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HBV 治疗 : 用什么开始 ?. This program is supported by educational grants from. 幻灯目录. HBV 治疗目标 已经公认的 HBV 治疗 病人的入选标准 初开始治疗方案 : 干扰素和核苷类 选择核苷类 选择干扰素类 其他考虑. HBV 治疗目标,病人评估和入选. HBV 的治疗目标. HBV 感染不能完全清除达到“治愈” 治疗目标 预防或逆转因严重肝损害导致的综合症及死亡 对 IHBeAg- 阳性和 HBeAg- 阴性病人 - PowerPoint PPT Presentation
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HBV 治疗 : 用什么开始 ?
This program is supported by educational grants from
clinicaloptions.com/hepatitis
HBV Treatment: What to Start?
幻灯目录 HBV 治疗目标 已经公认的 HBV 治疗 病人的入选标准 初开始治疗方案 : 干扰素和核苷类 选择核苷类 选择干扰素类 其他考虑
clinicaloptions.com/hepatitis
HBV Treatment: What to Start?
HBV 治疗目标,病人评估和入选
clinicaloptions.com/hepatitis
HBV Treatment: What to Start?
HBV 的治疗目标 HBV 感染不能完全清除达到“治愈” 治疗目标
– 预防或逆转因严重肝损害导致的综合症及死亡 对 IHBeAg- 阳性和 HBeAg- 阴性病人
– 治疗目的是降低复制使病毒量 HBV DNA <10-15 IU/mL
– Can allow biochemical remission and prevent further liver injury
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HBV Treatment: What to Start?
GoaHBV 治疗总目标 ls of HBV Therapy
In HBeAg- 阳性病人 positive patients (cont)
– HBeAg 下降和血清逆转是治疗成功的二期表现 loss and seroconversion represent a secondary form of treatment success
– Associated with improved long-term outcomes
In HBsAg- 阳性和阴性 HBeAg- 者– HBsAg 下降和血清转阴是最大的治疗成功
– 病毒抑制的最好指标
– 长期预后良好,发展为肝硬化程度最低
– 大多数病人都达不到这个效果
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HBV Treatment: What to Start?
Interferon alfa-2b
Lamivudine
Adefovir
Peginterferon alfa-2a
Telbivudine
Tenofovir
1990 1998 2002 2005 2006 2008
Entecavir
随时间演变的 HBV 治疗
clinicaloptions.com/hepatitis
HBV Treatment: What to Start?
HBeAg- 阳性者推荐的启动治疗
AASLD 2007[1] US Algorithm 2008[2] EASL 2009[3]
HBV DNA, IU/mL > 20,000 > 20,000 ≥ 2,000
ALT, x ULN* > 2 > 1 > 1
疾病程度 Moderate/severe necroinflammation and/or significant fibrosis
一线方案 ADV,† ETV, pegIFN
ETV, TDF,pegIFN
ETV, TDF,pegIFN
1. Lok A, et al. Hepatology. 2007;45:507-539. 2. Keeffe EB, et al. Clin Gastroenterol Hepatol. 2008;6:1315-1341. 3. EASL HBV Guidelines. J Hepatology. 2009;50:227-242.
*Persistent (> 3-6 mos). †TDF not FDA approved at time of publication.
Criteria for HBV DNA, ALT and disease stage/grade must all be met
– If not, guidelines recommend monitoring and consideration of treatment based on individual’s age, health status, and stage of infection/disease
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HBV Treatment: What to Start?
HBeAg- 阴性患者的启动治疗
AASLD 2007[1] US Algorithm 2008[2] EASL 2009[3]
HBV DNA, IU/mL > 20,000‡ > 2000 ≥ 2000
ALT, x ULN* 1 to > 2 > 1 > 1
疾病程度 Moderate/severe necroinflammation and/or significant fibrosis
一线治疗 ADV,† ETV, pegIFN
ETV, TDF,pegIFN
ETV, TDF,pegIFN
*Persistent (> 3-6 mos). †TDF not FDA approved at time of publication. ‡ Consider liver biopsy if > 2000 IU/mL and treat if moderate/severe inflammation and/or fibrosis found.
