Imagine a country that, while poor, serves as something of a model for getting treatment for HIV out to those who need it — addressing obstacles that can make the vision of full-scale coverage and treatment as prevention seem like a mirage elsewhere. That’s how international donors and implementers talk about Malawi, where, they say, strong public health leadership, community-based efforts and informed practices have kept costs down, and treatment coverage impressive.
Now picture that after patients get on and stay on treatment for a while, their faces take on a familiar gauntness that tells the world they’re being treated for AIDS, their limbs look wasted, and their extremities, first their legs, and then their arms begin to burn, tingle, go numb. They don’t feel so good otherwise, too — tired, nauseated and achy as lactic acid builds up in their blood, as their cholesterol reaches life-threatening levels, and pancreatitis adds to their ailments. These are some of the side effects of stavudine, also known as d4T, an antiretroviral treatment that was dropped in wealthy countries years ago and that the World Health Organization has recommended stop being included in treatment programs.
According to data from the Market Information Initiative at Boston University School of Medicine, the number of countries buying stavudine for adult treatment dropped from 76 to 48 between from 2009 to 2011. In 2011 a survey by Medecins Sans Frontieres of 16 countries the organization works in showed that seven had switched protocols to provide new patients with better tolerated medicine. The following year, all had removed the the drug from their national protocols for preferred first line treatment. But in 2011, with a stavudine treatment regimen costing $61, per patient patient, per year, while the safer, preferred tenofovir-based regimen cost $173 per patient, per year, the higher up front cost of other treatments slowed effecting the switch (the price of a tenofovir-based regimen has since dropped to $125 per person per year).
That’s the situation in Malawi, where the government changed its guidelines to a safer regimen, and where a recent study showed that stavudine carries its own built in obstacle to treatment adherence. Along with earlier studies, it demonstrated, in effect, that the cost of not switching is higher, in the long term costs of treatment drop out, as well as costs associated with monitoring and addressing side effects.
But while children and pregnant or breastfeeding women, as well as tuberculosis patients have access to less toxic treatments, stavudine continues to be the first treatment supplied to most Malawi patients under the terms of the country’s grant from the Global Fund to Fight AIDS, Tuberculosis and Malaria.
In a letter to Global Fund General Manager Gabriel Jaramillo and United States President’s Emergency Plan For AIDS Relief Global AIDS Coordinator Eric Goosby, the Centre for Devlopment of People (CEDEP), Health GAP (Global Access Project), and the Malawi Network of People Living with HIV/AIDS (MANET+) are asking the Global Fund to find a way to switch to first line treatment in Malawi that is acceptable to patients and World Health Organization standards. They are asking the President’s Emergency Plan For AIDS Relief, which supplies technical assistance but currently does not play a role in supplying treatment in Malawi to support the switch, and to focus on paying for treatment coverage expansion and health worker salaries. “Importantly, the Government of Malawi is committed to phasing out stavudine firstline regimens, as reflected in updated national guidelines — but has been unable to do so because of funding limitations” the letter says.
Malawi got one of the first Global Fund grants and used it to launch a successful treatment effort, Matthew Kavanagh, of Health GAP said. The country’s most recent application for funds was turned down, though, and then the subsequent round of funding was cancelled as the Global Fund reorganized its funding processes. Still, the country has held up its end of making treatment available, he said. “They’ve had troubles, but the program hasn’t collapsed.”
While the Global Fund has encouraged reprogramming on the part of recipients — directing funds from activities found to be less productive to ones considered to have higher impact on preventing transmission of HIV — the charity has told Malawi officials that existing funds will not allow the switch to a treatment reflecting current standards for another year, Kavanagh said. Even then, Kavanagh added, the Fund has told the country it must sacrifice an incentive program geared to keep the health care workers responsible for making treatment available in the public sector.
In the meantime, the long-term costs of treatment dropout and illness from the medicine’s side effects will quickly outstrip the up-front savings of continuing to buy cheap substandard medicine, he said.
“The Global Fund is being very short-sighted,” Kavanagh said.
Dr. Charles Holmes, chief medical officer of PEPFAR, praised Malawi’s effort and said he hopes for an earlier switch.
“PEPFAR is in discussions with the Global Fund, currently the main supporter of ARVs in Malawi, to register our concerns and to seek a solution that would accelerate the timeline for transitioning to the safer regimen as soon as possible without constraining any other important parts of Malawi’s response,” he said. “Both partner governments and donors need to collectively ensure that the health systems we’re doing so much to strengthen only deliver safe and efficacious regimens.”
Global Fund representative Andrew Hurst said: “We are currently in negotiations with Malawi and talking to key partners, including PEPFAR, with a view to making the transition for all patients as quickly as possible, ensuring that the infrastructure and procurement components are in place so that there is no one whose treatment is interrupted. Although D4T does need to be phased out as quickly as possible it is important that there are no interruptions with the potential for resistance — with possibly worse outcomes than a well-coordinated switch.” He added: “The Global Fund is committed to speeding up the switch from d4T but we have to discuss details with our partners in country.”