The Goal of HBV Therapy. Key Points. The Twin Pillars of HBV Therapy

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1 How to Follow Once You tart Hepatitis B Treatment And When To Worry About esistance American College of Gastroenterology October 16, 21 ra Jacobson, MD Vincent Astor Professor of Medicine Chief, Division of Gastroenterology and Hepatology Weill Cornell Medical College Attending Physician NewYork-Presbyterian Hospital The Goal of HBV Therapy Long term viral suppression mproved clinical outcomes equires finite course of therapy in some patients HBeAg seroconversion Long term treatment in others HBeAg-positive without seroconversion HBeAg-negative The Twin Pillars of HBV Therapy Key Points POFOUND VAL UPPEON AVODANCE OF ETANCE The goal in following patients on HBV therapy is to ensure that the dual goals of complete viral suppression and prevention of resistance are met. The best way to manage HBV resistance is to prevent it from developing in the first place by using a potent drug with an excellent resistance profile. Worry about resistance when there is viral breakthrough in a compliant patient, or viral persistence at a point when resistance may have emerged. Manage resistance by adding a drug from the other class. Jacobson M. J Hepatol. 28;48: A Fundamental Principle of esistance esistant virions emerge from pool of actively replicating virus Antiviral drug Less residual virus, less opportunity for resistance to emerge Which Drugs Are Most Likely To Enable us to each our Goals of Durable Viral uppression Without Viral esistance? 1

2 Treatment Guidelines: ecommendations for First-Line Therapy HBeAg Positive or Negative Chronic HBV Preferred Alternative Not Preferred Tenofovir DF Adefovir Lamivudine Entecavir Telbivudine* Peg-FN alfa-2a % Nucleoside-Naïve Cohort, HBeAg(+) & HBeAg(-): Cumulative Probability of ETV esistance Through 6 Years ETVr = LVDr (M24 ± L18M) + T184, 22 and/or M25 substitutions *HBV DNA must be undetectable at 24 weeks to continue Lok A, et al. Hepatology. 29;5: Available at: Keeffe EB, et al. Clin Gastroenterol Hepatol. 28;6: N= Brett-mith H., EAL 29; oral 2 esistance With Long-Term Treatment in Nucleoside-Naïve Patients Patients With esistance (%) Lamivudine 1 Adefovir 2 Telbivudine 3 1. Lok AF et al. Gastroenterology. 23;125: Hadziyqnnis J et al. Gastroenterology. 26;131: Tyzeka (telbivudine) Prescribing nformation. Novartis Pharmaceuticals Corporation, East Hanover, NJ. April, Year 1 Year 2 Year 3 Year 4 Year 5 The design of ETV-91 (rollover from.5 mg to 1. mg/day raises a question about how to treat patients: What should the long-term dose of entecavir be? Entecavir.5 mg/day is probably enough: Nonpivotal trials show excellent long term viral suppression with the.5 mg dose (e.g. eto et al, 21) HBeAg-Positive Patients Treated Up to 5 Years With Entecavir Tenofovir Pivotal tudy 12 (HBeAg-negative): Three Year Viral uppression (not TT) Proportion of Patients Achieving HBV DNA < 3 copies/ml through 5 Yrs Patients (%) ETV-22 Overall Cohort n = Yr Han, et al. AALD 28. Abstract 893. HBeAg-Positive ETV Long-term Cohort (ETV-22 ETV-91) Yr 1 Yr 2 Yr 3 Yr 4 Yr /354 8/ /14 116/131 98/18 88/94* (%) Patients with HBV DNA < 4 copies/ml andomized Double-Blind Open-label TDF On-treatment On-treatment observed observed 1 99% TDF-TDF 9 1% ADV-TDF % LAM-Exp Weeks on tudy ncludes 3 patients who had HBV DNA <4 copies/ml at week 144 on FTC + TDF Marcellin P et al, AALD 29, Poster 481 2