Criteria for HBV DNA, ALT and disease stage/grade must all be met
– If not, guidelines recommend monitoring and consideration of treatment based on individual’s age, health status, and stage of infection/disease
1. Lok A, et al. Hepatology. 2007;45:507-539. 2. Keeffe EB, et al. Clin Gastroenterol Hepatol. 2008;6:1315-1341. 3. EASL HBV Guidelines. Journal of Hepatology. 2009;50:227-242.
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HBV Treatment: What to Start?
某些可以考虑 HBV 治疗的情况 不管 HBV DNA 和 ALT 水平如何
– 迅速发生肝坏死的病人
– 肝硬化失代偿期– DNA > 2,000 IU/mL, ALT 水平忽略不计
– 肝硬化失代偿经病例证实
– 肝移植后 HBV 感染
– HBV 携带者免疫抑制或 cytotoxic chemotherapy
Lok A, et al. Hepatology. 2007;45:507-539. Keeffe EB, et al. Clin Gastroenterol Hepatol. 2008;6:1315-1341. EASL HBV Guidelines. Journal of Hepatology. 2009;50:227–242. Sorrell MF, et al. Ann Intern Med. 2009;150:104-110.
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HBV Treatment: What to Start?
HBeAg 状态和治疗反应关系
HBeAg 状态 基线病毒量 HBV DNA 测不到 病毒抑制持久性阳性 Higher 高 Less 少 Higher* 高阴性 Lower 低 More 多 低 Lower
*After seroconversion.
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HBV Treatment: What to Start?
一线核苷类和干扰素的选择Nucleos(t)ides Interferon-Based Therapy
Feature Pro Con Pro Con
Administration OralLong term/ indefinite
Finite duration Subcutaneous
Antiviral activity HighLow durable rates DNA suppression
ResistanceVery low
resistance† No
Adverse events MinimalRare renal tox with nucleotide
Substantial*
HBeAg loss and clearance
HBeAg loss over time
Lower rates vs IFN
Higher rates vs nucles(t)ides
HBeAg loss ≠ HBV DNA suppression
HBsAg loss and clearance
Higher and earlier events† Low rates
High rates (select populations)
Low rates in general patient groups
Other Anti HIV (TDF)May induce HIV
resistance (TDF/ETV)
Anti HCV/HDV
*Prolonged treatment not feasible. † Newer vs older nucles(t)ides.
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HBV Treatment: What to Start?
选择一线核苷类似物
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HBV Treatment: What to Start?
选择影响因素 对治疗反应好的相关因素
– 高 ALT
– 低 HBV DNA
特殊病人群体– 老年人
优先治疗 HIV 合并感染 没有 HCV 合并感染
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HBV Treatment: What to Start?
疗效
( 稳定性 =耐药屏障 )
考虑选择起始药物的几个问题
安全性
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HBV Treatment: What to Start?
有效性 (Potency)
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HBV Treatment: What to Start?
治疗 1 年 HBV DNA 测不到
*By PCR-based assay (LLD ~ 50 IU/mL) except for some LAM studies.
Lok A, et al. Hepatology. 2007;45:507-539. EASL HBV Guidelines. Journal of Hepatology. 2009;50:227-242.
Not head-to-head trials; different patient populations and trial designs
HBeAg 阳性 HBeAg 阴性
Un
det
ecta
ble
* H
BV
DN
A (
%) 100
80
60
40
20
0LAM ADV ETV LdT TDF
40-44
13-21
6760
76
60-73
51-63
90 88 91100
80
60
40
20
0LAM ADV ETV LdT TDF
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HBV Treatment: What to Start?
HBeAg- 阳性病人 1 年治疗后发生 HBeAg 下降 / 血清逆转
HB
eAg
Lo
ss/S
ero
con
vers
ion
(%
)
Lau GK, et al. N Engl J Med. 2005;352:2682-2695. Marcellin P, et al. N Engl J Med. 2003;348:808-816 Chang TT, et al. N Engl J Med. 2006;354:1001-1010. Lai CL, et al. N Engl J Med. 2007;357:2576-2588. Marcellin P, et al. N Engl J Med. 2008;359:2442-2455.
Not head-to-head trials; different patient populations and trial designs
HBeAg Loss HBeAg Seroconversion100
80
60
40
20
0LAM ADV ETV LdT TDF
3224 22 26
2212-18
21 23 21
100
80
60
40
20
0LAM ADV ETV LdT TDF
NR
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HBV Treatment: What to Start?
