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Boceprevir and Telaprevir: Efficacy and Side Effects, What Have We Learned in 2013

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Boceprevir and Telaprevir: Efficacy and Side Effects, What Have We Learned in 2013 Boceprevir and telaprevir: efficacy and side effects, what have we learned in 2013 Fred Poordad, MD VP, Academic and Clinical Affairs The Texas Liver Institute Professor of Medicine University of Texas Health Science Center San Antonio, Texas Disclosures • Grant/Research support: Abbott Laboratories, Achillion Pharmaceuticals, Anadys Pharmaceuticals, Biolex Therapeutics, Boehringer Ingelheim, Bristol-Myers Squibb, Gilead Sciences, GlaxoSmithKline, GlobeImmune, Idenix Pharmaceuticals, Idera Pharmaceuticals, Inhibitex Pharmaceuticals, Intercept Pharmaceuticals, Janssen, Medarex, Medtronic, Merck & Co., Novartis, Pharmasset, Roche, Schering-Plough, Santaris Pharmaceuticals, Scynexis Pharmaceuticals, Vertex Pharmaceuticals, ViroChem Pharma, ZymoGenetics; • Speaker: Gilead, Merck, Vertex, Salix, Onyx/Bayer, Kadmon, Janssen • Consultant/Advisor: Abbott Laboratories, Achillion Pharmaceuticals, Anadys Pharmaceuticals, Biolex Therapeutics, Boehringer Ingelheim, Bristol-Myers Squibb, GlaxoSmithKline, GlobeImmune, Inhibitex Pharmaceuticals, Merck & Co., Pharmasset, Santaris Pharmaceuticals, Tibotec/Janssen, Theravance. Outline • Creating the infrastructure to treat HCV successfully • Dealing with interferon side effects • Who responds well to the first wave protease inhbitors • Factors that can help decide who should be treated • Adverse events of first wave protease inhibitors and who not to treat Optimizing Adherence: A Collaborative Care Approach Hepatologists Gastroenterologists Internists/ID Social workers NPs/PAs/RNs Collaborative Care Approach Medication Other medical reimbursement specialists specialists Yozviak JL, et al. 2011 International Conference on Viral Hepatitis. Abstract 70752. Gujral H, et al. Cleve Clin J Med. 2004;71(suppl 3):S33-S37. Patient Education Is the Foundation of HCV Management • HCV transmission – Review CDC recommendations and go over high risk behavior risks • HCV natural history for that patient based on host/viral factors • Liver healthy lifestyle – Achieve and/or maintain a normal BMI – Avoid alcohol • Drug–drug interactions with HCV PIs – Careful medication history • Avoid pregnancy during and for 6 mos after RBV-based therapy Organ Systems Affected by Interferon Constitutional Ophthalmologic Events Disorders Neuropsychiatric Infectious Events Diseases Dermatologic Autoimmune Disorders Disorders Cardiovascular Hematologic Disorders Disorders Pulmonary GI Events Events Sulkowski MS, et al. Nat Rev Gastroenterol Hepatol. 2011;8:212-223. Peginterferon and Depression (Incidence 20%-60%) Contributors Symptoms • Pre-existing depressive and/or • Depression-specific symptoms anxiety symptoms - Low mood - Anhedonia • Depression during previous - Anxiety treatment - Cognitive complaints • RBV-induced anemia - Suicidal ideation and/or suicide (severe depression) • Long treatment duration • Neurovegetative symptoms • Lack of social support - Fatigue • Thyroid dysfunction - Anorexia - Pain • HIV coinfection - Psychomotor slowing • Organic brain impairment • HTR1A allelic variation Sulkowski MS, et al. Nat Rev Gastroenterol Hepatol. 