Three-Year Durability of Response Data Shows Sustiva(TM) Provides Greater Viral Suppression Than Protease Inhibitor Therapy

Apr 02, 2001, 01:00 ET from DuPont Pharmaceuticals Company

    ISTANBUL, Turkey, April 2 /PRNewswire/ -- Data presented today, at the
 11th European Congress of Clinical Microbiology and Infectious Diseases
 (ECCMID) meeting here, indicate that DuPont Pharmaceuticals' anti-HIV drug
 Sustiva(TM) (efavirenz), which is increasingly being used in protease
 inhibitor-sparing regimens, continues to provide greater and more durable
 viral suppression through three years of follow-up than combination therapy
 using a protease inhibitor.
     The data, from the initial cohort of patients enrolled in DuPont
 Pharmaceuticals' landmark 006 study by September 1997 (N=450) and using the
 rigorous method of reporting data called non-completer=failure(1), show a
 greater response in reduction of viral load to less than 50 copies/mL
 (52 percent) compared to a protease inhibitor-containing regimen (30 percent).
 These data were statistically significant (p=0.001).
     "The data clearly show that Sustiva is potent and durable enough to
 sustain undetectable viral load in naive patients for over three years of
 treatment," said Jose Arribas, M.D., HIV Unit, Internal Medicine, La Paz
 Hospital, Madrid.  "This is important because patients and physicians are
 looking for treatment regimens that are powerful and durable yet simple to
 take.  A regimen including Sustiva fits this profile and we now have proof
 that it can sustain its power for a long period of time."
     Additionally, at 144 weeks of follow-up, 55 percent of patients taking
 Sustiva+AZT+3TC were less than 400 copies/mL versus 34 percent taking
 indinavir+AZT+3TC.  These data were also statistically significant (p=0.001).
 Increases in CD4 cell counts were similar across treatment arms.
     Toxicities emerging with long-term anti-HIV therapy are of increasing
 concern in the treatment community.  Safety data from the initial cohort of
 patients in the Sustiva+AZT+3TC arm show that between weeks 72 and 144, only
 2 percent of patients discontinued due to adverse events and 8 percent of
 patients discontinued for administrative reasons or withdrew consent.
 Additionally, 2 percent of patients in this arm discontinued due to virologic
 failure.
     Study 006 was the first randomized, open-label study to compare the
 efficacy of anti-HIV treatments that included a non-nucleoside reverse
 transcriptase inhibitor (NNRTI), with those that include a protease inhibitor
 (PI) in PI-, NNRTI- and 3TC-naive patients.  Subjects included in the trial
 had mean HIV-1 RNA 4.78 log10 copies/mL (60,256 copies/mL) and mean CD4 counts
 of 341 cells/mm3.
     In this analysis, treatment failure was defined as either failure to
 achieve viral load below quantifiable levels (BQL; HIV-RNA less than 400
 copies/mL) by 24 weeks; confirmed viral load rebound of greater than 400
 copies/mL after successful viral suppression; development of an AIDS defining
 event; or discontinuation of study.
     In February 2001, the U.S. Department of Health and Human Services (DHHS)
 continued, for the second year in a row, to list Sustiva as the only
 non-nucleoside reverse transcriptase inhibitor "strongly recommended" for use
 in first-line combination with NRTIs for the treatment of HIV-infected
 individuals.
     Sustiva is generally well tolerated.  The most common adverse events are
 nervous system symptoms (e.g., dizziness, insomnia, impaired concentration,
 somnolence, and abnormal dreaming) and mild to moderate rash.  These symptoms
 occur early in treatment and generally resolve within two to four weeks.  In a
 small number of patients, serious psychiatric adverse experiences have been
 reported.  In controlled trials, serious psychiatric symptoms observed were
 severe depression (0.9%), suicidal ideation or attempts (0.5%), aggressive
 behavior (0.3%), paranoid reactions (0.2%) and manic reactions (0.1%).  These
 problems were seen at a similar frequency in control groups and tended to
 occur more often in patients with a history of mental illness, where the
 frequency of each of these events was approximately one percent.  A few
 suicides have been reported; however, a causal relationship to Sustiva has not
 been established.  Patients with serious psychiatric experiences should
 contact their physician.  Women should not become pregnant while taking
 Sustiva because birth defects have been seen in animals given Sustiva.
 Patients should be cautioned not to operate hazardous machinery or drive if
 they experience nervous system symptoms.
     Sustiva is administered as three 200 mg capsules once-daily.  Sustiva
 should not be administered concurrently with Hismanal(R) (astemizole),
 Propulsid(R) (cisapride), Versed(R) (midazolam), Halcion(R) (triazolam) or
 ergot derivatives.  Current treatment guidelines recommend against the use of
 any antiretroviral agent as monotherapy.  Therefore, Sustiva must not be used
 as a single agent to treat HIV or added on as a sole agent to a failing
 regimen.  The choice of new antiretroviral agents to be used in combination
 with Sustiva should take into consideration the potential for viral
 cross-resistance.  Sustiva therapy should always be initiated in combination
 with at least one other antiretroviral agent to which the patient has not been
 previously exposed.
     DuPont Pharmaceuticals Company, a wholly owned subsidiary of DuPont
 (NYSE:   DD), is a worldwide business focused on research, development and
 delivery of pharmaceuticals and imaging agents to treat unmet medical needs in
 the fights against HIV/AIDS, cardiovascular disease, inflammatory diseases,
 cancer and neurological diseases.
     DuPont is a science company, delivering science-based solutions that make
 a difference in people's lives in food and nutrition; health care; apparel;
 home and construction; electronics; and transportation.  Founded in 1802, the
 company operates in 70 countries and has 93,000 employees.
     For full Sustiva prescribing information, please visit the company's
 Website at www.sustiva.com or call 1-800-4PHARMA (1-800-474-2762).
 
