Evaluation of CD4+ counts after switching to INSTI-based regimen in virologically suppressed, treatment-experienced HIV patients: a retrospective, descriptive study

Abstract

Specific Aims: To determine if integrase strand transfer inhibitor (INSTI) based regimens initiated in antiretroviral treatment (ART) experienced, virologically suppressed HIV patients would result in favorable immunological function reflected by an increase in CD4 counts. Subjects: HIV-1 positive, age ≥ 18, on stable ART with non-INSTI based regimens and were switched to INSTI-based regimens. Methods: Patients were excluded for HIV RNA > 200 (copies/mL) within one year prior to switch or pregnancy. The primary outcome was the change in post-switch CD4 counts from baseline. A linear mixed effects model was used to define the change in CD4 counts over time. Secondary outcomes included comparison of median CD4 count at baseline and at furthest follow up, incidences of adverse effects, changes in safety profile (SCr, AST, ALT, lipids), and the number of HIV RNA > 200 during post-switch period. Main Results: A total of 53 patients were included: male (75%), white (57%), median age= 53, 74% had HIV ≥ 10 years, 58% were on non-nucleoside reverse transcriptase inhibitor (NNRTI), and 45% were on protease inhibitor (PI) based regimens. Median baseline CD4 = 588 cells/mm3 (CD4% = 30.0), and median CD8 = 818.5 (CD8% = 44). Median CD4 at furthest follow up was 622 (CD4% = 31.4), and median CD8 was 743.5 (CD8% = 44.2). The linear mixed effects model showed a statistically significant increase in CD4 count over time after switching to an INSTI-based regimen (P = 0.015). Higher baseline CD4 count was associated with higher CD4 counts later on (P = 0.001). Conclusions: Switching to an INSTI based regimen was associated with an increase in CD4 counts in ART experienced, stabilized individuals living with HIV.