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1 HBV Guidelines and Cases Presentation Prof. Gamal Esmat Prof. Hepatology &Vice President of Cairo University, Egypt Member of WHO Strategic Committee for Viral Hepatitis

HBV Guidelines and Cases Presentation

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HBV Guidelines and Cases Presentation. Prof. Gamal Esmat Prof. Hepatology &Vice President of Cairo University, Egypt Member of WHO Strategic Committee for Viral Hepatitis www.gamalesmat.com. A case study: “You are a carrier: be happy!!”. - PowerPoint PPT Presentation

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Page 1: HBV Guidelines and Cases Presentation

1

HBV Guidelines and Cases Presentation

Prof. Gamal EsmatProf. Hepatology &Vice President of Cairo University, Egypt

Member of WHO Strategic Committee for Viral Hepatitiswww.gamalesmat.com

Page 2: HBV Guidelines and Cases Presentation

A case study:“You are a carrier: be

happy!!”

Page 3: HBV Guidelines and Cases Presentation

21 year male has a history of

dental extraction since 2 years. He

was told that he has HBsAg +ve

before traveling to work aboard.

He is Asymptomatic.

Page 4: HBV Guidelines and Cases Presentation

What is the next step?

1. Assurance: A Benign disease. Needs no treatment. Be happy!

2. Fruther investigations

Page 5: HBV Guidelines and Cases Presentation

His liver function were completely

within normal range (ALT=37/40)

His Abdominal Ultrasound was also

normal

Page 6: HBV Guidelines and Cases Presentation

What is next step?

1. Assurance : you are OK. No

treatment. Be Happy.

2. Further investigations.

Page 7: HBV Guidelines and Cases Presentation

HBeAg is negative

Page 8: HBV Guidelines and Cases Presentation

Next Step

1. Assurance: No Active Disease. BE

Happy !!

2. Further investigations

Page 9: HBV Guidelines and Cases Presentation

HBeAg-negative CHB Egypt

156 HBsAg+ve CAHNLI, Unpublished, 2004

0%10%

20%30%

40%50%

60%70%

80%90%

100%

HBeAg+ven=12

8%

HBV-DNA+ ve,10372%66%

HBV-DNA- ve,41

28 %26%

HBeAg-ven=144

92%

Page 10: HBV Guidelines and Cases Presentation

Anti HBe Positive

Anti Delta IgG Negative

HB DNA 3000 IU/(15000

Copies)

Further Investigations

Page 11: HBV Guidelines and Cases Presentation

Next Step1. Assurance: you have a

mild disease just follow –

up. Need No Treatment.

2. Further investigations.

Page 12: HBV Guidelines and Cases Presentation

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Inclusion criteria for assessmentInclusion criteria for assessment

Age > 18 yearsAge > 18 years

HBsAg: (+ve)HBsAg: (+ve)

HBV DNA (+ve)HBV DNA (+ve)

Ministry Of Health Regulations For Ministry Of Health Regulations For Management of HBV in AdultsManagement of HBV in Adults

Page 13: HBV Guidelines and Cases Presentation

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Indication of TreatmentIndication of Treatment

• Treat if HBV >2000 IU + elevation of liver enzymes.Treat if HBV >2000 IU + elevation of liver enzymes.

• Follow up if HBV <2000 IU + normal liver enzymes.Follow up if HBV <2000 IU + normal liver enzymes.

• Grey zone do liver biopsyGrey zone do liver biopsy

Page 14: HBV Guidelines and Cases Presentation

Liver Biopsy: showed

HAI-8 and F-2

HBsAg +ve

HBcAg +ve

Page 15: HBV Guidelines and Cases Presentation

Liver biopsy : METAVIR scoring system

F1 F2 F3 F4

From Z. GoodmanFrom Z. Goodman

Page 16: HBV Guidelines and Cases Presentation

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Liver biopsy(Indications) Liver biopsy(Indications)

• HBV DNA > 2000 IU/ML with persistently normal HBV DNA > 2000 IU/ML with persistently normal enzymes .enzymes .

• HBV DNA < 2000 IU/ML with persistently elevated HBV DNA < 2000 IU/ML with persistently elevated enzymes .enzymes .