Years of Therapy
Pat
ien
ts (
%)
HBeAg- 阳性病人巩固治疗 HBeAg 血清逆转
*With sustained undetectable HBV DNA.
Chang TT, et al. N Engl J Med. 2006;354:1001-1010. Lai CL, et al. N Engl J Med. 2007;357:2576-2588. Marcellin P, et al.N Engl J Med. 2003;348:808-816. Marcellin P, et al. N Engl J Med. 2008;359:2442-2455. Lok AS, et al. Gastroenterology. 2003;125:1714-1722. Leung NW, et al. Hepatology. 2001;33:1527-1532. Dienstag JL, et al. Hepatology. 2003;37:748-755. Marcellin P, et al. Hepatology. 2008;48:750-758. Liaw YF, et al. Gastroenterology. 2009;136:486-495. Gane E, et al. AASLD 2008. Abstract 729. Heathcote E, et al. AASLD 2008. Abstract 158.
Not head-to-head trials; different patient populations and trial designs100
80
60
40
20
01 2 3 4 5
22
122123 21
29 31 29 27
40 3747 50 48
LAM ADV ETV LdT TDF
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HBV Treatment: What to Start?
HBeAg- 阳性治疗后逐渐 HBsAg 丢失
Not head-to-head trials; different patient populations and trial designs
Year 1 2 3 4 5
LAM 1 -- -- -- < 1
ADV 0 -- -- 5 5
ETV 2 5† NA NA NA
LdT 0 -- 5.6 NA NA
TDF 3 6 NA NA NA
*Patients generally withdrew from therapy after HBeAg seroconversion was achieved and any patients achieving HBsAg loss after this point are not calculated in rates. †Median follow-up 80 weeks.
*Patients generally withdrew from therapy after HBeAg seroconversion was achieved and any patients achieving HBsAg loss after this point are not calculated in rates. †Median follow-up 80 weeks.
Gish RG, et al. Gastroenterology. 2007;133:1437-1444. Heathcote E, et al. AASLD 2008. Abstract 158. Hsu, et al. EASL 2009. Abstract 911. Hadziyannis SJ, et al. Gastroenterology. 2006;131:1743-1751. Yao GB, et al. J Dig Dis. 2009;10:131-137. Gish RG, et al. J Viral Hep. 2009; In press.
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HBV Treatment: What to Start?
治疗 1 年 ALT 正常,组织学表现好转
HBeAg Positive
Outcome, % LAM ADV ETV LdT TDF
Normalization of ALT 41-75 48 68 77 69
Histologic improvement 49-56 53 72 65 74
HBeAg Negative
Outcome, % LAM ADV ETV LdT TDF
Normalization of ALT 60-79 72 78 74 77
Histologic improvement 60-66 64 70 67 72
Lai CL, et al. N Engl J Med. 1998;339:61-68. Dienstag JL, et al. N Engl J Med. 1999;341:1256-1263. Lau GK, et al. N Engl J Med. 2005;352:2682-2695. Chang TT, et al. N Engl J Med. 2006;354:1001-1010. Lai CL, et al. N Engl J Med. 2007;357:2576-2588. Marcellin P, et al. N Engl J Med. 2003;348:808-816. Marcellin P, et al. 2008;359:2442-2455.
*Significant variation in the baseline HBV DNA and ALT between trials.*Significant variation in the baseline HBV DNA and ALT between trials.
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HBV Treatment: What to Start?
耐药和治疗稳定性
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HBV Treatment: What to Start?
什么因素决定耐药率 ? Potency 和基因屏障 Potency is only 1 part of the equation
耐药相关的药物学屏障– 剂量安全性– 血液水平– 组织浓度 n
耐药基因屏障– The number of substitutions needed for primary antiviral drug
resistance
– Probably at least as important as potency Allen MI, et al. Hepatology. 1998;27:1670-1677. Yatsuji H, et al. Antimicrob Agents Chemother. 2006;50: 3867-3874. Qi X, et al. Antivir Ther. 2007;12:355-362. Villeneuve JP, et al. J Hepatol. 2003;39:1085-1089. Baldick CJ, et al. Hepatology. 2008;47:1473-1482. Seifer M, et al. Antiviral Res. 2009;81:147-155. Heathcote E, et al. AASLD 2008. Abstract 158. Marcellin P, et al. AASLD 2008. Abstract 146.
