The Eras of the HIV Epidemic
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1 The Eras of the HIV Epidemic rd Gen. HAART
2 3 rd Generation Future HAART: THE FUTURE OF ANTIRETROVIRAL THERAPY New drugs INSTI: Elvitegravir, Dolutegravir NNRTI: Lersivirine NRTI: GS 7340 (TDF prodrug) New combina1ons INSTI NRTI: TDF FTC EVG Cobi PI/cobi: DRV Cobicistat booster PI/c NRTI: DRV Cobi TDF pro FTC New strategies New classes Future needs
3 3 rd Generation Future HAART: New Drugs: INSTI Elvitegravir: once daily therapy EVR Non Inferior to RAL at Week 48 *TLOVR: Difference: 1.1% (95% CI: 6.0 to 8.2; P =.001). Noninferiority: lower limit of 95% CI for difference between arms 10%. Molina JM, et al. IAS Abstract WELBB05.
4 VIKING: Dolutegravir Func_onal Monotherapy in Pts With RAL Resistance Primary Endpoint* (%) 3 rd Generation Future HAART: New Drugs: INSTI Dolutegravir: active against resistance All Patients Q Other Mutation at Baseline Other Mutations *HIV-1 RNA < 400 copies/ml or 0.7 log 10 copies/ml reduction from baseline at Day Dolutegravir 50 mg QD (n = 27) Dolutegravir 50 mg BID (n = 24) Eron J. CROI 2011, Abstract 151LB.
5 3 rd Generation Future HAART: New Drugs: NNRTI Lersivirine: once daily without psych or CNS Lersivirine vs Efavirenz with TDF/FTC in ART Naive Pts HIV-1 RNA < 50 copies/ml Through Wk 48 (%) /63 (86%) 51/65 (79%) 51/65 (79%) LRV 500 mg LRV 750 mg EFV 600 mg HIV-1RNA < 50 copies/ml Through Wk 48 (%) n = VL < 100,000 VL 100,000 LRV 500 mg LRV 750 mg EFV 600 mg 82 Vernazza P, et al. IAS Abstract TUAB0101.
6 3 rd Generation Future HAART: New Drugs: GS-7340 TDF Prodrug 14 day monotherapy in HIV+ pa1ents: Lower TDF plasma concentra1ons Higher intracellular concentra1ons Greater VL reduc1on Change in VL From Baseline (log 10 c/ml) Day TDF 300 mg QD (n = 10) GS mg QD (n = 10) GS mg QD (n = 10) Markowitz M, et al. CROI Abstract 152LB. Graphic used with permission.
7 3 rd Generation Future HAART: New Combinations: 3 rd STR: The Quad : TDF-FTC-EVR-Cobi TDF-FTC-EVR/Cobi -vs- TDF-FTC-EFV Week 48 results in Tx-Naïve Patients Cohen AIDS 2011; 25:F7 12
8 3 rd Generation Future HAART: THE FUTURE OF ANTIRETROVIRAL THERAPY New drugs New combina_ons New strategies NRTI sparing regimens 2 drug potent regimens: INSTI PI/r New classes Mono clonal an_body Zinc fingers Future needs HIV Vaccine Func_onal cure
9 3 rd Generation Future HAART: New strategies: NRTI-Sparing 2-Drug CCR5-PI/r regimen MVC vs TDF/FTC With ATV/RTV in ART Naive Pa_ents Patients (%) HIV-1 RNA < 400 copies/ml HIV-1 RNA < 50 copies/ml Wk Portsmouth S, et al. IAS Abstract TUAB MVC + ATV/RTV (n = 59) TDF/FTC + ATV/RTV (n = 61)
10 3 rd Generation Future HAART: New strategies: NRTI-Sparing 2-Drug INSTI-PI/r regimen ACTG A5262: DRV/r + RAL in Tx Naïve: Faster failure at higher VL Taiwo B. CROI IAS Abstract 551
11 3 rd Generation Future HAART: New Classes: BMS : Oral Attachment Inhibitor Median Maximum Change in HIV-1 RNA From Baseline With Monotherapy in HIV-infected Patients Median Change in HIV-1 RNA From Baseline (log 10 copies/ml) mg q12h mg RTV q12h (n = 9) 1200 mg QHS mg RTV QHS (n = 9) mg q12h mg RTV q12h (n = 10) mg q12h mg RTV QAM (n = 10) mg q12h (n = 10) Overall (N = 48) Envelope polymorphisms may reduce baseline suscep_bility Nettles R, et al. CROI Abstract 49.
