Gabriel Jaramillo Ambassador Eric Goosby General Manager Global AIDS Coordinator Global Fund to Fight AIDS, Tuberculosis & President’s Emergency Plan for AIDS Relief US Department of State Geneva, Switzerland Washington, DC USA
9 August 2012
Dear Gabriel Jaramillo and Ambassador Eric Goosby: We are writing to call on the Global Fund to immediately support the elimination of stavudine from the national treatment programs in Malawi in order to conform with national guidelines and international recommendations. We understand that Malawi, PEPFAR and the Global Fund are in the midst of discussions regarding this step. We are deeply concerned that in these current negotiations, the Global Fund and Malawi have not yet generated a way to ensure Global Fund resources are used to purchase optimized treatment instead of sub-standard, toxic therapies— without sacrificing essential program components of the Malawi HIV RCC grant and without slowing the bold scale up of total people enrolled in treatment. We further call on PEPFAR to invest directly in the recurring costs of treatment in Malawi, including paying for antiretrovirals and salaries, to ensure sustainability of high-quality care. On World AIDS Day in 2009, almost three years ago, WHO recommended countries no longer use stavudine-based regimens for first line antiretroviral treatment. However, several countries continue to enroll treatment naïve patients on stavudine, due to concerns about up-front costs—despite the fact that toxicities make stavudine-based regimens less cost effective than recommended first line regimens.1 Importantly, the Government of Malawi is committed to phasing out stavudine based first line regimens, as reflected in updated national guidelines—but has been unable to do so because of funding limitations. Recently published research in a cohort of patients in Blantyre, Malawi2 taking stavudine-based regimens reported strikingly high rates of crippling side-effects that hurt patients and undermine adherence efforts: neuropathy was reported at 21.3% after one year, lipodystrophy at 14.7% and an increase in hypercholesterolemia and hypertriglyceridemia from 12.1% to 21.1% after 12 months. These high rates of toxicities provide further evidence of the harm of stavudine regimens, and the lack of value for money provided by the regimen. As drug side effects are the most important predictor of poor adherence, these stavudine-related toxicities also likely lead to poor adherence and virologic failure. In fact, a recent analysis from South Africa showed that stavudine/3TC/nevirapine is the least cost effective regimen, while tenofovir/lamivudine/efavirenz is the most cost effective.3 The community impact of these toxicities is real—for example, the Blantyre study reported high rates of attrition and substitution induced by stavudine-toxicities. Moreover, the Pharmacy, Medicines and Poisons Board of Malawi communicated on June 27 2012 to the Ministry of Health, confirming the need to phase out stavudine urgently due to high rates of toxicities and serious side effects.4 It is unacceptable that people with HIV in Malawi are still being subjected to use of this regimen. We understand that Global Fund is currently working with Malawi on reprogramming Malawi’s funding through its RCC HIV grant. It is our understanding, however, that a switch from stavudine5 is not currently set to happen until at least mid 2013. Even then the country is being forced to choose between continuing the highly-effective program
1Malawi and Zimbabwe are examples of Global Fund and PEPFAR supported countries with that continue to enrol new patients on stavudine based regimens because of increased upfront costs of tenofovir compared with stavudine based regimens.
2van Oosterhout JJ, Mal ewa J, Kaunda S, Chagoma N, Njalale Y, et al. (2012) Stavudine Toxicity in Adult Longer-‐Term ART Patients in Blantyre, Malawi. PLoS ONE 7(7): e42029. doi:10.1371/journal.pone.0042029
3Bendavid E, Grant P, Talbot A, Owens DK, Zolopa A (2011) Cost-‐effectiveness of antiretroviral regimens in the World Health Organization’s treatment guidelines: a South African analysis. AIDS 25: 211–20.
4 June 27 2012 letter to the Principal Secretary, Ministry of Health from the Pharmacy, Medicines and Poisons Board of Malawi, Ref. PMPB/MOH/162.
5 Currently tenofovir based regimens are reserved for children, pregnant and breastfeeding women and TB patients.
of salary top-ups needed to maintain the national health workforce or making this switch and drastically shortening the period of the grant. Having just come from the International AIDS Conference—where leading officials from around the world heralded the potential for an AIDS Free Generation—we are struck by the short-sightedness of the Global Fund. The country has accomplished impressive gains in the face of resource limitations. HIV treatment components of their Global Fund grants are exceeding their targets. And the demonstrated population level impact of the Global Fund supported HIV programs is well documented. In fact, Malawi could become an important success story in the use of community-based treatment as prevention efforts to reverse the epidemic and halt new infections—but not if they are forced to continue using sub-standard drugs or are not supported to address their dramatic health workforce shortage. For this reason, we are also calling for action from PEPFAR. While technical assistance, training and supply chain management are important, it is time for PEPFAR to support the Malawian government and civil society efforts more robustly through direct support of Malawi’s treatment programs—including direct procurement of antiretroviral treatment. We call for:
• The Global Fund Secretariat to immediately review the Malawi HIV portfolio to ensure that Global Fund
resources are investing in medicines that meet the international standard of care. The Global Fund is currently developing a new funding opportunity; providing additional funding to respond to country demand for optimized HIV treatment should be reflected in this new opportunity, as part of support for a demand driven funding model that rejects per-country allocations or envelopes. For example, in 2010 the Global Fund adopted a decision on acceleration of implementation of high performing grants, which already allows for additional funding to be invested during grant renewal processes (see GF/B21/4). This decision provides an important framework for additional funding to be invested in Malawi’s RCC. In this spirit we urge you, Mr. Jaramillo, to immediately intervene to ensure this switch happens. Further, this must not come at the expense of program-critical efforts to expand the health workforce and pay sufficient wages to retain them.
• PEPFAR to immediately expand direct support to treatment programs in Malawi. The biggest barrier to
both the switch away from stavudine and to the dramatic scale up of ARV access that would see huge clinical and prevention benefits is the recurring costs of the treatment program. Therefore we call on PEPFAR to commit to paying for medicines and paying health workforce salaries.
We urgently need the Global Fund, PEPFAR and the Government of Malawi to stop ignoring the science and to stop endorsing sub-standard, toxic therapy in Malawi. Hiding behind the excuse of increased upfront costs defies logic, considering the stronger value for money provided by tenofovir based regimens. Make the switch now. Signed, Gift Trapence [email protected] +265 599 157 3514 Centre for Development of People (CEDEP) Eddie Banda [email protected] +265 999 330 241 Malawi Network of People Living with HIV/AIDS (MANET+) Asia Russell [email protected] +1 267 475 2645 Health GAP (Global Access Project)
Beginning this month (July), we are highlighting the research activities of a number of leading researchers in the general field of taste aversion learning. The first in this series is that of Dr. Kathleen Chambers. In the mid seventies, Dr. Chambers and her colleagues introduced the phenomenon of sexual dimorphism in the extinction of conditioned taste aversions (with males showing significa
Best Practice & Research Clinical GastroenterologyIstituto Allergologico Lombardo, Piazza Monsignor Moneta 1, 20090 Cesano Boscone, Milan, ItalyS.C. Allergology and Clinical Immunology, Niguarda ‘Ca’ Granda’ Hospital, Piazza Ospedale Maggiore, 3, 20162 Milan, ItalyAdverse reactions to foods, aside from those considered toxic, are caused by a particularindividual intolerance toward