E-DRUG: MSF study on 2nd line ART: Access problem severe
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Data on second line treatment presented by MSF at the recent Conference
on Retroviruses and Opportunistic Infections (CROI) in LA. Journal
publication pending. "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".
Buddhi
Buddhima Lokuge <Buddhima.Lokuge@newyork.msf.org>
MSF STUDY SHOWS GOOD OUTCOMES FOR SECOND-LINE AIDS TREATMENT IN
RESOURCE-POOR SETTINGS
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 and AIDS Advisor at Medecins Sans Fronteres 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 early enough. 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 unnecessarily.'
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 need newer medicines and viral load tests rapidly and at a large-scale
because we know that we're going to be seeing a growing number of people
who need to switch regimens in our projects,' ? 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 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.
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[ * The lopinavir/ritonavir combination is available from Cipla in India. However it. also, is expensive and the logistics of transport at the appropriate temperature are quite a challenge. BS]