Description of Real World Antiviral Effectiveness and Sustainability of the 2-Drug Regimen Dolutegravir + Lamivudine in Untreated and Pre-treated Patients in Routine Clinical Care in Germany

Virologic suppression is defined as a viral load (VL) less than (\<) 50 copies (c)/mL or, if between 50-200 c/mL, with a subsequent next available measurement \<50 c/mL (within 120 days).

Time frame: At Year 3

Population: The analysis was performed on the Effectiveness Set (ES) which includes all participants from the Full Analysis Set (FAS) except those excluded for various reasons, such as protocol violations and participant withdrawal. As per protocol, data for this outcome measure were analyzed separately for ART-naive and Pre-treated participants, as the variable required different and/or additional response options depending on prior treatment status.

The following lipid parameters are presented: total cholesterol, low-density lipoprotein (LDL) cholesterol, high-density lipoprotein (HDL) cholesterol, and triglycerides. Baseline represents the last visit before the start of therapy with DTG+3TC.

Time frame: At years 1, 2 and 3 compared to Baseline

Population: The analysis was performed on the ES, which includes all participants from the FAS except those excluded for various reasons, such as protocol violations and participant withdrawal. As per protocol, data for this outcome measure were analyzed separately for ART-naive and Pre-treated participants, as the variable required different and/or additional response options depending on prior treatment status.

The change in symptom distress is based on the HIV Symptom Distress Module (SDM) questionnaire. The SDM is a 20-item self-reported tool that assesses the presence and distress of symptoms related to HIV or its treatment. It includes sub-scales for treatment satisfaction and individual satisfaction with treatment changes. The treatment satisfaction score sums all items, ranging from +30 (greater improvement) to -30 (greater deterioration). Individual item scores range from +3 (much more satisfied, convenient, flexible) to -3 (much less satisfied, convenient, flexible). General satisfaction and lifestyle scores sum all items, ranging from +15 (greater improvement) to -15 (greater deterioration). Baseline represents the last visit before the start of therapy with DTG+3TC.

Time frame: At years 1, 2 and 3 compared to Baseline

Population: The analysis was performed on the ES, which includes all participants from the FAS except those excluded for various reasons, such as protocol violations or withdrawal. As per protocol, data for this outcome measure were analyzed separately for ART-naive and Pre-treated participants, as the variable required different and/or additional response options depending on prior treatment status. Only participants who completed the HIV SDM questionnaire at the specified time points, were analyzed.

The change in treatment satisfaction is based on the HIV Treatment Satisfaction questionnaire (HIV TSQ). The HIV TSQ is a 10-item-self-reported scale that measures overall satisfaction with treatment and by specific domains e.g., convenience and flexibility. In treatment satisfaction score ranges from 0-60, where higher the score, greater the satisfaction with treatment. Individual item scores which included All rate score ranging from 0 (very dissatisfied, inconvenient, inflexible) to 6 (very satisfied, convenient, flexible), in case of general satisfaction, there will be 10 items which will be summed to produce a score ranging from 0 to 30, with higher the score greater the satisfaction with subscale. For lifestyle scale with 8 items which will be summed to produce a score ranging from 0 to 30, with higher the score greater the satisfaction with subscale. Baseline represents the last visit before the start of therapy with DTG+3TC.

Time frame: At years 1, 2 and 3 compared to Baseline

Population: The analysis was performed on the ES, including all FAS participants except those excluded for reasons such as protocol violations or withdrawal. Only Pre-treated participants were included, as the instrument compares to prior treatment, which requires a previous regimen before DTG + 3TC. Only those who completed the HIV TSQ at the specified time points were analyzed.

Baseline represents the last visit before the start of therapy with DTG+3TC.

Time frame: From Baseline until Year 3

Population: The analysis was performed on the Safety Analysis Set, which includes all ES participants who received at least one dose, plus those excluded from ES due to withdrawal but with available safety data.

Any = serious and non-serious ADRs. An ADR is 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. A serious ADR is any untoward medical occurrence that, at any dose results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect or is medically significant. Baseline represents the last visit before the start of therapy with DTG+3TC.

Time frame: From Baseline until Year 3

Population: The analysis was performed on the Safety Analysis Set, which includes all ES participants who received at least one dose, plus those excluded from ES due to withdrawal but with available safety data. As per protocol, data for this outcome measure were analyzed separately for ART-naive and Pre-treated participants, as the variable required different and/or additional response options depending on prior treatment status.

An adverse event 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 the treatment. A SAE is any untoward medical occurrence that, at any dose results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect or is medically significant. Baseline represents the last visit before the start of therapy with DTG+3TC.

Time frame: From Baseline until Year 3

Population: The analysis was performed on the Safety Analysis Set, which includes all ES participants who received at least one dose, plus those excluded from ES due to withdrawal but with available safety data. As per protocol, data for this outcome measure were analyzed separately for ART-naive and Pre-treated participants, as the variable required different and/or additional response options depending on prior treatment status.

Baseline represents the last visit before the start of therapy with DTG+3TC.

