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Clinical
Features
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Age
: 21-63 years (mean 40.3, median 39)
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Sex:
Male 5 (14%), Female 30 (83%), Unknown 1 (3%)
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Weight:
82-250 pounds (mean 173, median 165) |
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Duration
of 3TC therapy: 7-570 days (mean 255, median 230) |
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Duration
of d4T therapy: 150-450 days (mean 256, median 220) |
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Major
concomitant diagnoses |
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-
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Hepatic
steatosis: 25/36 (69%)
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-
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Pancreatitis:
8/36 (22%) |
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Liver
function abnormalities |
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-
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Peak
AST/ALT: 12-534 (mean 116, median 60)/23-230 (mean 84, median
57)
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-
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Peak
LDH: 480-5792 (mean 1561, median 1152) |
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-
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Peak
Alk phos: 58-622 (mean 178, median 96) |
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-
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Peak
bilirubin: 0.5-3.9 (mean 1.4, median 1.0) |
During the evaluation of the FDA data, Boxwell and Styrt identified
a number of characteristics and clinical features in the patients
who developed lactic acidosis.1
Most patients were females in their forties who were overweight.
The duration of therapy was also an important factor predisposing
individuals to lactic acidosis. In the 3TC/d4T group, lactic acidosis
was recognized a mean of 255 days after the start of both 3TC and
d4T.
Major concomitant diagnoses were also present. The majority
of cases, 69%, had hepatic steatosis, while 22% of the cases had
pancreatitis.
There were also a number of liver function abnormalities,
represented by various rises in liver enzymes.
Reference:
1. Boxwell DE, Styrt BA. Lactic acidosis (LA) in patients receiving
nucleoside reverse transcriptase inhibitors (NRTIs). Program and
abstracts of the 39th Interscience Conference on Antimicrobial Agents
and Chemotherapy, San Francisco, CA; Sept 26-29, 1999. Abstract
1284.
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