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Peripheral neuropathy during stavudine-didanosine combination therapy (QUINTET Trial).

Raffi F, Mussini JM, Reliquet V, Chennebault JM, La Feuillade A; International Conference on AIDS.

Int Conf AIDS. 1998; 12: 93 (abstract no. 12397).

Maladies Infectieuses Hotel-Dieu, Nantes, France.

OBJECTIVE: To assess incidence, evolution and predictive factors of peripheral neuropathy occurring during stavudine-didanosine combination therapy. METHODS: Sixty-five HIV-infected patients (pts) with prior antiretroviral therapy > 3 months, and naive for ddI and d4T, were included in QUINTET trial (ICAAC 1997). They received ddI (200 mg BID, 125 mg BID if < 60 kg) + d4T (40 mg BID, 30 mg BID if < 60 kg) for 24 weeks with extension for 24 more weeks in case of RNA response below 500 copies/ml. Addition of 3600 mg/day saquinavir was permitted in pts with insufficient antiviral response at week 24. Among the 65 pts, 23 had a neurological evaluation either systematically (n = 17) or for adverse neurological events (n = 6): clinical examination and standardized electromyography (EMG) protocol, with measurement of at least 3 different motor and sensory nerve conduction velocity (SNCV), and 3 muscle needle EMG. RESULTS: Seven of the 65 pts (10.8%) exhibited mild sensory peripheral neuropathy (PN) with mild paresthesia, loss of achillean reflexes and distal thermic or pink-prick sensation. Axonal sensory neuropathy could be detected by mean of SNCV in 7/7 pts. PN occurred between week 11 and 47 (mean: 23) of stavudine-didanosine treatment and led to interruption of stavudine in only one patient before week 24; in the others, reducing stavudine dosage led to symptoms improvement. None of baseline parameters was predictive of PN: previous nucleoside treatment with zidovudine (n = 65) and/or zalcitabine (n = 28), mean CD4 cell counts (PN = 189/mm3 vs no PN = 232/mm3), mean plasma HIV RNA (PN = 5.1 log10 vs no PN = 4.9 log10), previous neurological abnormalities (PN = 2/7 vs no PN = 4/58), stavudine daily dose (PN = 1.24 mg/kg/d vs no PN = 1.12 mg/kg/d). CONCLUSION: Benign sensory reversible peripheral neuropathy could hazardously be encountered in 10.8% patients treated for one year with stavudine-didanosine combination. No predictive factors of peripheral neuropathy occurrence could be identified.

Publication Types:
  • Meeting Abstracts
Keywords:
  • Acquired Immunodeficiency Syndrome
  • Anti-HIV Agents
  • CD4 Lymphocyte Count
  • Clinical Trials as Topic
  • Combined Modality Therapy
  • Didanosine
  • HIV
  • HIV Infections
  • Humans
  • Incidence
  • Nucleosides
  • Peripheral Nervous System Diseases
  • Stavudine
  • Zalcitabine
  • Zidovudine
  • reverse transcriptase, Human immunodeficiency virus 1
Other ID:
  • 98388012
UI: 102227425

From Meeting Abstracts




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