http://www.msfaccess.org/main/hiv-aids/msf-responds-to-world-health-organizations-new-hiv-treatment-guidelines/
http://www.msfaccess.org/main/hiv-aids/msf-letter-to-global-fund-concerning-replenishment-in-light-of-who-guidelines/
MSF responds to World Health Organization’s new HIV treatment guidelines
The World Health Organization (WHO) has issued new recommendations for the prevention and treatment of HIV/AIDS in developing countries, in line with the medical evidence and best practices. Below we outline the latest recommendations and our responses to them.
Earlier initiation for treatment
The most significant change in the treatment protocols recommended by WHO is to start antiretroviral treatment (ART) at a higher threshold of immunity (at CD4 350cells/mm3) a point at which many patients would not yet have progressed to AIDS. MSF supports the recommendation as it holds benefits for patients and their communities, such as lowering the incidence of tuberculosis and other opportunistic infections.
While MSF believes this recommendation for earlier treatment initiation is an excellent and long awaited step, it will entail significant challenges in implementation, given the increased number of people made eligible for treatment – many more than the estimated nine million people currently in need. Countries will need to get clear signals and substantial support from donors that continued treatment scale-up will be supported.
Improved first-line regimens recommended
The new guidelines recommend that treatment programmes . To phase out the use of the antiretroviral stavudine (d4T), substituting tenofovir (TDF) or zidovudine (AZT) – based first-line regimens insteadhe change in preferred first-line regimens, combined with the new treatment initiation threshold makes availability of affordable fixed-dose combination drugs even more important. Generic tenofovir-based fixed-dose combinations on the market today are not available in many countries, particularly middle-income countries, because of patent barriers. In addition to the use of public health safeguards in laws (TRIPS agreement) to limit or overcome patent barriers, a patent pool – such as the one currently under discussion by UNITAID – can help to overcome these barriers.
Increased role for laboratory monitoring
The new recommendations outline an expanded role for laboratory monitoring, including both CD4 testing and viral load monitoring to improve the quality of HIV treatment and care. Increased access to viral load monitoring would allow the rapid identification of patients who are failing their current treatment and need to be switched to new combinations and also will reduce unnecessary switching of antiretroviral combinations. MSF supports efforts to realise this new objective.
ART recommended for all pregnant women with HIV
For the first time, the WHO recommendations include the provision of antiretroviral therapy for all pregnant women with HIV, regardless of their CD4 count. MSF acknowledges that the improved ART protocols, option A (antepartum AZT, single-dose nevirapine at onset of labour, AZT+3TC during labour and delivery, AZT+3TC for seven days postpartum), and option B (triple therapy ARV drugs provided to pregnant women starting from as early as 14 weeks of gestation until one week after the end of breastfeeding) will improve the protection of mothers and their children from HIV infection.
Need for more evidence and clarity around use of efavirenz in first trimester of pregnancy
The guidelines note that efavirenz appears as safe as other drugs already recommended for use in pregnancy. But they do not actually recommend the drug during the first trimester of pregnancy. For MSF operationally it is a high priority to have clearer evidence on whether the drug could be recommended during this period of pregnancy. If the drug is proven safe in the first trimester, this would open the way to broad use of the fixed-dose combination TDF/3TC/EFV in pregnant women and women of child-bearing age.
Second-line recommendations simplified
The new recommendations for second-line treatment as set out in the guidelines are clearer and simpler to understand and implement. The guidelines list atazanavir/ritonavir or lopinavir/ritonavir as the preferred protease inhibitor options. Unfortunately, no heat-stable fixed-dose combination of atazanavir/ritonavir is currently available from generic producers because it is under patent in key generic producing countries and the two originator companies of the product have no plans to produce this combination. The creation of a patent pool would be a critical step in removing patent barriers that stand in the way of generic development and production of such essential drug combinations.
Acknowledgement of need to make third-line treatment available
The need for third-line treatment is recognised for patients whose first- and second-line therapy have failed. However, there is still a need to define recommended third-line regimens. WHO indicates these regimens could include drugs such as darunavir/ritonavir, etravirine and raltegravir. Cost and registration will be critical barriers to ensuring accessibility.
