'COMBINE-2': Real-world Evidence for Effectiveness of Two Drug Regimen, Antiretroviral Therapy With Integrase Inhibitors Plus a Reverse Transcriptase Inhibitor

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

Population: Analysis population included all the individuals, (among the Stable switch participants) who had initiated a 2DR with an integrase inhibitor plus a reverse transcriptase inhibitor prior to or during the study period (as a switching treatment option for HIV infection, whilst virologically suppressed on current treatment) and who had a VL measurement up to the specified time point.

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

Population: Analysis population included all the individuals, (among the Stable switch participants) who had initiated a 2DR with an integrase inhibitor plus a reverse transcriptase inhibitor prior to or during the study period (as a switching treatment option for HIV infection, whilst virologically suppressed on current treatment) and who had a VL measurement up to the specified time point.

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

Population: Analysis population included all the individuals, (among the Stable switch participants) who had initiated a 2DR with an integrase inhibitor plus a reverse transcriptase inhibitor prior to or during the study period (as a switching treatment option for HIV infection, whilst virologically suppressed on current treatment) and who had a VL measurement up to the specified time point.

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

Population: Analysis population included all the individuals, among the Prior virological failure participants, who had initiated a 2DR with an integrase inhibitor plus a reverse transcriptase inhibitor prior to or during the study period, as a second-line treatment, due to VF on prior treatment, and who had a VL measurement up to the specified time point.

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

Population: Analysis population included all the individuals, among the Prior virological failure participants, who had initiated a 2DR with an integrase inhibitor plus a reverse transcriptase inhibitor prior to or during the study period, as a second-line treatment, due to VF on prior treatment, and who had a VL measurement up to the specified time point.

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

Population: Analysis population included all the individuals, among the Prior virological failure participants, who had initiated a 2DR with an integrase inhibitor plus a reverse transcriptase inhibitor prior to or during the study period, as a second-line treatment, due to VF on prior treatment, and who had a VL measurement up to the specified time point.

Time frame: At Week 24

Population: Analysis population included only the Prior virological failure participants who had a viral load (VL) measurement at the specified time point (at the 24-week time point). Stable switch participants were not included in the analysis, as these participants were already suppressed (HIV RNA \<50 c/mL) at baseline. Per the protocol, the primary endpoints of suppression at 24, 48, and 96 weeks were only evaluated for Treatment-naïve participants and Prior virological failure participants.

Time frame: At Week 48

Population: Analysis population included only the Prior virological failure participants who had a viral load (VL) measurement at the specified time point (at the 48-week time point). Stable switch participants were not included in the analysis, as these participants were already suppressed (HIV RNA \<50 c/mL) at baseline. Per the protocol, the primary endpoints of suppression at 24, 48, and 96 weeks were only evaluated for Treatment-naïve participants and Prior virological failure participants.

Time frame: At Week 96

Population: Analysis population included only the Prior virological failure participants who had a viral load (VL) measurement at the specified time point (at the 96-week time point). Stable switch participants were not included in the analysis, as these participants were already suppressed (HIV RNA \<50 c/mL) at baseline. Per the protocol, the primary endpoints of suppression at 24, 48, and 96 weeks were only evaluated for Treatment-naïve participants and Prior virological failure participants.

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

Population: Analysis population included all the individuals, (among the Treatment-naïve participants) who had initiated a 2DR with an integrase inhibitor plus a reverse transcriptase inhibitor prior to or during the study period, as a first-line treatment for HIV infection, and who had at least one VL measurement up to the specified time point.

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

Population: Analysis population included all the individuals, (among the Treatment-naïve participants) who had initiated a 2DR with an integrase inhibitor plus a reverse transcriptase inhibitor prior to or during the study period, as a first-line treatment for HIV infection, and who had at least one VL measurement up to the specified time point.

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

Population: Analysis population included all the individuals, (among the Treatment-naïve participants) who had initiated a 2DR with an integrase inhibitor plus a reverse transcriptase inhibitor prior to or during the study period, as a first-line treatment for HIV infection, and who had at least one VL measurement up to the specified time point.

Time frame: At Week 48

Population: Analysis population included only the Treatment-naïve participants who had a viral load (VL) measurement at the specified time point (at the 48-week time point). Stable switch participants were not included in the analysis, as these participants were already suppressed (HIV RNA \<50 c/mL) at baseline. Per the protocol, the primary endpoints of suppression at 24, 48, and 96 weeks were only evaluated for Treatment-naïve participants and Prior virological failure participants.

Time frame: At Week 96

Population: Analysis population included only the Treatment-naïve participants who had a viral load (VL) measurement at the specified time point (at the 96-week time point). Stable switch participants were not included in the analysis, as these participants were already suppressed (HIV RNA \<50 c/mL) at baseline. Per the protocol, the primary endpoints of suppression at 24, 48, and 96 weeks were only evaluated for Treatment-naïve participants and Prior virological failure participants.

