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Lamivudine
Pancreatitis has been reported with the use of lamivudine. Lactic acidosis
and hepatic steatosis, hepatitis and liver failure have been reported with the
use of antiretroviral nucleoside analogs, alone or in combination. Other
side effects associated with the use of lamivudine are diarrhea, malaise and fatigue, headache, nausea and vomiting, abdominal pain and discomfort, peripheral neuropathy, artharalgias, myalgias, skin rash, pruritus, transient neutropenia and thrombocytopenia
and rarely, pancreatitis. Transiently elevated levels of hepatic enzymes and bili
rubin ( ³ 5 times the normal level ) have been observed occasionally during treatment
with the drug. Resolution of transient neutropenia and raised hepatic and bilirubin
levels occurred without dosage modification or discontinuation of therapy.
Stavudine Therapy with stavudine can be associated with severe
peripheral neuropathy, which is dose related and occurs more frequently in patients
with advanced HIV infection or who have previously experienced peripheral neuropathy.
Rash, diarrhoea, nausea/vomiting, pancreatitis, dementia and other peripheral
neurologic symptoms have been associated with the use of stavudine.
Nevirapine The most clinically important adverse events associated
with nevirapine therapy are rash and increases in liver function tests. Cases
of hypersensitivity reactions have been observed. The major clinical
toxicity of nevirapine is rash, with nevirapine-attributable rash occurring in
16% patients in combination regimens of Phase II/ III controlled studies. 35%
of patients treated with nevirapine experienced rash compared to 19% of patients
treated in control groups of either zidovudine + didanosine or zidovudine alone.
Severe or life-threatening rash occurred in 6.6% of nevirapine-treated patients
compared with 1.3% of patients treated in control groups. Rashes are
usually mild to moderate, maculopapular erythematous cutaneous eruptions; with
or without pruritus, located on the trunk, face and extremities. The majority
of severe rashed occurred within the first 28 days of treatment. 25% of the patients
with severe rashes required hospitalization, and one patient required surgical
intervention. Overall, 7% of patients discontinued nevirapine due to rash.
With respect to laboratory abnormalities, asymptomatic elevations in GGT
levels are more frequent in nevirapine recipients than in controls. Because clinical
hepatitis has been reported in nevirapine-treated patients, monitoring of ALT
(SGPT) and AST (SGOT) is strongly recommended, especially during the first 6 months
of nevirapine treatment (See Warnings and Precautions). Decreased neutrophils
(< 750/ mm3 ), platelets ( < 50, 000/ mm3 ) and Hb ( < 8.0 g/ dL ), and increased
total bilirubin ( > 2.5 mg/ dL ) have also been reported. | |