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

Percentage of Participants With Low Level Viremia

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

Percentage of Participants With Virologic Rebound

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

Percentage of Participants With Treatment Switch Due to Virologic Reasons or Due to Intolerability

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

Percentage of Participants With Missed Monthly Doses

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

Number of Serious Adverse Events (SAEs)

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

Frequency of Serious Adverse Events

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

Number of Serious and Non-serious Adverse Drug Reactions (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

Frequency of Any Adverse Drug Reactions

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

Discontinuation Rates Due to Adverse Drug Reactions

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

Time frame: From Baseline until Year 3

Percentage of Participants With VL > 50 c/mL With Emergent Resistance Mutations

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

Change in Lipid Laboratory Values

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

Percentage of Participants With Reasons for Therapy Switch to 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

Percentage of Participants With Reasons for DTG+3TC Therapy Initiation

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

Change in Treatment Satisfaction

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

Change in Symptom Distress

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

Number of HIV-RNA Monitoring Measures

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

Time frame: From Baseline until Year 3

Percentage of Participants Referred to Another Medical Specialist

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

Time frame: From Baseline until Year 3