Time frame: At Week 24

Population: Analysis population included only the Treatment-naïve participants who had a viral load (VL) measurement at the specified time point (at the 24-week time point). Stable switch participants were not included in the analysis, as these participants were already suppressed (HIV RNA \<50 c/mL) at baseline. Per the protocol, the primary endpoints of suppression at 24, 48, and 96 weeks were only evaluated for Treatment-naïve participants and Prior virological failure participants.

Time frame: At baseline (Week 0), Week 24, Week 48 and Week 96

Population: Analysis population included only the individuals, who had initiated a 2DR with an integrase inhibitor plus a reverse transcriptase inhibitor prior to or during the study period, as a first-line treatment, or as a switching treatment option whilst virologically suppressed on current treatment, or as a second-line treatment, due to VF on prior treatment and who had immunological data collected since first starting 2DR treatment.

Time frame: At baseline (Week 0), Week 24, Week 48 and Week 96

Population: Analysis population included only the individuals, who had initiated a 2DR with an integrase inhibitor plus a reverse transcriptase inhibitor prior to or during the study period, as a first-line treatment, or as a switching treatment option whilst virologically suppressed on current treatment, or as a second-line treatment, due to VF on prior treatment and who had immunological data collected since first starting 2DR treatment.

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

Population: Analysis population included all the individuals, who had initiated a 2DR with an integrase inhibitor plus a reverse transcriptase inhibitor prior to or during the study period, as a first-line treatment, or as a switching treatment option whilst virologically suppressed on current treatment, or as a second-line treatment, due to VF on prior treatment, and who had at least one VL measurement up to the specified time point.

Virologic rebound or virologic non-response in participants, was considered as virologic failure.

Time frame: Up to Week 96

Population: Analysis population included all the individuals, who had initiated a 2DR with an integrase inhibitor plus a reverse transcriptase inhibitor prior to or during the study period, as a first-line treatment, or as a switching treatment option whilst virologically suppressed on current treatment, or as a second-line treatment, due to VF on prior treatment, and who had at least one VL measurement up to the specified time point.

Safety reasons include tolerability, toxicity and other reasons.

Time frame: Up to Week 96

Population: Analysis population included all the individuals, who had initiated a 2DR with an integrase inhibitor plus a reverse transcriptase inhibitor prior to or during the study period, as a first-line treatment, or as a switching treatment option whilst virologically suppressed on current treatment, or as a second-line treatment, due to VF on prior treatment and had safety data collected in terms of drug related adverse events (AEs) and serious adverse events (SAEs) since first starting 2DR treatment.

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

Population: Analysis population included all the individuals, who had initiated a 2DR with an integrase inhibitor plus a reverse transcriptase inhibitor prior to or during the study period and had safety data collected in terms of drug related AEs and SAEs since first starting 2DR treatment.

Time frame: Up to Week 96

Population: Analysis population included (only) the individuals,who had initiated a 2DR with an integrase inhibitor plus a reverse transcriptase inhibitor prior to or during the study period, as a first-line treatment,or as a switching treatment option whilst virologically suppressed on current treatment, or as a second-line treatment, due to VF on prior treatment, and who had a VL measurement at the specified time points. No participants had emergent resistance mutations following VF events

Time frame: At Week 24, Week 48 and Week 96

Population: Analysis population included (only) the individuals, who had initiated a 2DR with an integrase inhibitor plus a reverse transcriptase inhibitor prior to or during the study period, as a first-line treatment, or as a switching treatment option whilst virologically suppressed on current treatment, or as a second-line treatment, due to VF on prior treatment, and who had a VL measurement at the specified time points.

Low level viremia was defined as virologic load \>=50 and \<200 c/mL.

Time frame: At Week 24, Week 48 and Week 96

Population: Analysis population included (only) the individuals, who had initiated a 2DR with an integrase inhibitor plus a reverse transcriptase inhibitor prior to or during the study period, as a first-line treatment, or as a switching treatment option whilst virologically suppressed on current treatment, or as a second-line treatment, due to VF on prior treatment, and who had a VL measurement at the specified time points.

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

Population: Number of participants analyzed (N=10) signifies participants who were evaluable for this outcome measure. As pre-specified in the protocol, a total of at least 320 stable switch participants should have been included for the power calculation of this endpoint.

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

Population: Number of participants analyzed (N=23, 15) signifies participants who were evaluable for this outcome measure. As pre-specified in the protocol, a total of at least 90 treatment-naïve participants and 90 prior virologic failure participants should have been included for the power calculation of this endpoint.