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Study Demonstrates Durable Viral Load Suppression With Combination Regimen Containing Sustiva™ in Heavily Pretreated Patients
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viral loads for the vast majority of first-time HAART recipients, regardless of their baseline viral load,” said Frank Palella, MD, an assistant professor in the Division of Infectious Diseases at Northwestern University Medical School. “This benefit was noted to persist for at least 2 years, with most patients remaining on such therapy at the time of our report.”
103
Viracept® in combination with other antiretroviral agents is indicated for the treatment of HIV infection. Coadministration of Viracept® with certain drugs is contraindicated. For a listing of these drugs and for information regarding the side effects of this medication therapy, please consult the Agouron Pharmaceuticals, Inc. Web site at www.agouron.com or obtain this information by calling 1-888-VIRACEPT.
Study Demonstrates Durable Viral Load Suppression With Combination Regimen Containing Sustiva™ in Heavily Pretreated Patients A four-drug regimen containing Sustiva
™
(efavirenz), a nonnucleoside reverse transcriptase inhibitor (NNRTI), nelfinavir, and two nucleoside reverse transcriptase inhibitors (NRTIs), provides greater and more durable viral load suppression compared to a tri™ ple combination of nelfinavir or Sustiva when combined alone with NRTIs in extensively nucleosideexperienced HIV-infected individuals. This finding is the result of a study released in August 2001 and funded by the National Institute of Allergy and Infectious Diseases. The study was a Phase II, randomized, multicenter, partially double-blinded three-arm trial that compared Sustiva™, nelfinavir, or Sustiva™ plus nelfinavir, in combination with open label NRTIs. The quadruple therapy arm demonstrated the highest rates of response through 48 weeks of treatment and achieved superior HIV-RNA suppression compared to the nelfinavir arm by both standard (HIV-RNA < 500 copies/mL) and ultrasensitive assays (HIV-RNA < 50 copies/mL) (p = .001 and p = .001, respectively). Similarly, the three-drug arm containing Sustiva ™ conferred significantly greater viral load reductions compared to the nelfinavir arm by the standard (p = .004) and ultrasensitive (p = .008) assays (this was the
first blinded head-to-head comparison of efavirenz with nelfinavir). The quadruple arm achieved superior virologic suppression compared to the three-drug arm containing Sustiva™ only in the ultrasensitive analysis (p = .008). Based on the intent-to-treat approach, 74% (n = 63) in the quadruple therapy arm had plasma HIV-RNA levels less than 500 copies/mL through 48 weeks compared to 60% (n = 65) in the arm containing Sustiva™ and 35% (n = 66) in the nelfinavir arm. Furthermore, through 48 weeks, 67% in the quadruple arm had a viral load less than 50 copies/mL compared to 44% in the arm containing Sustiva™ and 22% in the nelfinavir arm. “The data suggest pretreated individuals with NRTIs have an excellent chance of benefiting from a new regimen that includes both Sustiva ™ and nelfinavir with new NRTIs,” said Laura Bessen, MD, Executive Medical Director, Worldwide Medical Affairs, DuPont Pharmaceuticals Company. “People who need a potent regimen to help reduce viral load now have another proven option.” Durability of response, as determined by time from baseline to virologic failure (confirmed HIV-RNA ≥ 200 copies/mL), was longer in the quadruple therapy
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JANAC Vol. 12, No. 6, November/December 2001
arm (79% of patients were still responding through 48 weeks) compared to 36% in the nelfinavir arm (p < .001). Additionally, 58% in the arm containing Sustiva™ were still responding through 48 weeks (p = .01). The median CD4 cell increase over this period was 94 cells/mm3 (pooled arms, p < .001). A total of 195 NNRTI- and protease inhibitor–naive patients were recruited from 24 AIDS clinical trial units and five Regional National Hemophilia Foundation Units in the United States and Puerto Rico for this study and were subsequently randomized in the double-blind fashion. A full report of this study was
published in the August 9, 2001, issue of the New England Journal of Medicine (Vol. 345, No. 6, pp. 398407). Sustiva™ is indicated for use in first-line combination with NRTIs for the treatment of HIV infection. Coadministration of Sustiva™ with certain drugs is contraindicated. For a listing of these drugs and for information regarding the side effects of this medication therapy, please consult the DuPont Pharmaceuticals Web site for Sustiva™ at www.sustiva.com or obtain this information by calling 1-800-4PHARMA.
viral loads for the vast majority of first-time HAART recipients, regardless of their baseline viral load,” said Frank Palella, MD, an assistant professor in the Division of Infectious Diseases at Northwestern University Medical School. “This benefit was noted to persist for at least 2 years, with most patients remaining on such therapy at the time of our report.”
