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Antiretroviral simplification with darunavir/ritonavir monotherapy in routine clinical practice: safety, effectiveness, and impact on lipid profile.

Santos JR, Moltó J, Llibre JM, Negredo E, Bravo I, Ornelas A, Clotet B, Paredes R - PLoS ONE (2012)

Bottom Line: 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).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.

View Article: PubMed Central - PubMed

Affiliation: Lluita contra la SIDA Foundation, Hospital Universitari Germans Trias i Pujol, Badalona, Barcelona, Spain. jrsantos@flsida.org

ABSTRACT

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.

Methodology/principal findings: 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/significance: 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.

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Changes in fasting lipid profile in patients switched to DRV/r monotherapy in routine clinical practice (n = 92).Abbreviations: Total-c, total-cholesterol; HDL-c, high-density lipoprotein cholesterol; LDL-c, low-density lipoprotein cholesterol; TG, triglycerides; 95% CI, 95% Confidence Interval.
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pone-0037442-g003: Changes in fasting lipid profile in patients switched to DRV/r monotherapy in routine clinical practice (n = 92).Abbreviations: Total-c, total-cholesterol; HDL-c, high-density lipoprotein cholesterol; LDL-c, low-density lipoprotein cholesterol; TG, triglycerides; 95% CI, 95% Confidence Interval.

Mentions: Overall, the median (IQR) LDL-cholesterol level increased significantly from 116.05 (82.5–137.5) mg/dL at baseline to 137.3 (101.1–155.2) mg/dL at week 48 of follow-up (p = 0.001), with a median increase of 13.0 (−5.0 to 35.0) mg/dL. In addition, triglyceride levels decreased significantly by a median of −17.6 (−53.4 to 26.2) mg/dL. There were no significant changes in total cholesterol (p = 0.241) or HDL-cholesterol (p = 0.213) (Figure 3).


Antiretroviral simplification with darunavir/ritonavir monotherapy in routine clinical practice: safety, effectiveness, and impact on lipid profile.

Santos JR, Moltó J, Llibre JM, Negredo E, Bravo I, Ornelas A, Clotet B, Paredes R - PLoS ONE (2012)

Changes in fasting lipid profile in patients switched to DRV/r monotherapy in routine clinical practice (n = 92).Abbreviations: Total-c, total-cholesterol; HDL-c, high-density lipoprotein cholesterol; LDL-c, low-density lipoprotein cholesterol; TG, triglycerides; 95% CI, 95% Confidence Interval.
© Copyright Policy
Related In: Results  -  Collection

Show All Figures
getmorefigures.php?uid=PMC3362569&req=5

pone-0037442-g003: Changes in fasting lipid profile in patients switched to DRV/r monotherapy in routine clinical practice (n = 92).Abbreviations: Total-c, total-cholesterol; HDL-c, high-density lipoprotein cholesterol; LDL-c, low-density lipoprotein cholesterol; TG, triglycerides; 95% CI, 95% Confidence Interval.
Mentions: Overall, the median (IQR) LDL-cholesterol level increased significantly from 116.05 (82.5–137.5) mg/dL at baseline to 137.3 (101.1–155.2) mg/dL at week 48 of follow-up (p = 0.001), with a median increase of 13.0 (−5.0 to 35.0) mg/dL. In addition, triglyceride levels decreased significantly by a median of −17.6 (−53.4 to 26.2) mg/dL. There were no significant changes in total cholesterol (p = 0.241) or HDL-cholesterol (p = 0.213) (Figure 3).

Bottom Line: 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).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.

View Article: PubMed Central - PubMed

Affiliation: Lluita contra la SIDA Foundation, Hospital Universitari Germans Trias i Pujol, Badalona, Barcelona, Spain. jrsantos@flsida.org

ABSTRACT

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.

Methodology/principal findings: 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/significance: 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.

Show MeSH
Related in: MedlinePlus