Abstract
BackgroundThe CD4/CD8 ratio has been associated with the risk of AIDS and non-AIDS events. We describe trends in immunological parameters in people who underwent a switch to monotherapy or dual therapy, compared to a control group remaining on triple antiretroviral therapy (ART).MethodsWe included patients in Icona who started a three-drug combination ART regimen from an ART-naïve status and achieved a viral load ≤ 50 copies/mL; they were subsequently switched to another triple or to a mono or double regimen. Standard linear regression at fixed points in time (12-24 months after the switch) and linear mixed model analysis with random intercepts and slopes were used to compare CD4 and CD8 counts and their ratio over time according to regimen types (triple vs. dual and vs. mono).ResultsA total of 1241 patients were included; 1073 switched to triple regimens, 104 to dual (72 with 1 nucleoside reverse transcriptase inhibitor (NRTI), 32 NRTI-sparing), and 64 to monotherapy. At 12 months after the switch, for the multivariable linear regression the mean change in the log10 CD4/CD8 ratio for patients on dual therapy was −0.03 (95% confidence interval (CI) –0.05, –0.0002), and the mean change in CD8 count was +99 (95% CI +12.1, +186.3), taking those on triple therapy as reference. In contrast, there was no evidence for a difference in CD4 count change. When using all counts, there was evidence for a significant difference in the slope of the ratio and CD8 count between people who were switched to triple (points/year change ratio = +0.056, CD8 = −25.7) and those to dual regimen (ratio = −0.029, CD8 = +110.4).ConclusionsWe found an increase in CD8 lymphocytes in people who were switched to dual regimens compared to those who were switched to triple. Patients on monotherapy did not show significant differences. The long-term implications of this difference should be ascertained.
Highlights
The CD4/CD8 ratio has been associated with the risk of AIDS and non-AIDS events
The analysis of the data of our and other cohorts have shown that, in contrast with recent data from the Antiretroviral Therapy Cohort Collaboration (ART-CC) [15], a low CD4/CD8 ratio is a predictor of non-AIDS-related events independently from CD4 cell count [16, 17], while other studies have shown an association of this marker with non-AIDSdefining cancers [18] or, more recently, with pulmonary emphysema [19]
Gender, nationality, duration of HIV infection, hepatitis C virus (HCV) co-infection, or virological condition at the time of first starting antiretroviral therapy (ART) were observed among the three groups who switched to triple, mono, or dual therapy (Table 1)
Summary
The CD4/CD8 ratio has been associated with the risk of AIDS and non-AIDS events. We describe trends in immunological parameters in people who underwent a switch to monotherapy or dual therapy, compared to a control group remaining on triple antiretroviral therapy (ART). Based on the monitoring of surrogate markers of ART efficacy, most of these unconventional regimens, when used in switch studies, have been shown to have a non-inferior virological efficacy and a good CD4 recovery compared to standard triple drug-based therapy [3,4,5,6,7,8]. The results of these studies were so encouraging that dual combinations are currently being tested in randomized clinical trials of ART-naïve patients [9, 10]. The analysis of the data of our and other cohorts have shown that, in contrast with recent data from the Antiretroviral Therapy Cohort Collaboration (ART-CC) [15], a low CD4/CD8 ratio is a predictor of non-AIDS-related events independently from CD4 cell count [16, 17], while other studies have shown an association of this marker with non-AIDSdefining cancers [18] or, more recently, with pulmonary emphysema [19]
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