[P16] Increased antiretroviral therapy therapy experience in zidovudine-naïve subjects failing on a stavudine-containing regimen was significantly associated with peripheral neuropathy and wasting syndrome

2nd International Workshop on Adverse Drug Reactions and Lipodystrophy in HIV

13-15 September 2000, Toronto, Canada

INCREASED ANTIRETROVIRAL THERAPY EXPERIENCE IN ZIDOVUDINE-NAÏVE SUBJECTS FAILING ON A STAVUDINE-CONTAINING REGIMEN WAS SIGNIFICANTLY ASSOCIATED WITH PERIPHERAL NEUROPATHY AND WASTING SYNDROME

Antiviral Therapy 2000; 5(Suppl. 5):33 (abstract no. P16)

G Coodley¹, P Shalit², S Raffanti³, R Fisher⁴, Q Liao⁴, L Ross⁴ and J Hernandez⁴
¹Fanno Creek Clinic, Portland, Oreg.; ²Swedish Medical Center, Seattle, Wash.; ³Comprehensive Care Center, Nashville, Tenn.; ⁴Glaxo Wellcome, RTP, N.C., USA

BACKGROUND: Mitochondrial dysfunction has been associated with neuropathies and may contribute to clinical symptoms of NRTI-related lipodystrophy. Both ART-associated neuropathies and lipodystrophy may have been previously under-reported or misdiagnosed. Loss of subcutaneous tissue resulting in a cachectic appearance may have been diagnosed as wasting syndrome rather than NRTI-associated lipodystrophy. Accurate, early diagnosis and treatment of conditions that may be associated with NRTI-induced lipodystrophy and/or mitochondrial toxicity is essential as uncontrolled conditions can be fatal (lactic acidosis, hepatic steatosis with mitochondrial toxicity) and financially costly (plastic surgery and growth hormone for lipodystrophy).

OBJECTIVES: HIV isolates obtained from zidovudine naïve, ART-experienced subjects failing on a stavudine-containing regimen were evaluated in NZT40012. Past and present HIV-associated conditions were captured to quantify the frequency of specific clinical conditions.

DESIGN: A post hoc analysis was performed on 86 subjects according to criteria specified in the Symptomatic/Clinical Conditions of CDC Classification for HIV Infection and AIDS in Adolescents and Adults (1993 version).

RESULTS: Thirty-four (40%), 26 (30%) and 26 (30%) subjects had conditions in categories A, Band C, respectively. Subjects with CDC classification C illnesses were significantly more likely to have elevated HIV-1 RNA (P=0.007). More heavily pre-treated subjects (more than four prior ARTs) had significantly more occurrences of peripheral neuropathy (P=0.013) and wasting syndrome (P=0.047). Although not significant (P=0.110), peripheral neuropathy was seen more often in failing subjects having longer exposure to stavudine (29% of subjects with stavudine experience >24 months) compared to failing subjects with less exposure (13% of subjects with stavudine experience <24 months).

CONCLUSIONS: Zidovudine-naïve subjects failing on a stavudine-containing regimen with CDC classification C illnesses were significantly more likely to have higher HIV-1 RNA levels. More heavily ART-experienced subjects (more than four prior ART) had significantly increased incidence of peripheral neuropathy and wasting syndrome.

000913
P16

Copyright © 2000 - International Medical Press Ltd. Reproduction of this abstract (other than one copy for personal reference) must be cleared through the Medical Editor, International Medical Press, 36 St Mary-at-Hill, London EC3R 8DU, United Kingdom.