3 Tenofovir Pivotal tudy 13 (HBeAg-positive) : Three Year Viral uppression (Not TT) (%) Patients with HBV DNA < 4 copies/ml andomized Double-Blind Open-Label TDF Weeks on tudy ncludes 17 patients who had HBV DNA <4 copies/ml at week 144 on FTC + TDF On-treatment observed 95% TDF-TDF 91% ADV-TDF Definitions of esponse nterferon: Primary nonresponse: < 1 log decline in HBV DNA at 3 months Virologic response: HBV DNA < 2 U/mo at 24 weeks erologic response: HBeAg seroconversion (in e+ pts) Nucleosides and nucleotides: Primary nonresponse: < 1 log decline in HBV DNA at 3 months Virologic response: Undetectable HBV DNA at 48 weeks virologic response: > 1 log decline in HBV DNA but HBV DNA detectable Use to modify therapy at wks depending on drug being used EAL Clinical Practice Guidelines, Hepatology 29;5: Heathcote E-J, et al., AALD 29; Poster #483. ummary of esistance Analyses of TDF-Treated Patients Through Year 3 Number of patients Total Patients on tudy Patients with esistance Patients > 4 copies/ml (91%) 364 (85%) (9%) 24 (6%) 13* (4%) 1 5 Year 1 Year 2 Year 33 now-lampart A, et al., AALD 29; Poster # Number of patients Monitoring the Patient on HBV Treatment Combined ecommendations from AALD and EAL Guidelines nterferon CBC, liver panel every 4 weeks HBV DNA every 12 weeks Thyroid panel every 12 weeks HBeAg and anti-hbe every 24 weeks (for e+ patients) Change to nucleos(t)ide for primary nonresponse Nucleosides/nucleotides Liver panel every 12 weeks HBV DNA at week 12 and every weeks HBeAg and anti-hbe every 24 weeks (for e+ patients) HBsAg every 6-12 months in HBeAg negative pts with undetectable HBV DNA Lok AF, McMahon BJ. Hepatology 29;5:1-38 EAL Practice Gudelines, J Hepatology 29;5: * includes 7 patients on FTC+TDF combination therapy HBV oadmap (Oral Therapy): Definitions of Virologic esponse Following the Patient Once Treatment Has Been nitiated Primary Non-esponse at Week 12 (HBV DNA <1 log 1 U/mL decrease from baseline) esponse (PC Negative) esponse (HBV DNA >6 to <2 U/mL) esponse (HBV DNA >2 U/mL) Keeffe EB, et al. Clin Gastroenterol Hepatol. 28;6:

4 HBV oadmap: Treatment esponse to HBV DNA Does witching to a More Potent Drug Work? Entecavir in uboptimal esponders to Adefovir: (< 2 log reduction in HBV DNA at 24 wks or HBV DNA+ at 48 Weeks) No resistance to ETV esponse (PC Negative) esponse (HBV DNA >6 to <2 U/mL) esponse (HBV DNA >2 U/mL) HBV DNA neg % No Change in Treatment Keeffe EB, et al. Clin Gastroenterol Hepatol. 28;6: Nguyen M et al, AALD 21 #383 HBV oadmap: Treatment esponse to HBV DNA esponse (PC Negative) Low Genetic Barrier Drug witch or add alternative drug More frequent monitoring (every 3 months) esponse (HBV DNA >6 to <2 U/mL) Keeffe EB, et al. Clin Gastroenterol Hepatol. 28;6: esponse (HBV DNA >2 U/mL) High Genetic Barrier Drug No change in treatment More frequent monitoring (every 3 months) % of Patients with HBV DNA <69 U/mL (<4 copies/ml) by Baseline Mutation Category (missing/switch = failure) Percentage (%) Tenofovir in ADV uboptimal esponders Composite of 3 studies of TDF in ADV suboptimal responders Weeks on TDF Treatment Adv-r(N=12) Neither Lam-r/Adv-r(N=141) Lam-r(N=7) 1/12 (83%) patients with ADV- achieved HBV DNA <4 copies/ml on TDF monotherapy 6/7 (86%) patients with LAM- achieved HBV DNA <4 copies/ml on TDF monotherapy 86% 83% 75% Manns M et al, EAL 21 HBV oadmap: Treatment esponse to HBV DNA A implified oad Map for 21 esponse (PC Negative) esponse (HBV DNA >6 to <2 U/mL) esponse (HBV DNA >2 U/mL) witch or Add Alternative Therapy Narrow Monitoring Frequency Essential principle: Use a potent drug with an outstanding resistance profile (entecavir or tenofovir) Aim for negative HBV DNA in all patients by week 48 of therapy f levels low and still falling at week 48 with a potent agent, can continue if drug has robust resistance profile f low level and stable at > 48 weeks, switch or add a drug from the other class Keeffe EB, et al. Clin Gastroenterol Hepatol. 28;6:

5 A implified oad Map for 21 + witch or add Entecavir or Tenofovir HBV DNA+ (marked decline and still falling) Continue to week Continue 48 weeks HBV DNA HBV DNA+ (plateau) Add second drug HBV DNA- Continue esistance: ecognition and Management When is esponse Good Enough to Continue a Potent Drug? Predictive Value of Virologic esponse (PV) to Entecavir PV = HBV DNA >8 U/ml at wk 48 but >1 log decline 3 (19%) had PV to entecavir 16 had HBV DNA <1 U/ml 14 (88%) negative at week 96, no resistance 14 had HBV DNA > 1 U/ml 11 continued ETV alone 2 (18%) became HBV DNA negative at wk 96 Continuous viral decline observed in most of the rest Conclusion: Can continue ETV monotherapy after 1 year in most patients with PV Zoutendijk et al, AALD 21 #448 HBV DNA (Log 1 U/mL) ALT (U/mL) Manifestations of Antiviral esistance ULN Antiviral Treatment Virologic Breakthrough Genotypic esistance Virologic ebound Years Adapted from Lok AF, McMahon BJ. Hepatology. 29;5:1-36. Hepatitis Flare Biochemical Breakthrough Tenofovir witch for uboptimal esponse to Entecavir etrospective analysis: 7/236 patients (3%) with suboptimal response to ETV monotherapy switched to TDF (< 1 log decline in HBV DNA after 6 mo of ETV) LAM experienced: n = 2 (ETV dosed at 1. mg/day) No mutations identified at switch to TDF Mean ETV duration: 77 wks (range: ) With mean TDF duration of 34.8 wks (range: 16-76), all 7 cases achieved complete HBV DNA suppression HBV DNA < 16 copies/ml No patients had virologic breakthrough Wild-type M24 L18M + M24V A181T/V Cross-esistance Data for the Most Frequent esistant HBV Variants HBV Variant (Amino Acid ubstitutions) N236T L18M + M24V/ ± 169T ± V173L ± M25V L18M + M24V/ ± T184G ± 22/G Lamivudine Level of usceptibility Telbivudine Entecavir ntermediate - ensitive (educed usceptibility) *esistance to tenofovir has not been described so far Adefovir - esistant Tenofovir* Pan C, et al. AALD 28. Abstract 932. Adapted from EAL Clinical Practice Gudelines: Management of Chronic Hepatitis B, J Hepatology 29;5:

