IAS 2015: Return to Vancouver
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1 IAS 2015: Return to Vancouver Paul E. Sax, M.D. Clinical Director, Division of Infectious Diseases Brigham and Women s Hospital Professor of Medicine Harvard Medical School NEAETC
2 Memories from 1996 First realization for many that combination ART could suppress viral replication indefinitely? Panel of HIV researchers drenched in blood by ACT- UP activists; Marty Hirsch s new suit ruined Hospital installed high-speed internet access for all Elsewhere: Atlanta Olympics (and bombing), Clinton vs Dole, Fargo, Alanis Morissette Gulick R, et al. NEJM 1997;337:734
3 Kicking over chairs, throwing microphones, smashing glasses and overturning conference tables, protesters demanded an immediate end to the practice of treating AIDS patients with dangerous chemotherapeutic agents. The activists asserted that the therapies hyped during the week-long conference such as AZT, ddi, ddc and protease inhibitors impair the immune system's natural ability to fight HIV and control the opportunistic infections that kill people with AIDS.
4 December 30, 1996
5 IAS Vancouver 2015: Outline START: A landmark study Antiretroviral therapy
6 The biggest news out of Vancouver IAS 2015 was: 1. Teenager cured of HIV. 2. Results of the START study. 3. A clinical trial of ART with 100% of the participants women. 4. Largest switch study ever in stably suppressed patients. 5. Marty Hirsch got a new suit. 0% 0% 0% 0% 0%
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8 START Study: Study Design HIV-infected individuals who are ART-naïve with CD4+ count >500 cells/mm 3 Immediate ART Group Initiated ART immediately Following randomization N=2,326 Deferred ART Group Defer ART until the CD4+ count declines to <350 cells/mm 3 N=2,359 Primary Composite Endpoint, Target =213 Serious AIDS or death from AIDS Serious Non-AIDS Events and death not attributable to AIDS CVD, ESRD, decompensated live disease, & non-aids defining cancers DSMB Stopped Study on May 27, 2015 Lundgren J, et al; 8th IAS, Vancouver, Canada, July 19-22, 2015; Abst. MOSY0301.
9 START Study: Baseline Characteristics Characteristics Immediate-Initiation Group (N=2326) Deferred-Initiation Group (N=2359) All Patients (N=4685) Median Age (IRQ)-yr 36 (29-44) 36 (29-44) 36 (29-44) Female Sex no. (%) 624 (26.8) 633 (26.8) 1,257 (26.8) Mode of Infection with HIV no. (%) Sexual Contact Men Having Sex with Men 1,300 (55.9) 1,286 (54.5) 2,586 (55.2) With Person of Opposite Sex 873 (37.5) 917 (38.9) 1,790 (38.2) Injection-drug Use 37 (1.6) 27 (1.1) 37 (1.6) Blood Products, Other, or Unknown 116 (5.0) 129 (5.5) 116 (5.0) Median Time Since HIV Diagnosis (IQR) yr 1.0 ( ) 1.1 ( ) 1.0 ( ) Median CD4+ count (IQR) cells/mm 651 ( ) 651 ( ) 651 ( ) Median HIV RNA (IQR) copies/ml 13,000 ( ,808) 12,550 ( ,567) 13,000 ( ,808) Median CHD Risk at 10yr (IQR) - % 1.9 ( ) 1.9 ( ) 1.9 ( ) Lundgren J, et al; 8th IAS, Vancouver, Canada, July 19-22, 2015; Abst. MOSY0301. No significant differences between groups
10 Mean CD4+Count (cells/mm 3 ) START Study: B CD4+ Count CD4 Cell Counts Immediate Initiation Deferred Initiation Months CD4 at the start of ART in deferred. Median 408 Estimated difference 194 cells Lundgren J, et al; 8th IAS, Vancouver, Canada, July 19-22, 2015; Abst. MOSY0301.
11 START Study: Initial ART Combinations Immediate Deferred TDF/FTC/EFV TDF/FTC/ATV/r ZDV/3TC/EFV TDF/FTC/DRV/r TDF/FTC/RPV TDF/FTC/RAL Other N=2287 (98%) N=1134 (48%) EFV: 73% vs 51% TDF: 89% in both groups Lundgren J, et al; 8th IAS, Vancouver, Canada, July 19-22, 2015; Abst. MOSY0301.
