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

Completed

Conditions: HIV Infections

Interventions: Drug: JULUCA

Registration Number: NCT03518060

Lead Sponsor: ViiV Healthcare

Brief Summary: This was a prospective, non-interventional, single-arm, multi-center study aimed at gathering real-world data on JULUCA use in routine clinical care in Germany, to supplement clinical trial data to further improve/optimize care in HIV positive participants in Germany. Approximately 250 virologically suppressed HIV positive participants on stable antiretroviral therapy (ART) were included in the study at the discretion of treating physician. Eligible participants were followed up for approximately 3 years and data was collected during routine clinical care.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 209

Inclusion Criteria

Greated than or equal to (>=)18 years of age.
Documented HIV-1 infection.
Virologically suppressed (HIV-1 ribonucleic acid [RNA] less than [<] 50 copies [c]/mL for at least 6 months)
Prescription for JULUCA was issued independently from entering this study.
Ability to understand informed consent form and other relevant study documents

Exclusion Criteria

Any contraindication according to JULUCA SmPC.
Documented viral load greater than (>) 50 c/mL at any time point within 6 months prior to inclusion into this study.
History of treatment failure.
Known or suspected substitutions associated with resistance to any non-nucleoside reverse-transcriptase inhibitors (NNRTI) or integrase strand transfer inhibitor (INSTI).
Any ART for the treatment of HIV-1 in addition to JULUCA.
Hepatitis B virus (HBV)-co-infection.
Current participation in the ongoing non-interventional study TRIUMPH (study number: 202033) or any interventional clinical trial irrespective of indication.
Previous participation in clinical trials involving JULUCA.

Study & Design

Study Type: OBSERVATIONAL

Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Participants who received JULUCA	JULUCA	Virologically suppressed HIV positive participants, on a stable antiretroviral regimen, who switched to the 2-Drug Regimen JULUCA (Dolutegravir \[DTG\] / Rilpivirine \[RPV\]) were included in the study. Participants were followed-up for approximately 3 years during routine clinical practice.

Primary Outcome Measures

Name	Time	Method
Number of Participants With Sustained Virologic Suppression at Year 3	At Year 3	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.

Secondary Outcome Measures

Name	Time	Method
Number of Participants With Sustained Virologic Suppression at Year 1 and Year 2	At Year 1 and Year 2	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.
Number of Participants With Low Level Viremia	At Year 1, Year 2 and Year 3	Low level viremia was defined as a VL greater than (\>) 50 to \<200 c/mL.
Number of Participants With Virologic Rebound	At Year 1, Year 2 and Year 3	Virologic rebound was defined as two consecutive VL measurements of \>=200 c/mL.
Number of Participants With Treatment Switch	At Year 1, Year 2 and Year 3	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.
Number of Monitoring Measures During the 3-year Follow-up	Up to Year 3	The HIV monitoring measures included were defined as HIV-RNA measurements, normalized to participant years.
Number of Participants With Serious Adverse Events (SAEs)	Up to Year 3	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.
Number of Participants With Adverse Drug Reactions (ADRs)	Up to Year 3	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.
Number of Participants With Adherence to Therapy	At Year 1, Year 2 and Year 3	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).
Change From Baseline (BL) in Lipid Laboratory Values	At Year 1, Year 2 and Year 3	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.
Change in Treatment Satisfaction	At Year 1, Year 2 and Year 3	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).
Change in Symptom Distress	At Year 1, Year 2 and Year 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.
Number of Participants by Reasons for Therapy Switch to JULUCA	At Baseline (Day 1)	The primary and secondary reasons for therapy switch were presented.