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Track B Summary Jeff Lennox Emory University Atlanta

Track B Summary Jeff Lennox Emory University Atlanta. Special thanks to my fellow Track B Rapporteurs :. Annie Luetkemeyer San Francisco. Juergen Rockstroh Bonn. Trip Gulick New York. And to the wonderful people of Rome for their hospitality!. When to Start ART.

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Track B Summary Jeff Lennox Emory University Atlanta

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  1. Track B SummaryJeff LennoxEmory UniversityAtlanta

  2. Special thanks to my fellow Track B Rapporteurs: Annie Luetkemeyer San Francisco Juergen Rockstroh Bonn Trip Gulick New York And to the wonderful people of Rome for their hospitality!

  3. When to Start ART

  4. Risk of progression to AIDS or death in relation to CD4 cell levels in patients with sustained viral response to ART: COHERE cohortResults - event rates per 1000 years suppressed When to Start ART • Similar results in an analysis of 27,108 patients in 4 M.S.F. programs in Africa- Patients who achieved a CD4 of 350-499 had 1.69 AHR for mortality compared to those who achieved CD4 >500 WELB05 Heiner; TUBDP0106 Maman

  5. HPTN 052: Effects of early versus delayed initiation of ART on HIV clinical outcomes Death, WHO stage 4 clinical event, pulmonary TB or severe bacterial infection 1763 HIV-infected individuals were randomized to receive ART at a CD4 count of 350-550 (immediate arm) or after two consecutive CD4 counts< 250/μL>200 (delayed arm). HR: 0.6 [ 0.4, 0.9 ], P=0.01 Delayed Immediate Number at risk Delayed Immediate

  6. New Drugs and New Strategies

  7. Efficacy and safety of lersivirine vs efavirenz in antiretroviral treatment-naïve HIV-1-infected patients: Week 48 primary analysis results Randomized, double-blind Selection criteria ARV naïve, HIV-1 RNA ≥1000 c/mL, CD4+ >200 cells/mm3 No RT mutations by standard genotyping Stratified by viral load (<100,000 or ≥100,000 c/mL) & geographic region (A & B) LRV 500 mg QD + TDF/FTC Randomization 1:1:1 LRV 750 mg QD + TDF/FTC EFV 600 mg QD + TDF/FTC 6 weeks 0 24 wk 48 wk 96 wk Primary endpoint: Patients achieving HIV-1 RNA <50 c/mL TUAB0101, Pozniak

  8. 0 2 4 8 16 24 32 40 48 Lersivirine vs efavirenz- Efficacy results through Week 48(plasma HIV-1 RNA <50 c/mL, ITT, NC=F) 54/63 (86%) 51/65 (79%) 51/65 (79%) TUAB0101, Pozniak

  9. Once-daily Dolutegravir, a Next Generation Integrase Inhibitor in in Antiretroviral-naïve Adults 48 Week Results from SPRING-1 (ING112276) Phase IIb dose-ranging, partially-blinded, N~200 ART-naïve patients All arms include 2 NRTI backbone given once daily Primary endpoint: % <50 c/mL at 16 weeks (TLOVR) Planned interim analysis: % <50 c/mL at 48 weeks (TLOVR) DTG 10 mg • Stratified by • HIV RNA >100,000 • or ≤ 100,000 • Epzicom/Kivexa • or Truvada DTG 25 mg HIV-1 RNA >1000 c/mL CD4 ≥200 cells/mm3 1:1:1:1 Randomization DTG 50 mg EFV 600 mg Wk 96 Wk 48 interim analysis *Post hoc analysis using bioMONTR HIV-1 EQ SuperLow Assay LLOD=2 c/mL at Weeks 16, 24 and 48 TUAB0102 Van Lunzen

  10. DTG: Rapid and Sustained Antiviral ActivityWeek 48 Efficacy Analysis (%<50 c/mL) 91% 90% 88% 82% Proportion (%) <50 c/mL (TLOVR) DTG 50mg DTG 10mg EFV 600mg DTG 25mg 95% confidence intervals are derived using the normal approximation

  11. Laboratory Findings > Grade 3 lab abnormalities were rare (DTG 12% vs. EFV 14%) No Grade 3 or 4 ALT elevations in any subject Changes (+/- SD) in serum creatinine over time Note: no clinically relevant events nor discontinuations related to creatinine See also abstract TUPE238 (Min et. al.)

