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Slide 1 of XX IAS–USA Michael S. Saag, MD Eric S. Daar, MD Antiretroviral Therapy: A Case-Based Panel Discussion (Part I) MERGED: 03-21-13 From MS Saag,

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Presentation on theme: "Slide 1 of XX IAS–USA Michael S. Saag, MD Eric S. Daar, MD Antiretroviral Therapy: A Case-Based Panel Discussion (Part I) MERGED: 03-21-13 From MS Saag,"— Presentation transcript:

1 Slide 1 of XX IAS–USA Michael S. Saag, MD Eric S. Daar, MD Antiretroviral Therapy: A Case-Based Panel Discussion (Part I) MERGED: From MS Saag, MD and ES Daar, MD at San Francisco, CA: March 29, 2013, IAS-USA.

2 Slide 2 of 50 From MS Saag, MD and ES Daar, MD at San Francisco, CA: March 29, 2013, IAS-USA. Case 1 –30 yo white man –Diagnosed on routine insurance examination –PMHx remarkable for HTN, diet controlled –No medications –Understands treatment issues and wants to begin therapy if you think it is appropriate

3 Slide 3 of 50 From MS Saag, MD and ES Daar, MD at San Francisco, CA: March 29, 2013, IAS-USA. Case 1b –30 yo white man –Diagnosed on admission to jail for disorderly conduct –PMHx remarkable for HTN, diet controlled and paranoid schizophrenia –Doesn’t take any medications and doesn’t want to

4 Slide 4 of 50 From MS Saag, MD and ES Daar, MD at San Francisco, CA: March 29, 2013, IAS-USA. HIV Infected Cells Uninfected Resting CD4+ Lymphocytes Uninfected Activated CD4+ Lymphocytes Antiretroviral Rx Latently Infected CD4+ Lymphocytes HIV virions M Saag, UAB

5 Slide 5 of 50 From MS Saag, MD and ES Daar, MD at San Francisco, CA: March 29, 2013, IAS-USA. Inflammatory Biomarkers Predict Risk for All-Cause Mortality Among Treated Adults CohortDesignT cell acti- vation CRPIL-6K/T IDO Cysta- atin C sCD- 14 D- dimer Fibrin- ogen Hyalu- ronic Acid SMART ESPRIT Case- control ✔✔✔✔✔ FRAM Cohort ✔✔✔ SOCA/ SCOPE Cohort ✔✔✔✔✔✔ UARTO Cohort ✔✔ VACS Cohort ✔✔ FIRST (Pre-ART) Case- control ✔✔✔✔ Pfidisas (Pre-ART) Case- control ✔✔✔ T cells Innate Microbes Coagulation Fibrosis

6 Slide 6 of 50 From MS Saag, MD and ES Daar, MD at San Francisco, CA: March 29, 2013, IAS-USA. Effect on inflammation in predicting mortality higher in HIV disease than the general population (SOCA/SCOPE) Hunt et al CROI 12

7 Slide 7 of 50 From MS Saag, MD and ES Daar, MD at San Francisco, CA: March 29, 2013, IAS-USA. T cell “activation” is lower in treated than untreated adults, but consistently higher than “normal” Hunt et al JID 2003, PLoS ONE 2011 and unpublished HIV – (n=132) HIV + ART (n=65) HIV + Untreated (n=82)

8 Slide 8 of 50 From MS Saag, MD and ES Daar, MD at San Francisco, CA: March 29, 2013, IAS-USA. Inverse Probability Weighted Cox Regression Multivariate Analysis *Stratified by Cohort and Year Relative Hazard (RH)* 95% Confidence Interval P-value Deferral of HAART at , 2.1<0.001 Female Sex1.10.9, Older Age (per 10 years)1.61.5, 1.8<0.001 Baseline CD4 count (per 100 cells/mm 3 ) , Results were similar when restricting the analysis to the 50% of participants with baseline HIV RNA data Adjusted RH for deferral vs. immediate treatment was also % C.I. 1.4, 2.2; p < HIV RNA was not an independent predictor of mortality

9 Slide 9 of 50 Permanent Loss of CD4 if Wait to Start CD4-count increases on sustained suppressive (<400 c/mL) ARV treatment (n=655) by baseline count – >350 cells/mm 3 : CD4 counts return to near-normal levels – ≤350 cells/mm 3 : CD4 counts significantly increased but plateau after 4 years below normal range Differences in CD4 counts associated with differences in morbidity and mortality Median CD4 Counts Over 6 Years Stratified by Baseline CD4 Count Moore RD, Keruly JC. Clin Infect Dis 2007;44: Years After Starting HAART CD4 Count (cells/mm 3 ) <200201–350>350 From MS Saag, MD and ES Daar, MD at San Francisco, CA: March 29, 2013, IAS-USA.