2011;8:212-223. Sung H, et al. Curr Hepatitis Rep. 2011;10:33-44. Ribavirin: Anemia • Signature adverse event IDEAL Study: Hemoglobin – Incidence: up to 30% LD pegIFN alfa 2b + RBV (n=1008) • Common reason for SD-pegIFN alfa 2b + RBV (n=1000) PegIFN alfa 2a + RBV (n=1034) – Dose reduction: 9% to 22% 31% – Discontinuation: ~5% 30% • Hemoglobin reduction within the first 4 25% weeks of therapy – 2.5 to 3.0 g/dL • Impact (%) Patients – Persistent fatigue, shortness of breath, lower quality of life scores 3.8% 2.1% 2.5% Hemoglobin Discontinued: <10 g/dL Hemoglobin Sung H, et al. Curr Hepatitis Rep. 2011;10:33-44. <8.5 g/dL Reddy KR, et al. Gastroenterol. 2010;139:1972-1983. LD: low-dose; SD: standard-dose. McHutchison JG, et al. N Engl J Med. 2009;361:580-593. Sulkowski MS, et al. Nat Rev Gastroenterol Hepatol. 2011;8:212-223. Ribavirin: Dermatologic Adverse Events • Ribavirin monotherapy – May cause rash and pruritus Ribavirin Ribavirin Rash Interrupted • Combination with peginterferon – Increase incidence of dermatologic adverse events than with either drug alone • Generalized pruritus • Skin xerosis • Eczematiform lesions (extremities) • Management – Transient rashes • Topical corticosteroids • Ribavirin treatment interruption not needed – Discontinue ribavirin • Acute hypersensitivity reaction Sulkowski MS, et al. Nat Rev Gastroenterol Hepatol. 2011;8:212-223. Sung H, et al. Curr Hepatitis Rep. 2011;10:33-44. Ribavirin: Teratogenic Events • Pregnancy Category X Pregnancy 6 Months First – Contraindicated in pregnant woman and in the Outcomes Prior LMP Trimester male partners of pregnant women (2003-2009) (n=173) (n=173) • Avoid pregnancy during and 6 months post Direct exposure 90.6 9.4 ribavirin treatment completion outcomes (%) – Use 2 reliable forms of effective contraception Live births 52.9 4.7 Miscarriage 11.8 2.4 • Ribavirin-induced testicular toxicity Elective termination 25.9 2.4 – Recovery within 1 or 2 spermatogenesis cycles Fetal death/still birth -- -- following cessation of ribavirin therapy Indirect exposure 87.3 10.9 • Ribavirin pregnancy registry outcomes (%) – Birth defect rate Live births 53.6 7.3 • Direct exposure: 6.1% (1.2-16.9) Miscarriage 10.9 3.6 • Indirect exposure: 4.3 (0.9-12.2) Elective termination 21.8 -- Fetal death/still birth 0.9 -- Sung H, et al. Curr Hepatitis Rep. 2011;10:33-44. Roberts SS, et al. Birth Defects Res A Clin Mol Teratol. 2010;88:551-559. http://www.ribavirinpregnancyregistry.com/. The Addition of First Wave DAAs: Protease Inhibitors Telaprevir and Boceprevir SVR Rates With BOC or TVR + PR According to Treatment History 100 Relapsers Naive Partial Responders Null Responders 69-83 80 63-75 60 40-59 SVR (%) SVR 29-40 40 20 0 Poordad F, et al. N Engl J Med. 2011;364:1195-1206. Jacobson IM, et al. N Engl J Med. 2011;364: 2405-2416. Bacon BR, et al. N Engl J Med. 2011;364:1207-1217. Zeuzem S, et al. N Engl J Med. 2011;364: 2417-2428. Bronowicki JP, et al. EASL 2012. Abstract 11. Who is a Reasonable Candidate for Treatment Now? • First Criteria: – must be interferon willing and responsive • Secondary Considerations: – May not be able to safely wait for future therapies. Ie) advancing liver disease – May not have access to future therapies – May have non-hepatic complications of HCV such as cryoglobulinemia, etc – May want to be cured for non-medical reasons Some Baseline Predictors Can Help Guide Us • Subtype • Past treatment experience • Fibrosis • Ethnicity • IL28B Status • BMI/DM Baseline Predictors of SVR: SPRINT 2 and RESPOND 2 Poordad F, et