Safety and Efficacy of a Saquinavir-Containing Antiretroviral Regimen in Previously ART-Naïve or Pretreated but Protease Inhibitor-Naïve HIV-Positive Patients

Abstract

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 rainbow cohort: 96 week follow-up of saquinavir-containing regimens in previously antiretroviral therapy (ART)-naïve and pre-treated but protease inhibitor (PI)- naïve hiv-infected patients

“…The efficacy of SQV/r 1000/100 mg bid in treatment-naïve patients using the 500 mg film-coated formulation of SQV up to 48 weeks has been reported previously in the clinical trial setting [8], and confirmed by similar findings in our 48 week analysis of patients treated in routine clinical practice in the RAINBOW cohort [10]. The 96 week data presented here extend and support evidence of efficacy and safety of SQV/r in 'real world' settings.…”

“…Treatment with SQV/r was well tolerated up to one line 96 weeks, with only seven patients in the total cohort (2.5%) withdrawing from treatment due to side effect issues, confirming the low incidence reported at 48 weeks [8,10]. The incidence and nature of AEs were similar in both ART-naïve and pretreated but PI-naïve patients, and were similar to those previously reported (most commonly gastrointestinal and diarrhea).…”

“…Increases were also seen in LDL cholesterol, HDL cholesterol and triglyceride. Overall, median increases in TC and triglycerides from baseline in the current analysis are somewhat higher than those reported after 48 weeks of treatment in both our previous analysis and the GEMINI study [8,10], which might suggest a general increase in lipid levels with time on treatment. However, when changes were examined only in the cohort of patients treated for the full 96 weeks in the current analysis, increases were largely seen in the early stages of treatment and lipid levels remained relatively stable in later weeks.…”

“…The 96 week data presented here extend and support evidence of efficacy and safety of SQV/r in 'real world' settings. All efficacy parameters in the current study had increased at 96 weeks relative to the previously reported 48 week data [10]. As the current analysis included only a subset of patients from the initial 48 week cohort, we also compared the 96 week data with 48 week data from this subset only to confirm our findings.…”

“…The aim of RAINBOW was to assess the efficacy and safety of SQV/r in 'real world' situations, where patients are generally less strictly monitored and supported and often have more complex clinical backgrounds than in the necessarily controlled situation of the clinical trial. We have previously reported safety and efficacy data from the initial 48 week analysis of the German cohort of RAINBOW which demonstrated that SQV/r is effective and well tolerated in ART-naïve and pretreated but PI-naïve patients in a 'real-world' clinical setting [10]. The analysis presented here extends these data to 96 weeks of treatment.…”