ARV treatment Update Avondseminarie 18 december 2012 Eric Florence ITG, Antwerpen
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- Vivian Ellis
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From this document you will learn the answers to the following questions:
What day of the week was the START study?
What is the name of the third agent?
How many c / ml did the study show?
Transcription
1 ARV treatment Update 2012 Avondseminarie 18 december 2012 Eric Florence ITG, Antwerpen
2 Three big conferences in
3 Current situation: some positive things Mortality (/100 pts y) PI Use (/100 pts y) Palella FJ et al. N Engl J Med 1998;338: ITM data
4 Life expectancy Ref: Hogg R., CROI 2012, Abstract #137
5 Virological control Last viral load below detection limit (%) 89,7 64, ITM data
6 ITM data And some negative!
7 When to start ARV treatment? Still not reimbursed Guideline year AIDS CD4<350 CD CD4 >500 in Belgium DHHS 2012 Yes Yes Yes Yes IAS USA 2012 Yes Yes Yes Yes EACS 2012 Yes Yes some pts some pts WHO 2010 Yes Yes No No US guidelines (DHHS): Int. AIDS Society guidelines: European guidelines (EACS): WHO guidelines:
8 When to start ARV treatment? What are the choices? Wait for the results of the START study? vs. Already implement an early start? (surely a good option to decrease transmission risk Expanded Whether analysis this is of good HPTN052 for the trial* patient remains maybe controversial) Jury still not out! See webcast pro/contra session from Glasgow congress (Monday 12 november) *B Grinsztejn XIX International AIDS Conference, Washington. THLBB05
9 NRTI: nucleoside reverse transcriptase inhibitor, NNRTI: non- nucleoside reverse transcriptase inhibitor; PI/r: Protease inhibitor boosted with ritonavir; II: Integrase Inhibitor What to start with? Efavirenz Rilpivirine Tenofovir/emtricitabine Nevirapine Abacavir/lamivudine Atazanavir/ritonavir Darunavir/ritonavir Lopinavir/ritonavir + Not yet NNRTI 2 NRTI s possible in PI/r Belgium (II) Backbone 3 rd Agent
10 What to start with? Al lot of comparative trials, mostly non-inferior results. ACTG 5202 (JID 2011) Backbone: ABC/3TC vs. TDF/FTC Third agent: ATV/r vs. EFV Single Study (ICAAC 2012) DTG + ABC/3TC vs. EFV/TDF/FTC ACTG 5257 (ongoing) ATV/r vs DRV/r vs. Ral (backbone of TDF/FTC)
11 When to change? Guideline year Change treatment in case of: Change to: DHHS 2012 Persistent VL >200 copies/ml 2 (preferably 3) fully active drugs IAS USA 2012 Sustained VL> copies/ml 3 active drugs EACS 2012 Confirmed VL > copies/ml 2 (preferably 3) fully active drugs Detectable Viral load under treatment is infrequent But what is clinically significant?
12 When to change? Recent results against an early switch: Charpentier C: no risk of subsequent virological failure with viral loads c/ml. Wolf E: idem with VL c/ml. Eron: long-term outcome of experienced pts on raltegravir (VL <50 vs vs >400). Grennan JT, JID 2012 (VL<500). Influence of Viral load test (real time PCR)? Always assess adherence & drug interactions Ref: all from XIX International AIDS Conference, Washington. Charpentier C WEPDB0102; Eron J TUPE025
13 What s new in antiviral therapy? Three products approved in 2011 A few interesting drugs in the pipeline
14 Drug Approval in 2011 Rilpivirine (Edurant ) Viramune XR (Viramune ) Rilpivirine/Emtricitabine/Tenofovir (Eviplera )
15 Pipeline for antiviral drugs in 2012 Class Drug Sponsor Phase NRTI BMS BMS II NRTI CMX 157 Chimerix I NRTI GS 7340 Gilead II NNRTI Lersivirine Pfizer II NNRTI Rilpivirine LA Janssen I CCR5I/CCR2I Cenicriviroc Takeda II II Dolutegravir (DTG) ViiV III II Elvitegravir (EVG) Gilead Submitted II GSK GSK II II GSK LA GSK I AI BMS BMS II PK booster Cobicistat Gilead Submitted PK booster SPI 251 Sequoia Discontinued PK booster CTP 518 GSK On Hold FDC "QUAD" Gilead Submitted FDC EVG/cobi/FTC/GS7340 Gilead/Tibotec II FDC DRV/cobi/FTC/GS7340 Janssen/Gilead II FDC DTG/ABC/3TC ("Trii") ViiV III TAG 2012 Pipeline Report available at