Time frame: From Baseline until Year 3

Population: The analysis was performed on the ES, which includes all participants from the FAS except those excluded for various reasons, such as protocol violations and participant withdrawal. As per protocol, data for this outcome measure were analyzed separately for ART-naive and Pre-treated participants, as the variable required different and/or additional response options depending on prior treatment status.

An adverse event 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 the treatment. A SAE is any untoward medical occurrence that, at any dose results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect or is medically significant. Baseline represents the last visit before the start of therapy with DTG+3TC.

Time frame: From Baseline until Year 3

Population: The analysis was performed on the Safety Analysis Set, which includes all ES participants who received at least one dose, plus those excluded from ES due to withdrawal but with available safety data. As per protocol, data for this outcome measure were analyzed separately for ART-naive and Pre-treated participants, as the variable required different and/or additional response options depending on prior treatment status.

An ADR is 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. A serious ADR is any untoward medical occurrence that, at any dose results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect or is medically significant. Baseline represents the last visit before the start of therapy with DTG+3TC.

Time frame: From Baseline until Year 3

Population: The analysis was performed on the Safety Analysis Set, which includes all ES participants who received at least one dose, plus those excluded from ES due to withdrawal but with available safety data. As per protocol, data for this outcome measure were analyzed separately for ART-naive and Pre-treated participants, as the variable required different and/or additional response options depending on prior treatment status.

Baseline represents the last visit before the start of therapy with DTG+3TC.

Time frame: From Baseline until Year 3

Population: The analysis was performed on the ES, which includes all participants from the FAS except those excluded for various reasons, such as protocol violations and participant withdrawal. As per protocol, data for this outcome measure were analyzed separately for ART-naive and Pre-treated participants, as the variable required different and/or additional response options depending on prior treatment status.

Low level viremia is defined as a VL measurement greater than (\>) 50 - \<200 c/mL for pre-treated participants. For naive participants, a VL measurement between \>50 to \<200 c/mL after initial suppression of \<50 c/mL was evaluated.

Time frame: At Month 6 and years 1, 2 and 3

Population: The analysis was performed on the ES, which includes all participants from the FAS except those excluded for various reasons, such as protocol violations and participant withdrawal. As per protocol, data for this outcome measure were analyzed separately for ART-naive and Pre-treated participants, as the variable required different and/or additional response options depending on prior treatment status.

Participants were prompted to give an estimate of their level of adherence in a single-item question part of their self-assessment questionnaires. 0-2 missed doses, 3-4 missed doses, 5-6 missed doses, and \>6 missed doses were reported.

Time frame: At years 1, 2 and 3

Population: The analysis was performed on the ES, which includes all participants from the FAS except those excluded for various reasons, such as protocol violations and participant withdrawal.

The primary reasons for therapy switch are low potential for interaction, preference of a 2-drug regime, prevention of potential long-term toxicities of other therapies, tolerability profile of DTG+3TC, easy to take (once daily, independent of meals), and other. Baseline represents the last visit before the start of therapy with DTG+3TC.

Time frame: At Baseline

Population: The analysis was performed on the ES, which includes all participants from the FAS except those excluded for various reasons, such as protocol violations and participant withdrawal. Only ART-naive participants were included, as the instrument presents the reasons for therapy initiation, which requires no previous regimen before DTG + 3TC.

The primary reasons for therapy switch are side effects of previous ART, low potential for interaction, preference of a 2-drug regime, tolerability profile of DTG+3TC, pill size, easy to take (once daily, independent of meals), patient's preference, and other. Baseline represents the last visit before the start of therapy with DTG+3TC.

Time frame: At Baseline

Population: The analysis was performed on the ES, which includes all participants from the FAS except those excluded for various reasons, such as protocol violations and participant withdrawal. Only Pre-treated participants were included, as the instrument presents the reasons for therapy switch, which requires a previous regimen before DTG + 3TC.

The intolerability was determined at the discretion of the physician. Baseline represents the last visit before the start of therapy with DTG+3TC.

Time frame: From Baseline until Year 3

Population: The analysis was performed on the ES, which includes all participants from the FAS except those excluded for various reasons, such as protocol violations and participant withdrawal. As per protocol, data for this outcome measure were analyzed separately for ART-naive and Pre-treated participants, as the variable required different and/or additional response options depending on prior treatment status.

Virologic rebound is defined as 2 consecutive VL measurements \>=200 c/mL after suppression. Baseline represents the last visit before the start of therapy with DTG+3TC.

Time frame: From Baseline until Year 3

Population: The analysis was performed on the ES, which includes all participants from the FAS except those excluded for various reasons, such as protocol violations and participant withdrawal. As per protocol, data for this outcome measure were analyzed separately for ART-naive and Pre-treated participants, as the variable required different and/or additional response options depending on prior treatment status.

Newly identified resistance-associated mutations, including those detected before initiating treatment with DTG+3TC and most recent HIV-RNA levels. Baseline represents the last visit before the start of therapy with DTG+3TC.

Time frame: From Baseline until Year 3

Population: The analysis was performed on the ES, which includes all participants from the FAS except those excluded for various reasons, such as protocol violations and participant withdrawal. As per protocol, data for this outcome measure were analyzed separately for ART-naive and Pre-treated participants, as the variable required different and/or additional response options depending on prior treatment status.