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.