10 Slide 10 of 50 Universal ART in San Francisco Geng et al, CID 12 From MS Saag, MD and ES Daar, MD at San Francisco, CA: March 29, 2013, IAS-USA.

11 Slide 11 of 50 From MS Saag, MD and ES Daar, MD at San Francisco, CA: March 29, 2013, IAS-USA. HOPS Cohort: Resistance Development Major mutations 50% less likely in pts starting with CD4+ >350 vs <200 cells/mm 3, despite greater treatment exposure 1. Uy JP, et al. 4 th IAS, Sydney 2007, #WEPEB017; 2. van Sighem B, et al. ibid, #WEPEB cells/mm cells/mm 3 >350 cells/mm 3 GT mutations and virologic failure 1 Any mutation (n=78) NRTI mut. among NRTI-exp (n=50) NNRTI mut. among NNRTI-exp (n=37) PI mut. among PI-exp (n=48) Patients (%) p=0.076p=0.007p=0.051p=

12 Slide 12 of 50 From MS Saag, MD and ES Daar, MD at San Francisco, CA: March 29, 2013, IAS-USA. Cost-Effectiveness of Early vs. Deferred ART Markov modeling approach Johns Hopkins HIV clinic database “Starting ART earlier … rather than later … is a cost- effective strategy (by the generally accepted benchmark in the US).” Mauskopf JA, et al. JAIDS 2005;39: ART Initiation Incremental Lifetime Costs Incremental Discounted QALY* Gained Cost Per Life-Year Gained Cost Per QALY* Gained CD4 >350 vs $19, (0.61)$25,567$31,226

13 Slide 13 of 50 Most New Infections Transmitted by Persons who Do Not Know Their Status ~25% Unaware of Infection ~75% Aware of Infection account for… ~54% New Infections ~46% of New Infections Source: G. Marks et al. AIDS 2006 From MS Saag, MD and ES Daar, MD at San Francisco, CA: March 29, 2013, IAS-USA.

14 Slide 14 of 50 From MS Saag, MD and ES Daar, MD at San Francisco, CA: March 29, 2013, IAS-USA. HPTN HIV discordant couples (HIV+ partner CD ) 850 delayed HAART (CD4 250) *96% reduction in HIV transmission to HIV-negative partner median follow-up 2 years 1 transmission* & 3 cases of extrapulmonary TB 886 immediate HAART All receiving HIV prevention services 27 transmissions* & 17 cases of extrapulmonary TB

15 Slide 15 of 50 From MS Saag, MD and ES Daar, MD at San Francisco, CA: March 29, 2013, IAS-USA. Reasons to Start Early: The Biology Association of Inflammation and Disease Better Tolerated Medications Today Randomized Controlled Trial Data Cohort Data Public Health Common Sense!

16 Slide 16 of 50 From MS Saag, MD and ES Daar, MD at San Francisco, CA: March 29, 2013, IAS-USA. Slide 16 of 50 From MS Saag, MD and ES Daar, MD at San Francisco, CA: March 29, 2013, IAS-USA.

17 Slide 17 of 50 From MS Saag, MD and ES Daar, MD at San Francisco, CA: March 29, 2013, IAS-USA. Relative Time on Treatment… AGE (years) CD4 650/ul CD4 500/ul 40 years on Rx35 years on Rx 5 years

18 Slide 18 of 50 From MS Saag, MD and ES Daar, MD at San Francisco, CA: March 29, 2013, IAS-USA. Relative Time on Treatment… AGE (years) CD4 650/ul CD4 500/ul 40 years on Rx35 years on Rx 5 years HARM?