6 Methods to Detect HBV esistance Virological Breakthrough and ADV esistance in LAM- Patients ADV witch vs Add-on for LAM-esistant HBeAg neg CHB Commercially Available tandard populationbased sequencing Less sensitive Detects variants present at 25% of viral population Needed to detect new, previously undescribed substitutions NNO-LPA More sensitive Detects variants present at 5% of viral population Only detects only known mutations FLP esearch Allelespecific PC Detect variants present at 1% of the viral population Like NNO-LPA, only detects known mutations Coming soon: ultra deep sequencing Endpoints Virologic Breakthrough* All (N = 537) ADV Mono (n = 273) ADV+ LAM (n = 264) P value 8 (15%) 67 (24%) 13 (5%) <.1 ADV esistance** 29 (5%) 29 (11%) (%) <.1 Lampertico et al. EAL; April 11-15, 27; Barcelona, pain. Poster 52. When to Perform esistance Testing s Tenofovir Different From Adefovir? Tenofovir in LAM- CHB Virologic breakthrough Consider compliance if no resistant mutations present Most breakthroughs in ETV and TDF trials have not been associated with documented resistance esidual viremia at late stage of treatment when HBV DNA undetectability would be expected (depends on drug) % Patients Lamivudine naïve (n=377) Lamivudine experienced (n=49) P= P= P= Histological HBV DNA esponse mprovement <4 copies/ml No resistance to tenofovir was documented at week 48 for any subject. Manns M et al. J Hepatol. 28;48 (uppl. 2):33 (abstract 74). Tenofovir Monotherapy in Patients With Prior Adefovir Failure: Probability of Achieving Virologic esponse The Lesson Learned From Lamivudine esistance: Add, Don t witch hould it be extrapolated to all HBV resistance? Probability of HBV DNA <4 copies/ml Months P<.1 P<.7 ADV experienced, no resistance ADV resistance HBV DNA <1 7 at BL HBV DNA >1 7 at BL Van Bömmel F et al. Hepatology. 21;51:

7 Antiviral-esistant HBV: Treatment Lamivudine resistance Adefovir resistance AALD Guidelines Add adefovir or tenofovir top lamivudine, switch to Truvada Use tenofovir with entecavir Add lamivudine top adefovir, switch to Truvada witch to or add entecavir Entecavir resistance witch to or add tenofovir or Truvada Telbivudine resistance Add adefovir or tenofovir top telbivudine, switch to Truvada eroconversion top 12 months later Treatment Endpoints HBeAg+ No seroconversion Continue Therapy in cirrhotics should be continued until PC negative and loss of HBsAg HBeAg- Treat indefinitely Change regimen (switch or add) for incomplete response Lok AF, McMahon BJ. Hepatology 29;5:1-36. Keeffe EB et al. Clin Gastroenterol Hepatol. 28;6: Treatment of Established esistance One Drug From Each Class Nucleotides Lamivudine Telbivudine Entecavir Emtricitabine (FTC)* *Available with tenofovir Nucleotides Adefovir Tenofovir Conclusions Choose agents that confer high potency and excellent resistance profiles Follow to assess HBV DNA, chemistries, HBeAg/Ab, and HBsAg at appropriate intervals (q12weeks for HBV DNA) Aim for complete viral suppression in all patients: think about change if residual viremia present after 1-2 years; sooner if drug with low genetic barrier to resistance is used (but why should it be? esistance unlikely even with late residual viremia but check for it when change is contemplated or with virologic breakthrough do not take compliance for granted Combination therapy (nucleoside and nucleotide) for established resistance Consider entecavir and tenofovir for multiresistant HBV Entecavir and Tenofovir Combination Therapy 52 patients with advanced fibrosis/cirrhosis Median 3 lines of pretreatment with incomplete response 6% HBeAg positive % 81 Median 12 mo No lactic acidosis No renal impairment 8 42/52 4/52 Peterson J et al, EAL 21 abstract 12 7

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