Important note: Information in this article was accurate in 1997. The state of the art may have changed since the publication date.
PR Newswire, 810 Seventh Avenue, New York, NY 10019 - Tuesday September 16 3:01 PM EDT
In the Sustiva plus indinavir arm of the study, patients achieved a 2.38 log10 average reduction in HIV-RNA levels out of a possible 2.49 log10, and 88 percent of them achieved HIV-RNA levels below the level of quantification. In this arm, patients experienced an average CD4 cell count elevation of 240 cells/mm3.
"Studies continue to show Sustiva, when given in a once-daily dose in combination with other anti-HIV drugs, reduces HIV-RNA levels in patients," said Nancy Ruiz, M.D., F.A.C.P., Medical Director of Virology, DuPont Merck. "We are aggressively conducting studies to demonstrate the effect of Sustiva in combination with other antiretrovirals, including AZT, 3TC, nelfinavir, ritonavir and other marketed and investigational drugs."
To be eligible for the study, patients needed CD4 cell counts of 100-500 cells/mm3 and more than 20,000 copies/mL of HIV-RNA. In the study, 59 patients received Sustiva (200 mg, once daily) and indinavir (800 or 1,000 mg every eight hours) concomitantly. After a minimum of 36 weeks, the Sustiva dosing was increased to 600 mg once daily. In the control arm of the study, 42 patients were given indinavir alone for 12 weeks (800 mg or 1,000 mg every eight hours). At that time, Sustiva (200 mg once daily and a subsequent increase to 600 mg after a minimum of 36 weeks) and stavudine (d4T) (variable dosing) were added, and the indinavir dose was raised for all patients to 1,000 mg every eight hours. After 48 weeks in the study, these patients achieved a 1.89 log10 average reduction in HIV-RNA levels out of a possible 2.42 log10, and 68 percent of them achieved HIV-RNA levels below the level of quantification (400 copies/mL). In this arm, patients experienced an average CD4 cell count elevation of 150 cells/mm3.
Sustiva was generally well tolerated and there was no apparent increase in side effects for treatments containing Sustiva over using indinavir alone (only two patients in the indinavir arm of the study and three patients in the Sustiva plus indinavir combination arm of the study discontinued due to other adverse clinical events). The reported side effects from the combination included rash, headache, diarrhea, dizziness, sinusitis, influenza-like symptoms and nausea.
Additional studies are ongoing or planned to investigate the safety and effectiveness of triple combinations of higher doses of Sustiva with nucleoside reverse transcriptase inhibitors; combinations of Sustiva with nelfinavir, indinavir or ritonavir; interactions of Sustiva with other antiretrovirals and drugs to treat opportunistic infections; and, Sustiva in pediatric regimens.
The DuPont Merck Pharmaceutical Company is a worldwide, research-based pharmaceutical company, which markets its products under the DuPont Pharma name. Formed in 1991 as a partnership between DuPont and Merck & Co., Inc., DuPont Merck is focused on research, development and delivery of pharmaceuticals to treat unmet medical needs in the fight against HIV, cardiovascular disease, central nervous system disorders, cancer and arthritis-related disorders. The company is also a leader in radiopharmaceuticals.
SOURCE The DuPont Merck Pharmaceutical Company
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