EVALUATION OF THE SWITCH TO A DUAL ART REGIMEN WITH LAMIVUDINE PLUS DOLUTEGRAVIR OR PROTEASE INHIBITORS IN HIV-INFECTED VIROLOGICALLY SUPPRESSED PATIENTS. A REAL LIFE EXPERIENCE

Evaluation of the switch to a dual ART regimen with lamivudine plus dolutegravir or protease inhibitors in HIV-infected virologically suppressed patients. A real life experience BACKGROUND: Little is known about the durability of dual treatments in HIV-infected virologically suppressed patients. We explored the combination of lamivudine (3TC) + dolutegravir (DTG) and lamivudine + protease inhibitors (PI) as treatment options when switching from standard ART regimens. MATERIAL AND METHODS: We prospectively enrolled 36 HIV-infected patients under a standard ART regimen. Inclusion criteria were: HIV-RNAq < 40 cp/ml for at least 6 months and absence of mutations in the resistance assay. A simplification regimen with 3TC+DTG (13 pts; group A) or 3TC+PI (23; group B) has been adopted. HIV-RNAq, CD4, CD4/CD8 ratio, total cholesterol, triglycerides, creatinine and renal filtrate were compared at baseline and after 6 months from simplification. The same parameters were then evaluated among the groups A and B. A comparison between regimen costs was also investigated. RESULTS: All enrolled patients (36/36) maintained the same viro-immunological pattern after 6 months from the ART regimen simplification (no statistically significant difference was found in the HIV-RNAq and CD4 count), with the exception of an increase in the CD4/CD8 ratio (p<0.05). Total cholesterol was found to be statistically increased after 6 months of dual ART therapy compared with baseline (p<0.05). All the other parameters (triglycerides, creatinine and renal filtrate) were unchanged. The statistical comparison of the group A and B showed no significant difference in CD4 count, CD4/CD8 ratio, total cholesterol and triglycerides. Creatinine levels were statistically increased and decreased in group A and B, respectively (F (1) = 8.144, p = 0.007, repeated measures ANOVA for the interaction between simplification and creatinine). A marked decrease of renal filtrate (vegf) was observed in group A while an increase in group B. The comparison between the two groups at 6 months showed a statistically significance difference (p <0.05), while only group B showed a significantly higher value of VEGF at 6 months compared to baseline (Wilcoxon signed rank test, p <0.05). The assessment of the impact of the simplification regimen costs compared with baseline resulted statistically significant (p <0.05). CONCLUSION: Switching to a dual ART regimen with DTG or PI maintains virological efficacy up to 6 months, and is associated with slight improvements of the CD4/CD8 ratio. The increase in total cholesterol can be attributed to the statin-like effect of tenofovir, which is lost in the simplification regimen. The variations of creatinine and the renal filtrate observed in group A are consistent with DTG action as an inhibitor of the renal protein organic cation transporter 2 (OCT2). Finally, the dual therapy is less expensive in economic terms.