Conclusion
The new revised WHO guidelines propose significant improvements in treatment, prevention of transmission and monitoring tools for HIV patients. In order to help turn these recommendations into reality on the ground, it is important that the antiretroviral drugs which appear in the new recommendations should be included in the WHO Essential Medicines List. WHO’s prequalification programme should also take an active role in fast tracking the review of fixed-dose combination drugs that are recommended in the new guidelines
MSF letter to Global Fund concerning replenishment in light of WHO guidelines
Médecins Sans Frontières sent a letter to the Global Fund to Fight AIDS, Tuberculosis and Malaria (GFATM) to express concern over the financial resource scenarios for 2011-2013 it released at the first meeting for the Third Voluntary Replenishment on 24-25 March 2010 in The Hague.
MSF raised concerns that the resource scenarios presented to donors were not based on December 2009 WHO clinical recommendations for management and prevention of HIV.
Executive Director
Global Fund to Fight AIDS, Tuberculosis and Malaria
Chemin de Blandonnet 8
1214 Vernier
Geneva, Switzerland
Geneva, 23 March 2010
Dear Professor Kazatchkine,
I am writing to you on behalf of Médecins Sans Frontières to express concern over the financial resource scenarios for 2011-2013 the Global Fund to Fight AIDS, Tuberculosis and Malaria (GFATM) is releasing at the upcoming first meeting for the Third Voluntary Replenishment on 24-25 March 2010 in The Hague.
We are deeply concerned that the resource scenarios presented to donors are not based on the new WHO clinical recommendations for management and prevention of HIV, released in December 2009, that reflect a substantial evidence base on the benefits of implementation of these guidelines. In short, the Global Fund is taking a position that disregards the latest clinical evidence and sends a contradictory message to developing countries, several of which have already taken steps to make their AIDS programmes consistent with the new WHO guidelines.
MSF provides HIV/AIDS treatment to over 140,000 people in more than 30 countries and can attest to the importance of these changes. The benefits of the new recommendations include: earlier initiation of ARV therapy to improve survival, reduce the risk of tuberculosis and other opportunistic infections, and reduce community-level viraemia; the use of more robust antiretroviral drugs (ARVs) that cause fewer side-effects and can delay a switch to more costly second-line therapy; increased viral monitoring to reinforce adherence and avoid treatment failure; the provision of second-line and salvage ARV regimens. WHO also recommends improvements in PMTCT protocols to further reduce the risk of vertical transmission that also needs to be taken into serious consideration.
These are evidence-based measures to increase quality of patient care and public health goals. There is also evidence that these policy changes will ultimately result in cost savings by avoiding the need for more complex and resource-intense care at a later stage. It is therefore a matter of concern that the Global Fund’s message on financing needs fails to include these measures as a basis for estimating needs.
Financial forecasting should not be based on suboptimal treatment regimens and outdated treatment and prevention protocols, particularly as these practices are being phased out in a growing number of countries. As countries will request funding through reprogramming of existing grants as well as through new proposals, the Global Fund should anticipate these higher expenditures as part of the 2011-2013 Replenishment period. Without such support, countries may be forced to delay implementation of the new guidelines leading to the wilful continuation of less-than-optimal treatment and less effective prevention for implementing countries.
Similarly, GFATM financial resource scenarios do not take into account the latest evidence base for the management of malaria and tuberculosis. WHO’s revised guidelines recommend confirmatory diagnostic testing of malaria for those on artemisinin-based combination therapy (ACT). For tuberculosis, WHO estimates that the response to M/XDR-TB will require a 16-fold funding increase between 2010 and 2015. GFATM financing scenarios are unclear about how these new recommendations will be supported financially.
The WHO has taken considerable effort to ensure that its recommendations take into account the latest evidence of what works best for patients in resource-limited settings. The Global Fund should support this effort fully by providing clear financing forecasts for these new recommendations. In light of the critical importance and feasibility of improved interventions in these three diseases, new scenarios must be generated.
We hope you will take our concerns into consideration during the Global Fund Replenishment meeting this week, and we are eager to speak with you in the near future and in greater depth about our concerns and perspectives.
Yours sincerely,
Tido von Schoen-Angerer, MD
Executive Director
Campaign for Access to Essential Medicines
Médecins Sans Frontières International