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HBV Treatment: What to Start?
耐药率发生相关因素 ? Potency vs Genetic Barrier (cont) LAM: rtM204V/I and rtA181T (also possibly V)
– Compensatory mutations: rtL180M, rtV173L, and rtL80V/I
LdT: rtM204I (not rtM204V)
ADV: rtA181T and rtN236T
Combination of low genetic barrier drugs: at least 2 mutations required
ETV: at least 3 mutations required
– rtL180M + rtM204V + 1 of the following: rtT184G or rtS202I or rtM250V change
TDF: no signature resistance mutations identified at 2 yearsAllen MI, et al. Hepatology. 1998;27:1670-1677. Yatsuji H, et al. Antimicrob Agents Chemother. 2006;50: 3867-3874. Qi X, et al. Antivir Ther. 2007;12:355-362. Villeneuve JP, et al. J Hepatol. 2003;39:1085-1089. Baldick CJ, et al. Hepatology. 2008;47:1473-1482. Seifer M, et al. Antiviral Res. 2009;81:147-155. Heathcote E, et al. AASLD 2008. Abstract 158. Marcellin P, et al. AASLD 2008. Abstract 146.
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HBV Treatment: What to Start?
第一次口服核苷类患者耐药率的累积
Not head-to-head trials; different patient populations and trial designs
EASL HBV Guidelines. J Hepatol. 2009;50:227-242. Tenny DJ, et al. EASL 2009. Abstract 20.
Year
0
24
49
67 70
38
1 2 3 4 5
Pat
ien
ts (
%)
80
40
60
20
100
03
1118
29
0.2 1.2 1.24
00
17
1.2
6
1.2
LAM ADV ETV LdT TDF
0.5
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HBV Treatment: What to Start?
小结药力和基因屏障对耐药的影响 LAM and LdT
– Potent agents with low genetic barriers and high rates of resistance
ADV
– Less potent agent with low pharmacologic barrier with intermediate rate of resistance
ETV
– Potent agent with high pharmacologic and genetic barriers and low rates of resistance
TDF
– Potent agent with high pharmacologic and low rates of resistance, genetic barrier not yet defined
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HBV Treatment: What to Start?
复合治疗
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HBV Treatment: What to Start?
复合药物治疗组合方式 ?
No combination therapy has convincingly shown increased short-term efficacy in nucleos(t)ide-naive patients
– LdT + LAM vs LdT vs LAM[1]
– LAM + ADV vs LAM[2]
– FTC + ADV vs ADV[3]
– TDF + FTC vs TDF[4]
Currently available drugs have excellent resistance profile
Study to generate data sufficient for approval of frontline combination treatment unlikely to be performed
– Would have to be very large, very long, require shorter-term endpoints than resistance alone, and expensive
1. Lai CL, et al. Gastroenterol. 2005;129:528-536. 2. Sung JJ, et al. J Hepatol. 2008;48:728-735. 3. Hui CK, et al. J Hepatol. 2008;48:714-720. 4. Berg T, et al. EASL 2009; Abstract 903.
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HBV Treatment: What to Start?
推荐使用复合治疗的特殊病人 肝硬化
– 发耐药高危和肝坏死高危 HIV/HBV 双重感染
– 选择对两中感染都有抑制作用的药物预防耐药 已经存在耐药
– Rates of infection with resistant virus low but increasing
没有数据表明,选择复合治疗优于单一新药的治疗
Lok AS, et al. Hepatology. 2007;45:507-539. Jacobson IM. J Hepatol. 2008;48:687-691.
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HBV Treatment: What to Start?
小结 FDA 批准的口服 HBV 治疗
*Approximate and relative. †Number of mutations needed for primary antiviral drug resistance.‡Only includes reported adverse events that may differ in historical incidence associated with LAM and, therefore, potentially affecting selection vs other agents. Pancreatitis has been reported as a class effect and all agents have to be dose adjusted for renal insufficiency.§ From HIV databases
Oral Drug
Antiviral Potency*
Pharmacologic Barrier
Genetic Barrier†
Adverse Events‡
LAM + + 1 --
ADV ++ + 1 Nephrotoxicity (≤1% per year)
ETV ++++ ++++ 3 --
LdT ++ ++ 1 Myalgia, myositis, neuropathy,
cardiac arrhythmia (rare)
TDF ++++ ++++ ? Nephrotoxicity§
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HBV Treatment: What to Start?
