Dolutegravir/Rilpivirine, Antiretroviral Efficacy Study Using Real-world Data in Subjects With Human Immunodeficiency Virus (HIV)-1

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.

Time frame: At Year 3

Population: 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.

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.

Time frame: At Year 1, Year 2 and Year 3

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. 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.

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.

Time frame: At Year 1, Year 2 and Year 3

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. This analysis was performed only on the participants from the mFAS who completed the HIV SDM.

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).

Time frame: At Year 1, Year 2 and Year 3

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. This analysis was performed only on the participants from the mFAS who completed the HIV TSQs.

The HIV monitoring measures included were defined as HIV-RNA measurements, normalized to participant years.

Time frame: Up to Year 3

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.

Time frame: 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.

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).

Time frame: At Year 1, Year 2 and Year 3

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. This analysis was performed only on the participants from the mFAS who completed the self-assessment questionnaire of adherence.

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.

Time frame: Up to Year 3

Population: The analysis was performed on the SAS which included all participants who received at least one dose of DTG+RPV.

Low level viremia was defined as a VL greater than (\>) 50 to \<200 c/mL.

Time frame: At Year 1, Year 2 and Year 3

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.

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.

Time frame: Up to Year 3

Population: The analysis was performed on the safety analysis set (SAS) which included all participants who received at least one dose of DTG+RPV.

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.

Time frame: At Year 1 and Year 2

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 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.

Time frame: At Year 1, Year 2 and Year 3

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.

Virologic rebound was defined as two consecutive VL measurements of \>=200 c/mL.

Time frame: At Year 1, Year 2 and Year 3

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.