al. Gastroenterology 2012;143(3):608-618 . SVR According to Race ADVANCE (TVR): Naive Patients With Genotype 1 HCV T12PR 100 PR48 80 75 74 75 62 60 46 44 39 SVR (%) SVR 40 25 20 n/N = 244/ 147/ 16/ 7/ 26/ 15/ 245/ 143/ 325 318 26 28 35 38 328 323 0 White Black Latino Non-Latino Jacobson IM, et al. N Engl J Med. 2011;364:2405-2416. SVR According to Race SPRINT-2 (BOC): Naive Patients With Genotype 1 HCV BOC/PR48 100 BOC/PR RGT PR48 80 68 67 60 53 42 40 SVR (%) SVR 40 23 20 n/ 213/ 211/ 125/ 29/ 22/ 12/ N = 311 316 311 55 52 52 0 Nonblack Black Poordad F, et al. N Engl J Med. 2011;364:1195-1206. IL-28B Predicts SVR with Boceprevir and Telaprevir SVR % SVR SPRINT 2 ADVANCE Poordad, et al. Gastroenterology. 2012;143(3):608-618 Jacobson, et al. Presented at the European Association for the Study of the Liver Annual Meeting; March 30–April 3, 2011; Berlin, Germany. Abstract 1369 On Treatment Response is Best Assessment of IFN Response High SVR rates in Early Viral Responders SPRINT-2: BOC + PegIFN/RBV in GT1 Treatment-Naive Patients . 57% of patients undetectable at week 8 and eligible for shorter therapy HCV RNA undetectable HCV RNA detectable at Week 8, at Weeks 8 through24 undetectable at Week 24 Nonblacks Blacks 100 97 96 95 100 93 100 87 88 80 74 74 80 62 66 58 60 60 40 40 SVR (%) SVR 20 20 37/ 78/ 143/ 52/ 137/ 48/ n/ 3/ 8/ 13/ 7/ 18/ 7/ 40 118 147 70 142 65 N = 3 13 15 12 19 8 0 0 PR48 BOC/PR BOC/PR PR48 BOC/PR BOC/PR RGT 48 Wks RGT 48 Wks Poordad F, et al. N Engl J Med. 2011;364:1195-1206. IL-28B CC Polymorphism is the Best Predictor of Early Response CC CT + TT RNA by TW8 by RNA - HCV % Patients with undetectable 118 158 41 80 132 304 50 156 SPRINT-2 RESPOND-2 *Decision point for short vs. long treatment duration with RGT Early Interferon Response (Lead-In) Further Defines Likelihood of Success for Non-CC Patients 1 1 0 2 2 56 83 58 27 19 20 37 83 109 20 6 10 13 23 26 2 3 4 75 102 72 51 45 117 111 133 25 25 26 28 34 CC CT TT Poordad F, et al. Gastroenterology 2012;143(3):608-618 . Early Responders do Well Early Response has Two Critical Time Points • Week 4 of Interferon and Ribavirin when using Lead In • Week 8 (4 weeks into boceprevir dosing) • Week 4 and 12 of Telaprevir based therapy Those with advanced fibrosis do not do well SVR by Fibrosis Stage With Boceprevir or Telaprevir Fibrosis Stage SVR Rate (Phase III Trials), % Treatment-naive patients (TVR and BOC)[1,2] Stage 0/1/2 67-78 Stage 3/4 41-62 Treatment-experienced patients Stage 0/1/2 (BOC)[3] 66 Stage 3/4 (BOC)[3] 44 Relapser (TVR)[4] . No/minimal/portal 86 . Bridging 85 . Cirrhosis 84 Partial responder (TVR)[4] . No/minimal/portal 72 . Bridging 56 . Cirrhosis 34 Null responder (TVR)[4] . No/minimal/portal 41 . Bridging 39 . Cirrhosis 14 1. Jacobson IM, et al. N Engl J Med. 2011;364:2405-2416. 2. Poordad F, et al. N Engl J Med. 2011;364:1195-1206. 3. Bacon BR, et al. N Engl J Med. 2011;364:1207-1217. 4. Zeuzem S, et al. EASL 2011. Abstract 5. REALIZE: SVR by Baseline Fibrosis Stage and Prior Response Prior Relapsers Prior Partial Responders Prior Null Responders Pooled T12/PR48 PBO/PR48 SVR (%) n/N= 144/167 12/38 53/62 2/15 48/57 2/15 34/47 3/17 10/18 0/5 11/32 1/5 24/59 1/18 15/38 0/9 7/50 1/10 No, minimal Bridging Cirrhosis No, minimal Bridging Cirrhosis No, minimal Bridging Cirrhosis Stage or portal fibrosis or portal fibrosis or portal fibrosis fibrosis fibrosis fibrosis 27 Zeuzem S, et al.
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