Transmitted and Acquired HIV Drug Resistance in Latin America. Dr. Luis Enrique Soto Ramírez MEXICO
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1 Transmitted and Acquired HIV Drug Resistance in Latin America Dr. Luis Enrique Soto Ramírez MEXICO
2 Disclosure Advisory boards and speaker for: Abbvie GSK/ViiV MSD Roche Diagnostics
3 OVERVIEW The development and transmission of drug-resistant HIV variants continues to limit the efficacy of treatments for HIV infection. Transmitted drug resistance may jeopardize the goals of early antiretroviral treatment among acute/recent HIV infected patients. Secondary resistance after one or more treatment failures compromise the success of ART due to cross-resistance, decreasing treatment options and life expectancy
4 Factors related to high ARV resistance in Latin America 1.- Limited-access to monitoring tests - Viral load not available in all settings - No resistance assays before treatment and sometimes not even after ART failure 2.- Low frequency or absent follow-up after treatment initiation or modification 3.- Limited number of ARV drugs 4.- Inadequate treatment combinations 5.- Poor adherence 6.- Many socioeconomic barriers 7.- Elevated prevalence of coinfections (mainly Tuberculosis)
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6 TRANSMITTED ARV DRUG RESISTANCE (TDR) IN LATIN AMERICA
7 Overview TDR in Latin America Many local (in-country) and regional surveys Not representative of the complete population Convenience sampling Very limited sample size (more than half < 47) Use of different survey populations Many in about to start treatment patients but not with recent infection 90% No data on time of infection Limited repeated surveillance Different interpretation algorithms IAS, Stanford DB and CPR, WHO, ANRS Limited effect on local or regional guidelines or policies
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10 TDR prevalence in Latin America and the Caribbean
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14 Brazil (50), Mesoamerica (17), Southern Cone (16), Andean (8) and Caribbean (7). Ninety-eight studies published between January 2000 and June 2015 PLOS ONE DOI: /journal.pone June 29, 2016
15 PLOS ONE DOI: /journal.pone June 29, 2016
16 PLOS ONE DOI: /journal.pone June 29, 2016
17 TDR in Different regions of Latin America, PLOS ONE DOI: /journal.pone June 29, 2016
18 PLOS ONE DOI: /journal.pone June 29, 2016
19 PLOS ONE DOI: /journal.pone June 29, 2016
20 PLOS ONE DOI: /journal.pone June 29, 2016
21 Change in prevalence of DRM in TDR in Brazil, vs PLOS ONE DOI: /journal.pone June 29, 2016
22 Subtype distribution in Brazil
23 This review and meta- analysis provides a moderate level, with a significant temporal increase in NNRTI TDR, consistent with the dominant use of EFV-containing first-line ART regimens in the region based on current WHO recommendations. PLOS ONE DOI: /journal.pone June 29, 2016
24 TDR in MEXICO First studies of TDR in MEXICO Study type INCMNSZ 1 INER 2 Recent Dx Some Some n Time frame States n/ Overall Prevalence 10.2% 6.8% NRTIs 6.8% 4.2% NNRTIs 3.1% 1.9% PIs 2.2% 1.8% 1.- Clin Infect Dis 2012:54(S4): PLoS One. 2011; 6(11): e27812
25 TDR in MEXICO 2015 Lancet HIV Dec;3(12):e579-e591. doi: /S (16) Epub 2016 Sep 14.
26 Lessons Learned from Survey Implementation Have Mexican National Guidelines changed due to these findings?: EFV continue as preferred 1st line regimen DR testing is not performed in all starters Use of HIVDR is not widespread for continuing routine surveillance Only If costs change, integrase inhibitors might become the preferred 1 st line option
27 Patients with acute/recent HIV infection who underwent resistance test before antiretroviral treatment initiation Comparison between patients with and without transmitted drug resistance Transmitted drug resistance was identified according to the Stanford HIV Database Instituto Nacional de Infectologia Evandro Chagas, Fundac Oswaldo Cruz, Rio de Janeiro, Brazil. 10 October 2016, Transmitted drug resistance in patients withacute/recent HIV infection in Brazil
28 POPULATION DISTRIBUTION Instituto Nacional de Infectologia Evandro Chagas, Fundac Oswaldo Cruz, Rio de Janeiro, Brazil. 10 October 2016, Transmitted drug resistance in patients withacute/recent HIV infection in Brazil
29 Instituto Nacional de Infectologia Evandro Chagas, Fundac Oswaldo Cruz, Rio de Janeiro, Brazil. 10 October 2016, Transmitted drug resistance in patients withacute/recent HIV infection in Brazil
30 SECONDARY ARV DRUG RESISTANCE (SDR) IN Latin America
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32 Overview SDR in Latin America Mostly local (in-center) surveys Not representative of the complete population Convenience sampling Use of different survey populations 1 st failure (most), 2 nd failure or more No data on time on failure Not comparable data Different interpretation algorithms IAS, Stanford DB, ANRS Limited effect on local or regional guidelines or policies
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36 Undetectable Viral Load According to Age
37 Resistance to different antiretroviral classes and number of class resistances
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47 Use of resistance testing in 3 classresistance salvage in Mexico
