Abstract
Background:
The RAINBOW survey is a multinational observational study assessing the tolerability and efficacy of ritonavir-boosted saquinavir (SQV/r), using the 500-mg filmcoated SQV formulation, in routine clinical practice. This analysis presents data from the German subgroup of antiretroviral therapy (ART)-naïve and pretreated but protease inhibitor (PI)-naïve patients.
Methods:
This was a multicenter, prospective, open-label, 48-week observational cohort study. Tolerability assessments included changes in liver enzymes and lipid levels from baseline to week 48. Efficacy assessments included changes in the proportion of patients with HIV-1 RNA <50 and <400 copies/ml, and changes in CD4 cell count from baseline to week 48.
Results:
The analysis included 275 ART-naïve and 179 pretreated but PI-naïve patients. The proportion of ART-naïve patients achieving <50 copies/ml by 48 weeks was 53.1% by intent-to-treat (ITT) analysis and 67.3% using last observation carried forward (LOCF) analysis. In pretreated but PInaïve patients, the proportions achieving <50 copies/ml by 48 weeks were 53.1% (ITT) and 70.4% (LOCF). The median increase in CD4 count at week 48 was +174 cells/mm3 (interquartile range [IQR] 86, 265) in the ART-naïve group and +100 cells/mm3 (IQR 0, 209) in the pretreated but PInaïve group (p < 0.01 for both; LOCF). Drug-related adverse events were reported in 7.6% of ART-naïve and 2.8% of pretreated but PI-naïve patients. Treatment with SQV/r was stopped in 21.5% of ART-naïve and 17.9% of pretreated but PI-naïve patients (due to side effects in 3.3% and 2.8%, respectively). There were no clinically relevant changes in liver enzyme levels. Overall, the total cholesterol, triglyceride, low-density lipoprotein, and high-density lipoprotein levels increased to week 48, although the levels remained within normal ranges in the majority of patients.
Conclusions:
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.
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References
Mocroft A, Brettle R, Kirk O, Blaxhult A, Parkin JM, Antunes F, Francioli P, D’Arminio Monforte A, Fox Z, Lundgren JD, EuroSIDA study group: Changes in the cause of death among HIV positive subjects across Europe: results from the EuroSIDA study. AIDS 2002; 16: 1663–1671.
Hariri S, McKenna MT: Epidemiology of human immunodeficiency virus in the United States. Clin Microbiol Rev 2007; 20: 478–488.
Hammer SM, Eron JJ Jr, Reiss P, Schooley RT, Thompson MA, Walmsley S, Cahn P, Fischl MA, Gatell JM, Hirsch MS, Jacobsen DM, Montaner JS, Richman DD, Yeni PG, Volberding PA, International AIDS Society-USA: Antiretroviral treatment of adult HIV infection: 2008 recommendations of the International AIDS Society-USA panel. JAMA 2008; 300: 555–570.
Bittner B, Riek M, Holmes B, Grange S: Saquinavir 500 mg film-coated tablets demonstrate bioequivalence to saquinavir 200 mg hard capsules when boosted with twice-daily ritonavir in healthy volunteers. Antivir Ther 2005; 10: 803–810.
Bangsberg DR, Hecht FM, Charlebois ED, Zolopa AR, Holodniy M, Sheiner L, Bamberger JD, Chesney MA, Moss A: Adherence to protease inhibitors, HIV-1 viral load, and development of drug resistance in an indigent population. AIDS 2000; 14: 357–366.
Paterson DL, Swindells S, Mohr J, Brester M, Vergis EN, Squier C, Wagener MM, Singh N: Adherence to protease inhibitor therapy and outcomes in patients with HIV infection. Ann Intern Med 2000; 133: 21–30.
Gardner EM, Sharma S, Peng G, Hullsiek KH, Burman WJ, Macarthur RD, Chesney M, Telzak EE, Friedland G, Mannheimer SB: Differential adherence to combination antiretroviral therapy is associated with virological failure with resistance. AIDS 2008; 22: 75–82.
