Health Vidya

INVIRASE in combination with ritonavir and other antiretroviral agents is indicated for the treatment of HIV infection. The twice daily administration of INVIRASE in combination with ritonavir is supported by safety data from the MaxCmin 1 study (see Table 6 ) and pharmacokinetic data (see Table 1 ). The efficacy of INVIRASE with ritonavir has not been compared against the efficacy of antiretroviral regimens currently considered standard of care. In a randomized, double-blind clinical study (NV14256) in zidovudine-experienced, HIV-infected patients, INVIRASE in combination with zalcitabine was shown to be superior to either INVIRASE or zalcitabine monotherapy in decreasing the cumulative incidence of clinical disease progression to AIDS-defining events or death. Furthermore, in a randomized study (ACTG229/NV14255), patients with advanced HIV infection with history of prolonged zidovudine treatment and who were given INVIRASE 600 mg (three times daily) + zidovudine + zalcitabine experienced greater increases in CD4 cell counts as compared to those who received INVIRASE + zidovudine or zalcitabine + zidovudine. It should be noted that HIV treatment regimens that were used in these initial clinical studies of INVIRASE are no longer considered standard of care. Saquinavir gel capsule 1000 mg twice daily coadministered with ritonavir 100 mg twice daily was studied in a heterogeneous population of 148 HIV-infected patients (MaxCmin 1 study). At baseline 42 were treatment naïve and 106 were treatment experienced (of which 52 had an HIV RNA level <400 copies/mL at baseline). Results showed that 91/148 (61%) subjects achieved and/or sustained an HIV RNA level <400 copies/mL at the completion of 48 weeks.