12 Cumulative Percent with an Event START Study: Primary Endpoint Immediate ART Deferred ART No. with Event (%) 42 (1.8%) 96 (4.1%) Rate/100PY HR (Imm/Def) 0.43 (95% CI: 0.30 to 0.62, p<0.001) 10 8 Immediate ART Deferred ART Months Lundgren J, et al; 8th IAS, Vancouver, Canada, July 19-22, 2015; Abst. MOSY0301.
13 Cumulative Percent with an Event START Study: Serious AIDS Events Immediate ART Deferred ART No. with Event (%) Rate/100PY HR (Imm/Def) 0.28 (95% CI: 0.15 to 0.50, p<0.001) 10 8 Immediate ART Deferred ART Months Lundgren J, et al; 8th IAS, Vancouver, Canada, July 19-22, 2015; Abst. MOSY0301.
14 Cumulative Percent with an Event START Study: Serious NON-AIDS Events Immediate ART Deferred ART No. with Event (%) Rate/100PY HR (Imm/Def) 0.61 (95% CI: 0.38 to 0.97, p=0.04) 10 8 Immediate ART Deferred ART Months Lundgren J, et al; 8th IAS, Vancouver, Canada, July 19-22, 2015; Abst. MOSY0301.
15 START Study: Primary and Secondary Endpoints End Point Immediate- Initiation Group (N=2326) Deferred- Initiation Group (N=2359) Hazard Ratio (95% CI) P Value No. No. /100 person-yr No. No. /100 person-yr Composite Primary End Point ( ) <0.001 Components of the Primary End Point Serious AIDS-Related Event ( ) <0.001 Serious Non-AIDS-Related Event ( ) 0.04 Death From Any Cause ( ) 0.13 Tuberculosis ( ) Kaposi s Sarcoma ( ) 0.02 Malignant Lymphoma ( ) 0.07 Cancer Not Related to AIDS ( ) 0.09 Cardiovascular Disease ( ) 0.65 Lundgren J, et al; 8th IAS, Vancouver, Canada, July 19-22, 2015; Abst. MOSY0301.
16 Primary Endpoint Subgroup Analysis Subgroup Percentage in Group Immediate Initiation Deferred Initiation no. of patients with event (rote per 100 person-yr) Hazard Ratio (95% CI) Age yr 48.8 I5 (0.43) 31 (0.91) 0.47 >35yr (0.78) 65 (1.85) 0.42 Sex 0.38 Male (0.66) 74 (1.40) 0.47 Female (0.42) 22 (1.34) 0.31 Race 0.65 Black 30.1 I5 (0.82) 28 (1.52) 0.57 White (0.63) 53 (1.54) 0.40 Other (0.34) 15 (0.91) 0.37 Geographic region 0.55 High income (0.56) 51 (1.42) 0.39 Low or moderate income (0.65) 45 (1.35) 0.48 Baseline CD <600 cells/mm (0.44) 35 (1.54) cells/mm (0.70) 46 (1.38) 0.50 >800 cells/mm (0.63) 15 (1.14) 0.56 Baseline HIV RNA 0.25 <5000 copies/ml (0.56) 18 (0.83) ,000 copies/ml (0.53) 36 (1.41) 0.38 > copies/ml (0.72) 42 (1.92) 0.37 Smoker 0.93 Yes (0.78) 43 (1.81) 0.43 No (0.52) 53 (1.16) 0.44 Framingham 10-yr CHD risk 0.56 < (0.35) 17 (0.77) (0.48) 27 (1.23) 0.39 > (1.00) 50 (2.05) P Value for Interaction Immediate Initiation Better Deferred Initiation Better Lundgren J, et al; 8th IAS, Vancouver, Canada, July 19-22, 2015; Abst. MOSY0301.
