Clinical trial NCT06393387: Retrospective Review of DTG/3TC Versus BIC/F/TAF Across a Multi Clinic Infectious Disease Organization in Southeast United States
Official title: Retrospective Review of DTG/3TC Versus BIC/F/TAF Across a Multi Clinic Infectious Disease Organization in Southeast United States (REVIVE Study)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hiv
HIV-1-infection
HIV Infections
Keywords: HIV
Social Determinants of Health
Adherence
Viral Suppression
Percent of Days Covered
Lead sponsor: Midway Specialty Care Center
Sponsor class: OTHER
First posted: 2024-05-01
Enrollment: 800
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: PWH from all 12 sites in Florida across Midway Specialty Care Center.

Brief summary: This real-world retrospective study describes the clinical efficacy of 2DR (DOVATO® (DTG/3TC)) versus 3DR (BIKTARVY® (BIC/F/TAF)) in PWH, including those with at least 2 social determinants of health indicators, across a multi clinic infectious disease organization in the Southeast United States

Detailed description: 3-drug regimens (3DR) have been the foundation of HIV treatment for the last two decades; however, based on more recent data from GEMINI 1 and 2, TANGO, SALSA and STAT clinical trials, 2-drug regimens (2DR), such as dolutegravir/lamivudine, have shown similar efficacy in viral suppression as compared to 3DR1,2,5,6. Furthermore, real-world evidence (RWE) data has reinforced the clinical trial data, showing similar effectiveness outcomes data of DTG/3TC vs. 3DR across \~38,000 people living with HIV, in a variety of sub-populations, including more than 1,200 who are ART naïve. Test and treat strategies have also been successful with both 2DR and 3DR3, but analysis of clinical outcomes, including barriers to resistance as evidenced by viral suppression, in persons with more challenging to treat HIV (PWH), are needed, including PWH with social determinant of health (SDOH) indicators (including but not limited to unstable housing, food insecurity, unemployment, uninsured and/or unstable transportation). PWH may prioritize addressing these needs over adherence to antiretroviral therapy and lower adherence to antiretroviral therapy raises the concern for lack of viral suppression and/or the development of resistance.

A recent study demonstrated that PWH in the United States with 2 or more SDOH indicators were 20% less likely to report excellent adherence in the prior 30 days and 10% less likely to achieve sustained viral suppression in the prior year4 . Furthermore, as HIV disproportionately affects persons of lower socioeconomic status who are experiencing multiple SDOH indicators, identifying ART that can be used to achieve viral suppression in this patient population is essential.

This retrospective study will be performed across a not-for-profit multi-clinic infectious disease organization in the Southeast United States comprising 12 clinics. This multi-clinic infectious disease organization provided care to over 6,000 PWH over the last 5 years. 25% of those PWH identified as cisgender females. 60% of the total PWH were ages 50 years and older. Over 50% of PWH identified their race as a racial and/or ethnic minority.

10 out of 12 clinics are located in 5 of Florida's 6 top counties for prevalence of persons with HIV (Miami-Dade, Broward, Orange, Palm Beach, and Hillsborough Counties). 6 out of 12 clinics provide care for persons with HIV with Ryan White (persons with federal poverty level below 400%). Clinics across the organization provide rapid entry to care for PWH to enter care for the first time (treatment naïve) and/or re-enter care, after being out of care and/or off of ART. The rapid entry to care model also provides the opportunity to review clinical outcomes of PWH starting on either 2DR or 3DR who are re-entering care with an unknown history of resistance.

Eligibility criteria: Inclusion Criteria:

* Adults, aged 18 years and older;
* Diagnosis of HIV-1;
* Have a history of ART consisting of DTG/3TC or BIC/F/TAF, initiated from May 1, 2019 through January 28, 2023;
* Have at least 48 weeks of clinical follow up after initiation of DTG/3TC or BIC/F/TAF; clinical follow-up can include time post-discontinuation of either index regimen;
* Complete data, for HIV-1 RNA viral load at all study time points, including baseline, through 24 weeks and through 48 weeks;
* Received care from a physician, nurse practitioner or physician assistant at the organization

Exclusion Criteria:

* Index regimen is BIC/F/TAF and has a history of ART consisting of DTG+3TC or DTG/3TC;
* Index regimen is DTG/3TC and has a history of ART consisting of BIC/F/TAF

Primary outcomes:
measure: Viral Suppression
timeFrame: 48 Weeks
Secondary outcomes:
measure: Viral Suppression
timeFrame: 24 Weeks
measure: Viral Suppression
timeFrame: 48 Weeks
measure: Viral Suppression
timeFrame: 24 Weeks
measure: Viral Suppression
timeFrame: 48 Weeks
measure: Viral Suppression
timeFrame: 24 Weeks
measure: Clinical Characteristics of Persons with HIV
timeFrame: Baseline
measure: Tolerability
timeFrame: 24, 48 Weeks
measure: Treatment Discontinuation
timeFrame: 24, 48 Weeks
Other outcomes:
measure: Viral Suppression
timeFrame: 48 Weeks
measure: Viral Suppression
timeFrame: 48 Weeks
measure: Viral Suppression
timeFrame: 48 Weeks
measure: Weight Change
timeFrame: 48 Weeks
measure: Change in Absolute CD4 and CD4/CD8 Ratio
timeFrame: 48 Weeks
measure: Viral Suppression
timeFrame: 24, 48 Weeks
measure: Persistence on DTG/3TC versus BIC/F/TAF
timeFrame: 24, 48 Weeks
Locations:
city: West Palm Beach
country: United States
facility: Midway Specialty Care Center
state: Florida
Study officials:
affiliation: Midway Specialty Care Center
name: Jennifer Kuretski, DNP
role: PRINCIPAL_INVESTIGATOR
References:
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