19 Slide 19 of 50 From MS Saag, MD and ES Daar, MD at San Francisco, CA: March 29, 2013, IAS-USA. So ….what is the harm? Destruction of Lymphoid Tissue Inflammation Increased Cardiovascular Events Increased incidence of certain malignancies Increased ‘Aging’ Accelerated Cognitive Decline

20 Slide 20 of 50 From MS Saag, MD and ES Daar, MD at San Francisco, CA: March 29, 2013, IAS-USA. Balance of data support starting Rx in ~ all individuals regardless of CD4+ T cell counts –Understanding of HIV pathogenesis –Cohort data –Public health implications –No randomized clinical trial data for higher CD4 counts (START study is enrolling) Waiting until RCT data could well lead to harm that likely will not be reversible Conclusions

21 Slide 21 of 50 From MS Saag, MD and ES Daar, MD at San Francisco, CA: March 29, 2013, IAS-USA. Case 2  42 year old man diagnosed with HIV in 1999; several OIs  Has ‘taken’ most existing antiretroviral drugs available, on and off, for years  Currently on TDF / FTC / DRV / rit  CD4 count is 33 /µL (nadir CD4 = 6)  CD4 count 3 months ago was 76 cells/µL  HIV RNA 128,000 c/mL (max VL 167,000)  Phenotype: Pan-sensitive

22 Slide 22 of 50 From MS Saag, MD and ES Daar, MD at San Francisco, CA: March 29, 2013, IAS-USA. Case 3  34 yo woman is diagnosed with TB  As part of evaluation she is found to be HIV+  Initial lab values —CD4 82 cells/µL —VL 76,000 c/mL  No other significant medical condition  She is started on 4-drug anti-TB therapy (including INH and rifabutin)  Virus is wild-type virus

23 Slide 23 of 50 From MS Saag, MD and ES Daar, MD at San Francisco, CA: March 29, 2013, IAS-USA. Case 1 —30 yo white man —Diagnosed on routine insurance examination —PMHx remarkable for HTN, diet controlled —No medications —Understands treatment issues and wants to begin therapy if you think it is appropriate

24 Slide 24 of 50 From MS Saag, MD and ES Daar, MD at San Francisco, CA: March 29, 2013, IAS-USA. A 49 year old asymptomatic man presents to your clinic after recently being diagnosed with HIV History of HTN with CrCl ~75 mL/min HBsAb+, HCV antibody negative CD4 cells repeatedly cells/uL Plasma HIV RNA 30-50,000 copies/mL Not anxious to start antiretrovirals but willing if you think it is necessary

25 Slide 25 of 50 From MS Saag, MD and ES Daar, MD at San Francisco, CA: March 29, 2013, IAS-USA. Factors to consider in choosing first-line therapy Patient’s willingness to commit to therapy Baseline resistance Efficacy data Tolerability Convenience Comorbid conditions Consequences of failure (resistance) Since the introduction of potent ARV therapy preferred regimens all include NRTIs + third drug

26 Slide 26 of 50 From MS Saag, MD and ES Daar, MD at San Francisco, CA: March 29, 2013, IAS-USA. Boosted-Protease Inhibitors Adapted from: 1. Eron J, et al. Lancet 2006; 368: ; 2. Mills A, et al. AIDS May 29, Molina J-M, et al. 48 th ICAAC/46 th IDSA, Washington, DC, Abst. H-1250d ARTEMIS 2 (ITT, TLOVR) 96 weeks LPV/r QD or BID DRV/r 800/100 QD n=343n= CASTLE 3 (ITT, NC=F) 96 weeks ATV/r 300/100 QD LPV/r 400/100 BID n=443n=440 KLEAN 1 (ITT-E, TLOVR) 48 weeks LPV/r 400/100 BID FPV/r 700/100 BID N=444n=

27 Slide 27 of 50 From MS Saag, MD and ES Daar, MD at San Francisco, CA: March 29, 2013, IAS-USA. ATV/r vs. EFV Primary Endpoint Daar ES, et al. Ann Intern Med 2011; 154:

28 Slide 28 of 50 From MS Saag, MD and ES Daar, MD at San Francisco, CA: March 29, 2013, IAS-USA. STARTMRK: RAL vs. EFV Rockstroh J, et al, 19th IAC; Washington, DC; July 22-27, 2012; Abst. LBPE19. ITT, NC=F Raltegravir 400 mg BID Efavirenz 500 mg QHS Number of Contributing Patients Weeks Percentage of Patients with HIV RNA Levels <50 Copies/mL CD4 Change: RAL +374 vs. EFV +312

29 Slide 29 of 50 From MS Saag, MD and ES Daar, MD at San Francisco, CA: March 29, 2013, IAS-USA. Rimsky L, et al. 50 th ICAAC 2010, Boston, MA. Abst. H % 82.3% Pooled ECHO and THRIVE: Virologic Response (ITT-TLOVR)