103
Viracept® in combination with other antiretroviral agents is indicated for the treatment of HIV infection. Coadministration of Viracept® with certain drugs is contraindicated. For a listing of these drugs and for information regarding the side effects of this medication therapy, please consult the Agouron Pharmaceuticals, Inc. Web site at www.agouron.com or obtain this information by calling 1-888-VIRACEPT.
Study Demonstrates Durable Viral Load Suppression With Combination Regimen Containing Sustiva™ in Heavily Pretreated Patients A four-drug regimen containing Sustiva
™
(efavirenz), a nonnucleoside reverse transcriptase inhibitor (NNRTI), nelfinavir, and two nucleoside reverse transcriptase inhibitors (NRTIs), provides greater and more durable viral load suppression compared to a tri™ ple combination of nelfinavir or Sustiva when combined alone with NRTIs in extensively nucleosideexperienced HIV-infected individuals. This finding is the result of a study released in August 2001 and funded by the National Institute of Allergy and Infectious Diseases. The study was a Phase II, randomized, multicenter, partially double-blinded three-arm trial that compared Sustiva™, nelfinavir, or Sustiva™ plus nelfinavir, in combination with open label NRTIs. The quadruple therapy arm demonstrated the highest rates of response through 48 weeks of treatment and achieved superior HIV-RNA suppression compared to the nelfinavir arm by both standard (HIV-RNA < 500 copies/mL) and ultrasensitive assays (HIV-RNA < 50 copies/mL) (p = .001 and p = .001, respectively). Similarly, the three-drug arm containing Sustiva ™ conferred significantly greater viral load reductions compared to the nelfinavir arm by the standard (p = .004) and ultrasensitive (p = .008) assays (this was the
first blinded head-to-head comparison of efavirenz with nelfinavir). The quadruple arm achieved superior virologic suppression compared to the three-drug arm containing Sustiva™ only in the ultrasensitive analysis (p = .008). Based on the intent-to-treat approach, 74% (n = 63) in the quadruple therapy arm had plasma HIV-RNA levels less than 500 copies/mL through 48 weeks compared to 60% (n = 65) in the arm containing Sustiva™ and 35% (n = 66) in the nelfinavir arm. Furthermore, through 48 weeks, 67% in the quadruple arm had a viral load less than 50 copies/mL compared to 44% in the arm containing Sustiva™ and 22% in the nelfinavir arm. “The data suggest pretreated individuals with NRTIs have an excellent chance of benefiting from a new regimen that includes both Sustiva ™ and nelfinavir with new NRTIs,” said Laura Bessen, MD, Executive Medical Director, Worldwide Medical Affairs, DuPont Pharmaceuticals Company. “People who need a potent regimen to help reduce viral load now have another proven option.” Durability of response, as determined by time from baseline to virologic failure (confirmed HIV-RNA ≥ 200 copies/mL), was longer in the quadruple therapy
104
JANAC Vol. 12, No. 6, November/December 2001
arm (79% of patients were still responding through 48 weeks) compared to 36% in the nelfinavir arm (p < .001). Additionally, 58% in the arm containing Sustiva™ were still responding through 48 weeks (p = .01). The median CD4 cell increase over this period was 94 cells/mm3 (pooled arms, p < .001). A total of 195 NNRTI- and protease inhibitor–naive patients were recruited from 24 AIDS clinical trial units and five Regional National Hemophilia Foundation Units in the United States and Puerto Rico for this study and were subsequently randomized in the double-blind fashion. A full report of this study was
published in the August 9, 2001, issue of the New England Journal of Medicine (Vol. 345, No. 6, pp. 398407). Sustiva™ is indicated for use in first-line combination with NRTIs for the treatment of HIV infection. Coadministration of Sustiva™ with certain drugs is contraindicated. For a listing of these drugs and for information regarding the side effects of this medication therapy, please consult the DuPont Pharmaceuticals Web site for Sustiva™ at www.sustiva.com or obtain this information by calling 1-800-4PHARMA.