E-DRUG: WHO's new HIV treatment guidelines
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4 December 2009
The World Health Organization (WHO) has issued new recommendations for the
prevention and treatment of HIV-related illness 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 phase out the use of
the antiretroviral stavudine (d4T), substituting tenofovir (TDF) or
zidovudine (AZT) - based first-line regimens instead. The 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
A patent pool, being developed by UNITAID, would significantly help to
overcome the barriers of the high cost of antiretroviral drugs and also
stimulate the development of new fixed-dose combinations. The pool could
increase the availability of new drugs, including third-line drugs.
http://www.msfaccess.org/main/access-patents/make-it-happen-campaign/
MSF notes that financial challenges of implementing the revised
recommendations are made more acute given what appear to be early signs of
a retreat from international donors. There is a need for renewed commitment
to ensure that the latest WHO recommendations are implemented.
For more information on the funding retreat, read the report: HIV/AIDS:
Punishing Success ? Early Signs of a Retreat from Commitment to HIV/AIDS
Care and Treatment
http://www.msfaccess.org/resources/key-publications/key-publication-detail/?tx_ttnews[tt_news]=1591&cHash=61861d07dc
MSF operates HIV/AIDS programmes in 30 countries and provides
antiretroviral treatment to more than 140 000 HIV-positive adult and child
patients.
To read the new WHO guidelines, follow this link
http://www.who.int/hiv/pub/arv/advice/en/index.html
Kind regards,
Michelle Vilk
Coordination and Communications Assistant
Medecins Sans Frontieres
Campaign for Access to Essential Medicines
Rue de Lausanne 78
1211 Geneva, Switzerland
Tel: + 41(0) 22 849 89 02
Fax: + 41 (0) 22 849 84 04
michelle.vilk@geneva.msf.org