What precaution should I take with Duovir-N (Lamivudine/Zidovudine/Nevirapine)?
The combination of Zidovudine and Lamivudine and Nevirapine (on which is based Duovir-N) offer highly effective synergistic antiretroviral properties. Thus this effective antiretroviral clinical remedy is widely prescribed all over the world to patients who are suffering from an infection with HIV.
The following precaution can be considered for using Duovir-N (Lamivudine/Zidovudine/Nevirapine).
Use of antiretroviral nucleoside analogues alone or in combination, including stavudine and lamivudine has led to lactic acidosis/severe hepatomegaly with steatosis, including fatal cases. It happens particularly in women. Obesity and prolonged nucleoside exposure may be risk factors.
Zidovudine and lamivudine should be administered to any patient with proper care, and particularly to those who have problems for liver. Cases have also been reported in patients with unknown risk aspects. Therapy should be interrupted in any patient who develops clinical or laboratory findings indicating lactic acidosis or hepatotoxicity (which may include hepatomegaly and steatosis), even in the lack of marked amino-transferase elevations.
Caution is much needed while using Duovir-N in patients who have bone marrow compromise evidenced by granulocyte count < 1000 cells/mm3 or hemoglobin < 9.5 g/dl (see Side Effects).
Prolonged use of zidovudine has been capable of bringing myopathy and myositis, with pathological changes resembling that produced by HIV disease, and therefore may come about by treatment with Duovir-N (Lamivudine/Zidovudine/Nevirapine).
Clinical studies made on some patients with HIV infection who have chronic liver disease experienced clinical or laboratory evidence of frequent hepatitis upon discontinuation of lamivudine. Chronic liver disease is caused by hepatitis B virus infection. Results may be more severe in patients with decompensate liver disease.
Patients treated with nevirapine have observed severe, life-threatening skin reactions, including fatal cases. These have incorporated cases of Stevens-Johnson syndrome, toxic epidermal necrolysis, and hypersensitivity reactions such as rash, constitutional findings, and organ dysfunction. Patients developing signs or symptoms of severe skin reactions or hypersensitivity reactions including, but not limited to, severe rash or rash along with fever, blisters, oral lesions, conjunctivitis, facial edema, muscle or joint aches, general malaise and/or significant hepatic abnormalities must put an end to nevirapine right away. Nevirapine therapy must be started with a 14-day lead - in period of 200 mg/day (4 mg/kg/day in paediatric patients), which can decrease the frequency of rash. If rash happens during this lead-in period, dose escalation and administration of Duovir-N should not happen until the rash has resolved.
Patients treated with nevirapine have reported serious or life-threatening hepatotoxicity, including fatal fulminant hepatitis (transaminase elevations, with or without hyperbilirubinemia, prolonged partial thromboplastin time, or eosinophilia). Some of these cases started in the first few weeks of therapy, and some were along with rash. Nevirapine administration should be discontinued in patients experiencing moderate or severe ALT or AST abnormalities until these return to usual values. Nevirapine should be permanently stopped if liver function abnormalities come back upon re-usage. Monitoring of ALT and AST is strongly suggested, in particular during the first six months of nevirapine therapy.