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

Completed

Conditions: HIV Infections

Registration Number: NCT03754803

Lead Sponsor: ViiV Healthcare

Brief Summary: This is a prospective, non-interventional, multi-center study, in participants with clinical indication of Human Immunodeficiency Virus (HIV)-1 infection. The aim of the study was to generate the real world evidence for the use of DTG+3TC in routine clinical care in Germany to supplement data obtained from controlled clinical trials. Treatment naïve and pre-treated HIV-1 positive participants were enrolled in the study. The observation period for the study was 3 years. Data was collected from routine clinical care via electronic data capture (EDC) system.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 376

Inclusion Criteria

Participants >= 18 years of age.
Participants with documented HIV-1 infection.
Prescription of DTG + 3TC was issued independently from entering this study.
Participants with the ability to understand informed consent form and other relevant regulatory documents.

Exclusion Criteria

Any contraindication according to Tivicay or Lamivudine summaries of product characteristics (SmPCs).
Participants with VL > 500 c/mL.
Any antiretroviral therapy for the treatment of HIV-1 in addition to DTG and 3TC or the DTG/3TC fixed dose combination (FDC).
Participants with hepatitis B virus (HBV)- coinfection.
Participants with current participation in the ongoing non-interventional study TRIUMPH (study number: 202033, NCT number: NCT02342769) or in any interventional clinical trial irrespective of indication.
Participants who had previously participated in clinical trials assessing DTG+ 3TC.

Study & Design

Study Type: OBSERVATIONAL

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Percentage of Participants With Sustained Virologic Suppression	At Year 3	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).

Secondary Outcome Measures

Name	Time	Method
Frequency of Any Adverse Drug Reactions	From Baseline until Year 3	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.
Discontinuation Rates Due to Adverse Drug Reactions	From Baseline until Year 3	Baseline represents the last visit before the start of therapy with DTG+3TC.
Percentage of Participants With Low Level Viremia	At Month 6 and years 1, 2 and 3	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.
Percentage of Participants With Missed Monthly Doses	At years 1, 2 and 3	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.
Frequency of Serious Adverse Events	From Baseline until Year 3	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.
Percentage of Participants With Reasons for DTG+3TC Therapy Initiation	At Baseline	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.
Change in Symptom Distress	At years 1, 2 and 3 compared to Baseline	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.
Percentage of Participants Referred to Another Medical Specialist	From Baseline until Year 3	Baseline represents the last visit before the start of therapy with DTG+3TC.
Percentage of Participants With Virologic Rebound	From Baseline until Year 3	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.
Percentage of Participants With Treatment Switch Due to Virologic Reasons or Due to Intolerability	From Baseline until Year 3	The intolerability was determined at the discretion of the physician. Baseline represents the last visit before the start of therapy with DTG+3TC.
Number of Serious Adverse Events (SAEs)	From Baseline until Year 3	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.
Number of Serious and Non-serious Adverse Drug Reactions (ADRs)	From Baseline until Year 3	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.
Change in Lipid Laboratory Values	At years 1, 2 and 3 compared to Baseline	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.
Number of HIV-RNA Monitoring Measures	From Baseline until Year 3	Baseline represents the last visit before the start of therapy with DTG+3TC.
Percentage of Participants With VL > 50 c/mL With Emergent Resistance Mutations	From Baseline until Year 3	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.
Percentage of Participants With Reasons for Therapy Switch to DTG+3TC	At Baseline	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.
Change in Treatment Satisfaction	At years 1, 2 and 3 compared to Baseline	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.