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14th International AIDS ConferenceBarcelona, Spain — July 7-12, 2002 |
Int Conf AIDS. 2002 Jul 7-12;14:Abstract No. MoOrB1059
BACKGROUND: Symptomatic hyperlactatemia (SHL) is a complication of nucleoside analog HIV therapy and specifically stavudine (D4T). SHL is also seen in HIV and HCV co-infected (HIV/HCV) patients treated with didanosine (DDI) and ribavirin (RIB). The objective of this study was to characterize SHL presenting in HIV/HCV patients receiving HAART and HCV interferon-based therapy (HCV RX).
METHODS: We reviewed all cases of SHL reported from a 751 patient, randomized, partially-blinded HCVRX trial of pegylated interferon-alfa 2a (PEG) + RIB/placebo (PEG±RIB) vs. interferon-alfa 2a (IFN)+RIB. Baseline characteristics of HIV and HCV disease, presentation of SHL, and outcomes were compared to that published in the literature. Values are reported in median (range).
RESULTS: Six of 751 middle-aged subjects (4/6 men) presented with SHL (2 IFN+RIB, 1 PEG, 3 PEG±RIB). Baseline HAI and fibrosis scores were 6 (5-9) and 2 (1-2), respectively. 5/6 were infected with genotype 1. HCV RNA was 7 (4-7) log10 IU/ml. ALT and alkaline phosphatase were 92 (15-185) and 105 (59-627) IU/ml, respectively. All had HIV RNA <50 copies/ml with median CD4 count of 469 (326-741). HAART regimens included 6 D4T, 5 DDI, 3 PI, and 3 NNRTI, and were unchanged for 16.2 (4.8-26.5) months prior to trial. Symptoms (abdominal pain, nausea, paresthesias) developed after 10 (3-18) weeks of HCV RX initiation. Two required hospitalization and one died. At presentation of SHL, all stopped HAART and 4/6 stopped HCVRX. One patient restarted HAART, while 4/5 restarted HCVRX. At 12 weeks all had responded to HCVRX with (HCV RNA <600 IU/ml in 3/6). In this trial, SHL occurred at a rate of 6 per 606 patient-years of HCVRX compared to a published rate of 7 per 516 patient-years on HAART.
CONCLUSIONS: SHL is a rare but potentially fatal event. These data may represent the expected complication of HAART independent of HCVRX or an unmasking of underlying sub-clinical hepatic mitochondrial dysfunction by HCVRX.
Presenting author: Davey Smith
1University of California, San Diego, UCSD Antiviral Research Center, 150 West Washington St. Suite 100, San Diego, California, United States.
2Clin. Mal. Infet., University of Brescia, Brescia, Italy.
3John Hopkins University, Baltimore, United States.
4Hosp. Clin. Buenos Aires, Buenos Aires, Argentina.
5Hoffmann La-Roche Pharmaceuticals, Nutley, United States.
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MoOrB1059
Copyright © 2002 - International AIDS Society (IAS). Reproduction of this abstract (other than one copy for personal reference) must be cleared through the IAS.
