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Everyone is excited. The new Guidelines are here and they are ‘game changers’. There is not a single copy left in Kuala Lumpur- they were all taken on the first day when the Guidelines were announced. There is a lot of new material in these Guidelines- the CD4 count has been shifted to ≤ 500 and independent of CD4 count, treatment is recommended for sero-discordant couples, pregnant women and all positive children under 5 years of age. The guidelines are aspirational and provide individuals with a strong tool with which to approach their respective jurisdictions and insist from a policy level that changes be implemented. While I understand that these Guidelines have been developed for that purpose, I have some questions and concerns about how all of this will translate into practice and one concern is how it will directly affect positive women, particularly in resource poor settings.
The new Guidelines recommend that ALL pregnant women are initiated onto a specific ART regime and are maintained on this regime during the transmission risk window. The recommendations then go on to say that treatment should then be maintained over the lifetime of the individual with the question changing from ‘when to start’ to ‘whether to stop’. The paradigm was clearly one of a ‘National Program decision and not an individual decision’. I am concerned, not just because of the significant amount of data being presented here showing that adherence is a complex beast fed by a variety of factors we do not fully understand, I am concerned because I haven’t seen any work on post-birth adherence and strategies to improve this in different contexts which perhaps should have preceded this announcement. I am concerned because it does not discuss strategies for couples to negotiate the treatment differential where a pregnant partner is prioritized for treatment and maintained beyond the risk period when the non-pregnant partner misses out. I am also concerned by the gap in our knowledge around women and treatment more broadly. At a symposia session on women living with HIV last night it was discussed that women are significantly underrepresented in clinical trials and that when pooled, all RCTs received by the FDA between 2000-2008 only had 20% representation by women. We know that women are different. We have different metabolism, higher body fat percentages, different hormones and varying reproductive intentions just to flag a few. Clinicians need the freedom to allow treatment progression to take all of these factors into account at an individual level but for many clinicians, particularly those operating in resource poor settings where the capacity does not exist to look extensively beyond the guidelines into more detailed research or where policy decisions around types of treatment limit the options available, it is possible that these factors may not be taken into account.
The new Guidelines are exciting but there is still work which needs to be done to ensure that we all understand how to reach the aspirations within the Guidelines and that individuals are given appropriate and sustainable treatment options.