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Clinical Trial Report

Effectiveness, durability, and safety of darunavir/ritonavir in HIV-1-infected patients in routine clinical practice in Italy: a postauthorization noninterventional study

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Pages 1589-1603 | Published online: 06 May 2016

Figures & data

Figure 1 Flow of patients through the study.

Abbreviations: AE, adverse event; ART, antiretroviral therapy; DRV/r, darunavir/ritonavir; EAP, Early Access Program; exp, experienced; mITT, modified intention-to-treat; OT, on-treatment; VL, viral load.
Figure 1 Flow of patients through the study.

Table 1 Baseline patient characteristics and demographics (full analysis set)

Table 2 Concomitant ARV treatments and DRV/r dose during the study

Table 3 Virological response (VL <50 copies/mL) at last study visit (LOCF) for the mITT and OT analyses in the four HIV-infected patient groups treated with DRV/r, according to VL and CD4+ cell count at study entry

Table 4 Virological response (VL <50 copies/mL) at 48 weeks and 96 weeks for the mITT and OT analyses in the four HIV-infected patient groups treated with DRV/r, according to VL at study entry

Table 5 Reasons for discontinuation from the study

Figure 2 Kaplan–Meier curves from start of prospective observation showing study discontinuation by reason of interruption in Group 1 (n=235) – patients who were part of the DRV/r Early Access Program (EAP).

Abbreviations: AE, adverse event; DRV/r, darunavir/ritonavir.
Figure 2 Kaplan–Meier curves from start of prospective observation showing study discontinuation by reason of interruption in Group 1 (n=235) – patients who were part of the DRV/r Early Access Program (EAP).

Figure 3 Kaplan–Meier curves from start of prospective observation showing study discontinuation by reason of interruption in Group 2 (n=407) – patients already receiving DRV/r in routine clinical practice.

Abbreviations: AE, adverse event; DRV/r, darunavir/ritonavir.
Figure 3 Kaplan–Meier curves from start of prospective observation showing study discontinuation by reason of interruption in Group 2 (n=407) – patients already receiving DRV/r in routine clinical practice.

Figure 4 Kaplan–Meier curves from start of prospective observation showing study discontinuation by reason of interruption in Group 3 (n=116) – ARV-experienced DRV-naïve patients.

Abbreviations: ARV, antiretroviral; AE, adverse event; DRV, darunavir.
Figure 4 Kaplan–Meier curves from start of prospective observation showing study discontinuation by reason of interruption in Group 3 (n=116) – ARV-experienced DRV-naïve patients.

Figure 5 Kaplan–Meier curves from start of prospective observation showing study discontinuation by reason of interruption in Group 4 (n=117) – ARV-naïve patients.

Abbreviations: AE, adverse event; ARV, antiretroviral.
Figure 5 Kaplan–Meier curves from start of prospective observation showing study discontinuation by reason of interruption in Group 4 (n=117) – ARV-naïve patients.

Table 6 CD4+ cell count at study entry and at last study visit in the four groups of HIV-infected patients treated with DRV/r (LOCF analysis)

Table 7 Median (Q1–Q3) of serum biochemistry values during the study in patients with complete observations