  12. QD maraviroc 150 mg in combination with ATV/r vs. FTC/TDF + ATV/r in treatment-naïve patients infected with R5 HIV-1 (Study A4001078): 48 week results Randomization 1:1N=121 FTC/TDF + ATV/r (300/100 mg QD) MVC (150 mg QD) + ATV/r (300/100 mg QD) Screening(6 weeks) 0 16 wk 24 wk 48 wk Interim analyses Primary analysis • Patient eligibility criteria • R5 HIV at screening • HIV-1RNA ≥1000 copies/mL • CD4 ≥100 cells/mm3 • No evidence of resistance to ATV/r, TDF, or FTC • Study is not powered to show a treatment difference and no formal comparative statistics will be performed TUAB0103, Mills

  13. HIV-1 RNA <50 copies/mL at Week 24 and Week 48 according to baseline viral load MVC + ATV/r 94.9 100 Patients with HIV-1 RNA <50 copies/mL (%) FTC/TDF + ATV/r 37/39 87.2 90 81.3 81.4 34/39 77.3 76.7 77.3 35/43 13/16 80 17/22 17/22 33/43 68.8 70 11/16 60 50 40 30 20 10 0 Week 24 Week 48 Week 24 Week 48 <100,000 copies/mL ≥100,000 copies/mL Baseline HIV-1 RNA Intent-to-treat. Missing=failure TUAB0103, Mills

  14. 702 Treatment-experienced patients, double blind, randomized • Background regimen (BR) based on resistance testing: • 2nd Agent: fully active PI/r • 3rd Agent: NRTI, ETR, MVC, T-20; If M184V/I, may add 3TC or FTC • Non Inferiority Study with lower limit 95% CI at -10% Elvitegravir QD is non-inferior to raltegravir BID in treatment experienced patients:48 week results WELBB05, Molina

  15. MOAC0201- Valacyclovir suppression reduces breast milk and plasma HIV-1 RNA postpartum: -results of a randomized clinical trial TUAB0202- Peripartumvalacyclovir improves markers of HIV-1 disease progression in women co-infected with HSV-2: a randomized trial 2011- The Year of (val)Acyclovir? TUAB0104- Impact of HSV-2 suppressive therapy with daily acyclovir on HIV-1 disease progression: a randomized placebo-controlled trial in Rakai, Uganda WEPDB0106- High-dose valacyclovir suppressive therapy results in greater reduction in plasma HIV-1 levels compared to standard dose acyclovir suppression among HIV-1/HSV-2 co-infected persons: a randomized, open-label, crossover trial

  16. Complications

  17. US VA Database- ARV Exposure and Risk of Osteoporotic Fractures 1984-2009: >900 fractures in >56,000 patients Hazard Ratio MV Model 1: Controlling for CKD, age, race, tobacco use, diabetes and BMI; MV Model 2: Controlling for Model 1 variables + concomitant exposure to other ARVs. MAOB0101, Bedimo

  18. HIV-Related Predictors and Outcomes in 125 Liver and 150 Kidney Transplant Recipients • Studied rates and predictors of • Patient survival • AIDS-related opportunistic infections (OI) and neoplasms • Other serious infections with hospitalization (SI) • 1 & 3 year patient survival • Kidney: 95% (90%, 98%) & 91% (84%, 95%) • Liver: 80% (72%, 86%) & 67% (56%, 75%) • Predictors of Mortality • Liver: • Dual organ HR 4.86 (1.93, 12.2) • Pre-TX BMI<21 HR 2.74 (1.25, 5.98) • Age >40 HR 2.23 (1.07, 4.64) • Kidney: • HCV HR 3.17 (1.10, 9.09) • Age HR 1.06 (1.01,1.11) MOAB0105, Beatty

  19. Infections

  20. CARINEMO ANRS 12146 • 2NRTI + NVP 200mg BID vs EFV begunat 4-6 weeks of Rifampincontainingtherapy for TB • No difference in incidence of hepatitis or grade >2 rash betweenarms ART + RMP ART alone Bhatt WELBX05

  21. Riskfactors for TB-IRIS • CAMELIA- ART initiation ‘‘early’’ (at 2 weeks) vs. ‘‘late’’ (at 8 weeks) after TB treatment onset in 661 naïve HIV-infected adults with CD4 cell count ≤200/µL • 26% of patients developed TB IRIS a median of 2 weeks after ART • CAMELIA Causes of Death- 149/661 (22%) patients died, mortality was highest in the first 6 months. • -TB was the most common cause of death, occurring early in therapy. • - Drug Toxicity was the second most common cause of death, with a majority being due to D4T and occurring after 50 weeks WEAX0104 Laureillard, WEPDB0202 Marcy

  22. Evaluation of a Point of Care Cryptococcal Antigen Test on Serum, Plasma and Urine from Patients with HIV-associated Cryptococcal Meningitis

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