In addition, serious hepatotoxicity including liver failure requiring transplantation in one instance has been reported in hiv-1 uninfected individuals receiving multiple doses of viramune in the setting of post-exposure prophylaxis pep , an unapproved use.
Information about Viramune.
Nevirapine has been studied in several combination regimens for the treatment of HIV infectionEarly trials comparing nevirapine-containing regimens with regimens of established potency were relatively smallIn one small studyinitial therapy with nevirapinedidanosinestavudine compared favorably with the combination of efavirenz with the same 2 nucleoside analogues at 48 weeks of therapy2A larger comparison of nevirapine with efavirenzeach combined with lamivudinestavudine in initial therapyfound no significant difference between treatment arms in rates of virologic suppression or CD4 increase at 48 weeks3This study also compared once-daily dosing of nevirapine with standard twice-daily dosing and found no significant differences in treatment outcomes between the two nevirapine armsA large trial comparing once-daily extended release nevirapine with twice-daily immediate release formulationeach given in combination with emtricitabinetenofovir in initial therapyfound comparable rates of HIV RNA suppression at 48 weeks4)
Interferons have no known effect on CYP 3A4 or 2B6No clinically relevant drug-drug interaction is expected.
To support the use of the prolonged-release tabletsthe company conducted studies to show that the immediateand prolonged-release tablets both had adequate drug levelsand the same effect on the viral load in the bodyStudies were also done to show successful switching from immediate-release tabletstwice daily to prolonged-release tabletsonce daily.
In a 200 mg nevirapine single dose pharmacokinetic study of HIV-negative patients with mild and moderate hepatic impairmentChild-Pugh An=6Child-Pugh Bn=4a significant increase in the AUC of nevirapine was observed in one Child-Pugh B patient with ascites suggesting that patients with worsening hepatic function and ascites may be at risk of accumulating nevirapine in the systemic circulationBecause nevirapine induces its own metabolism with multiple dosingthis single dose study may not reflect the impact of hepatic impairment on multiple dose pharmacokineticssee section 4.4
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