Bristol-Myers Squibb Company announced that Sustiva (efavirenz) has received approval from the US FDA to include new long-term virologic and clinical data from BMS Study 006 in its prescribing information. The new data demonstrate the long-term durability of virologic response in people living with HIV-1 who are naïve to protease inhibitors, lamivudine (3TC) and non-nucleoside reverse transcriptase inhibitors (NNRTI) through more than three years of treatment on a combination regimen containing Sustiva.

"The new data from Study 006 provide valuable information to health care professionals supporting first-line use of Sustiva-based combination therapy," said Karen Tashima, associate professor of medicine, Brown Medical School, Miriam Hospital, Providence, Rhode Island. He added, "The long-term data suggest that patients who stay on Sustiva as part of their combination therapy may experience durable viral suppression for more than three years reinforcing its use in first-line HIV combination therapy."

BMS Study 006 was a randomized, open-label, multi-centre, multinational study of 1,266 HIV-1 positive people in the United States, Europe and Canada who were naïve to protease inhibitors, lamivudine and NNRTIs and who had a viral load greater than or equal to 10,000 copies/mL and a CD4+ cell count greater than or equal to 50 cells/mm3. Patients were given one of three treatment regimens: Sustiva+zidovudine+lamivudine (EFV 600 mg once-daily+ZDV 300 mg every 12 hours+LAM 150 mg every 12 hours; n=422), or Sustiva+indinavir (EFV 600 mg once-daily+IDV 1,000 mg every 8 hours; n=429), or indinavir+zidovudine+lamivudine (IDV 800 mg every 8 hours+ZDV 300 mg every 12 hours+LAM 150 mg every 12 hours; n=415).

Through 168 weeks, the percentage of patients who achieved and maintained HIV-1 RNA less than 400 copies/mL was 48 per cent (EFV+ZDV+LAM), 40 per cent (EFV+IDV) and 29 percent (IDV+ZDV+LAM) using an intent-to-treat, time-to-loss of virologic response analysis. The response rate for achieving viral load less than 50 copies/mL through 168 weeks was 43 per cent (EFV+ZDV+LAM), 31 percent (EFV+IDV) and 23 per cent (IDV+ZDV+LAM). A Kaplan-Meier analysis of time to loss of virologic response (HIV-1 RNA less than 400 copies/mL) suggests that both the trends of virologic response and differences in response continue through four years. Kaplan-Meier is a method of statistical analysis commonly used by biomedical researchers to predict the probability of a particular outcome over a given period of time.

Patients who remained on therapy through 168 weeks demonstrated mean CD4+ cell count increases (from a median baseline of 320 cells/mm3) of 329 cells/mm3 (EFV+ZDV+LAM; n=205), 319 cells/mm3 (EFV+IDV; n=158), and 329 cells/mm3 (IDV+ZDV+LAM; n=129).

"This sNDA approval represents another important addition to the support for combination therapy containing Sustiva in treating people living with HIV-1 infection," said Anthony Hooper, president, US Pharmaceuticals, Bristol-Myers Squibb Company. "Since it first became available in 1998, Sustiva has been administered to thousands of patients in combination therapy to treat their HIV-1 infection. With this new labelling, health care professionals now have additional information to draw on when creating a durable antiretroviral regimen for their treatment-naïve patients," he added.

Sustiva is a medication for use in treating people infected with Human Immunodeficiency Virus type 1 (HIV-1), the virus that causes AIDS. It is a member of a class of medications known as non-nucleoside reverse transcriptase inhibitors (NNRTIs).