Gastrointestinal tolerability and quality of life in antiretroviral-naïve HIV-1-infected patients: data from the CASTLE study

Abstract

Most ritonavir-boosted protease inhibitor (PI)-based antiretroviral regimens offer comparable levels of virological efficacy. Thus, the tolerability of the regimen becomes a distinguishing factor with implications for patient quality of life (QoL), treatment adherence, and clinical outcome. This article describes results from the CASTLE study (comparing once-daily atazanavir/ritonavir [ATV/RTV] with twice-daily lopinavir/ritonavir [LPV/RTV], both in combination with fixed-dose tenofovir/emtricitabine, in treatment-naïve HIV-infected patients) and an evaluation of the impact of gastrointestinal (GI) complications of treatment on patient QoL, as measured by the irritable bowel syndrome (IBS) QoL questionnaire (IBS-QoL). Changes in IBS-QoL from baseline over time (to week 24) were classified as: “Improvement” (≥2-point positive change from baseline), “No change” (<2-point change), or “Worsening” (≥2-point negative change). Data were collected on GI adverse events (AEs) and use of GI medications. Of the 599 patients with IBS-QoL-evaluable data through week 24, fewer patients in the ATV/RTV group than in the LPV/RTV group experienced grade 2–4 treatment-related GI AEs including diarrhea (3% versus 10%), nausea (5% versus 7%), and vomiting (<1% on both arms). Nearly three times as many patients receiving LPV/RTV used GI medications. ATV/RTV was associated with an increase in overall IBS-QoL scores and more patients receiving ATV/RTV than LPV/RTV experienced improvement in IBS-QoL through week 24. In contrast to LPV/RTV, ATV/RTV treatment was associated with earlier and more positive improvements in QoL scores across CD4 sub-groups. Differences in the health-related QoL profile between ATV/RTV and LPV/RTV may be important when selecting PI-based antiretroviral regimens.

Keywords:

• HIV-1
• atazanavir
• GI tolerability
• health-related quality of life

Acknowledgements

We thank the investigators, the study coordinators and the patients for their contributions. We also thank Yanni Yu for assistance with the analysis. This study was sponsored by Bristol-Myers Squibb. Editorial support was provided by Jean Turner, of PAREXEL, and was funded by Bristol-Myers Squibb.

Notes

1. CASTLE study team: Argentina – J. Benetucci, A. Casiro, I. Cassetti, J. Corral, J. Galindez, N. Luna, S. Lupo, E. Pallone, C. Rodriguez. Australia – D. Baker, N. Roth, C. Workman. Austria – N. Vetter. Belgium – J. Pelgrom. Brazil – J.L. Andrade, M. Da Eira, B. Grinsztejn, R. De Jesus Pedro, F. Rangel, R. Zajdenverg. Canada – J.-G. Baril, F. Crouzat, R. LeBlanc, C. Tremblay. Chile – L. Bavestrello Fernandez, P. Gaete Gutierrez, L. Noriega, C. Perez. Columbia – O. Sussmann. Costa Rica – G. Herrera. Dominican Republic – E. Koenig. France – J-F. Bergmann, P. Dellamonica, C. Katlama, J-M. Molina, D. Vittecoq, L. Weiss. Germany – K. Arasteh, G. Faetkenheuer, J. Rockstroh, A. Stoehr. Guatemala – E. Arathoon, J-F. Garcia, C. Mejia-Villatoro. Hong Kong – P. Li. Indonesia – S. Djauzi. Italy – A. Antinori, A. Lazzarin, A. D'Arminio Monforte, G. Penco, V. Vullo. Mexico – M. Magana Aquino, G. Amaya, J. Andrade-Villanueva, D. Jorge, J. Sierra, J. Carlos Tinoco, I. Zavala. Netherlands – I.M. Hoepelman, S. Van Der Geest. Panama – C. Alfredo, N. Sosa. Peru – R. Cabello, J. Echevarria, A. La Rosa, R. Salazar. Portugal – F. Antunes. Puerto Rico – S. Saavedra, G. Sepulveda. Singapore – L. Lin. Spain – J. Arribas, B. Clotet, J. Gatell, P. Miralles, F. Pulido Ortega, A. Rivero, I. Santos Gil, J. Santos Gonzalez. South Africa – N. David, C. Firnhaber, D. Johnson, E. Krantz, G. Latiff, D. Malan, D. Martin, J. Pitt, M. Zeier. Thailand – P. Chetchotisakd, K. Supparatpinyo. Taiwan – S-M. Hsieh, Y-C. Liu, W.W. Wong. UK – J. Ainsworth, M. Johnson, G. Moyle, G. Scullard, I. Williams. USA – D. Brand, F. Cruickshank, E. DeJesus, C. McDonald, R. Myers, S. Reddy, M. Sension, D. Ward.