     Sustiva(TM) is a trademark of the DuPont Pharmaceuticals Company.
 
     The other brands listed are the registered trademarks of their respective
 owners and are not the trademarks of DuPont Pharmaceuticals.
 
     (1) Patients who remained in the study and maintained viral suppression
 (did not meet criteria for virologic failure) at the timepoint were considered
 successes.  Patients who had confirmed virologic rebound, discontinued the
 study or had missing data at the timepoint for any reason were considered
 failures.
 
 

SOURCE DuPont Pharmaceuticals Company
    ISTANBUL, Turkey, April 2 /PRNewswire/ -- Data presented today, at the
 11th European Congress of Clinical Microbiology and Infectious Diseases
 (ECCMID) meeting here, indicate that DuPont Pharmaceuticals' anti-HIV drug
 Sustiva(TM) (efavirenz), which is increasingly being used in protease
 inhibitor-sparing regimens, continues to provide greater and more durable
 viral suppression through three years of follow-up than combination therapy
 using a protease inhibitor.
     The data, from the initial cohort of patients enrolled in DuPont
 Pharmaceuticals' landmark 006 study by September 1997 (N=450) and using the
 rigorous method of reporting data called non-completer=failure(1), show a
 greater response in reduction of viral load to less than 50 copies/mL
 (52 percent) compared to a protease inhibitor-containing regimen (30 percent).
 These data were statistically significant (p=0.001).
     "The data clearly show that Sustiva is potent and durable enough to
 sustain undetectable viral load in naive patients for over three years of
 treatment," said Jose Arribas, M.D., HIV Unit, Internal Medicine, La Paz
 Hospital, Madrid.  "This is important because patients and physicians are
 looking for treatment regimens that are powerful and durable yet simple to
 take.  A regimen including Sustiva fits this profile and we now have proof
 that it can sustain its power for a long period of time."
     Additionally, at 144 weeks of follow-up, 55 percent of patients taking
 Sustiva+AZT+3TC were less than 400 copies/mL versus 34 percent taking
 indinavir+AZT+3TC.  These data were also statistically significant (p=0.001).
 Increases in CD4 cell counts were similar across treatment arms.
     Toxicities emerging with long-term anti-HIV therapy are of increasing
 concern in the treatment community.  Safety data from the initial cohort of
 patients in the Sustiva+AZT+3TC arm show that between weeks 72 and 144, only
 2 percent of patients discontinued due to adverse events and 8 percent of
 patients discontinued for administrative reasons or withdrew consent.
 Additionally, 2 percent of patients in this arm discontinued due to virologic
 failure.
     Study 006 was the first randomized, open-label study to compare the
 efficacy of anti-HIV treatments that included a non-nucleoside reverse
 transcriptase inhibitor (NNRTI), with those that include a protease inhibitor
 (PI) in PI-, NNRTI- and 3TC-naive patients.  Subjects included in the trial
 had mean HIV-1 RNA 4.78 log10 copies/mL (60,256 copies/mL) and mean CD4 counts
 of 341 cells/mm3.
     In this analysis, treatment failure was defined as either failure to
 achieve viral load below quantifiable levels (BQL; HIV-RNA less than 400
 copies/mL) by 24 weeks; confirmed viral load rebound of greater than 400
 copies/mL after successful viral suppression; development of an AIDS defining
 event; or discontinuation of study.
     In February 2001, the U.S. Department of Health and Human Services (DHHS)
