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.
|
