Outcomes for Second-line AIDS Treatment in Resource-poor Settings

[Guest guest]

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.

andra 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 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.

t 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.

http://www.doctorswithoutborders.org/pr/2007/03-01-2007_1.cfm