 continued, for the second year in a row, to list Sustiva as the only
 non-nucleoside reverse transcriptase inhibitor "strongly recommended" for use
 in first-line combination with NRTIs for the treatment of HIV-infected
 individuals.
     Sustiva is generally well tolerated.  The most common adverse events are
 nervous system symptoms (e.g., dizziness, insomnia, impaired concentration,
 somnolence, and abnormal dreaming) and mild to moderate rash.  These symptoms
 occur early in treatment and generally resolve within two to four weeks.  In a
 small number of patients, serious psychiatric adverse experiences have been
 reported.  In controlled trials, serious psychiatric symptoms observed were
 severe depression (0.9%), suicidal ideation or attempts (0.5%), aggressive
 behavior (0.3%), paranoid reactions (0.2%) and manic reactions (0.1%).  These
 problems were seen at a similar frequency in control groups and tended to
 occur more often in patients with a history of mental illness, where the
 frequency of each of these events was approximately one percent.  A few
 suicides have been reported; however, a causal relationship to Sustiva has not
 been established.  Patients with serious psychiatric experiences should
 contact their physician.  Women should not become pregnant while taking
 Sustiva because birth defects have been seen in animals given Sustiva.
 Patients should be cautioned not to operate hazardous machinery or drive if
 they experience nervous system symptoms.
     Sustiva is administered as three 200 mg capsules once-daily.  Sustiva
 should not be administered concurrently with Hismanal(R) (astemizole),
 Propulsid(R) (cisapride), Versed(R) (midazolam), Halcion(R) (triazolam) or
 ergot derivatives.  Current treatment guidelines recommend against the use of
 any antiretroviral agent as monotherapy.  Therefore, Sustiva must not be used
 as a single agent to treat HIV or added on as a sole agent to a failing
 regimen.  The choice of new antiretroviral agents to be used in combination
 with Sustiva should take into consideration the potential for viral
 cross-resistance.  Sustiva therapy should always be initiated in combination
 with at least one other antiretroviral agent to which the patient has not been
 previously exposed.
     DuPont Pharmaceuticals Company, a wholly owned subsidiary of DuPont
 (NYSE:   DD), is a worldwide business focused on research, development and
 delivery of pharmaceuticals and imaging agents to treat unmet medical needs in
 the fights against HIV/AIDS, cardiovascular disease, inflammatory diseases,
 cancer and neurological diseases.
     DuPont is a science company, delivering science-based solutions that make
 a difference in people's lives in food and nutrition; health care; apparel;
 home and construction; electronics; and transportation.  Founded in 1802, the
 company operates in 70 countries and has 93,000 employees.
     For full Sustiva prescribing information, please visit the company's
 Website at www.sustiva.com or call 1-800-4PHARMA (1-800-474-2762).
 
     Sustiva(TM) is a trademark of the DuPont Pharmaceuticals Company.
 
     The other brands listed are the registered trademarks of their respective
 owners and are not the trademarks of DuPont Pharmaceuticals.
 
     (1) Patients who remained in the study and maintained viral suppression
 (did not meet criteria for virologic failure) at the timepoint were considered
 successes.  Patients who had confirmed virologic rebound, discontinued the
 study or had missing data at the timepoint for any reason were considered
 failures.
 
 SOURCE  DuPont Pharmaceuticals Company