[Efficacy and safety of a reduced-dose of stavudine in HIV-infected patients under immunological and virological stable conditions].

Abstract

BACKGROUND AND OBJECTIVE:

Stavudine (d4T) has shown a favourable short and long-term tolerability profile. Nevertheless, its usage is currently decreasing due to some safety concerns. We aimed to evaluate the efficacy and safety of d4T low-dose-based regimens.

PATIENTS AND METHOD:

This was a multicenter and retrospective review chart of patients receiving standard doses of d4T for > or = 6 months (weight > 60 kg: 40 mg/12 h; weight < 60 kg: 30 mg/12 h) and having undetectable viral load for at least 3 months before the d4T dose reduction (weight > 60 kg: 30 mg/12 h; weight < 60 kg: 20 mg/12 h). Immunological and viral parametres, lipid profile and side effects were determined.

RESULTS:

A total of 982 patients were included. The main reason for reducing the dose was prevention of toxicity (76%). After 6 months of follow-up, 97% and 84% patients had less than 400 and 50 cp/ml, respectively, and the CD4 cell count increased by 38 cel/ml. Lipids, lipodystrophy and peripheral polineuropathy improved but there was no statistical significance.

CONCLUSIONS:

A d4T dose reduction in an immuno-virologically stable population does not affect treatment efficacy. Longer follow-ups are required to confirm improvements in the safety profile.

• Authors: Enric Pedrol, Teodoro Martín, Miguel Angel del Pozo, Juan Flores, José Sanz, José A Cartón, Juan-José Jusdado, Piedad Arazo, Esteve Ribera, Elisabet Deig, Grupo de Estudio de Evaluación del uso de Análogos de Nucleósidos
• Journal: Medicina clinica (Med Clin (Barc)) Vol. 129 Issue 10 Pg. 361-5 (Sep 22 2007) ISSN: 0025-7753 [Print] Spain
• Vernacular Title: Impacto de la reducción de dosis de estavudina en su perfil de eficacia/seguridad en pacientes con infección por el virus de la inmunodeficiencia humana inmunológica y virológicamente estables.
• PMID: 17915129 (Publication Type: English Abstract, Journal Article, Multicenter Study)

Chemical References

• Anti-HIV Agents
• Reverse Transcriptase Inhibitors
• Stavudine

Topics

• Adult
• Anti-HIV Agents (administration & dosage)
• Antiretroviral Therapy, Highly Active
• CD4 Lymphocyte Count
• Female
• HIV Infections (drug therapy, immunology)
• Humans
• Male
• Middle Aged
• Retrospective Studies
• Reverse Transcriptase Inhibitors (administration & dosage)
• Stavudine (administration & dosage)
• Viral Load