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| |  FDA Approves Epivir For Use In HIV Patients Three-Months Old And Up RESEARCH TRIANGLE PARK, NC -- March 24, 1999 -- The United States Food and Drug Administration has approved expanded prescribing information on the use of Glaxo Wellcome’s Epivir(R) (lamivudine), also known as 3TC(R), in infants, children and adolescents. This new approval expands the FDA-approved pediatric information to include HIV patients from three months to 16 years of age. In addition, this approval also includes an important revision to the indication for use of Epivir in combination with other antiretroviral agents for the treatment of HIV infection in adults and children. This broad indication reflects the demonstrated safety and efficacy of Epivir, a nucleoside analogue reverse transcriptase inhibitor (RTI), in numerous clinical studies since 1991. Epivir Tablets and Oral Solution have been a key component of successful combination therapies in patients with HIV infection. Epivir products are the world's most widely-prescribed antiretroviral drug and in the U.S., are part of combination therapy for nearly 75 percent of patients receiving treatment. Epivir originally received accelerated approval for use in combination with Retrovir(R) (zidovudine, AZT) for the treatment of HIV on Nov. 17, 1995. Combination therapy with Epivir has been proven to prevent AIDS-related infections and prolong life in several landmark HIV studies, including ACTG 320 and the CAESAR trial. The CAESAR study was the basis for traditional approval of Epivir in the U.S. in April 1997. This new approval expands the FDA-approved pediatric information to include patients from three months to 16 years of age. Since the original approval in 1995, Epivir has been used safely in combination with many other antiretroviral agents, and was part of the pivotal clinical trials used as part of the basis of approval of four other HIV therapies: the nucleoside analogue RTI Ziagen(TM) (abacavir sulfate), the non-nucleoside RTI efavirenz, and the protease inhibitors indinavir and nelfinavir. Studies have found that the overall frequency of HIV disease progression or death is less with Epivir/Retrovir (6.4 percent) than didanosine (15.7 percent). Second, the frequency of death is less with Epivir/Retrovir (0.8 percent) than didanosine (4.7 percent). In adults and adolescents (12 to 16 years of age) with HIV infection, Epivir is dosed as one 150 mg tablet, twice daily, administered in combination with other antiretroviral drugs. The recommended oral dose of Epivir for pediatric patients three months to 12 years of age is 4 mg/kg twice daily (up to a maximum of 150 mg twice a day) administered in combination with other antiretroviral agents. In clinical trials in HIV, Epivir was generally well tolerated, with the most commonly reported side effects including headache, nausea, malaise and fatigue, nasal congestion and runny nose and diarrhea. Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with the use of nucleoside analogues alone or in combination, including Epivir and other antiretrovirals. Pancreatitis, which can be fatal, has occurred in pediatric patients with a history of prior antiretroviral therapy. Related Links: Epivir, Glaxo Wellcome
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