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Dangerously High Lactates in Black Women Starting d4T
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7th International Workshop on Adverse Drug Reactions and Lipodystrophy in HIV
Exclusive report for NATAP
Dublin, November 17, 2005
Black African women living in France whose first antiretroviral regimen included stavudine (d4T) ran a high risk of symptomatic high lactate levels when compared with black African men and Europeans.
Although the study was small, French clinicians pointed out at the November 13-17 Lipodystrophy Workshop, the findings raise concern because d4T is often prescribed as first-line therapy in African countries hard hit by AIDS.
Yann Gerard and colleagues in Tourcoing, France undertook the study because their earlier work (now in press) found that black women have an 18.2-fold higher risk of symptomatic high lactates than men. In the same multivariate analysis other women had a 5.6-fold higher risk of hyperlactatemia than men.
The new study involved 574 treatment-naive people who started antiretrovirals from 1997 through 2004. Almost half of them, 284, started d4T. In that group 43 were black women and 31 black men from sub-Saharan Africa.
From 1997 through 2000 Gerard and colleagues measured lactates whenever someone had symptoms of high lactates. From 2000 to 2002 they also got lactates readings when systematically measured anion gap exceeded 16. Since February 2002 they routinely measured lactates in everyone.
Of the 31 African women starting d4T, 15 controlled viral replication in 6 months, a signal of adherence to treatment. Seven of these 15 (46.7%) had side effects—three cases of severe hyperlactatemia, three cases of mild asymptomatic hyperlactatemia, and one case of neuropathy.
Among the 43 African men starting d4T, 16 controlled HIV in 6 months. None of those 16 men had severe hyperlactatemia, though 5 (31.2%) had side effects, including symptomatic hyperlactatemia in one, asymptomatic mild hyperlactatemia in two, and neuropathy in two.
Because the World Health Organization recommends d4T for first-line therapy in poor or developing countries, and because many generic fixed-dose combinations include d4T, Gerard and coworkers worry that thousands of African women will take the drug. Because symptoms of high lactates are nonspecific, they fear African health workers will miss the problem. Uncontrolled lactates can culminate in fatal lactic acidosis.
The French clinicians point out that their survey is small and that some people they studied took d4T with didanosine (ddI), which could heighten the risk of dangerous lactates. But they saw a similarly high incidence of elevated lactates in Africans taking d4T with lamivudine (3TC).
Y. Gerard, Y. Yazdanpanah, F. Ajana, et al. Use of stavudine is associated with a high risk of severe hyperlactatemia in black women. 7th International Workshop on Adverse Drug Reactions and Lipodystrophy in HIV. November 13-16, 2005. Dublin. Abstract 69.
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