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.
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