[pronut-hiv] Fat loss beginning to trigger treatment changes in South African patients

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Fat loss beginning to trigger treatment changes in South African
patients

Fat loss caused by the d4T (stavudine) component of triple
antiretroviral therapy is beginning to trigger treatment changes among
people receiving HIV treatment in South Africa, doctors from Durban's
McCord Hospital reported at last week's 2006 Implementers Meeting of
the President's Emergency Plan for AIDS Relief in Durban, South
Africa. 

These data are the first substantial indicator from southern Africa
that fat loss due to d4T is a problem for African patients. The study,
reported by Jane Hampton of McCord Hospital, showed a switch rate of 73
cases per 1000 patient years of follow-up. 

Previous data from Cape Town, presented at the Thirteenth Conference on
Retroviruses and Opportunistic Infections earlier this year, had
suggested that switching from d4T-based treatment due to lipodystrophy
was uncommon. The study found an unexpectedly high incidence of lactic
acidosis, a life-threatening side-effect of d4T treatment, especially
among women with a higher body mass, and led in part to the publication
of guidelines by the Southern African HIV Clinicians Society on
monitoring and managing patients at risk of lactic acidosis. 

The McCord Hospital study reported data from 2323 patients who had
initiated antiretroviral therapy at its Sinikithemba clinic since 2004.
Just over eight per cent had died after beginning treatment, 3.8% were
lost to follow-up and 8.9% had changed treatment centre. 

The predominant regimen prescribed was d4T/3TC/efavirenz. The cohort
had accumulated 1204 patient years of treatment with d4T, while 2022 had
received treatment with efavirenz, 290 with nevirapine and 330 with AZT
in their first-line regimen. 

The most common reason for a switch of treatment was peripheral
neuropathy caused by d4T, which caused 160 switches (56% taking place
between months 6 and 12 of treatment). 

A total of 40 cases of hyperlactatemia (lactate levels above 5mmol/l)
were observed up until March 2006. Twenty-six cases were observed up to
July 2005 (two men, 24 women), leading to four deaths, an incidence rate
of 37 per 1000 patient years of d4T treatment. This compares with an
incidence rate of 15 cases per 1000 patient years of follow-up in the
Cape Town cohort, although the two groups may not be strictly
comparable. 

No further deaths occurred after July 2005, when new guidelines on
starting treatment were introduced. Women with a body mass index above
28 (the highest risk group for developing lactic acidosis among South
African patients) would henceforth start treatment with AZT/3TC rather
than a d4T-containing regimen, whilst women with a BMI above 28 already
receiving d4T would be switched to AZT and given dietary advice in a bid
to reduce their weight. No cases of hyperlactatemia have occurred in
those who have received AZT or switched to it. 

Ninety-seven patients switched from d4T due to lipodystrophy, a rate of
73 switches per 1000 patient years. Fat loss manifested more commonly in
the buttocks and thighs than in the arms or face among women. Changes
were a consequence not only of fat loss, but of fat accumulation too.
Twenty-three women who switched treatment experienced breast enlargement
and 19 experienced abdominal fat accumulation, but no details were
available to describe whether these women had received
efavirenz-containing regimens. 

The study's authors say that the documentation of side-effects and
reasons for switching treatment is necessary in order to inform policy
makers, and that the choice of ARV drugs presently used in South Africa
will need to be reconsidered. 

Further discussion of serious side effects in resource-limited settings
can be read in HIV & AIDS Treatment in Practice, NAM's electronic
newsletter on HIV treatment in resource-limited settings. 

Reference 

Hampton J et al. ART side effects resulting in a change of regimen in a
cohort of patients treated at McCord Hospital, Durban, KZN, South
Africa. The 2006 HIV/AIDS Implementers Meeting of the President's
Emergency Plan for AIDS Relief, Durban, South Africa, abstract 488.