30 Slide 30 of 50 From MS Saag, MD and ES Daar, MD at San Francisco, CA: March 29, 2013, IAS-USA. Rimsky L, et al. 50 th ICAAC 2010, Boston, MA. Abst. H-1810 Pooled ECHO and THRIVE: Virologic Response (ITT-TLOVR)

31 Slide 31 of 50 From MS Saag, MD and ES Daar, MD at San Francisco, CA: March 29, 2013, IAS-USA. GS102 & GS103: EVG/COBI/TDF/FTC vs. EFV/TDF/FTC or ATV/RTV + TDF/FTC Sax P, et al, Lancet 2012: 379:: ; DeJesus E, et al, Lancet 2012; 379: Randomized, Phase III, Double-blind, Double Dummy, Active-controlled, International Studies Treatment Naïve HIV-1 RNA ≥5,000 c/mL Any CD4 cell count eGFR ≥70 mL/min 48 weeks 192 weeks GS 102 ~89% men 33% >10 5 c/mL CD4= ~385 c/uL GS 103 ~90% men ~41% >10 5 c/mL CD4= ~370 c/uL Quad QD EFV/FTC/TDF Placebo QD EFV/FTC/TDF QD Quad Placebo QD Quad QD ATV/r +TDF/FTC Placebo QD QUAD Placebo QD ATV/r +TD/FTC QD

32 Slide 32 of 50 From MS Saag, MD and ES Daar, MD at San Francisco, CA: March 29, 2013, IAS-USA. Study : Primary Endpoint: HIV-1 RNA < 50 copies/mL +3.6%, 95% CI 3.6 (-1.6% to +8.8%) CD4+ change: Quad +239 vs. EFV +206 c/mm 3 (p=0.009) No difference by baseline characteristics Sax P, et al. 19th CROI; Seattle, WA; March 5-8, Abst. 101.

33 Slide 33 of 50 From MS Saag, MD and ES Daar, MD at San Francisco, CA: March 29, 2013, IAS-USA. Study : Common Adverse Events Quad (n=348) EFV/FTC/TDF (n=352) Treatment Emergent Adverse Events in ≥ 10% of subjects (%) Diarrhea23%19% Nausea *21%14% Abnormal Dreams ^ 15%27% Upper Respiratory Infection14%11% Headache14%9% Fatigue12%13% Insomnia *9%14% Depression9%11% Dizziness ^ 7%24% Rash # 6%12% * p<0.05; ^ p<0.001; # p=0.009 Sax P, et al, Lancet 2012: 379::

34 Slide 34 of 50 From MS Saag, MD and ES Daar, MD at San Francisco, CA: March 29, 2013, IAS-USA. Study : ATV/r vs. TDF/FTC/COBI/EVG HIV-1 RNA < 50 c/mL QUAD ATV/r Changes in CD4+ count: Quad +207 vs. ATV/r +211 cells/mm 3 (p=0.61) No difference by baseline characteristics Changes in CD4+ count: Quad +207 vs. ATV/r +211 cells/mm 3 (p=0.61) No difference by baseline characteristics DeJesus E, et al, Lancet 2012; 379:

35 Slide 35 of 50 From MS Saag, MD and ES Daar, MD at San Francisco, CA: March 29, 2013, IAS-USA. Study : Adverse Events Adverse Events > 10% in Either Group Discontinuation rates due to renal events were identical in both arms (0.3%) Quad (n=353) ATV/r + FTC/TDF (n=355) Diarrhea22%27% Nausea20%19% Upper respiratory infection15%16% Headache15%12% Fatigue14%13% Ocular icterus1%14% DeJesus E, et al, Lancet 2012; 379:

36 Slide 36 of 50 From MS Saag, MD and ES Daar, MD at San Francisco, CA: March 29, 2013, IAS-USA. TDF/FTC/EVG/COBI vs. EFV or ATV/r: Lipid changes P =0.001 P <0.001 P= P =0.44 P =0.006 Conclusion: While some lipid fractions better with Quad than EFV or ATV/r, overall differences were modest and unlikely to be of clinical significance. Sax P, et al, Lancet 2012: 379:: ; DeJesus E, et al, Lancet 2012; 379:

37 Slide 37 of 50 From MS Saag, MD and ES Daar, MD at San Francisco, CA: March 29, 2013, IAS-USA. EVG/COBI/TDF/FTC vs. EFV or ATV/r: Creatinine Changes Conclusion: Cobicistat is associated with reduced active secretion of creatinine in the renal tubules leading to initial rises in creatinine levels. Sax P, et al, Lancet 2012: 379:: ; DeJesus E, et al, Lancet 2012; 379:

