Aptivus® (tipranavir) demonstrates potent and durable treatment response in HIV-positive women

An analysis of the RESIST trials shows that Aptivus® (tipranavir), used with ritonavir (Aptivus/r) as part of combination antiretroviral therapy, provides a potent and durable treatment response in highly treatment-experienced female patients through 48 weeks of treatment.1 These data were presented at the International AIDS Society congress in Sydney, Australia.

“The findings from the RESIST trials reinforce that Aptivus provides therapeutic benefits for treatment-experienced HIV-positive women with limited treatment options. This analysis helps meet the need for more comparative data in HIV-positive women, as cohort studies and clinical trials have shown that the efficacy and safety of antiretroviral agents may vary across genders,” said Sharon Walmsley, M.Sc., M.D., professor of medicine, University of Toronto, senior scientist, Toronto Hospital Research Institute, and director, Clinical Research, Immunodeficiency Clinic, Toronto Hospital.

Worldwide, there are more HIV-positive women than ever before, with nearly 18 million now living with the disease. Women of African and Latin American decent are disproportionately affected and account for a large number of infections in developed countries, including those in Europe.2

The combined RESIST trials enrolled 1,483 treatment-experienced HIV-positive patients, of those approximately 13 percent were women. One hundred and seventeen women were randomised to receive Aptivus/r. At week 48:
25.6 percent of women and 22.1 percent of men taking Aptivus/r achieved viral loads of less than 50 copies/mL.
After adjusting for protease inhibitor stratum, enfuvirtide use, and background reverse transcriptase inhibitor sensitivity, mean viral load change at last observation to week 48 from baseline was -1.46 log10 copies/mL in women and -1.30 log10 in men taking APTIVUS/r (p=0.1890).
The adjusted mean CD4 cell change from baseline at week 48 was 84.2 cells/mm3 in women and 52.4 cells/mm3 in men (p=0.0017).
“Although a higher plasma concentration of tipranavir was observed in women, there were no increased subjective adverse events nor laboratory abnormalities versus male patients,” added Dr. Walmsley. “It is unclear whether this was the reason for the better CD4 cell count response among women participating in the study.”

The overall safety profile was similar in men and women. Rates of adverse events leading to discontinuation were similar for both genders, and severe or serious adverse event rates were slightly higher for men.

Boehringer Ingelheim recently announced the initiation of the SPRING study, which will be one of the largest racially and gender diverse international studies of highly treatment-experienced HIV-1 infected patients. The trial will examine the safety, efficacy and pharmacokinetics of Aptivus/r in a racially diverse group of 200 female and 200 male treatment-experienced patients across eight countries in three continents.