• Patients < 2000 IU/ML with normal enzymes who show Patients < 2000 IU/ML with normal enzymes who show clinical evidence of liver disease or have a family history clinical evidence of liver disease or have a family history of HCCof HCC

Treatment is recommended for those with >A1

and / or >F1 on the Metavir score

Page 17: HBV Guidelines and Cases Presentation

What is the next step?

1. Lamivudine

2. New oral antiviral therapy

3. Pegylated interferon

4. Combination

Page 18: HBV Guidelines and Cases Presentation

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• Treatment has advanced dramatically due to the Treatment has advanced dramatically due to the introduction of new agents with different safety, efficacy, introduction of new agents with different safety, efficacy, and resistance profilesand resistance profiles

Treatment LandscapeTreatment Landscape

Adefovir dipivoxil (2003)

Tenofovir (2008)

Lamivudine (1999)

Entecavir (2005)

Telbuvidine (2006)

Cytokines Nucleoside Analogue Nucleotide Analogue

Interferon (1992)

Peg Interferon -2a (2005)

Page 19: HBV Guidelines and Cases Presentation

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MedicationsMedications

All Naïve patients are candidates for the most potent drugs Entecavir 0.5 or

Tenofovir 300 mg as a first line therapy.

Entecavir 0.5 mg O.Dor

Tenofovir 300mg O.D.

Page 20: HBV Guidelines and Cases Presentation

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Page 21: HBV Guidelines and Cases Presentation

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Tenofovir is preferred in: Tenofovir is preferred in: patients who received lamivudine previouslypatients who received lamivudine previously young women who plan to start a family in next few young women who plan to start a family in next few

yearsyears patients who want more flexibility with regard to the patients who want more flexibility with regard to the

time of day at which they take their medicinetime of day at which they take their medicine

Entecavir is preferred in:Entecavir is preferred in: older patientsolder patients patients with medical conditions that increase risk patients with medical conditions that increase risk

of renal failureof renal failure

Page 22: HBV Guidelines and Cases Presentation

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Pegylated InterferonPegylated InterferonEffect of GenotypeEffect of Genotype

• A large multicenter study A large multicenter study of 52 weeks of pegylated of 52 weeks of pegylated interferon alfa-2b, alone or interferon alfa-2b, alone or in combination with LAM, in combination with LAM, according to genotype: according to genotype:

• HBeAg-positive patients HBeAg-positive patients with genotype A with genotype A responded significantly responded significantly more frequently than those more frequently than those with genotypes B, C, or D with genotypes B, C, or D in descending order. in descending order.

Percent HBeAg response irrespective of treatment assignment (pegylated interferon/placebo vs pegylated interferon/LAM).

Page 23: HBV Guidelines and Cases Presentation

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Pegylated InterfonPegylated Interfon

• Poor response in Egyptian patients with Poor response in Egyptian patients with predominant Genotype D.predominant Genotype D.

• HbeAg positive patients with high liver enzymes HbeAg positive patients with high liver enzymes could be offered a chance of treatment with peg could be offered a chance of treatment with peg Inf alfa for 24 weeks.Inf alfa for 24 weeks.

• Seroconversion to HBeAb →continue for 48 wksSeroconversion to HBeAb →continue for 48 wks• No seroconversion →stop ttt and shift to oral No seroconversion →stop ttt and shift to oral

antiviral therapy according to previous antiviral therapy according to previous guidelinesguidelines

Page 24: HBV Guidelines and Cases Presentation

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For Patients already on treatmentFor Patients already on treatment

• Chronic patients responding on regular Chronic patients responding on regular Lamivudine treatment (undetectable HBV DNA) Lamivudine treatment (undetectable HBV DNA) →continue treatment and HBV PCR every 3 to →continue treatment and HBV PCR every 3 to 6 months.6 months.

• Patients on combined LAM & Adefovir →Patients on combined LAM & Adefovir →continue treatment or shift to Tenofovir 300 mgcontinue treatment or shift to Tenofovir 300 mg

• Newly developed resistance → Shift to Newly developed resistance → Shift to Tenofovir 300 mg O.D.Tenofovir 300 mg O.D.

Page 25: HBV Guidelines and Cases Presentation

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Immuntolerant casesImmuntolerant cases

• Young patients under 40 years of age who are Young patients under 40 years of age who are HBeAg positive ,with high viral load and HBeAg positive ,with high viral load and persistently normal enzymes are not candidates persistently normal enzymes are not candidates for immediate liver biopsy or treatment.for immediate liver biopsy or treatment.