38 Slide 38 of 50 From MS Saag, MD and ES Daar, MD at San Francisco, CA: March 29, 2013, IAS-USA. A5202: Study Design Stratified by screening HIV-1 RNA (< or ≥ 100,000 c/mL) Enrolled Followed through Sept 2009, 96 wks after last pt enrolled HIV-1 RNA ≥1000 c/mL Any CD4+ count > 16 years of age ART-naïve N=1858 Randomized 1:1:1:1 TDF/FTC QD ABC/3TC Placebo QD EFV QD ABC/3TC QD TDF/FTC Placebo QD EFV QD TDF/FTC QD ABC/3TC Placebo QD ATV/r QD ABC/3TC QD TDF/FTC Placebo QD ATV/r QD A B C D Arm ART-naïve 1857 enrolled Randomized 1:1:1:1 TDF/FTC QD EFV QD ABC/3TC QD TDF/FTC Placebo QD EFV QD TDF/FTC QD ABC/3TC Placebo QD ATV/r QD ABC/3TC QD TDF/FTC Placebo QD ATV/r QD

39 Slide 39 of 50 From MS Saag, MD and ES Daar, MD at San Francisco, CA: March 29, 2013, IAS-USA. No. at Risk ABC-3TC TDF-FTC A5202: Time to Virologic Failure in Patients with HIV RNA >100,000 c/mL Sax PE, et al. NEJM 2009;361: P<0.001, log-rank test Hazard ratio, 2.33 (95% CI, ) TDF-FTC (26 events) ABC-3TC (57 events) Probability of No Virologic Failure

40 Slide 40 of 50 From MS Saag, MD and ES Daar, MD at San Francisco, CA: March 29, 2013, IAS-USA. ABC/3TC vs. TDF/FTC Low Viral Load Stratum Sax PE, et al. JID 2011: 204:

41 Slide 41 of 50 From MS Saag, MD and ES Daar, MD at San Francisco, CA: March 29, 2013, IAS-USA. HEAT: Virologic Failure by Baseline HIV-1 RNA (A5202 Efficacy Endpoint) Percent without Virologic Failure n =n = Pappa K, et al. 17th IAC, Mexico City, Abst. THAB0304. Young B, et al. 48th ICAAC/46th IDSA, Washington, DC, Abst. H ABC/3TC TDF/FTC ≥500,000 c/mL 250,000 - <500,000 c/mL 100,000 - <250,000 c/mL <100,000 c/mL 41% 63% 18% 19% 18% 4% 22% 15% 0% 20% 40% 50% 80% 100% Proportion of Subjects with VF ~59% ~37%

42 Slide 42 of 50 From MS Saag, MD and ES Daar, MD at San Francisco, CA: March 29, 2013, IAS-USA. D:A:D Study: NRTIs and Risk of MI Lundgren J, et al. 16th CROI, Montreal, Canada, Abst. 44LB. Sabin C, et al. Lancet 2008;371: ZDV ddI ddC d4T 3TC ABC TDF #PYFU: 138,109 74,407 29,676 95, ,009 53,300 39,157 #MI: Recent Exposure*: yes/no Cumulative Exposure: per year ** Relative Risk of MI (95% CI) Adjusting for eGFR does not change ABC MI finding: Adjusted RR 1.89; 95% CI (1.46 – 2.44; P =0.0001) Adjusting for eGFR does not change ABC MI finding: Adjusted RR 1.89; 95% CI (1.46 – 2.44; P =0.0001) * Recent use=current or within the last 6 months. **Not shown (low number of patients currently on ddC)

43 Slide 43 of 50 From MS Saag, MD and ES Daar, MD at San Francisco, CA: March 29, 2013, IAS-USA. Concerns regarding NRTIs Many studies have not seen relationship between ABC and CV events TDF-associated with greater decline in bone mineral density TDF-associated with variable decline in renal function

