If this is not your name, click here.
| | If this is not your name, click here. | | |
| | Contact Us | Order Now | Journals | Bookstore | Register a colleague | | |
| |  ICAAC: Sustiva + D4T + DDI Effective In Treatment-Naive Patients SAN FRANCISCO, CA. -- September 29, 1999 -- Data presented at the 39th Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC), in San Francisco, describe anti-viral activity of DuPont Pharmaceuticals’ Sustiva™ (efavirenz) in patients with high viral load (greater than or equal to 100,000 copies/mL). These findings from Study 044 demonstrates anti-viral activity of Sustiva in combination treatment in patients infected with HIV. Using the most rigorous method of reporting data called non-completer=failure analysis, the study results indicate that after 24 weeks of treatment with Sustiva+d4t+ddI, 67 percent (n=25) of patients achieved HIV-RNA suppression less than 50 copies/mL after 24 weeks. The mean increase in CD4 cell count for all patients (n=59) at 24 weeks was 123.5 cells/mm3 (+/- 21.0). "The efficacy of combination treatment with Sustiva in providing sustained viral suppression and improved CD4 cell counts indicates that the therapy is an important tool in helping even some of the most challenging patients achieve lower viral load," said Douglas J. Ward, M.D., DuPont Circle Physicians Group, Washington, DC. Safety data from 044 indicate that adverse events greater than or equal to grade 2 were experienced by 42 percent (n=22) of patients and did not prompt discontinuation. The most frequently reported adverse events were diarrhea, paresthesia, fatigue and influenza-like symptoms. Study 044 was a single-arm, open-label study of 61 antiretroviral-naive patients. Mean HIV-1 RNA and CD4 counts of patients included in the study were 4.85 (+/- 0.89) log10 copies/mL (i.e., 71,009 copies/mL) and 289.0 +/- 218.5 cells/mm3 respectively. Previously reported 006 data from an analysis of a subgroup of patients with baseline viral load greater than or equal to 100,000 copies/mL indicated that anti-HIV treatment that included Sustiva+AZT+3TC demonstrated greater duration of response than treatment with indinavir+AZT+3TC.
Accelerated Approval and Product Labeling On September 17, 1998, the FDA granted accelerated approval for Sustiva, a non-nucleoside reverse transcriptase inhibitor (NNRTI), indicated for the treatment of HIV-1 infection in combination with other antiretroviral agents. This indication is based on analyses of plasma HIV-RNA levels and CD4 cell counts in controlled studies of up to 24 weeks in duration. At present, product labeling indicates there are no results evaluating long-term suppression of HIV-RNA with Sustiva. DuPont has submitted an application for traditional approval of Sustiva based on two studies showing long-term (48-week) durability. Sustiva has also received full approval in several countries in Europe, and received full approval in Canada on an accelerated basis.
Related Link: DuPont Pharmaceuticals.
|