17 Percent of Follow-up Time START Study: CD4 at Event 60 Immediate ART (4.7) (0.8) (0.4) (0.6) (0.6) Deferred ART No. of Participants with Events (Rates per 100 PY) (1.8) (2.0) (1.5) (0.6) (1.1) < < Latest CD4+ Count (Cells per Cubic Millimeter) Primary Events at Latest CD4 count >500 c/mm Immediate Defer Percent 88% 59% Rate (/100 PY) Lundgren J, et al; 8th IAS, Vancouver, Canada, July 19-22, 2015; Abst. MOSY0301.
18 The START study results will profoundly influence clinical practice. 1. True now it is proven that HIV treatment is beneficial for all. 2. False we have been treating everyone regardless of CD4 for years anyway. 0% 0% 1 2 ART is recommended for all HIV-infected individuals. --DHHS Guidelines,
19 IAS Vancouver 2015: Outline START: A landmark study Antiretroviral therapy
20 WAVES : Initial ART in Women Baseline Week 48 WAVES 1:1 (n=575) EVG/COBI/FTC/TDF QD ATV+RTV+FTC/TDF Placebo QD ATV+RTV+FTC/TDF QD EVG/COBI/FTC/TDF Placebo QD Open Label Extension Key Eligibility Criteria: HIV infected womem HIV-1 RNA 500 copies/ml Estimated GFR 70 ml/min No history of prior antiretroviral therapy Sensitivity to FTC, TDF, and ATV Stratification: HIV-1 RNA (<=100,000, >100,000-<=400,000, >400,000 copies/ml) Race (Black or non-black) Squires K, et al; 8th IAS, Vancouver, Canada, July 19-22, 2015; Abst. MOLBPE08.
21 WAVES: Study Enrollment Squires K, et al. IAS 2015, #MOLBPE08 21
22 STB (n=289) ATV+RTV+TVD (n=286) Age (years), median (Q1,Q3) 34 (28,43) 35 (29,42) Race White Black Asian Mode of Infection Heterosexual 96% 94% HIV Disease Asymptomatic AIDS 44% 49% 3% 81% 4.2% 42% 47% 6% 75% 4.5% Body Mass Index (BMI), Mean (SD) 26 (7.02) 26 (5.69) Positive HBsAg 3.1% 2.4% Positive HCV Antibody 7.6% 8.7% HIV-1 RNA (log 10 copies/ml), Median (Q1,Q3) < 100,000 c/ml >100, ,000 c/ml > 400,000 c/ml 4.46 (4.09,4.97) 76% 15% 9% CD4 cell count (cells/mm 3 ), Median (Q1,Q3) 344 (246,466) <200 cells/mm 3 17% Squires K, et al; 8th IAS, Vancouver, Canada, July 19-22, 2015; Abst. MOLBPE08. WAVES Study: Baseline Characteristics 4.56 (4.02,5.00) 75% 17% 8% 370 (244,489) 18%
23 HIV-1 RNA < 50 c/ml, % WAVES Study: Primary Endpoint EVG/COBI/FTC/TDF (n=289) ATV+ RTV + FTC/TDF (n=286) Treatment Difference (95% CI) Favors ATV+ RTV Favors STB % Virologic Success Virologic Failure No Virologic Data 4-12% +12% Mean CD4 Cell Increase (cells/mm 3 ) was 196 (EVG/COBI/FTC/TDF & ATV/RTV + FTC/TDF) % 12.6% RESISTANCE STB: Only on pt with emergent D67D/N ATV/r: 3 with M184V/I Squires K, et al; 8th IAS, Vancouver, Canada, July 19-22, 2015; Abst. MOLBPE08.
