[afro-nets] Good Outcomes for Second-line AIDS Treatment

[Jean-Marc Jacobs <Jean-Marc.JACOBS@brussels.msf.org>]

MSF Study Shows Good Outcomes for Second-line AIDS Treatment in
Resource-poor Settings
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But Access to Needed Newer Medicines Remains Alarming Problem

Los Angeles, March 1, 2007 ­ New data released by the
international medical humanitarian organization Doctors Without
Borders/Médecins Sans Frontières (MSF) at the 14th Conference on
Retroviruses and Opportunistic Infections (CROI) in Los Angeles
this week demonstrates good clinical outcomes for second-line
antiretroviral therapy (ART) in resource-poor settings. Newer
medicines needed for second-line regimens, however, remain
unaffordable and largely unavailable in affected countries, and
adapted diagnostic tools needed to appropriately monitor
lifelong treatment are missing.

MSF presented a study of 352 adult patients from 50 MSF-
supported ART projects in 22 countries who had been on first-
line treatment for at least six months and then needed to switch
to a second-line regimen either because of a drop in CD4 count
or a clinical event. The second-line regimen included a new drug
class, a protease inhibitor, and at least one change in the
nucleoside component. The median follow-up period was seven
months. Overall probability of survival was 86% at 12 months,
and median CD4 gain +131 at 12 months.

?Our outcomes tell us that second-line AIDS therapy is working
for people living with AIDS in resource-poor settings,? said Dr.
Alexandra Calmy, HIV/AIDS Advisor at Médecins Sans Frontières
Campaign for Access to Essential Medicines, speaking at a press
conference at CROI. ?This despite several obstacles, like the
lack of access to the best regimens and the fact that patients
tend to go on second line late in the course of the disease.?

According to the MSF study, there was a switch rate to second-
line treatment of 4.4/1,000 patients per year, indicating that
patients in resource-poor settings tended to stay on a first-
line regimen much longer than in developed countries.

?Patients might die before they even get a chance to switch to a
second-line regimen,? Dr. Calmy added. ?We simply lack the
diagnostic tools to efficiently diagnose treatment failure. And
doctors are reluctant to switch to second line because it is the
last therapeutic option and they are afraid to burn the two
treatment lines available by switching patients too early.?

While the needs for a second-line regimen are likely to increase
in the coming years, medicines used for second-line therapy are
mostly unavailable or unaffordable in developing countries. For
example, the heat-stable form of the boosted protease-inhibitor
lopinavir/ritonavir, marketed as Kaletra by Abbott Laboratories,
is only sold in high-income countries [US, Europe, Australia]
because Abbott has taken few steps to make it available in any
resource-poor country except South Africa. The company?s price
for middle-income countries such as Thailand is unacceptably
high. The technology required to monitor the viral load in
patients? blood is also extremely expensive and not very
accessible in developing countries. Without viral load testing,
determining the moment at which patients need to be switched to
a newer regimen is difficult and relying on clinical symptoms or
immunological failure is often too late.

MSF currently provides ART to more than 80,000 patients in over
30 countries. In one MSF project in Khayelitsha, South Africa,
where regular monitoring with viral load testing is available,
20% of people needed to be switched to a second-line regimen
after being on treatment for five years, according to data
presented at CROI by Dr. Gilles van Cutsem, from MSF in South
Africa.

?We know that we?re going to be seeing a growing number of
people who need to switch regimens in our projects, so newer
medicines and viral load tests will be indispensable,? said Dr.
Laurent Ferradini, also of MSF, who presented the first study
based on virological indicators on the efficacy of second-line
ART in Cambodia. ?But the newer medicines we now use in second-
line regimens are used as a final, salvage-therapy option. What
will we do once people start to again fail on this regimen??

Regimens that consist of newer medicines can cost between 10 and
50 times more than today?s standard first-line therapy. Beyond
price, many newer medicines are marketed under monopoly-like
conditions, as was the case for first-line drugs in the late
1990s. Competition among multiple manufacturers, including
generic producers is what helped bring prices of first-line
therapy down by 99% and increase availability. But due to
increased patenting in key generics producing countries such as
India, sources of affordable medicines are increasingly drying
up.

--
Jean-Marc Jacobs
Médecins Sans Frontières (MSF)
Brussels
Tel. +41774385914 (mobile)
mailto:Jean-Marc.JACOBS@brussels.msf.org