• Follow up is mandatory every 3- 6 months by Follow up is mandatory every 3- 6 months by liver profile and every 6-12 months HBeAg .liver profile and every 6-12 months HBeAg .

• Consider liver biopsy with fluctuating ALT levels Consider liver biopsy with fluctuating ALT levels or a positive family history of HCC .or a positive family history of HCC .

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Special GroupsSpecial Groups

I) Compensated Cirrhosis:Naive Cirrhotic patients with any detectable level of HBV

DNA should receive Entecavir 0.5 mg or Tenofovir

300mg.

II)Decompensated Cirrhosis :Entecavir 1 mg may be appropriate. The dose of all NA,s

needs to be adjusted in patients with low creatinine

clearance (< 50ml/min)

lll)Renal Insufficiency:Entecavir preferred with dose adjustments according to

creatinine clearance.

Page 27: HBV Guidelines and Cases Presentation

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PregnancyPregnancy

For mothersFor mothers::

- All pregnant females should be screened for HBsAg- All pregnant females should be screened for HBsAg

- Newly diagnosed pregnant women in the last trimester - Newly diagnosed pregnant women in the last trimester showing an HBV DNA level showing an HBV DNA level >> 100.000 IU/ML are 100.000 IU/ML are candidates for Lamivudine 100 mg or Tenofovir 300 mg candidates for Lamivudine 100 mg or Tenofovir 300 mg starting last trimester and for 3 months after delivery to starting last trimester and for 3 months after delivery to decrease chance of new-born infection . Re-evaluate decrease chance of new-born infection . Re-evaluate the condition after 3 months of delivery and consider the condition after 3 months of delivery and consider treatment according to the previous guidelinestreatment according to the previous guidelines

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PregnancyPregnancy

• For newbornsFor newborns::

• HB Ig and HBV vaccine first (birth) dose for HB Ig and HBV vaccine first (birth) dose for the baby in the first 6-12 hours after delivery. the baby in the first 6-12 hours after delivery.

• Birth dose vaccination is recommended for Birth dose vaccination is recommended for all newborns.all newborns.

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Females who become pregnant while on Females who become pregnant while on

treatmenttreatment

– On Lamivudine monotherapy: Continue on On Lamivudine monotherapy: Continue on

treatmenttreatment

– On Other lines of treatment : shift to class B drug On Other lines of treatment : shift to class B drug

(Tenofovir 300 mg O.D.)(Tenofovir 300 mg O.D.)

Page 30: HBV Guidelines and Cases Presentation

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HBV/HDV CoinfectionHBV/HDV Coinfection• Peg –INF is the only effective drug against HDV.Peg –INF is the only effective drug against HDV.

• Efficacy of Peg –INF is assessed during treatment Efficacy of Peg –INF is assessed during treatment after 3-6 months by measuring HDV RNA levels.after 3-6 months by measuring HDV RNA levels.

• Optimal duration of therapy is not well defined but Optimal duration of therapy is not well defined but therapy for at least 72 wks .therapy for at least 72 wks .

• NAs have no impact on HDV replication and related NAs have no impact on HDV replication and related disease.disease.

• Refer the patient to a specialized HBV center. Refer the patient to a specialized HBV center.

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Acute HBVAcute HBV

• Spontaneous recovery in more than 95% of Spontaneous recovery in more than 95% of casescases and seroconversion to anti HBs without and seroconversion to anti HBs without antiviral therapy. Supportive management and antiviral therapy. Supportive management and close monitoring for early identification of close monitoring for early identification of fulminant hepatitis or liver cell failurefulminant hepatitis or liver cell failure

• Fulminant or impending liver cell failureFulminant or impending liver cell failure:: Entecavir 0.5 mg during the condition and for at Entecavir 0.5 mg during the condition and for at

least 6 months after seroconversion to anti HBs least 6 months after seroconversion to anti HBs or for at least 12 months after seroconversion to or for at least 12 months after seroconversion to anti HBe without HBs Ag lossanti HBe without HBs Ag loss

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Dialysis and Renal patients Dialysis and Renal patients

• All renal patients should be screened for HBV .All renal patients should be screened for HBV .

