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Stakeholder Insight: Hepatitis B & C - Winning Battles But Not The War
Datamonitor, Dec 2004, Pages: 329
CHAPTER 1 EXECUTIVE SUMMARY 3
Scope of the analysis 3
Insight into the Hepatitis B and C market 4
Despite substantial prevalence for both HBV and HCV, the incidence of new infections within the seven major markets has reduced over the last decade due to HBV vaccination, increased blood and pre-natal screening along with awareness campaigns regarding routes of transmission. Our recent physician survey indicates that while diagnosis rates of HBV have remained flat since 2002, HCV diagnosis rates have increased 2–4 fold, with highest growth in Japan. 4
Average treatment rates for HBV and HCV within the seven major markets are calculated at 53% and 58%, respectively. Based on current estimates of prevalence and diagnosis, this determines current patient pools of between 1.8–2.0m per disease, where a large majority (60–80%) are receiving first-line therapy. To increase the treatment pool, manufacturers of hepatitis treatments can either tap into a substantial amount of unidentified cases or meet the needs of non-responder or ‘difficult-to-treat’ patients. 4
Lamivudine dominates first-line therapy for hepatitis B, with adefovir a first switch for resistant virus. This standard sequence is modulated by market cost-sensitivity, HIV co-infection and increasing use of peginterferon monotherapy (20–30%). Our research has also uncovered off-label use of tenofovir and experimental combinations but, in general, current options are suboptimal for growing numbers of HBeAg- patients and the ultimate goal of cccDNA clearance. 4
Increased uptake and aggressive life-cycle management of peginterferons (plus ribavirin) have driven the current standard of care to 73% of first-line choice for HCV. Our physician research (180 respondents) reveals higher use of branded peginterferon plus ribavirin packages, where consistency was cited as key selection criterium. Again, the treated patient pool will be increased by higher diagnosis, redefinition of ‘normal’ ALT and maintenance therapy. However, the needs of non-responders, genotype 1 and intolerant patients will not be satisfied in the short term. 5
CHAPTER 2 COVERAGE 16
Coverage of the Stakeholder Insight Survey 16
CHAPTER 3 ETIOLOGY AND EPIDEMIOLOGY 17
HBV and HCV epidemiology 17
HBV epidemiology 18
HCV epidemiology 20
Disease definition and etiology 23
HBV 24
Basic virology and serology 24
Disease progression 27
Complications and risk factors 34
Transmission 35
HCV 39
Basic virology and serology 39
Disease progression 41
Clinical manifestations 44
Risk factors 44
Transmission 45
Key patient segmentations 47
Comorbidities and complications 52
Liver fibrosis/cirrhosis 52
Hepatocellular carcinoma (HCC) 54
Coinfection with other viruses (HDV, HIV and HBV/HCV) 55
Coinfection with HDV 56
Coinfection with HIV 56
HBV/HCV coinfection 57
Fatty liver (steatosis) 58
Transplant patients 59
CHAPTER 4 DIAGNOSIS AND TREATMENT RATES 60
Presentation and diagnosis rates 60
HBV 60
HCV 64
Treatment rates 69
HBV 69
HCV 70
CHAPTER 5 TREATMENT OPTIONS 71
HBV Therapy 72
Approved treatment options 76
Interferons 77
Antivirals 78
Combination therapy 81
Actual prescription choices 83
Prevention 92
Active immunization: HBV vaccination 92
Passive immunization: immune prophylaxis with HBIG 94
HCV therapy 95
Approved treatment options 97
Interferon (IFN) monotherapy 98
Combination therapy 100
Actual prescription choices 101
Treatment guidelines 113
HBV 113
Normal versus elevated ALT levels 115
Viral threshold: HBV DNA levels 117
HCV 118
Prolongation of treatment & maintenance therapy 120
Normal versus elevated ALT levels 121
Liver histology as assessed by liver biopsy 121
Niche populations 122
HBV 122
HBeAg- patients 122
Others 122
HCV 123
Partial responders, non-responders and relapsers 123
Genotype 1 and racial differences 124
CHAPTER 6 PRESCRIBING TRENDS AND INFLUENCING FACTORS 126
Factors influencing physician decision making: HBV therapy 127
Rating of drugs currently used for HBV therapy 128
Conclusions 135
Factors influencing physician decision making: HCV therapy 137
Rating of drugs currently used for HCV therapy 138
PegIntron versus Pegasys 140
Conclusions 150
Treatment outcomes 151
HBV 151
Durability of treatment response 151
Complications, morbidity and mortality 152
HCV 153
Durability of treatment response 153
Complications, morbidity and mortality 154
Unmet needs 154
HBV 154
Diagnostic unmet needs 154
Physician/patient education 155
Patient perspective 156
Therapeutic unmet needs 157
HCV 160
Diagnostic unmet needs 160
Physician/patient education 160
Patient perspective 161
Therapeutic unmet needs 162
CHAPTER 7 COUNTRY TREATMENT TREES 166
CHAPTER 8 OPINION LEADER TRANSCRIPTS 181
Key opinion leader 1 – Spanish Infectious Disease physician 181
SECTION 1 – Epidemiology 181
SECTION 2 – Presentation and diagnosis 181
SECTION 3 – Disease treatment and management 182
HBV 182
HCV 188
Key opinion leader 2 – Japanese Hepatologist 193
SECTION 1 – Epidemiology 193
SECTION 2 – Presentation and diagnosis 194
SECTION 3 – Disease treatment and management 195
HBV 195
HCV 199
Key opinion leader 3 – Italian Infectious Disease physician 202
SECTION 1 – Epidemiology 202
SECTION 2 – Presentation and diagnosis 202
SECTION 3 – Disease treatment and management 204
HBV 204
HCV 211
Key opinion leader 4 – French Hepatologist 218
SECTION 1 – Epidemiology 218
SECTION 2 – Presentation and diagnosis 218
SECTION 3 – Disease treatment and management 219
HBV 219
HCV 225
Key opinion leader 5 – UK Infectious Disease physician 229
SECTION 1 – Epidemiology 229
SECTION 2 – Presentation and diagnosis 229
SECTION 3 – Disease treatment and management 232
HBV 232
HCV 240
Key opinion leader 6 – Spanish Hepatologist 249
SECTION 1 – Epidemiology 249
SECTION 2 – Presentation and diagnosis 249
SECTION 3 – Disease treatment and management 251
HBV 251
HCV 257
Key opinion leader 7 – German Hepatologist, Gastroenterologist and Internal Medicine physician 262
SECTION 1 – Epidemiology 262
SECTION 2 – Presentation and diagnosis 263
SECTION 3 – Disease treatment and management 264
HBV 264
HCV 270
Key opinion leader 8 – US Internal Medicine and Infectious Disease physician 275
SECTION 1 – Presentation and diagnosis 275
SECTION 2 – Disease treatment and management 276
HBV 276
HCV 280
APPENDIX A 285
Bibliography 285
Journal articles 285
Conference abstracts 290
Epidemiology sources 293
Country populations 293
Prevalence Data 293
Key associations and websites 295
News and press releases 296
Miscellaneous 298
APPENDIX B 300
Physician research methodology 300
Physician sample breakdown 300
US 300
Japan 301
France 301
Germany 302
Italy 302
Spain 303
UK 303
APPENDIX C 304
APPENDIX D 321
Non-weighted drug rating 321
HBV 321
US 321
Japan 322
France 322
Germany 323
Italy 323
Spain 324
UK 324
HCV 325
US 325
Japan 325
France 326
Germany 326
Italy 327
Spain 327
UK 328
Disclaimer 329
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