24 Virologic Success (%) WAVES Study: Efficacy by Baseline HIV-1 RNA & CD4 Count EVG/COBI/FTC/TDF ATV+RTV+FTC/TDF Overall VL 100,000 VL > 100,000 CD4 350 N CD4 > 350 Squires K, et al; 8th IAS, Vancouver, Canada, July 19-22, 2015; Abst. MOLBPE08. HIV-1 RNA (c/ml) CD4 Cell Count (/µl) AERs leading to d/c: E/C/F/T - 7 vs ATV/r - 20
25 Integrase-Based First-Line Therapy: It s Better WAVES: EVG/COBI/TDF/FTC better than ATV/r SPRING-2: DTG better than EFV FLAMINGO: DTG better than DRV/r ACTG 5257: RAL better than DRV/r and ATV/r
26 Probability of Suicidality ACTG: Risk of EFV Suicidality May Be Associated with CYP2B6 and 2A6 Metabolizer Genotypes Extensive (levels: 1-2) Intermediate (3-7) Slow (8-12) 7 events* 18 events * Hazard ratio (95% CI): 1.85 (1.05, 3.26), P= events Weeks Since EFV Initiation Unweighted No. at risk: Extensive Mid Slow Mollan K, et al; 8th IAS, Vancouver, Canada, July 19-22, 2015; Abst. TUPEB273.
27 TDF/FTC + Doravirine vs EFV: Results by Baseline HIV RNA 100,000 c/ml >100,000 c/ml n/n: 55/66 54/63 25: 51/66 58/63 11: 23/38 25/38 35/38 36/38 % <40 c/ml % <200 c/ml % <40 c/ml % <200 c/ml Doravirine 100 mg q.d. Efavirenz 600 mg q.d. Virologic failures: DRV 17, EFV mostly due to low-level viremia at week 24 (no resistance detected) 1 or more CNS adverse events: DRV 27%, EFV 46% -- difference -19.4% (95% CI -31.7, -6.6) Gatell J, et al; 8th IAS, Vancouver, Canada, July 19-22, 2015; Abst. TUAB04.
28 Three ECF-TAF Switch Studies 1. From first regimens TDF/FTC/EFV, TDF/FTC + ATV/r or ATV/c, or TDF/FTC/EVG/c 2. In chronic renal insufficiency 3. In hepatitis B/HIV co-infection
29 Tenofovir Alafenamide (TAF) GI TRACT PLASMA Tenofovir (TFV) Parent Nucleotide DIANION TFV TFV HIV TARGET CELL Tenofovir disoproxil fumarate (TDF) Tenofovir alafenamide (TAF) ESTER TDF 300 mg TAF 25 mg T 1/2 = 0.4 min T 1/2 = 90 min TFV HIV TFV AMIDATE 91% lower plasma TFV levels minimize renal and bone effects while maintaining high potency for suppressing HIV T 1/2 based on in vitro plasma data. 1. Lee W et. Antimicr Agents Chemo 2005;49(5): Birkus G et al. Antimicr Agents Chemo 2007;51(2): Babusis D, et al. Mol Pharm 2013;10(2): Ruane P, et al. J Acquir Immune Defic Syndr 2013; 63: Sax P, et al. JAIDS ;67(1): Sax P, et al. Lancet 2015;385:
30 Switch to E/C/F/TAF from First Regimen Primary Endpoint HIV-1 RNA <50 c/ml Randomized (2:1), active-controlled, open-label study Virologically Suppressed Adults Baseline Characteristics E/C/F/TDF (n=459) EFV/FTC/TDF (n=376) Boosted ATV + FTC/TDF (n=601) Mills A, et al; 8th IAS, Vancouver, Canada, July 19-22, 2015; Abst. TUAB0102. Week 0 n=959 n=477 E/C/F/TAF n= Switch to E/C/F/TAF Continue TDF-Based Regimen TDF-Based Regimen n=477 Median age, years Female, % Race, % White Black or African descent Hispanic/Latino ethnicity Median CD4 count, cells/mm Patients with <200 cells/mm 3, % Median estimated GFR, ml/min* Dipstick proteinuria, % Grade Grade
31 HIV-1 RNA <50 c/ml, % Switch to E/C/F/TAF from First Regimen: Results Virologic Outcome Treatment Difference (95% CI) E/C/F/TAF TDF-Based Regimen n= TDF Based E/C/F/TAF Success Failure No Virologic Data n= % 0 +12% Mills A, et al; 8th IAS, Vancouver, Canada, July 19-22, 2015; Abst. TUAB
32 Patients With HIV-1 RNA <50 c/ml, % Virologic Outcome By Prior Treatment Primary Endpoint E/C/F/TAF TDF-Based Regimen p <0.001 p=0.02 p=0.02 p=ns % CI = All Prior Regimens Prior EFV/FTC/TDF Mills A, et al; 8th IAS, Vancouver, Canada, July 19-22, 2015; Abst. TUAB Prior Boosted ATV + FTC/TDF Prior E/C/F/TDF
33 Median % Change Switch to E/C/F/TAF in Suppressed Adults: Effect on Tubular Proteinuria Urine Urine Urine Retinol Urine Beta 2 Protein:Creatinine UPCR Albumin:Creatinine UACR Binding RBP: Protein:Creat Ratio Microglobulin:Creatinine B2MG: Ratio Switch to E/C/F/TAF associated with: Improvement in spine and hip BMD Reduction in proportion classified as osteopenia or osteoporosis Reduction in tubular proteinuria; no change in egfr Increase in fasting lipids E/C/F/TAF TDF-Based Regimen Mills A, et al; 8th IAS, Vancouver, Canada, July 19-22, 2015; Abst. TUAB0102.
