Bangkok- Treatment of people living with HIV/AIDS with antiretroviral medicines (ARVs) is effective, even for patients at advanced stages of the disease living in resource-poor settings, according to new clinical data released by Médecins Sans Frontières (MSF) today at the XV International AIDS Conference in Bangkok.

Simplification of treatment, including use of three-in-one fixed-dose combinations (FDCs) of ARVs, has allowed MSF to rapidly scale up its AIDS treatment programs from 1,500 patients in 10 countries to 13,000 patients in 25 countries over two years. But the organization also reported that significant challenges remain, including the lack of affordable second-line drugs and pediatric formulations.

Observational safety and outcomes data collected on 12,058 adults (median age 34 years; 55.6% women) from 31 MSF programs in 16 countries demonstrate encouraging clinical and immunological responses. Although most patients who initiated treatment were already in advanced stages of AIDS - 87.7% were in WHO stage 3 or 4 - overall probability of survival at 24 months was 85.3% and the proportion of patients who were lost to follow-up was 12.1%.

A continuous increase of CD4 counts was also observed among MSF patients. Median CD4 increases for patients who had been on ARV therapy for 24 months were 101 cells/mm3 at six months, 135 cells/mm3 at 12 months, 193 cells/mm3 at 18 months and 208 cells/mm3 at 24 months. Patients also gained three to five kilograms during treatment.

Viral load is not available in most MSF treatment programs, and is often not done routinely, but in the case of MSF program in Chiradzulu, Malawi, viral load was measured on 477 patients who had been on treatment for at least six months, and a preliminary analysis of the data shows that 407 (85%) had undetectable levels of virus (less than 400 copies/ml).

Using FDCs, eliminating the requirement for CD4 and viral load tests to begin treatment, and delegating responsibility from doctors to nurses and clinical officers have been essential to MSF’s rapid expansion of the numbers of patients benefiting from treatment. By May 2004, 76% of new patients in MSF projects were receiving their treatment in the form of a generic triple FDC of a one-pill-twice-a-day regimen of d4T/3TC/NVP.

Although data presented at the conference demonstrate decisively that current FDCs are safe and effective, MSF physicians expressed concern that when patients need second-line drugs, they will not be affordable.

"Resistance to first-line ARVs is as inevitable in poor countries as in rich ones," says Dr. Alexandra Calmy, MSF AIDS advisor. "Yet with second-line treatments costing as much as $5,000 per patient per year in developing countries - 15 times the cost of first-line treatments - it will simply be out of reach. Unless this situation changes, per patient costs will skyrocket and people will die needlessly."

The availability and affordability of second-line and other newer medicines are also threatened by the nearing deadline for implementation of the World Trade Organization (WTO) TRIPS Agreement in key manufacturing countries such as India, and by regional and bilateral trade agreements. Further, internationally and nationally, treatment scale-up initiatives remain under-funded, politically constrained, or suffer from bureaucratic inertia, which all delay implementation.

"MSF was late in starting to treat people living with HIV/AIDS, but now that we and others have decisively shown that it can be done, even for the sickest of patients in the poorest of settings, it is a tragedy that barely 7% of all of those in need of treatment in developing countries are receiving it," said Dr. Myrto Schaefer of MSF. "There is no excuse for accepting inaction. Governments can and must do better."

MSF provides antiretroviral treatment to more than 13,000 patients spread across 56 projects in 25 countries. MSF has been caring for people living with HIV/AIDS in developing countries since the mid 1990s, and the first MSF ARV treatment projects began in 2000 (in Thailand and South Africa).