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Information about Gender and Race
According to the FDA-Approved Labeling of Anti-HIV Drugs

Summer 2000

A note from TheBody.com: Since this article was written, the HIV pandemic has changed, as has our understanding of HIV/AIDS and its treatment. As a result, parts of this article may be outdated. Please keep this in mind, and be sure to visit other parts of our site for more recent information!

Drug

 

Gender

Race

AZT (Retrovir)
zidovudine
  No information provided No information provided
ddI (Videx)
didanosine
  "The effects of gender on didanosine pharmacokinetics have not been studied." No information provided
ddC (Hivid)
zalcitabine
  No information provided No information provided
d4T (Zerit)
stavudine
  "The effects of gender on stavudine pharmacokinetics are not known." "The effects of race on stavudine pharmacokinetics are not known."
3TC (Epivir)
lamivudine
  "There are no significant gender differences in lamivudine pharmacokinetics." "There are no significant racial differences in lamivudine pharmacokinetics."
abacavir
(Ziagen)
  "The pharmacokinetics of Ziagen with respect to gender have not been determined." "The pharmacokinetics of Ziagen with respect to race have not been determined."
nevirapine
(Viramune)
  "In one Phase I study in healthy volunteers (15 females, 15 males), the weight-adjusted apparent volume of distribution (Vdss/F) of nevirapine was higher in the female subjects (1.54L/kg) compared to the males (1.38 L/kg), suggesting that nevirapine was distributed more extensively in the female subjects. However, this difference was offset by a slightly shorter terminal-phase half-life in the females resulting in no significant gender difference in nevirapine oral clearance or plasma concentrations following either single- or multiple-dose administration(s)."* An evaluation of nevirapine plasma concentrations (pooled data from several clinical trials) from HIV-1-infected patients (27 Black, 24 Hispanic, 189 Caucasian) revealed no marked difference in nevirapine steady-state trough concentrations (median Cminss = 4.7 mg/mL Black, 3.8 mg/mL Hispanic, 4.3 mg/mL Caucasian) with long-term nevirapine treatment at 400 mg/day. However, the pharmacokinetics of nevirapine have not been evaluated specifically for the effects of ethnicity."**
delavirdine
(Rescriptor)
  "Following administration of delavirdine (400mg every 8 hours), median AUC was 31% higher in female (n=12) than in male patients (n=55)." "No significant differences in the mean trough delavirdine concentrations were observed between different racial or ethnic groups."
efavirenz
(Sustiva)
  "The pharmacokinetics of efavirenz in patients appear to be similar between men and women and among the racial groups studied." "The pharmacokinetics of efavirenz in patients appear to be similar between men and women and among the racial groups studied."
amprenavir
(Agenerase)
  "The pharmacokinetics of amprenavir do not differ between males and females." "The pharmacokinetics of amprenavir do not differ between Blacks and non-Blacks."
indinavir
(Crixivan)
  "Pharmacokinetics of indinavir appear to be comparable in men and women based on phamacokinetic studies including 32 women (15 HIV positive)." "Pharmacokinetics of indinavir appear to be comparable in Caucasians and Blacks based on pharmacokinetic studies including 42 Caucasians (26 HIV positive) and 16 Blacks (4 HIV positive)."
nelfinavir
(Viracept)
  "No significant pharmacokinetic differences have been detected between males and females." "Pharmacokinetic differences due to race have not been evaluated."
ritonavir
(Norvir)
  "A study of ritonavir pharmacokinetics in healthy males and females showed no statistically significant differences in the pharmacokinetics of ritonavir." "Pharmacokinetic differences due to race have not been identified."
saquinavir
(Fortovase)
  "The effect of gender was investigated in healthy volunteers receiving single 1200-mg doses of Fortovase (n=12 females, 18 males). No effect of gender was apparent on the pharmacokinetics of saquinavir in this study." "The effect of race on the pharmacokinetics of saquinavir when administered as Fortovase is unknown."
* Rough translation: more Viramune seemed to get into the system in women, but didn't stay there quite as long as in men. Hopefully this means that the differences will all come out in the wash. Note that a recent study suggests that this more extensive distribution in women may be associated with a higher incidence of rash (see main article).

** Rough translation: when the company looked back at study samples, Viramune levels didn't seem to vary too much between ethnic groups. However, they didn't design a study specifically to look at this issue, so they don't know for sure.

Glossary:

AUC (Area Under the Curve): a way of calculating the amount of drug that gets into the system and how long it stays there.
Healthy: not HIV positive.
Median and Mean: two slightly different ways of calculating averages.
Pharmacokinetics: a term used to describe the action of a drug in the body over a period of time, including the processes of absorption, distribution and elimination.
Trough Level: the level of drug in the system just before you take the next dose.


A note from TheBody.com: Since this article was written, the HIV pandemic has changed, as has our understanding of HIV/AIDS and its treatment. As a result, parts of this article may be outdated. Please keep this in mind, and be sure to visit other parts of our site for more recent information!



  
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This article was provided by AIDS Community Research Initiative of America. It is a part of the publication CRIA Update. Visit ACRIA's website to find out more about their activities, publications and services.
 
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