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 - Monday October 13 2:35 PM EDT
In a 137-patient Phase III study of three Sustiva doses (200, 400 or 600 mg, once daily) in combination with AZT (300 mg, twice daily) and 3TC (150 mg, twice daily), significant reductions in plasma HIV-RNA were observed. After 16 weeks of treatment, the 25 patients who completed the study at the 600 mg dose achieved a 1.89 log10 average reduction in HIV-RNA levels out of a possible 2.04 log10, and 88 percent of them achieved HIV-RNA levels below the level of quantification (400 copies/mL). In addition, these patients experienced an average CD4 cell count elevation of 157 cells/mm3.
"Sustiva in first-line therapy with two nucleoside analogs significantly suppressed viral loads over the first four months in a regimen without a protease inhibitor," said Paul Friedman, M.D., President, DuPont Merck Research Laboratories. "We will continue to study these patients to evaluate long-term benefits of the combination. These results, if confirmed, could influence future treatment standards."
"I think these data are very encouraging and suggest that a combination of efavirenz and two nucleosides might prove to be a good initial regimen for treating HIV-infected patients," said Charles Hicks, M.D., Assistant Professor of Medicine at Duke University Medical Center. "Only subsequent follow-up will reveal if the effect is sustained."
In the study, Sustiva was generally well tolerated. The most commonly reported side effects were nausea, headache, fatigue and dizziness. Four patients discontinued due to adverse effects at the 600 mg dose; adverse effects leading to discontinuation included body ache, dizziness, elevated ALT (liver enzyme) and rash. The study included antiretroviral-naive patients with CD4 counts of more than 50 and HIV-RNA greater than or equal to 10,000 copies/mL.
In another study presented at the conference, DuPont Merck demonstrated that viral load readings giving no signal as measured by the standard Amplicor(TM) assay are highly significant and predictive of long-term viral suppression. Researchers conducted a retrospective evaluation of patient outcome as evidenced by viral load during >52 weeks of combination therapy with Sustiva and the protease inhibitor Crixivan(R) (indinavir) to determine predictors of long-term viral suppression. In the study, two consecutive viral load readouts of <400 copies/mL using the standard Amplicor assay were considered "below the level of quantification" (BQL), while two consecutive viral load readings giving no signal were considered "undetectable." DuPont Merck found that patients in whom viral load was "undetectable" achieved significantly better results than those whose viral load was only "BQL"; these patients showed viral load rebounds over the next 100 days of eight percent and 42 percent, respectively.
A separate presentation at the conference reported that the Sustiva and Crixivan combination suppressed patient HIV-RNA in blood to "undetectable levels" in a higher percentage of patients than Crixivan monotherapy at all time points. Patients who reached "BQL" (whether "undetectable" or not) did so within the first 24 weeks of therapy. These data show that the goal of therapy should be viral load at "undetectable" rather than "BQL." Using the currently available standard Amplicor assay, confirmed viral load at "undetectable" is a good predictor of long-term response for HIV-infected individuals.
In addition to findings presented at the meeting, The DuPont Merck Pharmaceutical Company initiated an expanded access program October 1 in the United States and Canada. The company also is working with representatives from European HIV/AIDS patient advocacy organizations to develop early access programs in Europe starting in the fourth quarter of 1997.
Sustiva is available in the United States and Canada through an expanded access program to people who have CD4 cell counts of 50 cells/mm3 or less and who are failing therapy or are intolerant to their current treatment regimen. In the program, Sustiva must be used in combination with at least one other commercial or investigational antiretroviral to which a patient has not been previously exposed.
Additional studies are ongoing or planned to investigate the safety and effectiveness of triple combinations of 600 mg of Sustiva with nucleoside analog reverse transcriptase inhibitors; combinations of Sustiva with Viracept(R) (nelfinavir), Crixivan or Norvir(R) (ritonavir); interactions of Sustiva with other antiretrovirals and drugs to treat opportunistic infections; and, Sustiva in pediatric regimens with other antiretrovirals.
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 DuPont Merck Pharmaceutical Company
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