初开始治疗最佳核苷类选择 Use nucleos(t)ides as monotherapy with
– Highest antiviral potency and genetic barrier to resistance
– Low incidence of resistance over time
– Rapid and sustained to maximize cumulative benefit
– LAM/LdT/ADV not generally recommended as first-line therapy
– Combination therapy may be considered in patients where avoiding resistance is especially important
– Currently no data supporting this approach vs newer monotherapies
Consider individual patient characteristics in relation to safety
– Comorbidities (ie, compromised renal function)
– Coinfections (ie, anti-HIV activity of agents)
– Conception planning
Keeffe EB, et al. Clin Gastroenterol Hepatol. 2008;6:1315-1341. EASL HBV Guidelines. J Hepatol. 2009;50:227-242. Lok AS, et al. Hepatology. 2007;45:507-539.
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小结:选择干扰素做为初始治疗
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HBV Treatment: What to Start?
选择干扰素的相关因素 适合用药者
– 基因型 A or B > C or D
– 基线低 HBV DNA (baseline and on treatment)
– 基线高 ALT (baseline)
特殊人群– 年轻人
– 将来有生育欲望的年轻女性 病人自己选择 没有 HIV 合并感染 合并 HCV 感染
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HBV Treatment: What to Start?
培干扰素治疗相关的副作用 Patients should be carefully monitored for adverse events
Most common adverse events: flu-like symptoms (fever, chills, headache, malaise, and myalgia) as well as psychological impairment
Months
Depression
Fatigue
Flu-like symptoms
Anxiety
1 2 3 40
Incr
ease
in
In
cid
ence
/Sev
erit
y
Keeffe EB, et al. Clin Gastroenterol Hepatol. 2008;6:1315-1341. Keeffe EB, et al. Clin Gastroenterol Hepatol. 2008;6:1315-1341.
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HBV Treatment: What to Start?
0
20
40
60
80
100
PegIFN 180 µg (n = 271) PegIFN + LAM (n = 271) LAM 100 mg (n = 272)
27 24 20
HBV DNA< 105 copies/mL(~ 20,000 IU/mL)
ALTNormal
HBeAgLoss
HBeAgSeroconversion
30 27 22
52
86
62
3946
62
Pat
ien
ts (
%)
HBsAg seroconversion: 0% in all 3 arms
HBV DNA< 400 copies/mL
(~ 80 IU/mL)
25
69
40
Lau GK, et al. N Engl J Med. 2005;352:2682-2695.
HBeAg- 阳性病人:培干扰素 alfa-2a 或拉米夫定或同时使用两种治疗 48 周比较
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HBV Treatment: What to Start?
Lau GK, et al. N Engl J Med. 2005;352:2682-2695.
HB
eAg
Ser
oco
nve
rsio
n (
%)
3227
19
0
10
20
30
4050
PegIFN(n = 271)
PegIFN + LAM(n = 271)
LAM(n = 272)
P < .001
P = .023
HBsAg seroconversion: 3% of pegIFN groups/0% in LAM group (P = .001) HBsAg seroconversion: 3% of pegIFN groups/0% in LAM group (P = .001)
60
70
80
90100
Off-Treatment Follow-up (Week 72)
HBeAg Seroconversion After EOT (Week 48) 停药后随访
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HBV Treatment: What to Start?
HBeAg- 阴性者使用培干扰素 PegIFN-2a ± 拉米夫定治疗病毒抑制情况
Marcellin P, et al. AASLD 2006. Abstract. 972. Marcellin P, et al. EASL 2007. Abstract 53. Marcellin P, et al. EASL 2008. Abstract 103.
*~ 80 IU/mL, missing data considered a nonresponse.
Years After Therapy Completed
Pat
ien
ts w
ith
HB
V D
NA
≤
400
cop
ies/
mL
(%
)*
100908070605040302010
01 2 3 4
13 13 18 17
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HBV Treatment: What to Start?