34 Study 112: Switch to E/C/F/TAF in Patients With Renal Impairment Phase 3 study (96 weeks) Treatment-experienced Open-label HIV RNA <50 copies/ml egfr ml/min Switch to E/C/F/TAF (n=242) Primary Endpoint Week 24 Change From Baseline in egfr E/C/F/TAF: elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide. TAF 25 mg. Pre-switch ART regimens: NRTI: tenofovir DF (65%), abacavir (22%), other (7%), none (5%). Third agent (some regimens included >1 third agent): PI (44%), NNRTI (42%), INSTI (24%), CCR5 antagonist (3%). Baseline characteristics: Median age: 58 years. Hypertension/diabetes: 40%/14%. Median CD4: 632 cells/mm 3. Median egfr: 56 ml/min (<60 ml/min: 66%). Dipstick proteinuria grade 1/2/3-4: 23%/10%/0%. Gupta S, et al. J Int AIDS Soc. 2015;18(suppl 4): Abstract TUAB0103..
35 Actual GFR (ml/min) Change in egfr (ml/min) Study 112: Change in GFR After Switch to E/C/F/TAF in Patients With Renal Impairment Actual GFR at Week 24 (Iohexol Clearance) Mean Change in egfr at Week 48 (Cockcroft-Gault) 80 Baseline Week All Patients Yes No TDF in Previous Regimen -4-6 Baseline egfr (ml/min): All Patients Yes No TDF in Previous Regimen Gupta S, et al. J Int AIDS Soc. 2015;18(suppl 4): Abstract TUAB0103..
36 Study 112: Change in GFR and Other Outcomes After Switch to E/C/F/TAF Actual GFR was unaffected by E/C/F/TAF switch, regardless of previous regimen egfr remained unchanged through week 48 Significant improvements after E/C/F/TAF switch (P<0.05) Spine and hip bone mineral density Urinary tubular proteins and fractional excretion of uric acid Albuminuria and proteinuria Cholesterol fractions in patients not on a TDF-based regimen at time of switch Gupta S, et al. J Int AIDS Soc. 2015;18(suppl 4): Abstract TUAB0103..
37 Mother at delivery HIV-1 Remission for >12 ddc since 13 weeks gestation Years After Early ART HIV RNA 4.63 log 10 copies/ml and CD4 81 cells/mm 3 Infant (delivery 37 weeks, 5 days of gestation) At birth Zidovudine prophylaxis, HIV RNA undetectable at day 3 HIV DNA undetectable at days 3 and 14, detected at week 4 Week 6: zidovudine interrupted, HIV RNA rose sharply to 2.17 million copies/ml Month 3: initiate ART (zidovudine, didanosine, abacavir, ritonavir) Loss to follow-up between 5.8 and 6.8 years ART interrupted by mother at approximately year 6.5 Remains HIV RNA undetectable after returning to care Unknown if HIV-1 remission in this infant represents early treatment translating into long-term control or if long-term control is related to other factors Frange P, et al. J Int AIDS Soc. 2015;18(suppl 4):3-4. Abstract MOAA0105LB.
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39 Thank you! February 12, 1996
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