Retrospective Review of DTG/3TC Versus BIC/F/TAF Across a Multi Clinic Infectious Disease Organization in Southeast United States
- Conditions
- HivHIV-1-infectionHIV Infections
- Interventions
- Drug: DTG/3TC versus BIC/F/TAF
- Registration Number
- NCT06393387
- Lead Sponsor
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 800
- 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
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Persons with HIV on DTG/3TC DTG/3TC versus BIC/F/TAF All data for PWH, initiated on DTG/3TC or BIC/F/TAF, between May 1, 2019 through January 28, 2023, will be collected for purposes of this retrospective study. 400 PWH on DTG/3TC and 400 PWH on BIC/F/TAF, for a total of 800 PWH, will be selected at random for inclusion in this retrospective study. Persons with HIV on BIC/F/TAF DTG/3TC versus BIC/F/TAF All data for PWH, initiated on DTG/3TC or BIC/F/TAF, between May 1, 2019 through January 28, 2023, will be collected for purposes of this retrospective study. 400 PWH on DTG/3TC and 400 PWH on BIC/F/TAF, for a total of 800 PWH, will be selected at random for inclusion in this retrospective study.
- Primary Outcome Measures
Name Time Method Viral Suppression 48 Weeks To evaluate the effectiveness of switching treatment to DTG/3TC vs. BIC/F/TAF through 48 weeks in virally suppressed ART experienced individuals with no interruptions in prior therapy.
- Secondary Outcome Measures
Name Time Method Viral Suppression 24 Weeks To evaluate the effectiveness of DTG/3TC vs. BIC/F/TAF through 24 weeks in ART experienced individuals who are returning to care.
Clinical Characteristics of Persons with HIV Baseline To describe the baseline demographics and clinical characteristics of individuals on DTG/3TC and BIC/F/TAF by the following sub-groups: (1) Virally suppressed, (2) ART experienced individuals, \& (3) ART naïve individuals ART experienced individuals who are returning to care
Tolerability 24, 48 Weeks To assess the tolerability (i.e., all drug-related adverse reactions (ARs) as per label) of DTG/3TC vs. BIC/F/TAF through 24 weeks and 48 weeks by the following sub-groups: (1) Virally suppressed ART experienced individuals, (2) ART naïve individuals \& (3) ART experienced individuals who are returning to care.
Treatment Discontinuation 24, 48 Weeks To assess treatment discontinuations (i.e., withdrawals due to drug-related ARs) of DTG/3TC vs. BIC/F/TAF through 24 weeks and 48 weeks by the following sub-groups: (1) Virally suppressed ART experienced individuals, (2) ART naïve individuals, (3) ART experienced individuals who are returning to care.
Trial Locations
- Locations (1)
Midway Specialty Care Center
🇺🇸West Palm Beach, Florida, United States