Randomized trial to evaluate cardiometabolic and endothelial function in patients with plasma HIV-1 RNA suppression switching to darunavir/ritonavir with or without nucleoside analogues.
BACKGROUND
We performed a study to evaluate change in cardiometabolic and endothelial function in HIV-infected patients switching to darunavir/ritonavir (DRV/r) monotherapy versus triple therapy.


METHODS
The MONARCH trial recruited 30 patients who were taking triple combination therapy and with HIV RNA<40 copies/ mL. Patients were randomized to either DRV/r 800/100 mg once daily (OD) monotherapy or DRV/r 800/100 mg OD plus 2 nucleoside reverse transcriptase inhibitors (NRTIs). The primary objective was to assess endothelial function change from baseline to 24 and 48 weeks in brachial artery flow-mediated dilation (FMD) test; changes in endothelial precursor cells (EPCs) and circulating endothelial cells (CECs) were secondary objectives.


RESULTS
At baseline, the median age of participants was 43 years, 77% were men, and median CD4 cell count was 585 cells/μL. The median FMD (%) decreased in both arms in the study period (P ≯ .05), with no statistically significant difference between arms (10.7% at baseline and 6.7% at week 48 in the DRV/r + 2 NRTIs arm; 11.1% at baseline and 8.8% at week 48 in the DRV/r arm). The changes at week 48 were similar in the 2 arms for EPCs and CECs. Total cholesterol and low-density lipoprotein (LDL) cholesterol showed larger rises to week 48 in the DRV/r arm monotherapy group than in the triple-therapy group (+26 vs +9 mg/dL for total cholesterol and +14 vs +5 mg/dL for LDL cholesterol).


CONCLUSIONS
In the MONARCH trial, switching from triple combination treatment to DRV/r, with or without nucleoside analogues, did not translate into clinically meaningful reductions in endothelial function as measured by FMD.
University of Modena and Reggio Emilia, Modena, Italy. g.guaraldi@unimore.it
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Guaraldi
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Zona
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Cossarizza
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Vernacotola
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Carli
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Lattanzi
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Beghetto
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Orlando
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De Biasi
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Termini
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Garau
D000163:Acquired Immunodeficiency Syndrome / Q000097:blood / Q000188:drug therapy* / Q000503:physiopathology / Q000821:virology; D000328:Adult; D019380:Anti-HIV Agents / Q000008:administration & dosage*; D001916:Brachial Artery / Q000503:physiopathology; D008078:Cholesterol, LDL / Q000097:blood; D000069454:Darunavir; D004359:Drug Therapy, Combination; D042783:Endothelial Cells / Q000502:physiology*; D005260:Female; D015497:HIV-1; D006801:Humans; D008297:Male; D008875:Middle Aged; D009705:Nucleosides / Q000008:administration & dosage*; D012367:RNA, Viral / Q000097:blood*; D019438:Ritonavir / Q000008:administration & dosage*; D013449:Sulfonamides / Q000008:administration & dosage*; D019562:Viral Load
D019380:Anti-HIV Agents; D008078:Cholesterol, LDL; D009705:Nucleosides; D012367:RNA, Viral; D013449:Sulfonamides; D019438:Ritonavir; D000069454:Darunavir