http://www.bhiva.org British HIV Association (BHIVA) Guidelines 1 July 2003 British HIV Association (BHIVA) guidelines for the treatment of HIV-infected adults with antiretroviral therapy July 2003 BHIVA Writing Committee on behalf of the BHIVA Executive Committee* Correspondence: Dr Anton Pozniak and Professor Brian Gazzard, Chelsea and Westminster Hospital, 369 Fulham Road, London SW10 9NH, UK; E-mail: anton.pozniak@chelwest.nhs.uk; http://www.bhiva.org *BHIVA Writing Committee members: A Pozniak, B Gazzard, J Anderson, A Babiker, D Churchill, S Collins, M Fisher, M Johnson, S Khoo, C Leen, C Loveday, G Moyle, M Nelson, B Peters, A Phillips, D Pillay, E Wilkins, I Williams, M Youle Contents 1.0 Synopsis 4 1.1 When to start treatment 4 1.2 Initial therapy 4 1.3 When to switch therapy for virological failure 5 1.3.1 Which drugs to use following failure of initial therapy 5 1.4 When to switch therapy in the absence of virological failure 5 1.5 Resistance testing 5 1.6 Therapeutic drug monitoring (TDM) 5 1.7 New drugs likely to be used in the near future 6 1.7.1 Atazanavir 6 1.7.2 Enfuvirtide (T20) 6 2.0 Introduction 6 2.1 Purpose of guidelines 6 2.2 Basing recommendations on evidence 7 2.3 Use of evidence published as abstracts 7 2.4 Implication for research 7 2.5 Use of surrogate marker data 7 2.6 Issues concerning design and analysis of clinical trials 8 2.6.1 Trial designs 8 2.6.2 Method of analysis 8 2.6.3 Intention to treat and on treatment analysis 9 2.6.4 Equivalence 9 2.6.5 Cross-study comparisons: presentation of data 9 2.7 Adverse event reporting 10 3.0 When to start treatment 10 3.1 Primary HIV infection 10 3.1.1 Treatment of primary HIV infection to alter the natural history 10 3.1.2 Use of structured treatment interruption in acute infection 11 3.1.3 Treatment during PHI for immediate clinical benefit 11 3.1.4 Treatment during PHI to reduce onward transmission 11 3.1.5 Recommendations for starting treatment in PHI [CIII] 11 3.2 Symptomatic HIV infection 11 3.3 Asymptomatic HIV infection 12 3.3.1.1 Individuals with CD4 counts <200 cells/mm 3 12 3.3.1.2 Individuals with CD4 counts >350 12 3.3.1.3 Individuals with CD4 counts 201-350 cells/mm 3 12 3.3.2 Recommendations regarding asymptomatic chronic HIV infection 12