24 weeks
Number of Treatment-naïve Participants Experiencing VF [Up to 48 Weeks]
VF was defined as virologic rebound (after achieving suppression, 2 consecutive HIV RNA level greater than or equal to \[\>=\] 50 copies/mL or 1 HIV RNA level \>=50 copies/mL followed by study treatment discontinuation) or virologic non-response (2 consecutive VL\>=200 copies/mL after at least 48 weeks of treatment).
Time frame: Up to 48 weeks
Number of Treatment-naïve Participants Experiencing VF [Up to 96 Weeks]
VF was defined as virologic rebound (after achieving suppression, 2 consecutive HIV RNA level greater than or equal to \[\>=\] 50 copies/mL or 1 HIV RNA level \>=50 copies/mL followed by study treatment discontinuation) or virologic non-response (2 consecutive VL\>=200 copies/mL after at least 96 weeks of treatment).
Time frame: Up to 96 weeks
Number of Stable Switch Participants With VF Within the First 24 Weeks
VF was defined as 2 consecutive HIV RNA \>=50 c/mL or 1 HIV RNA \>50c/mL followed by study treatment discontinuation or missing value.
Time frame: Up to Week 24
Number of Stable Switch Participants With VF Within the First 48 Weeks
VF was defined as 2 consecutive HIV RNA \>=50 c/mL or 1 HIV RNA \>50c/mL followed by study treatment discontinuation or missing value.
Time frame: Up to Week 48
Number of Stable Switch Participants With VF Within the First 96 Weeks
VF was defined as 2 consecutive HIV RNA \>=50 c/mL or 1 HIV RNA \>50c/mL followed by study treatment discontinuation or missing value.
Time frame: Up to Week 96
Number of Treatment-experienced Viremic Participants Experiencing VF [Up to 24 Weeks]
VF was defined as virologic rebound (after achieving suppression, 2 consecutive HIV RNA \>= 50 copies/mL or 1 HIV RNA level \>=50 copies/mL followed by study treatment discontinuation) or virologic non-response (2 consecutive VL \>=200 copies/mL after at least 24 weeks of treatment). Treatment-experienced viremic participants refers to individuals who have previously undergone HIV treatment but had virological failure in prior treatment.
Time frame: Up to 24 weeks
Number of Treatment-experienced Viremic Participants Experiencing VF [Up to 48 Weeks]
VF was defined as virologic rebound (after achieving suppression, 2 consecutive HIV RNA \>= 50 copies/mL or 1 HIV RNA level \>=50 copies/mL followed by study treatment discontinuation) or virologic non-response (2 consecutive VL \>=200 copies/mL after at least 48 weeks of treatment). Treatment-experienced viremic participants refers to individuals who have previously undergone HIV treatment but had virological failure in prior treatment.
Time frame: Up to 48 weeks
Number of Treatment-experienced Viremic Participants Experiencing VF [Up to 96 Weeks]
VF was defined as virologic rebound (after achieving suppression, 2 consecutive HIV RNA \>= 50 copies/mL or 1 HIV RNA level \>=50 copies/mL followed by study treatment discontinuation) or virologic non-response (2 consecutive VL \>=200 copies/mL after at least 96 weeks of treatment). Treatment-experienced viremic participants refers to individuals who have previously undergone HIV treatment but had virological failure in prior treatment.
Time frame: Up to 96 weeks
Number of Participants With HIV RNA Levels >=200 c/mL After 24 Weeks, 48 Weeks and 96 Weeks
Time frame: At Week 24, Week 48 and Week 96
Number of Participants With Low Level Viremia
Low level viremia was defined as virologic load \>=50 and \<200 c/mL.
Time frame: At Week 24, Week 48 and Week 96
Time to Virologic Suppression Among Treatment-naïve Participants and Treatment-experienced Viremic Participants, Who Achieved Suppression
Suppression of VL was evaluated at 24 weeks, 48 weeks and 96 weeks and time to virologic suppression was planned to be evaluated until 96 weeks.
Time frame: Up to Week 96
Time to Virologic Failure in the Stable Switch Population
VF was defined as virologic rebound (after achieving suppression, 2 consecutive HIV RNA level greater than or equal to \[\>=\] 50 copies/mL or 1 HIV RNA level \>=50 copies/mL followed by study treatment discontinuation) or virologic non-response (2 consecutive VL\>=200 copies/mL after at least 48 weeks of treatment).
Time frame: Up to Week 96
Number of Participants With Emergent Resistance Mutations Following Virologic Failure (VF) Events
Time frame: Up to Week 96
Number of Participants Who Discontinue Their Baseline 2DR and Who Stable Switch to a Different Regimen While Virologically Suppressed (HIV RNA <50 Copies/mL) at Switch
A stable switch was defined as a switching option for participants with HIV RNA suppression on current treatment with viral load \<50 c/mL at time of switch.
Time frame: Up to Week 96
Number of Participants Who Discontinue Their Baseline 2DR and Who Switch Following Virologic Failure
Virologic rebound or virologic non-response in participants, was considered as virologic failure.
Time frame: Up to Week 96
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Number of Participants Who Discontinue Their Baseline 2DR Who Are Switching for Safety or Other Reasons
Safety reasons include tolerability, toxicity and other reasons.
Time frame: Up to Week 96
Number of Participants With AEs and SAEs
An AE is any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. A SAE is any untoward event resulting in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect or any other situation according to medical or scientific judgment. Determination of an event as AE or SAE was at the discretion of the treating clinician and taken from the medical record.
Time frame: Up to Week 96
Cluster of Differentiation (CD)4+ and CD8+ T Cell Counts
Time frame: At baseline (Week 0), Week 24, Week 48 and Week 96
CD4/CD8 Ratio
Time frame: At baseline (Week 0), Week 24, Week 48 and Week 96