• Seronegative patients should be vaccinated.Seronegative patients should be vaccinated.

• Entecavir is preferred for treatment.Entecavir is preferred for treatment.

• All drugs should be dose adjusted according to All drugs should be dose adjusted according to creatinine clearance.creatinine clearance.

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HBV/HCV Co infection-Treat predominant virus according to PCR level.-Patients fulfilling the inclusion criteria for HBV

treatment and have co-infection with active

HCV (HCV RNA +ve by quantitative PCR)

Monitoring for HBV is performed every 3-6

months.Reassessment of the condition after termination

of the course and starting oral HBV treatment if

needed..

Peg IFN + Ribavirin

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-Mass vaccination is recommended.-Mass vaccination is recommended.

-Vaccination is highly recommended for:-Vaccination is highly recommended for:

VaccinationVaccination

Health care workers Close contacts of viremic patients

Chronic renal failure patients before they start renal

dialysis.Chronic hepatitis C patients.Immunosupressed patients.

Multitransfused individuals

Page 35: HBV Guidelines and Cases Presentation

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Follow upFollow up

Follow up visits (every 2-3 months)for receiving

medications & follow up for side effects and relapsing

symptoms.Checking liver enzymes every 3 months.

Serum creatinine is done every 3 months in those

receiving Adefovir. For Tenofovir in addition monitor

creat.clearance and serum phosphate for risk of renal

impairement and osteomalacia.Liver function tests, complete blood count, A.F.P.,

Abdominal U/S & HBV/DNA by PCR quantitative is

done every 6 months

Page 36: HBV Guidelines and Cases Presentation

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Immunosupressed PatientsImmunosupressed Patients

• All candidates for chemotherapy and All candidates for chemotherapy and immunosuppressive therapy should be screened for immunosuppressive therapy should be screened for HBsAg and anti HBcAb prior to initiation of treatmentHBsAg and anti HBcAb prior to initiation of treatment

• Vaccination is mandatory for seronegative casesVaccination is mandatory for seronegative cases

• HBsAg positive patients with any detectable level of HBsAg positive patients with any detectable level of viremia should receive NA during therapy and for 6 viremia should receive NA during therapy and for 6 months after cessation of therapymonths after cessation of therapy

Page 37: HBV Guidelines and Cases Presentation

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Immunosupressed PatientsImmunosupressed Patients

• Patients with high HBV DNA level should receive Patients with high HBV DNA level should receive NA with high viral potency according to NA with high viral potency according to guidelines.guidelines.

• HBsAg HBsAg neg neg patients with positive anti- HBc patients with positive anti- HBc antibodies should be tested for HBV DNA. antibodies should be tested for HBV DNA. Patients with detectable viremia should be Patients with detectable viremia should be treated as HBsAg positive cases.treated as HBsAg positive cases.

• Follow up of cases with undetectable viremia Follow up of cases with undetectable viremia every 1-2 months during treatment by liver every 1-2 months during treatment by liver enzymes and HBV DNA. enzymes and HBV DNA.

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Case 2Case 2

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A 30 years old female patient presented with A 30 years old female patient presented with easy fatigability and right hypochondrial easy fatigability and right hypochondrial pain.pain.

CBC : Normal .CBC : Normal .• ALT: 80/40ALT: 80/40 HBsAg : +veHBsAg : +ve HBeAg: -veHBeAg: -ve Anti HCV: - veAnti HCV: - ve HBV- DNA: 2500 IU/mlHBV- DNA: 2500 IU/ml

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• Fibroscan F2Fibroscan F2• Does this patient needs treatment?Does this patient needs treatment?

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• Patient received mono therapy in the form Patient received mono therapy in the form of lamivudine. After 6 months of therapy of lamivudine. After 6 months of therapy her ALT normalized and her HBV-DNA her ALT normalized and her HBV-DNA decreased to 200 IU/ml.decreased to 200 IU/ml.

• What are the goals for treatment of HBV?What are the goals for treatment of HBV?• What is the end point in treatment of HBV?What is the end point in treatment of HBV?

