For patients with HIV infection, switching from a 3-drug to a 2-drug antiretroviral therapy (ART) regimen of dolutegravir plus lamivudine showed a favorable trend for 2 soluble inflammatory biomarkers, according to results of a study published in HIV Research & Clinical Practice.
Researchers conducted a longitudinal study between August 2019 and May 2021 among patients with virologically-suppressed HIV infection receiving a 3-drug ART regimen. The researchers compared inflammatory biomarkers between patients who switched to a 2-drug ART regimen of dolutegravir plus lamivudine at baseline and those who continued treatment with a 3-drug ART regimen (controls). Patients in the 2-drug and control groups were matched on the basis of age, sex, and type of anchor drug. At baseline and week 48, plasma concentrations of interleukin-6 (IL-6), intestinal fatty-acid binding protein (I-FABP), D-dimer, and C reactive protein (CRP) were quantified via microfluidic ultrasensitive enzyme-linked immunosorbent assay and compared between the 2 groups.
A total of 208 patients were included in the analysis, of whom 101 were in the 2-drug group and 107 were in the control group. Among all patients, the median age was 55.4 (IQR, 47.7-61.3) years, 63% were men, 89.9% were White, and the median duration of ART was 13.0 (IQR, 6.4-20.6) years.
At baseline, the mean plasma concentrations of IL-6, I-FABP, D-dimer, and CRP were similar between the 2 patient groups. However, the median CD4+ count (cells/mm3) was significantly increased among patients in the 2-drug group vs those in the control group (746 vs 624; P =.006).
A significant decrease in the mean plasma concentration of I-FABP (log10 pg/mL) occurred among patients in the 2-drug group (-0.088; 95% CI, -0.14 to -0.041) compared with those in the control group (0.033; 95% CI, -0.007 to 0.072) between baseline and week 48 (P <.001). There also were significant differences in the mean plasma concentrations of CRP (log10 pg/mL) noted between patients in the 2-drug group (-0.028; 95% CI, -0.118 to 0.063) vs those in the control group (0.118; 95% CI, 0.024-0.211) at this time (P =.028). The mean plasma concentrations of IL-6 and D-dimer between baseline and week 48 did not significantly differ for patients in either group.
Similar results were noted after the analysis was restricted to patients receiving integrase strand transfer inhibitor-based ART at baseline (70.7%), with the exception of a favorable trend in the mean plasma concentration of IL-6 observed among those in the 2-drug group vs those in the control group.
Although virologic suppression was maintained for most patients through week 48, a single HIV viral rebound occurred among 2 patients in the 2-drug group during the study period.
This study was potentially limited by unmeasured and uncontrolled biases due to its longitudinal design.
According to the researchers, “further studies with a longer follow-up are warranted to further reveal the inflammatory consequences of switching to the dolutegravir plus lamivudine regimen in patients with sustained virological suppression, and [to] better elucidate if it might be an advantage over triple therapy.”
Disclosure: Some authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of disclosures.
Lombardi F, Belmonti S, Moschese D, et al. Inflammation markers in virologically suppressed HIV-Infected patients after switching to dolutegravir plus lamivudine vs continuing triple therapy: 48-week results in real-life setting. HIV Res Clin Pract. 2022;23(1):28-36. doi:10.1080/25787489.2022.2080625