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Ramon Teira and the VACH Study Group

Effect of viral suppression below 20 copies of HIV-RNA / mL of plasma on virological outcome of treated HIV- infected patients . Ramon Teira and the VACH Study Group. Disclosures.

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Ramon Teira and the VACH Study Group

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  1. Effect of viral suppression below 20 copies of HIV-RNA /mL of plasma on virological outcome of treated HIV- infected patients RamonTeira and the VACH StudyGroup

  2. Disclosures • RamonTeira has receivedtravelgrants and honoraria as a speaker in privatesymposiaoradvisoryboardsfrom • Abbie, BristolMyers-Squibb, Gilead, Janssen-Cilag and ViiVHealthcare • None of these has hadanyinfluence in the concept, design, analysisorresults of thisstudy

  3. VACH SG PI´sforthisstudy • RamonTeira • Hospital de Sierrallana • Pepa Muñoz • Hospital de Basurto • Ignacio Suarez-Lozano • Hospital de Huelva • Marta Montero • Hospital de La Fe, de Valencia • Elisa Martínez • Hospital de Albacete • Belen de la Fuente • Hospital de Cabueñes, Gijón • Paloma Geijo • Hospital V. de la Luz, Cuenca • Agustín Muñoz • Hospital I. Cristina, Badajoz • Trinitario Sánchez • Hospital V. del Rosell, Cartagena • Manuel Castaño • Hospital Carlos Haya, Málaga • Teresa Puig • Hospital Arnau de Vilanova, Lleida • Elisabeth Deig • Hospital General de Granollers • Pere Domingo • Hospital Santa Creu, Barcelona • Esteban Ribera • Hospital Valld´Hebron, Barcelona • EnricPedrol • Hospital Santa Tecla, Tarragona • Pepa Galindo • Hospital Clínico de Valencia • Alberto Terrón • Hospital del SAS, Jerez de la Frontera • Javier Borrallo • Hospital Clinico de Puerto Real • Pompeyo Viciana • Hospital V. del Rocío Sevilla • Fernando Lozano • Hospital de Valme, Sevilla • Bernardino Roca • Hospital General de Castellón • Vicente Estrada • Hospital Clínico de San Carlos, Madrid • Francesc Vidal • Hospital Joan XXXIII, Tarragona • Myriam Garrido • VACH Data Management

  4. Background • Unquestionablevalidity of plasma concentrations of HIV-RNA (viral load, VL) in • Prognosis of untreated HIV infection • Efficacy of ART • Validationstudiesperformedwithassaysdetectingfrom 200-400 copies/mL • Mainbody of evidencegeneratedwithassaysdetectingfrom 50 copies/mL • New assaysreleasedaround 2009, detectfrom 20 copies/mLupwards • Uncertainty in prognosis and Rxrecommendations

  5. Objectives • Hypothesis: thedetection of 20-50 copies/mL of HIV-RNA in the plasma of treated HIV-infectedpatientsisnotassociatedwithanincreasedrisk of viral failure (VF) as comparedmantaining plasma HIV-RNA belowthe 20 copies/mLdetectionlevel

  6. The VACH StudyGroup • An open cohort of HIV-infectedadults in Spain • Recruitspatients • Olderthan 18 • Informedconsent • Firstvisitto a VACH clinic • ComplieswithSpanishlaws of data protection and biomedicalinvestigation

  7. Yes excluded failure >200 no ChangeRx. Cens. 50-200 Yes no yes All Yes 20-49 Cens. Other VL no StartRx. no 20-49 Yes Cens. yes no no no yes Cambio tto. 2 VLs<50 no yes no indetermined success yes no censoring >200 Other VL Yes Yes no 50-200 censoring ChangeRx. no yes Yes 20-49 censoring no Yes <20 censoring no

  8. Inclusioncriteria • Startingcombination(triple) antiretroviraltreatment (ART) • Achievingeffective viral suppressionbelow 50 ( 2 consecutive) • Achieving full viral suppressionbelow 20 (oneadditional VL determination)

  9. Definitions • Outcomes • Success: no failure and VL at censoring <50 • Failure: one VL >200 followedby: a secondone, orcensoringorchange of treatmentorlossto FU • Indeterminate: Neithersuccessorfailure • Predictive • Persistentlysuppresed: all VL <20 • VIoIV: any posterior VL between 20-50 butnot>50 • LoLV: any posterior VL between 50-200 butnot>200 • Transient HLV: any posterior >200 notdefiningfailure

  10. Analysis • Kaplan-Meier curves of time tofailureaccordingtothemainpredictive variable • Id. plus bivariate Cox regressiontoidentifyother variables associatedwithoutcome • Multivariate Cox regressiontoadjustforpossibleimbalances in predictive variables, ifappropiate

  11. Results 21480 patientsstarted ART 13671 patientsreachedeffectivesuppression <50 6834 patientsreached full suppresion <20 4289 reached full suppresionafter june 2009

  12. Results. Patientscharacteristics

  13. Results: Outcomes • 4289 patientseversuppressedbelow 20 • 199 failure, 138 indeterminate, 3952 success

  14. Results: Outcomes • 4289 patientseversuppressedbelow 20 • 199 failure, 138 indeterminate, 3952 success • 2623 alwaysfullysuppressed • 98 failure, 36 indeterminate, 2489 success • 824 anybutonlyVIoIV (20-50) • 30 failure, 1 indeterminate, 793 success • 563 anyLoLV (50-200) butnever >200 • 44 failure, 68 indeterminate, 451 success • 278 any HLV (>200) notfailure • 27 failure, 33 indeterminate, 218 success

  15. Kaplan-Meier curves of time free of failureaccordingtopermanent full suppressionorVIoIV Failurerates: 2.34 % fullysuppressedpatient-years 1.56 % VIoIViremicpatient-years RR: 1.492, 95% CI 1-2.78 Log-rank test p:0.0345

  16. Variables in the final Cox model of time tofailure • VIoIV, RH: 0.588, 95% CI: 0.399-0.899 • Nadir CD4 cellcount (per unit), RH: 0.998, 95% CI: 0.997-0.999 • Time undereffective ART combination (per year), RH: 0.916, 95% CI: 0.853-0.983 • Riskgroup (MSM relativeto IVDU), RH: 0,577, 95% CI: 0,337-0.989

  17. Kaplan-Meier curves of time free of failureaccordingtopermanent full suppressionorLoLVor HLV p:0.0949 p:0.0157

  18. Kaplan-Meier curves of time free of failure (modified) accordingtopermanent full suppressionorVIoIV p: 0.3447

  19. Conclusions • In the population of HIV-infected patients on ART who achieve full viral suppression below 20 cop/mL, those who experience subsequent episodes of VLoLV (between 20 and 50 cop/mL), the risk of VF (as defined in our protocol) is not higher than that of patients who remain fully suppressed. • In this conditions, nadir CD4 cell count (inversely), some categories of HIV-transmission risk-groups, and time effectively suppressed (below 50) prior to full suppression (inversely) were associated with VF. • The selection criteria, and variable definitions used in this study, and probably in most if not all epidemiological and even experimental, probably have as deep an impact in the results as the biological factors themselves.

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