44 Slide 44 of 50 From MS Saag, MD and ES Daar, MD at San Francisco, CA: March 29, 2013, IAS-USA. Preferred Regimens EFV/TDF/FTC ATV/r + TDF/FTC DRV/r (once daily) + TDF/FTC RAL + TDF/FTC [Pregnant Women Only: LPV/r (twice daily) + ZDV/3TC] Alternative Regimens EFV + ABC/3TC RPV + (TDF or ABC)/(FTC or 3TC) ATV/r or DRV/r + ABC/3TC FPV/r or LPV/r (qd or bid) ABC/3TC or TDF/FTC RAL + ABC/3TC EVG/COBI/TDF/FTC (9/18/12) Acceptable Regimens EFV or RPV + ZDV/3TC NVP + TDF/FTC or ZDV/3TC or ABC/3TC ATV + (ABC or ZDV)/3TC ATV/r, DRV/r, LPV/r, FPV/r, RAL + ZDV/3TC MVC + ZDV or ABC/3TC SQV/r + TDF/FTC or ABC/3TC or ZDV/3TC (with caution) DHHS Guidelines for Adolescents/Adults: What to Start DHHS Guidelines. Available at: Revision March 27,

45 Slide 45 of 50 From MS Saag, MD and ES Daar, MD at San Francisco, CA: March 29, 2013, IAS-USA. ART: What to Start IAS–USA Recommendations, 2012 Thompson MA, et al. JAMA. 2012;308(4): ComponentRecommended Regimens NNRTI plus nRTIs Efavirenz/tenofovir/emtricitabine (AIa) Efavirenz plus abacavir/lamivudine (AIa) in HLA-B*5701-negative patients with baseline plasma HIV-1 RNA <100,000 copies/mL PI/r plus nRTIs Darunavir/r plus tenofovir/emtricitabine (AIa) Atazanavir/r plus tenofovir/emtricitabine (AIa) Atazanavir/r plus abacavir/lamivudine (AIa) in patients with plasma HIV-1 RNA <100,000 copies/mL InSTI plus nRTIs Raltegravir plus tenofovir/emtricitabine (AIa)

46 Slide 46 of 50 From MS Saag, MD and ES Daar, MD at San Francisco, CA: March 29, 2013, IAS-USA. Your Patient 43 year old man found to be HIV infected HIV VL 56,000 c/ml CD4 count 340 cells/ul Seropositive for HBV

47 Slide 47 of 50 From MS Saag, MD and ES Daar, MD at San Francisco, CA: March 29, 2013, IAS-USA. Initial Evaluation Physical exam: normal; no hepatosplenomegaly Initial laboratory studies – ALT 1.7 x ULN, bilirubin normal – Platelet count: 150,000 – HCV Ab negative – HBV DNA 6.1 x 10 5 IU/mL – HBsAg+ / HBeAg+

48 Slide 48 of 50 From MS Saag, MD and ES Daar, MD at San Francisco, CA: March 29, 2013, IAS-USA. FDA Approved Therapies First Line TherapyYear Peginterferon alfa-2a2005 Entecavir2005 Tenofovir2008 Second Line TherapyYear Adefovir dipivoxil2002 Telbivudine2006 Third Line TherapyYear Lamivudine1998 Available at Accessed 02/18/10. CLDF HBV Advisory Board

49 Slide 49 of 50 From MS Saag, MD and ES Daar, MD at San Francisco, CA: March 29, 2013, IAS-USA. Response HBeAg- Patients (Study 102) HBeAg+ Patients (Study 103) Year 5Year 6Year 5Year 6 HBV DNA < 400 copies/mL Intent-to-treat *, % (n/N) 83 (291/350) 81 (281/345) 65 (150/248) 63 (157/251) HBV DNA < 400 copies/mL On treatment †, % (n/N) 99 (292/295) 99.6 (283/284) 97 (170/175) 99 (167/169) ♦ 80% of 585 patients entering the open-label phase remained on study at year 6; 73% of enrolled patients remained on study ♦ HBeAg loss/seroconversion rates of 50% and 37%, respectively, through 6 years ♦ 11% of HBeAg+ patients had confirmed HBsAg loss (8% with seroconversion) ♦ No resistance to TDF was detected through 6 years TDF: Virologic Suppression at Year 6 Marcellin P, et al. AASLD 2012; Boston. #374.

50 Slide 50 of 50 From MS Saag, MD and ES Daar, MD at San Francisco, CA: March 29, 2013, IAS-USA. Months 33% HBsAg Loss Occurred in 33% of HBeAg+ Pts Treated With 5 Years of ETV HCC developed at yearly rate of 2.5% despite good viral suppression Conclusions: Long-term ETV monotherapy efficiently suppressed HBV replication in naïve HBV patients High rates of HBsAg loss can also be seen with this therapy Lampertico P, et al. 63rd AASLD; Boston, MA; November 9-13, 2012; Abst Patients at risk HBsAg Loss in HBeAg-positive Patients


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