Lima VD, Harrigan R, Bangsberg DR, Hogg RS, Gross R, Yip B, Montaner JS: The combined effect of modern highly active antiretroviral therapy regimens and adherence on mortality over time. J Acquir Immune Defic Syndr 2009; 50: 529–536.
Dragsted UB, Gerstoft J, Youle M, Fox Z, Losso M, Benetucci J, Jayaweera DT, Rieger A, Bruun JN, Castagna A, Gazzard B, Walmsley S, Hill A, Lundgren JD, MaxCmin2 Trial Group: A randomized trial to evaluate lopinavir/ritonavir versus saquinavir/ritonavir in HIV-1-infected patients: the MaxCmin2 trial. Antivir Ther 2005; 10: 735–743.
Ananworanich J, Gayet-Ageron A, Ruxrungtham K, Chetchotisakd P, Prasithsirikul W, Kiertiburanakul S, Munsakul W, Raksakulkarn P, Tansuphasawadikul S, LeBraz M, Jupimai T, Ubolyam S, Schutz M, Hirschel B, Staccato Thailand Study Group: Long-term efficacy and safety of first-line therapy with once-daily saquinavir/ritonavir. Antivir Ther 2008; 13: 375–380.
Walmsley S, Avihingsanon A, Slim J, Ward DJ, Ruxrungtham K, Brunetta J, Bredeek UF, Jayaweera D, Guittari CJ, Larson P, Schutz M, Raffi F: Gemini: a noninferiority study of saquinavir/ritonavir versus lopinavir/ritonavir as initial HIV-1 therapy in adults. J Acquir Immune Defic Syndr. 2009; 50: 367–374.
Dragsted UB, Gerstoft J, Pedersen C, Peters B, Duran A, Obel N, Castagna A, Cahn P, Clumeck N, Bruun JN, Benetucci J, Hill A, Cassetti I, Vernazza P, Youle M, Fox Z, Lundgren JD, MaxCmin1 Trial Group: Randomized trial to evaluate indinavir/ritonavir versus saquinavir/ritonavir in human immunodeficiency virus type 1-infected patients: the MaxCmin1 Trial. J Infect Dis 2003; 188: 635–642.
Casado JL, Sabido R, Perez-Elías MJ, Antela A, Oliva J, Dronda F, Mejía B, Fortún J: Percentage of adherence correlates with the risk of protease inhibitor (PI) treatment failure in HIV-infected patients. Antivir Ther 1999; 4: 157–161.
García de Olalla P, Knobel H, Carmona A, Guelar A, López-Colomés JL, Caylà JA: Impact of adherence and highly active antiretroviral therapy on survival in HIV-infected patients. J Acquir Immune Defic Syndr 2002; 30: 105–110.
Le Moing V, Chêne G, Carrieri MP, Alioum A, Brun-Vézinet F, Piroth L, Cassuto JP, Moatti JP, Raffi F, Leport C, Aproco Study Group: Predictors of virological rebound in HIV-1-infected patients initiating a protease inhibitor-containing regimen. AIDS 2002; 16: 21–29.
Raboud JM, Harris M, Rae S, Montaner JS: Impact of adherence on duration of virological suppression among patients receiving combination antiretroviral therapy. HIV Med 2002; 3: 118–124.
Autar RS, Boffito M, Hassink E, Wit FW, Ananworanich J, Siangphoe U, Pozniak A, Cooper DA, Phanuphak P, Lange JM, Ruxrungtham K, Burger DM: Interindividual variability of once-daily ritonavir boosted saquinavir pharmacokinetics in Thai and UK patients. J Antimicrob Chemother 2005; 56: 908–913.
Calza L, Manfredi R, Chiodo F: Dyslipidaemia associated with antiretroviral therapy in HIV-infected patients. J Antimicrob Chemother 2004; 53: 10–14.
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Knechten, H., Stephan, C., Mosthaf, F.A. et al. Safety and Efficacy of a Saquinavir-Containing Antiretroviral Regimen in Previously ART-Naïve or Pretreated but Protease Inhibitor-Naïve HIV-Positive Patients. Infection 38, 108–116 (2010). https://doi.org/10.1007/s15010-009-9249-x
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DOI: https://doi.org/10.1007/s15010-009-9249-x