Antiretroviral simplification with darunavir/ritonavir monotherapy in routine clinical practice: safety, effectiveness, and impact on lipid profile.
BACKGROUND
Simplification of antiretroviral treatment (ART) with darunavir/ritonavir (DRV/r) monotherapy has achieved sustained suppression of plasma viral load (pVL) in clinical trials; however, its effectiveness and safety profile has not been evaluated in routine clinical practice.


RESULTS
We performed a retrospective cohort analysis of HIV-1-infected patients who initiated DRV/r monotherapy once daily with a pVL <50 copies/mL under ART and at least 1 subsequent follow-up visit in our clinic. The primary study endpoints were the percentage of patients with virological failure (VF, defined as 2 consecutive pVL>50 copies/mL) at week 48, and time to VF. Other causes of treatment discontinuation and changes in lipid profile were evaluated up to week 48. Ninety-two patients were followed for a median (IQR) of 73 (57-92) weeks. The median baseline and nadir CD4+ T-cell counts were 604 (433-837) and 238 (150-376) cells/mm3, respectively. Patients had previously received a median of 5 (3-9) ART lines and maintained a pVL<50 copies/mL for a median of 76 (32-176) weeks before initiating DRV/r monotherapy. Nine (9.8%) patients developed VF at week 48; time to VF was 47.1 (IQR: 36.1-47.8) weeks among patients with VF. Other reasons for changing ART were gastrointestinal disturbances (n = 3), rash (n = 1), and impaired CD4 recovery (n = 2). Median low-density lipoprotein cholesterol levels increased from 116.1 mg/dL at baseline to 137.3 mg/dL at 48 weeks (p = 0.001).


CONCLUSIONS
Treatment simplification with DRV/r monotherapy seems safe and effective in routine clinical practice. Further research is needed to elucidate the effect of DRV/r monotherapy on cholesterol levels.
Lluita contra la SIDA Foundation, Hospital Universitari Germans Trias i Pujol, Badalona, Barcelona, Spain. jrsantos@flsida.org
José R
JR
Santos
José
J
Moltó
Josep M
JM
Llibre
Eugenia
E
Negredo
Isabel
I
Bravo
Arelly
A
Ornelas
Bonaventura
B
Clotet
Roger
R
Paredes
D000328:Adult; D015331:Cohort Studies; D000069454:Darunavir; D005215:Fasting; D060005:Genotyping Techniques; D015658:HIV Infections / Q000188:drug therapy / Q000235:genetics / Q000378:metabolism; D017320:HIV Protease Inhibitors / Q000008:administration & dosage / Q000009:adverse effects / Q000494:pharmacology / Q000627:therapeutic use; D015497:HIV-1 / Q000187:drug effects / Q000472:pathogenicity; D006801:Humans; D050356:Lipid Metabolism / Q000187:drug effects*; D008297:Male; D008875:Middle Aged; D012189:Retrospective Studies; D019438:Ritonavir / Q000008:administration & dosage / Q000009:adverse effects* / Q000494:pharmacology* / Q000627:therapeutic use; D012449:Safety; D013449:Sulfonamides / Q000008:administration & dosage / Q000009:adverse effects* / Q000494:pharmacology* / Q000627:therapeutic use
D017320:HIV Protease Inhibitors; D013449:Sulfonamides; D019438:Ritonavir; D000069454:Darunavir