Meta-analysis of gender differences in efficacy outcomes for HIV-positive subjects in randomized controlled clinical trials of antiretroviral therapy (2000-2008).
Women are often underrepresented in randomized clinical trials (RCT) of HIV-1 drugs. As a result, determining whether women have different virologic outcomes compared to men is not always possible because the gender-related analyses usually lack statistical power. To address this important public health concern, the Food and Drug Administration's (FDA) Division of Antiviral Products (DAVP) created a database including 20,328 HIV-positive subjects from 40 RCTs in 18 New Drug Applications (NDAs) submitted to the FDA between 2000 and 2008. These RCTs were conducted for at least 48 weeks in duration and were used to support approval of new molecular entity, new formulation, or major label change. To delineate potential gender differences in antiretroviral treatment (ART), we evaluated the percentage of subjects with HIV RNA less than 50 copies per milliliter at 48 weeks. Analyses of the database represent the most systematic review of gender-related ART efficacy data to date. Overall, the meta-analyses did not demonstrate statistically or clinically significant gender differences in virologic outcome at week 48. However, the corresponding subgroup analyses appear to show several statistically significant gender differences favoring males.
Office of Biostatistics, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD 20993, USA. Guoxing.Soon@fda.hhs.gov
Guoxing Greg
GG
Soon
Min
M
Min
Kimberly A
KA
Struble
Kirk M
KM
Chan-Tack
Thomas
T
Hammerstrom
Karen
K
Qi
Susan
S
Zhou
Rafia
R
Bhore
Jeffrey S
JS
Murray
Debra B
DB
Birnkrant
D019380:Anti-HIV Agents / Q000008:administration & dosage*; D005260:Female; D006679:HIV Seropositivity / Q000188:drug therapy* / Q000453:epidemiology; D054624:Health Status Disparities; D006801:Humans; D008297:Male; D016032:Randomized Controlled Trials as Topic; D017678:Sex Distribution; D012737:Sex Factors; D016896:Treatment Outcome; D014481:United States / Q000453:epidemiology
D019380:Anti-HIV Agents