16 Pipelines in infectious diseases From the race against drug resistance (
17 New treatment strategies Start earlier ( Test & Treat, START study ) Modify the third agent (PI- or NNRTI free) - 2 Nucl. analogues + Integrase inhibitor - 2 Nucl. analogues + CCR5 inhibitors Modify the backbone ( NRTI sparing ): - Protease inhibitor + Integrase inhibitors - Protease inhibitor + CCR5 inhibitors - Protease inhibitor + NNRTI - Simplification (PI/r monotherapy) New treatment combinations
18 New treatment strategies Start earlier ( Test & Treat, START study ) Modify the third agent (PI- or NNRTI free) - 2 Nucl. analogues + Integrase inhibitor - 2 Nucl. analogues + CCR5 inhibitors Modify the backbone ( NRTI sparing ): - Protease inhibitor + Integrase inhibitors - Protease inhibitor + CCR5 inhibitors - Protease inhibitor + NNRTI - Simplification (PI/r monotherapy) New treatment combinations
19 New treatment strategies Start earlier ( Test & Treat, START study ) Modify the third agent (PI- or NNRTI free) - 2 Nucl. analogues + Integrase inhibitor - 2 Nucl. analogues + CCR5 inhibitors Modify the backbone ( NRTI sparing ): Protease inhibitor + NNRTI Protease inhibitor + Integrase inhibitors Protease inhibitor + CCR5 inhibitors Simplification (PI/r monotherapy) New treatment combinations
20 NRTI sparing therapy: a holy grail? 1. PI + NNRTI EFV + LPV/r study A5142 (Riddler SA, NEJM 2008) 2. PI + Integrase inhibitor Ral + LPV/r Progress trial (Reynes J, HIV Clin Trials 2011) Ral + ATV/r Spartan trial (Kozal MJ, HIV Clin Trials 2012) Ral + DRV/r Radar study (Bedimo R, 6th IAS, Rome 2011) Ral + DRV/r ACTG5262 trial (Taiwo B, AIDS 2011) Ral + DRV/r NEAT001 trial (ongoing ) 3. PI + CCR5 inhibitor MVC + ATV/r Study A (Mills A XIX AIDS conf TUAB0102) MVC + DRV/r Midas trial (Taiwo B XIX AIDS conf TUPE099) MVC + DRV/r Study A (ongoing)
21 PI Monotherapy Is it still a valuable option? See: Mathis S Plos One 2011 (meta-analysis) Guiguet M AIDS 2012 (long term observational study)
22 Generic antiviral drugs End patent in the coming years for some antiviral drugs. Zidovudine 2005 Lamivudine 2011 Combivir 2013 Nevirapine 2013 Efavirenz 2013 Abacavir 2014 Lopinavir/ritonavir 2015 Emtricitabine 2016 Will it affect the way we prescribe antiviral drugs in Belgium? Interesting presentation on how to deal with ARV in time of crisis Another on the use of generic ARV s in Europe
23 New (co-)formulations: STR* STR: Single Tablet Regimen Till 2011 Atripla Since 2012 Eviplera (Rilpivirine/tenofovir/emtricitabine) In the future Elvitegravir/cobicistat/tenofovir/emtricitabine= «QUAD» (Submitted) Dolutegravir/Lamivudine/Abacavir («Trii») (phase III) Darunavir/cobicistat/GS7340/emtricitabine (phase II) Elvitegravir/cobicistat/GS7340/emtricitabine (phase II) Is STR better than QD?
24 New (co-)formulations: STR* STR: Single Tablet Regimen Before 2011 Atripla Since 2011 Eviplera Rilpivirine/tenofovir/emtricitabine In the future Elvitegravir/cobicistat/tenofovir/emtricitabine= «QUAD» (Submitted) Dolutegravir/Lamivudine/Abacavir («Trii») (phase III) Darunavir/cobicistat/GS7340/emtricitabine (phase II) Elvitegravir/cobicistat/GS7340/emtricitabine (phase II) Is STR better than QD?* * Uthman OA, XIX International AIDS Conference, Washington. TUPE096
25 Long-Acting drugs Rilpivirine LA SGSK Both phase I studies Ref: 1. Jackson A, CROI 2012 Paper # Spreen W, XIX AIDS conference TUPE040)
26 Take Home Message Tritherapy remains the gold standard But: Products works far better than in Better safety profile, much better tolerance. Administration is much easier (Once a day, STR). Big questions remains What is the optimal timing to start antiretroviral treatment? Is there something better than the classical tritherapy?
27 Bedankt voor jullie aandacht Contactgegevens: 03/
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