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WHO Guidelines and future perspectives for treatment monitoring. Nathan Ford Dept of HIV/AIDS World Health Organization. WHO ART guidelines evolution. Vitoria M, et al, Current Opinions HIV/AIDS, 2013. WHO ART guidelines evolution. Earlier initiation. Simpler treatment.
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WHO Guidelines and future perspectives for treatment monitoring Nathan FordDept of HIV/AIDSWorld Health Organization
WHO ART guidelines evolution Vitoria M, et al, Current Opinions HIV/AIDS, 2013
WHO ART guidelines evolution Earlier initiation Simpler treatment Less toxic, more robust regimens Better monitoring Vitoria M, et al, Current Opinions HIV/AIDS, 2013
Recommendations on ART Monitoring • Viral load is recommended as the preferred monitoring approach to diagnose and confirm ARV treatment failure • (strong recommendation, low-quality evidence) • If viral load is not routinely available, CD4 count and clinical monitoring should be used to diagnose treatment failure • (strong recommendation, moderate-quality evidence) • Definition of virological failure: plasma viral load above 1000 copies/ml based on two consecutive viral load measurements after 3 months, with adherence support (6 months post ART) • Higher threshold for DBS and point-of-care technologies
Mortality • Mortality (3 RCTs): adding viral load monitoring to immunological and/or clinical monitoring has not been associated with reduced mortality • Longer follow-up required to assess longer-term impact on survival, resistance profile and HIV transmission.
Immunological and clinical criteria Rutherford et al, IAS 2014
Immunological and clinical criteria Immunological and clinical monitoring have poor sensitivity and lower positive predictive value for identifying virologic failure Rutherford et al, IAS 2014
Transmission Loutfyet al, PLoS ONE, 2013 Loutfyet al, PLoS ONE, 2013
Viral load to reinforce adherence and confirm treatment failure Proportion resuppressingafter adherence intervention Bonner et al, JAIDS 2013
Implementation considerations • ART access should be the first priority: Lack of laboratory tests for monitoring treatment response should not be a barrier to initiating ART • Prioritization: If viral load availability is limited, it should be phased in using a targeted approach to confirm treatment failure. • This may be particularly relevant in populations receiving ARVs to reduce HIV transmission, such as pregnant and breastfeeding women and in sero-discordant couples.
Implementation considerations • Feasibility of phasing in VL capacity (DBS) • PoC viral load on horizon • Enables monitoring of treatment for prevention • Equity • Cost-effectiveness influenced by monitoring approach (frequency, additive or as replacement to CD4)
Future of CD4 for monitoring? If VL <200 copies/mL and CD4 >300 cells/uL, 97% probability of CD4 > 200 cells/uL for 4 years Hill A, IAS 2013; Gale et al CID 2013
Acknowledgements • Marco Vitoria • Meg Doherty • Andrew Hill • Kimberley Bonner • Teri Roberts