48 Multidrug failure with resistance to 3 classes. Use at least two, preferentially three completely active ARV drugs.
49 Virological and Immunological response at w 24 and 48 according to basal viral load Baseline viral load Virological suppression 3 FAA <3 FAA p RR (IC95%) Viral load < copies per ml (n=228) Viral load copies per ml (n=85) Baseline viral load Viral load < copies per ml (n=228) Viral load copies per ml (n=85) At week 24 (n=181) 65/79 (82.3%) 86/102 (84.3%) 0.87 At week 48 (n=165) 64/70 (91.4%) 85/95 (89.5%) 0.88 At week 24 meses (n=65) 20/28 (71.4%) 27/37 (73.0%) 1 At week 48 (n=57) 20/25 (80.0%) 27/32 (84.4%) 0.94 CD4 cell count change from baseline count 3 FAA <3 FAA p At week 24 (n=175) 63.8 (±212.6) 77.8 (±220.7) 0.67 At week 48(n=151) (±209.5) (±207.4) 0.87 At week 24 (n=65) (±223.1) (±235.4) 0.66 At week 48 (n=53) (±227.7) (±248.9) ( ) 1.1 ( ) 0.97 ( ) 0.87 ( ) Difference between means (IC95%) ( ) 9.9 ( ) 25.4 ( ) 3.1 ( ) International Workshop onantiviral Drug Resistance, Berlin Abstract 62
50 International Workshop onantiviral Drug Resistance, Berlin Abstract 62
51 Cummulative probability of virologic failure Cumulative incidence of virologic failure according to GSS n=568 Relative risk p value Time since salvage ART start GSS and n patients 12 months 24 months 36 months 48 months CORESAR OFID 2014
52 Secondary resistance to Integrase Inhibitors in Mexico
53 VIKING-3: STUDY DESIGN (N=183)
54 VIKING 3: VIROLOGIC RESPONSE AT WEEK 24 ACCORDING TO INSTI-DRM Day 8 response 1 Response week 24 1 INSTI DRM N HIV-1 ARN mean decrease (log10 c/ml) Complete response a N(%) N < 50 c/ml, N (%) No Q (92%) (79%) Q148+1 b (71%) 20 9 (45%) Q b (45%) 9 1 (11%) a Respuesta completa: disminución del ARN VIH-1 1 log10 c/ml o 50 c/ml al día 8. b L74I, E138A/K/T y G140A/C/S Adaptado de Vavro C, et al. IDRW Abstract 29
55 Cross-resistance to integrase strand transfer inhibitors (INSTIs) in 23 multiexperienced Mexican patients failing to raltegravir Orta-Reséndiz A 1, Rodríguez-Díaz RA 1, Hernández-Flores M 1, Angulo-Medina Luis 2, Calva-Mercado JJ 1, Ramirez JP 1, Soto-Ramírez LE 1. 1 Laboratorio de Virología Molecular, Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City, Mexico, 2 Complejo Hemato Oncológico y Radiocirugía/Instituto Venezolano de los Seguros Sociales IVSS, Caracas, Venezuela. Abst#_O_05 July 16, Durban, South Africa
56 Methods Retrospective data and plasma samples from 23 multiexperienced patients failing to RAL from 2009 to Plasma viral load, COBAS AmpliPrep/COBAS TaqMan HIV-1 Test, v2.0. Amplification and Sanger sequencing (PR-RT-IN): ViroSeq HIV-1 Integrase Genotyping Kit. Integrase home-made technique. v7.0 v9.1.0 Molecular Virology Laboratory Infectious Diseases Department
57 Study population n=25(%) Gender Male 80 HIV-1 Subtype B 100 HIV-1 RNA VL Log 10 c/ml (Mean, SD) 4.17 (1.11) CD4+ T-Cell count Cells/mm 3 (Mean, SD) (217.07) Time on RAL prior failure Months (Mean, SD) (20.38) Optimized backbone regimen NRTIs NRTI(s) + PI NNRTIs + PI NRTIs + NNRTI 5.88 Other* Time on ART Years (Mean, SD) (5.7) Total prior ART regimens Combinations (Mean, SD) 5.31 (3.13)
58 ARV drugs used with RAL OBR (n=15) n (%) NRTIs 5 (33.3) NRTIs+PIs 4 (26.7) NNRTIs+PIs 2 (13.3) NRTIs+NNRTIs 1 (6.7) Other 3 (20) In all cases RAL containing regimens were third or more advanced line of treatment. TDF was the most common companion to RAL.
59 INSTIs DRMs in RAL failing patients (N=13) 35,0 30,0 30,4 Major Primary Mutations Major Accessory Mutations Frequency (%) 25,0 20,0 15,0 21,7 13,0 17,4 17,4 13,0 10,0 8,7 8,7 8,7 5,0 4,3 4,3 0,0 Primary RAMSs distribution n = 13
60 DRM decreasing response to Dolutegravir A Comparison with VIKING-3 RAMs combinations after RAL use Prevalence (%) VIKING-3 [20] This study No INSTIs mutations No Q148* Q148+1 secondary mutation 20 8 Q secondary mutations 11 4
61 Conclusions Despite a decrease in developed countries, TDR is still increasing in Latin America, specially to NNRTIs Many of our countries have no access to genotype. This would increase secondary resistance The prevalence detected should favored the use of other ARV options No action has been taken with these results Secondary resistance is widespread in Latin America due to poor adherence and repeated failure. Information should be analyzed in specific situations Salvage treatment with at least 2 active drugs seems to be enough to rescue 3 class resistance failures Resistance to RAL is still limited and guarantee sequencing with DTG
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