Liver damage is another serious potential side effect of Viramune. Cases of hepatotoxicity, including cases resulting in death, have been reported with the use of Viramune. Patients experiencing moderate or severe liver function test abnormalities should interrupt therapy until liver function tests return to normal. If the abnormalities return after restarting Viramune, the drug should be permanently discontinued. In particular, women with T cell counts greater than 250 are at an increased risk (12 fold) of hepatotoxicity; males with T cell counts greater than 400 are at a 3-fold increased risk of hepatoxicity. The greatest risk is within the first 6 months of treatment (often seen with rash), but close monitoring by a doctor should continue for the first 18 weeks of treatment. Some liver damage could progress even after the drug is stopped.
Nizoral (ketaconazole) should not be co-administered with Viramune. Since Viramune decreases the level of oral contraceptives when the two are co-administered, an additional or alternative method of birth control should be used. Also, St. John's Wort (Hypericum perforatum) is likely to decrease Viramune levels in the body and therefore should be avoided when taking Viramune. Also, methadone levels may need to be adjusted in patients taking Viramune.
Viramune should not be combined with the hard-gel protease inhibitor Invirase. Viramune decreases the levels of Crixivan and increasing the dose of Crixivan to 1000 mg every 8 hours is recommended. There are no data regarding the interaction between Agenerase and Viramune. A dose increase in Kaletra (to 4 capsules twice a day) is recommended for protease-inhibitor-experienced patients, but not for protease-inhibitor-naive patients, when combining Kaletra with Viramune.
BI Trial 1046 or INCAS studied Viramune in antiretroviral-naive patients comparing the following regimens: Viramune/Retrovir/Videx compared to Viramune/Retrovir or Retrovir/Videx. At week 52 there was a significant difference in the number of patients with viral loads below 400 copies/mL among the arms. In the triple-therapy arm 51% of the patients had viral loads below 400 copies/mL compared to less than 6% in the other 2 arms. The mean CD4 T cell count increase from baseline was was 139 cells/mm3 in the triple-therapy arm versus less than 90 cells/mm3 in the other 2 arms.
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