HBeAg(-) 患者 HBsAg 水平是长期耐受干扰素治疗与否的指标 4-yr and 6-mo response rates higher with Wk 12 HBsAg level
≤ 1500 IU/mL vs > 1500 IU/mL in long-term cohort
Marcellin P, et al. AASLD 2008. Abstract 919.
6 mos posttreatment4 yrs posttreatment
HBsAg ≤ 1500 IU/mL
HBV DNA ≤10,000
copies/mL
HBV DNA ≤400
copies/mL
HBsAg Clearance
Pat
ien
ts W
ith
R
esp
on
se (
%)
59
39 3931
7
23
60
40
20
0
6 mos posttreatment4 yrs posttreatment
HBsAg > 1500 IU/mL
HBV DNA ≤ 10,000
copies/mL
HBV DNA ≤400
copies/mL
HBsAg Clearance
Pat
ien
ts W
ith
R
esp
on
se (
%)
34
12 9 82 4
60
40
20
0
100
80
100
80
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HBV Treatment: What to Start?
早期 HBsAg 动力学反应是长期干扰素治疗成功与否的预期指标 治疗 12 周发生病毒抑制 对的 HBsAg 监测 提示
– 病人可能是长期耐受者
– 病人可能成为无反应者– 这群人需换药
Lau GK, et al. APASL 2009. Abstract PE083. Moucari R, et al. Hepatology. 2009;49:1151-1157. Brunetto MR, et al. Hepatology. 2009;49:1411-1150. Moucari R, et al. J Hepatol. 2009;50:1084-1092. Perillo RP. Hepatology. 2009;49:1063-1065.
Lau GK, et al. APASL 2009. Abstract PE083. Moucari R, et al. Hepatology. 2009;49:1151-1157. Brunetto MR, et al. Hepatology. 2009;49:1411-1150. Moucari R, et al. J Hepatol. 2009;50:1084-1092. Perillo RP. Hepatology. 2009;49:1063-1065.
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关于使用培干扰素 alfa-2a 作为一线治疗的小结 利处持久的治疗耐受,持久治疗反应,不发生耐药 弊处:需要粘膜下给药,很多患者发生明显毒副作用 HBeAg 和 HBsAg 血清逆转率,耐受性,和跟核苷类治疗
比较等是决定治疗的因素 HBsAg 动力学分析可以对治疗反应提供前期评估
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HBV Treatment: What to Start?
其他跟启动治疗相关因素
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HBV Treatment: What to Start?
对有生育欲望 HBV 女性治疗推荐 有肝损害,低病毒量
– 先怀孕,后治疗 中度肝损害,没有肝硬化
– 怀孕前治疗,如果起效,受孕前停止治疗 严重肝损害
– 孕前或孕中治疗,直到分娩前 轻度肝损害,高病毒量
– 在妊娠后期使用“ B” 类药治疗
Wedemeyer H, et al. Dtsch Med Wochenschr. 2007;132:1775-1782.EASL HBV Guidelines. J Hepatol. 2009;50:227-242.
clinicaloptions.com/hepatitis
HBV Treatment: What to Start?
血透和肾移植病人 ADV and TDF have been linked to worsening renal function and
should be used with caution in renally impaired patients
– TDF can be used if dose adjustments are made in response to changes in glomerular filtration rates
– No specific renal toxicity associated with entecavir
Dose-adaptation should be used with any agent
– Should be made according to the prescribing information
Monitoring of renal function before and during therapy particularly important in patients who have multiple risk factors for renal impairment
EASL HBV Guidelines. J Hepatology. 2009;50:227-242. Ha NB. AASLD 2008. Abstract 901.
clinicaloptions.com/hepatitis
HBV Treatment: What to Start?
小结 选择初始治疗方案强调高效和治疗稳定性
– 一旦 HBV 复制受抑制,丢失和血清逆转表明治疗好转 – 分析治疗反应的预期因素
核苷类– 选择耐药屏障最高的药物– 合并组合治疗大多数人不适用
干扰素 alfa-2a
– 评估 HBsAg 动力学越来越重要
Go Online for Additional Components of This Program!
CME/CE-certified Text Module: of all the key data, plus discussions exploring the clinical implications
CME/CE-certified Interactive Case Challenges: follow along and test your learning on cases with experts
Downloadable PowerPoint slides
clinicaloptions.com/HBVstart