Background
Despite significant progress made in antiretroviral (ARV) therapy for human immunodeficiency virus-1 (HIV-1) treatment, one of the major challenges facing the efficacy of ARV is drug resistance. The objective of this study was to evaluate clinical outcomes associated with resistance to ARV among people with HIV (PWH).
Methods
This national retrospective cohort study was conducted using data from the United States Department of Veterans Affairs. The Veterans Affairs Informatics and Computing Infrastructure (VINCI) was utilized to obtain individual-level information of structured claims data on demographics, medical claims, and pharmacy dispensation. Study cohorts were created by resistance testing results (non-resistance cohort, those with any resistance associated mutation (RAM) and those with ≥1 major RAM). The resistance cohorts had ≥1 documented RAM in integrase, protease or reverse transcriptase genes as defined by the International Antiviral Society-USA.
Results
A total of 7,746 veterans had an interpretable resistance test with 1,875 with no detectable resistance, 4,466 with ≥1 minor RAM detected and 1,405 patients having ≥1 major RAM, and. Median CD4 counts within 60 days of index were higher among those without RAMs (358 cells/mm3) compared with those with any RAM (294 cells/mm3) or major RAMs (285 cells/mm3). Opportunistic infections occurred during follow up for 3.8% of the non-resistance cohort compared to 5.6% of those with ≥1 minor RAM (p=0.005) and 5.1% of those with major RAMs (p=0.07). The number of hospitalizations post index was also greater in both the resistance and major RAM cohorts compared to those without resistance (p<0.001 for both). Among veterans who did not have an active ARV prescription at the time of the resistance test and who then initiated ARV (n=3,522), those with no resistance were more likely to persist on therapy at one year compared to those with resistance, with differences being even more pronounced in those with major RAMs (Figure), both p<0.0001. Among those with resistance taking complete ARV regimen at index who switched therapies, veterans generally switched to INSTI- or PI-based regimens.
Conclusions
HIV drug resistance was associated with a more complex patient profile in both clinical and therapy outcomes. Patients harboring major RAMs exhibited lower CD4 counts, more frequent hospitalizations, and reduced ARV persistence. Interventions to prevent resistance development may reduce patient complexity and burden.
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