[Ip-health] MSF study on second-line AIDS treatment in resource poor settings: But Access to newer medicines remains an alarming proglem

[Buddhima Lokuge]

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Data on second line treatment presented by MSF at the recent  Conference=0D
on Retroviruses and Opportunistic Infections (CROI) in LA. Journal=0D
publication pending. "While the needs for a second-line regimen are likely=
=0D
to increase in the coming years, medicines used for second-line therapy=0D
are mostly unavailable or unaffordable in developing countries".=0D
Buddhi=0D
=0D
=0D
MSF STUDY SHOWS GOOD OUTCOMES FOR SECOND-LINE AIDS TREATMENT IN=0D
RESOURCE-POOR SETTINGS=0D
But Access to Needed Newer Medicines Remains Alarming Problem=0D
=0D
Los Angeles, March 1, 2007 =E2=80=93 New data released by the international=
=0D
medical humanitarian organization Doctors Without Borders/M=C3=A9decins San=
s=0D
Fronti=C3=A8res (MSF) at the 14th Conference on Retroviruses and Opportunis=
tic=0D
Infections (CROI) in Los Angeles this week demonstrates good clinical=0D
outcomes for second-line antiretroviral therapy (ART) in resource-poor=0D
settings.  Newer medicines needed for second-line regimens, however,=0D
remain unaffordable and largely unavailable in affected countries, and=0D
adapted diagnostic tools needed to appropriately monitor lifelong=0D
treatment are missing.=0D
=0D
MSF presented a study of 352 adult patients from 50 MSF-supported ART=0D
projects in 22 countries who had been on first-line treatment for at least=
=0D
six months and then needed to switch to a second-line regimen either=0D
because of a drop in CD4 count or a clinical event.  The second-line=0D
regimen included a new drug class, a protease inhibitor, and at least one=
=0D
change in the nucleoside component.  The median follow-up period was seven=
=0D
months.  Overall probability of survival was 86% at 12 months, and median=
=0D
CD4 gain +131 at 12 months.=0D
=0D
=E2=80=9COur outcomes tell us that second-line AIDS therapy is working for =
people=0D
living with AIDS in resource-poor settings,=E2=80=9D said Dr. Alexandra Cal=
my,=0D
HIV/AIDS Advisor at M=C3=A9decins Sans Fronti=C3=A8res Campaign for Access =
to=0D
Essential Medicines, speaking at a press conference at CROI. =E2=80=9CThis =
despite=0D
several obstacles, like the lack of access to the best regimens and the=0D
fact that patients tend to go on second line late in the course of the=0D
disease.=E2=80=9D=0D
=0D
According to the MSF study, there was a switch rate to second-line=0D
treatment of 4.4/1,000 patients per year, indicating that patients in=0D
resource-poor settings tended to stay on a first-line regimen much longer=
=0D
than in developed countries.=0D
=0D
=E2=80=9CPatients might die before they even get a chance to switch to a=0D
second-line regimen,=E2=80=9D Dr. Calmy added. =E2=80=9CWe simply lack the =
diagnostic=0D
tools to efficiently diagnose treatment failure early enough. And doctors=
=0D
are reluctant to switch to second line because it is the last therapeutic=
=0D
option and they are afraid to burn the two treatment lines available by=0D
switching patients unnecessarily.=E2=80=9D=0D
=0D
While the needs for a second-line regimen are likely to increase in the=0D
coming years, medicines used for second-line therapy are mostly=0D
unavailable or unaffordable in developing countries. For example, the=0D
heat-stable form of the boosted protease-inhibitor lopinavir/ritonavir,=0D
marketed as Kaletra by Abbott Laboratories, is only sold in high-income=0D
countries [US, Europe, Australia] because Abbott has taken few steps to=0D
make it available in any resource-poor country except South Africa. The=0D
company=E2=80=99s price for middle-income countries such as Thailand is=0D
unacceptably high. The technology required to monitor the viral load in=0D
patients=E2=80=99 blood is also extremely expensive and not very accessible=
 in=0D
developing countries. Without viral load testing, determining the moment=0D
at which patients need to be switched to a newer regimen is difficult and=
=0D
relying on clinical symptoms or immunological failure is often too late.=0D
=0D
MSF currently provides ART to more than 80,000 patients in over 30=0D
countries.  In one MSF project in Khayelitsha, South Africa, where regular=
=0D
monitoring with viral load testing is available, 20% of people needed to=0D
be switched to a second-line regimen after being on treatment for five=0D
years, according to data presented at CROI by Dr. Gilles van Cutsem, from=
=0D
MSF in South Africa.=0D
=0D
=E2=80=9CWe need newer medicines and viral load tests rapidly and at a larg=
e-scale=0D
because we know that we=E2=80=99re going to be seeing a growing number of p=
eople=0D
who need to switch regimens in our projects,=E2=80=9D said Dr. Laurent Ferr=
adini,=0D
also of MSF, who presented the first study based on virological indicators=
=0D
on the efficacy of second-line ART in Cambodia. =E2=80=9CBut the medicines =
we now=0D
use in second-line regimens are used as a final, salvage-therapy option.=0D
What will we do once people start to again fail on this regimen?=E2=80=9D=
=0D
=0D
Regimens that consist of newer medicines can cost between 10 and 50 times=
=0D
more than today=E2=80=99s standard first-line therapy.  Beyond price, many =
newer=0D
medicines are marketed under monopoly-like conditions, as was the case for=
=0D
first-line drugs in the late 1990s. Competition among multiple=0D
manufacturers, including generic producers is what helped bring prices of=
=0D
first-line therapy down by 99% and increase availability.  But due to=0D
increased patenting in key generics producing countries such as India,=0D
sources of affordable medicines are increasingly drying up.=0D
# # #=0D