ObjectiveThe RAINBOW survey is a multinational observational study assessing the tolerability and efficacy of ritonavir-boosted saquinavir (SQV/r), using the 500 mg film-coated SQV formulation, in routine clinical practice. This analysis presents data from the German subgroup of protease inhibitor (PI)-pretreated, but SQV-naïve patients.MethodsMulticenter, prospective, open-label, 48 week cohort study. Efficacy assessments included the proportion of patients with HIV-1 RNA < 50 and < 400 copies/mL and changes in CD4 cell count from baseline to week 48. Tolerability assessments included changes in liver enzymes and lipid levels from baseline to week 48.ResultsA total of 426 patients were included in the analysis. The proportion of patients with HIV RNA levels < 50 copies/mL at week 48 was 60.3% (compared with 31.7% at switch to SQV/r) (intent-to-treat, last observation carried forward analysis). After 48 weeks, median CD4 count increased by +61 cells/mm3 from baseline (p < 0.01) and 60.3% of patients achieved HIV-1 RNA < 50 copies/mL. Median changes in fasting triglyceride levels (stratified according to baseline level) at week 48 were: +14 mg/dL (IQR -8; 57) for patients with baseline triglyceride < 200 mg/dL; -50 mg/dL (IQR -139; 0) for baseline triglyceride 200-750 mg/dL, and -656 mg/dL (IQR 1024; 0) for baseline triglyceride > 750 mg/dL (p < 0.01 for all). Median changes in fasting total cholesterol (TC) levels (stratified according to baseline) were +16 mg/dL (IQR -3; 43) for patients with baseline TC < 200 mg/dL (p < 0.01), -3 mg/dL (IQR -25; 25) for baseline TC 200-300 mg/dL (p = 0.4), and -47 mg/dL (IQR -87; -4) for baseline TC > 300 mg/dL (p < 0.01). No significant changes in liver enzymes or bilirubin were observed. SQV treatment was discontinued in 22% of patients, 6% due to side effects.ConclusionsThese data confirm the efficacy and tolerability of SQV/r in PI-experienced, SQV-naïve patients treated in a real-life clinical setting. Of particular relevance are the improvements in triglycerides and TC levels observed in patients with baseline grade III-IV elevations.

The results of this observational cohort study of treatment with the 500-mg tablet formulation of SQV are consistent with high efficacy and tolerability results seen in controlled studies of SQV/r. This analysis confirms that SQV/r is effective and well tolerated in ART-naïve and pretreated but PI-naïve patients in 'real-world' clinical settings.

The aim of the Rainbow Cohort is to assess the tolerability and efficacy of initiating treatment with, or switching treatment to saquinavir (SQV) 500 mg film-coated tablet formulation. We present the final 48-week subgroup analysis of antiretroviral therapy (ART)-naïve patients. MethodsMulticenter, prospective, open-label, observational cohort study. Tolerability assessments include changes in liver enzymes and lipid levels from baseline to week 48, efficacy assessments include changes in viral load (VL) and CD4 count. Summary of results48-week analysis of n = 275 ART-naïve patients. Baseline characteristics: 83% male, median age 39 years, median time since HIV diagnosis 1 year (IQR 0; 4), median baseline viral load (VL) 115,781 HIV-RNA cp/mL (IQR 35,375; 347,450), median CD4 count 200 cells/mm 3 (IQR 89; 297). Antiretroviral regimen included SQV/r plus tenofovir/emtricitabine, zidovudine/lamivudine or abacavir/lamivudine in 49%, 19% and 7% of patients, respectively.In week 48, the proportion of patients achieving a VL <50 cp/mL was 75.3% (OT analysis) and 67.3% (ITT, LOCF analysis), respectively. Median increase in CD4 cell count was + 174 cells/mm 3 (IQR 86; 265). Median changes in triglycerides, total cholesterol, ALT, AST and γ-GT were +17 mg/dL (IQR -27; 71), +27 mg/dL (4; 55), -6 U/L (-26; 1), -1 U/L (-9; 6), -2 U/L (-25; 6), respectively. SQV treatment was stopped in 21% of the patients (3% due to sideeffects, 1% due to virologic failure). See Figure 1. ConclusionThese data confirm that SQV/r is effective and well tolerated in ART-naïve patients in the real-life clinical setting. The results of this observational cohort of treatment with the 500 mg tablet formulation of SQV are consistent with high efficacy and tolerability results seen in controlled studies with SQV/r.

ObjectiveWe have previously reported data from the German cohort of the multinational observational prospective RAINBOW survey which assessed the tolerability and efficacy of ritonavir-boosted saquinavir (SQV/r)-containing regimens over 48 weeks in routine clinical practice. This analysis presents data from antiretroviral (ART)-naïve and pretreated but protease inhibitor (PI)-naïve patients treated in a long-term one line (96 weeks) follow-up of the initial study.MethodsAll ART-and PI-naïve patients from the initial RAINBOW cohort who had recorded data to one line 96 weeks of treatment were eligible for inclusion in the current analysis. Efficacy assessments included the proportion of patients with HIV-1 RNA < 50 and < 400 copies/mL and changes in CD4 cell count from baseline to week 96. Tolerability assessments included changes in liver enzymes and lipid levels from baseline to week 96. For evaluation of efficacy, intent-to-treat analysis, in which missing values were recorded as failure (ITT), and last-observation-carried-forward (LOCF) analysis were used. Metabolic parameters were assessed using LOCF analysis.ResultsThe analysis included 175 ART-naïve and 109 pretreated but PI-naïve patients. After 96 weeks, a similar proportion of patients in the ART-naïve and in the pretreated but Pi-naïve group had HIV-1 RNA levels < 400 copies/mL (68.0% and 70.6% [ITT], respectively; 96.6% and 90.8% [LOCF], respectively). The proportion of patients with HIV RNA < 50 copies/mL was higher in the ART-naïve group compared with the pretreated but PI-naïve group (61.1% and 56.9% [ITT], respectively; 84.0% and 75.2% [LOCF], respectively). Median change in CD4 cell count from baseline to week 96 was'+263 cells/mm3 (IQR 170; 384. LOCF; p < 0.0001) in the ART-naïve group, and one line +181 cells/mm3 (IQR 60; 309. LOCF; p < 0.0001) in the pretreated but PI-naïve group. Treatment was well tolerated, with only 2.5% of patients withdrawing from treatment due to side effects. There were no clinically relevant changes in liver enzyme levels. Overall total cholesterol, triglyceride, and low-and high-density lipoprotein levels increased to week 96, although levels remained within normal ranges in the majority of ART-naïve and pretreated patients.ConclusionsThis follow-up analysis confirms the long term efficacy and tolerability of SQV/r in ART-naïve and pretreated but PI-naïve patients in the real-life clinical setting.

The aim of the Rainbow Cohort is to assess the tolerability and efficacy of initiating treatment with, or switching treatment to the saquinavir (SQV) 500 mg film-coated tablet formulation. We present the final 48-week subgroup analysis of PI-experienced, but SQV-naïve patients.