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Switch to Tenofovir: lipoatrophy, Adverse Events Outcomes
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"Identification and Follow-Up of Adverse Events Related to NRTI Use that in the Clinical Practice Cause their Substitution by Tenofovir DF
(48 Week Data from the RECOVER Study)"
Reported by Jules Levin
Presented at IAS-Rio: Poster Number TuPe2.4C09
S Moreno1, P Domingo2, MJ Perez Elias1, P Arazo3, R Palacios4,
P Labarga5, M Fernandez Guerrero6, MI Ruiz7, I Ocana7, JM Llibre8,
J Sanz9, J Santos4, X Camino10, S Echevarría11, E Ribera7,
S Pérez12, and the Recover Group
1Hospital Ramon y Cajal, Madrid, Spain; 2Hospital de Sant Pau, Barcelona,
Spain;3Hospital Miguel Servet, Zaragoza, Spain; 4Hospital Virgen de la Victoria,
Málaga, Spain; 5Hospital de San Millan, Logrono, Spain; 6Fundacion Jiménez
Días, Madrid, Spain; 7Hospital Vall d'Hebron, Barcelona, Spain; 8Hospital
San Jaume, Calella, Spain;9Hospital La Princesa, Madrid, Spain;
10Hospital Donostia, Donosti, Spain; 11Hospital Marqués de Valdecilla,
Santander, Spain; 12Gilead Sciences, Madrid, Spain
AUTHOR CONCLUSIONS
- The most frequent NRTI-associated toxicity leading to NRTI switch to TDF was lipoatrophy followed by peripheral neuropathy
- The drug most frequently switched to tenofovir DF due to toxicity was stavudine
- Lipodystrophy/lipoatrophy resolved or improved in 35%-40% of patients with adequate follow-up
- In this study, tenofovir DF has shown to be a useful and safe alternative when a single NRTI must be substituted due to adverse events
BACKGROUND
- The advent of potent highly active antiretroviral treatment (HAART) has
changed radically the evolution of the human immunodeficiency virus
(HIV) infection in terms of mortality and morbidity. However, its use may
lead to the development of both short- and long-term drug related
toxicities that may compromise the success of the regimen.
- Strategies to manage antiretroviral- (ARV) related toxicities are needed.
In vitro and clinical studies have shown that tenofovir disoproxil fumarate
(TDF), a novel nucleotide analogue that inhibits HIV-1 reverse transcriptase activity, has a good safety profile and a low potential to develop mitochondrial toxicity.
- So far, all available data suggest that TDF is a valid alternative if a single
NRTI is causing toxicity in patients receiving HAART.
Study Objective
- To identify and assess the outcome of the most frequent NRTI-related
toxicities that in the clinical practice leads to its substitution by TDF
Methods
- From September 2002 to September 2004, we conducted a
prospective, observational, multicenter, switch study to identify the most
frequently NRTI-associated toxicities causing the NRTI withdrawal
- We included patients who switched from a single NRTI to TDF due to
toxicity
- No other drug substitution was allowed concomitantly with TDF
- All patients who have reached 48 weeks were analyzed
RESULTS
- We included data of 48 weeks follow-up from 1286 patients with at least
1 or more visit post-baseline after switching to TDF
- Most frequently discontinued drugs were d4T (67.9%), ddI (12.2%), and
AZT (12.6%)
- After 48 week, 353 patients (27%) withdrew from the cohort
- In 130 cases, the cause of the withdrawal was not reported
- Mean CD4 cell count increase was 46 cell/µL (p < 0.001)
a. 4 related to TDF: 2 nausea/vomiting, 2 rash
b. Virological failure is defined as two consecutive viral load values > 400 copies/mL taken at least four weeks apart
c. 15 deaths, 3 cancers, 3 pregnancies, 2 systemic disease, 7 non-adherence, 12 changed to other HAART combination
Outcomes of the Most Frequent NRTI-Related
Toxicities Through Week 48 (after Switching to TDF)
References
1. Palacios R, Santos J, Camino X, et al. Treatment-limiting toxicities associated with nucleoside analogue reverse transcriptase inhibitor therapy: a prospective, observational study. Curr Ther Res Clin Exp. 2005; 66 (2):117-129.
2. Domingo P, Labarga P, Palacios R et al. Improvement of dyslipidemia in patients switching from stavudine to tenofovir DF: preliminary results. AIDS 2004; 18 (10): 1475-1477.
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