Principal Investigator: Ava Avalos, MD

Study Objectives

Primary Objectives

1. Cohort 1 Primary Objective: To determine the effectiveness of TDF/3TC or FTC (XTC)/DTG as compared to TDF/XTC/EFV in ART treatment naïve patients. Treatment effectiveness will be assessed in terms of rates of virological suppression, time to virological suppression, virological rebound and virological non-response.
2. Cohort 2 Primary Objective: To determine the effectiveness of DTG in INSTI naïve ART experienced adults and adolescents, switching to a DTG regimen from first or second-line ART regimens. Treatment effectiveness will be assessed in terms of rates of virological suppression, time to virological suppression, virological rebound and virological non-response.

Secondary Objectives

1. To determine the number and proportion of patients with HIV-1 RNA of <50 and <200 copies/mL by treatment group summarized at 3, 6, 12, 24, 36, 48, 60 months post treatment initiation, and stratified by viral load status at baseline (suppressed vs not suppressed).
2. To determine the incidence of safety events and their outcomes reported among adults and adolescents who were initiated or switched to DTG in first- and second-line ART treatment.
3. To determine the documented clinical outcomes of adults and adolescents who develop opportunistic infections (including tuberculosis, cryptococcal meningitis, herpes simplex, cytomegalovirus, syphilis, candidiasis and toxoplasmosis) while taking DTG containing regimens at baseline, 3, 6, 12, 18, 24, 36, 48 and 60 months.
4. To determine and summarize documented clinical events and comorbidities (including HTN, CVD, HIV related and non-related cancers, weight gain, diabetes and COVID-19 infection) beginning 1 January 2016 through 31 December 2021 in patients initiated or switched to DTG containing regimens at baseline, 3, 6, 12, 24, 36, 48 and 60 months., 12,18, 24, 36 months.

Study Design: The Study is designed as an Observational/Noninterventional Retrospective Cohort Study that will review 4,500 patient records from 2 Cohorts in 4 districts.

Study population and size:

Cohort 1:  ART INSTI Naïve adults initiated per the Standard of Care of the Botswana National ART Treatment Guidelines on or after 2012 with one of the following treatment regimens:  

• TDF/XTC/EFV (n=1,500)
• TDF/XTC/DTG (n=1,500)       

Adults >18 years of age, registered and initiated per the Botswana National ART Treatment Programme on TDF/XTC/EFV after 1 January 2012 or TDF/XTC/DTG containing regimens after 1 January 2016, with at least one follow-up visit post initiation.

Cohort 2:  First- or Second-Line ART-Experienced & INSTI-Naïve patients, switched to DTG containing regimens from any of the following regimens:

• AZT or TDF or ABC /  XTC  / EFV or NVP
• AZT or TDF or ABC /  XTC   /LPV/r or ATA/r
   

Adults   >18 years of age, Adolescents > 13 years <18 years, registered and initiated within the Botswana National ART Treatment Programme after 1 January 2005 on standard first line or second line ART treatment regimens switched to DTG containing regimens after 2016 for documented toxicities, intolerance, treatment optimization, failure or any other reasons.

Study duration: 18 Months

Study Results: Study is on-going and no data analyses have been completed yet.