12 3 rd Generation Future HAART: New Classes: Ibalizumab: IV Entry Inhibitor Ibalizumab + OBR in Treatment Experienced Pa_ents Monoclonal an_body to non HIV binding epitope of CD4 Blocks HIV 1 entry into cell IV infusion Ibalizumab gp41 gp120 V3 loop CD4 HIV-1 RNA <50 (%) mg q2w 2000 mg q4w < 400 c/ml < 50 c/ml Khanlou H, et al. ICAAC Abstract H2-794b Wk
13 3 rd Generation Future HAART: New Classes: Zinc Finger Nuclease (ZFN) Disruption of CCR5 Gene in Autologous CD4+ Cells ZFP 32 mutation DNA Fokl ZFP Fokl Mechanism: T: ZFN cleavage results in doublestranded DNA break with nonhomologous end repair leading to permanent CCR5 gene modifica_on Treated CD4+ cells an_cipated to be resistant to HIV infec_on CCR5 ZFN modification Site 165 Early HIV infected pa1ent studies : Engralment with rapid clonal expansion and persistence of ZFN modified cells in circula_on and rectal mucosa Median ~100 cells/mm3 increase in CD4+ count aler 1 year Most AEs mild; no SAEs by median 337 d Mitsuyasu R. ICAAC Abstract H1-375; Lalezari J. CROI Abstract 46.
14 3 rd Generation Future HAART: New Classes: Investigational Targets LEDGF/p75 Inhibitors Cellular tethering factor for integra_on In vitro iden_fica_on of inhibitory pep_des Gag Inhibitors Viral factor for par_cle assembly at cell membrane In vitro iden_fica_on of inhibitory molecules CXCR4 Zinc Finger Nucleases Cell culture mouse model proof of concept tested Capsid Assembly Inhibitors Forma_on of viral core In vitro iden_fica_on of inhibitory molecules Desimmie CROI 2011 #526; Urano CROI 2011 #525; Wilen CROI 2011 #47; Titolo CROI 2010 #50.
15 3 rd Generation Future HAART: Future Needs: Potential for HIV Vaccine Concept proven: Thai RV144 study: 31% protec_on Human studies on going to determine correlates of immunity from elite controllers: Broadly reac_ng neutralizing an_bodies Specific neutralizing envelope epitopes Precise B cell clonal expansion Animal studies on going to elucidate immune response Comments, A. Fauci, NIH, 2011
16 3 rd Generation Future HAART: Future Needs: Functional Cure -vs- Microbial Eradication Early Treatment: Smaller latent reservoir Subsequent therapeu_c vaccina_on boos_ng of immune control Novel Therapies: Therapies to eliminate latent reservoir Gene therapy to inac_vate or excise incorporated virus Comments, A. Fauci, NIH, 2011
17 Challenges Facing the Global AIDS Pandemic: Expanded Prevention Efforts Uganda mobile male circumcision clinic
18 Challenges Facing the Global AIDS Pandemic: Multi-Pronged Prevention Approach Efficacy of HIV Preven1on Strategies From Randomized Clinical Trials Study Effect Size, % (95% CI) ART for prevention; HPTN 052, Africa, Asia, Americas PrEP for discordant couples; Partners PrEP, Uganda, Kenya PrEP for heterosexual men and women; TDF2, Botswana Medical male circumcision; Orange Farm, Rakai, Kisumu PrEP for MSMs; iprex, Americas, Thailand, South Africa Sexually transmitted diseases treatment; Mwanza, Tanzania Microbicide; CAPRISA 004, South Africa HIV vaccine; RV144, Thailand 96 (73-99) 73 (49-85) 63 (21-84) 54 (38-66) 44 (15-63) 42 (21-58) 39 (6-60) 31 (1-51) Efficacy (%) Abdool Karim SS, et al. Lancet. 2011;[Epub ahead of print]. 100
19 Challenges Facing the Global AIDS Pandemic: Gender Inequality
20 Challenges Facing the Global AIDS Pandemic: Maternal Child Health
21 Challenges Facing the Global AIDS Pandemic: Comprehensive Reduction Of Women s Vulnerability hpp://
22 Challenges Facing the Global AIDS Pandemic: Stigma and Discrimination hpp://
23 Challenges Facing the Global AIDS Pandemic: Country Policies That Impede Access To HIV Services hpp:// unaidspublica_on/2011/ _jc2069_30outlook_en.pdf
24 Challenges Facing the Global AIDS Pandemic: Health Infrastructure
25 Challenges Facing the Global AIDS Pandemic: External Factors: Compe_ng health problems Global financial downturn Donor fa_gue and shiling priori_es De Cock; Jaffe; Curran. Emerging Infec_ous Diseases. 2011;17(6) (CDC)
26 Challenges Facing the Global AIDS Pandemic: Patient Engagement in HIV Care Not in HIV Care Engaged in HIV Care Unaware of HIV infec1on Aware of HIV infec1on not in care Receiving medical care not HIV care Entered HIV care but lost to follow up Intermi[ent user of HIV care Fully engaged in HIV care Source of infec1on spread Increased tes1ng Risk of infec1on spread Test and Treat Risk of disease progression Outreach to medical providers Risk of disease progression Outreach to pa1ents Risk of ARV resistance Outreach to pa1ents Poten1al eventual epidemic containment Adapted from Gardner Clin Inf Dis 2011;52:181
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28 The Eras of the HIV Epidemic
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