Microsoft word - cso malawi letter final.docx

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)

Source: http://healthgap.squarespace.com/s/CSO_Malawi.pdf