Early clinical experience with atazanavir in treatment-experienced patients
Sarangapany Jeganathan A B , Don Smith A and Julian Gold AA Albion Street Centre, 150–154, Albion Street, Surry Hills, NSW 2010, Australia.
B Corresponding author. Email: sarangapanyj@sesahs.nsw.gov.au
Sexual Health 3(1) 33-35 https://doi.org/10.1071/SH05022
Submitted: 23 April 2005 Accepted: 19 October 2005 Published: 20 February 2006
Abstract
Background: Atazanavir (ATV) is a newly approved protease inhibitor following successful clinical trials in naive and treatment-experienced patients. We describe early experience with ATV in treatment-experienced patients attending a single ambulatory care clinic in Sydney. Methods: Patients commencing ATV between February 2003 and May 2004 in an expanded access program were identified from the clinic pharmacy’s database. Data were retrospectively collected from patients’ medical records. Results: Data from 30 patients were analysed. Reasons for commencing ATV were: virological failure in six patients (20%); toxicity to previous regimen in 13 patients (43%); simplification strategy in two patients (7%); and recommencing therapy in nine patients (30%) following treatment interruption. Six patients (20%) discontinued ATV. One patient discontinued ATV due to virological failure, two patients discontinued due to toxicity to concomitant antiretrovirals, two as a result of the patient’s choice and one as a result of the physician’s decision. Eighteen patients commenced ATV in combination therapy with a detectable viral load (VL). From a baseline VL of 4.3 ± 1.1 log10 copies mL–1, 15 (83%) had >1.0 log decrease in VL with 11 (61%) achieving viral suppression (<50 copies mL–1). Three (16%) failures were recorded in this group. Twelve subjects commenced ATV with an undetectable VL. One failure was recorded in this group. Bilirubin increased by 22.7 μmol L–1 (P < 0.001), with significant decreases in cholesterol (1.4 mmol L–1, P = 0.01) and triglycerides (1.5 mmol L–1, P = 0.01) in 12 patients on ritonavir-boosted ATV. Conclusion: This audit found ATV to be safe, well tolerated and had good potency in treatment-experienced patients. However caution should be exercised in switching to ATV in heavily pre-treated patients.
Additional keywords: antiretroviral, HIV, salvage therapy, treatment-experienced patients.
Acknowledgements
The authors would like to thank the doctors, nurses and clients who participated in the Expanded Access Program.
[1] Becker S. Atazanavir: improving the HIV protease inhibitor class. Expert Rev Anti-infect Ther 2003; 1(3): 403–13.
| Crossref | GoogleScholarGoogle Scholar | PubMed |
[2] Guffanti M, De Pascalis CR, Seminari E, Fusetti G, Gianotti N, Bassetti D, et al. Pharmacokinetics of amprenavir given once or twice a day when combined with atazanavir in heavily pre-treated HIV-positive patients. AIDS 2003; 17 2669–70.
| Crossref | GoogleScholarGoogle Scholar | PubMed |
[3] Haas DW, Zala C, Schrader S, Piliero P, Jaeger H, Nunes D, et al. Therapy with atazanavir plus saquinavir in patients failing highly active antiretroviral therapy: a randomized comparative pilot trial. AIDS 2003; 17 1339–49.
| Crossref | GoogleScholarGoogle Scholar | PubMed |
[4] Murphy RL, Sane I, Cahn P, Phanuphak P, Percival L, Kelleher T, et al. Dose-ranging, randomized, clinical trial of atazanavir with lamivudine and stavudine in antiretroviral-naive subjects: 48-week results. AIDS 2003; 17(18): 2603–14.
| Crossref | GoogleScholarGoogle Scholar | PubMed |
[5] Sanne I, Piliero P, Squires K, Thiry A, Schnittman S. A1424–007 Clinical Trial Group. Results of a phase 2 clinical trial at 48 weeks (AI424–007): a dose-ranging, safety, and efficacy comparative trial of atazanavir at three doses in combination with didanosine and stavudine in antiretroviral-naive subjects. J Acquir Immune Defic Syndr 2003; 32 18–29.
| PubMed |
[6] Wood R, Phanuphak P, Cahn P, Podrovsky V, Rozenbaum W, Panteleo G, et al. Long-term efficacy and safety of atazanavir with stavudine and lamivudine in patients previously treated with nelfinavir or atazanavir. J Acquir Immune Defic Syndr 2004; 36(2): 684–92.
| PubMed |
[7] Barrios A, Rendon AL, Gallego O, Carbonero LM, Valer L, Rios P, et al. Predictors of virological response to atazanavir in protease inhibitor-experienced patients. HIV Clin Trials 2004; 5(4): 201–5.
| PubMed |
[8] Taburet AM, Piketty C, Chazallon C, Vincent I, Gerard L, Calvez V, et al. Interactions between atazanavir-ritonavir and tenofovir in heavily pretreated human immunodeficiency virus-infected patients. Antimicrob Agents Chemother 2004; 48(6): 2091–6.
| Crossref | GoogleScholarGoogle Scholar | PubMed |
[9] Piliero PJ. Mechanisms of lipid elevations associated with the treatment of patients with HIV infection. Medscape General Medicine 2003; 5(2): 1–11.
| PubMed |
[10] Data Collection on Adverse Events of Anti-HIV Drugs (DAD) Study Group. Data collection on adverse events of anti-HIV drugs (DAD) Study Group. Combination antiretroviral therapy and the risk of myocardial infarction. N Engl J Med 2003; 349(21): 1993–2003.
| Crossref | GoogleScholarGoogle Scholar | PubMed |