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goals for treatment of HBVgoals for treatment of HBV

• The goal of therapy for hepatitis B is to improve quality of The goal of therapy for hepatitis B is to improve quality of life and survival by preventing progression of the disease life and survival by preventing progression of the disease to cirrhosis, decompensated cirrhosis, end-stage liver to cirrhosis, decompensated cirrhosis, end-stage liver disease, HCC and death. This goal can be achieved if disease, HCC and death. This goal can be achieved if HBV replication can be suppressed in a sustained HBV replication can be suppressed in a sustained manner, the accompanying reduction in histological manner, the accompanying reduction in histological activity of chronic hepatitis lessening the risk of cirrhosis activity of chronic hepatitis lessening the risk of cirrhosis and decreasing the risk of HCC in non-cirrhotic patients and decreasing the risk of HCC in non-cirrhotic patients and probably also, but to a lesser extent, in cirrhotic and probably also, but to a lesser extent, in cirrhotic patients. However, patients. However, HBV infection cannot be completely HBV infection cannot be completely eradicated due to the persistence of covalently closed eradicated due to the persistence of covalently closed circular DNA (cccDNA) in the nucleus of infected circular DNA (cccDNA) in the nucleus of infected hepatocytes.hepatocytes.

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Higher viral loadsHigher viral loads associated with long-term complicationsassociated with long-term complications

Year of follow-up

>>101066c/mlc/ml

101055-10-1066c/mlc/ml

101044-10-1055c/mlc/ml

300-10300-1044cmlcml

> >300c/ml300c/ml 0

2

4

6

8

10

12

14

0 1 2 3 4 5 6 7 8 9 10111213

Cum

ulat

ive

inci

denc

e of

HC

C%

≥106c/ml

Year of follow-up

Cum

ulat

ive

inci

denc

e of

cirr

hosi

s%

0

.01

.02

.04

.03

0 21 3 4 5 6 7 8 9 10111213

105-106c/ml

>300 c/ml

104-105c/ml

300-104c/ml

Progression to CirrhosisProgression to Cirrhosis Progression to HCCProgression to HCC

Iloeje UH et al. Gastroenterology 2006; 130: 678–86. Chen CJ et al.Chen CJ et al. JAMA JAMA 2006; 295: 65-732006; 295: 65-73

Page 44: HBV Guidelines and Cases Presentation

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End point in treatment of HBVEnd point in treatment of HBV

• Therapy must reduce HBV DNA to as low a Therapy must reduce HBV DNA to as low a level as possible, ideally below the lower limit level as possible, ideally below the lower limit of detection of real-time PCR assays (10–15 of detection of real-time PCR assays (10–15 IU/ml), to ensure a degree of virological IU/ml), to ensure a degree of virological suppression that will then lead to biochemical suppression that will then lead to biochemical remission, histological improvement and remission, histological improvement and prevention of complications. prevention of complications.

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End point in treatment of HBV (cont.)End point in treatment of HBV (cont.)

• Sustained HBV DNA reduction to Sustained HBV DNA reduction to undetectable levels is necessary to reduce undetectable levels is necessary to reduce the risk of resistance to NUCs. It also the risk of resistance to NUCs. It also increases the chance of HBe increases the chance of HBe seroconversion in HBeAg-positive patients seroconversion in HBeAg-positive patients and the possibility of HBsAg loss on the and the possibility of HBsAg loss on the mid to long term in HBeAg-positive and mid to long term in HBeAg-positive and HBeAg-negative patients.HBeAg-negative patients.

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End point in treatment of HBV (cont.)End point in treatment of HBV (cont.)

(1)(1) In HBeAg-positive and HBeAg-negative patients, the In HBeAg-positive and HBeAg-negative patients, the ideal end-point of therapy is sustained HBsAg loss with ideal end-point of therapy is sustained HBsAg loss with or without seroconversion to anti-HBsor without seroconversion to anti-HBs.. This is This is associated with a complete and definitive remission of associated with a complete and definitive remission of the activity of chronic hepatitis B and an improved long-the activity of chronic hepatitis B and an improved long-term outcome.term outcome.

(2)(2) In HBeAg-positive patients, durable In HBeAg-positive patients, durable HBe seroconversionHBe seroconversion is a satisfactory end-point because it has been shown is a satisfactory end-point because it has been shown to be associated with improved prognosis.to be associated with improved prognosis.

(3(3) In HBeAg-negative and in In HBeAg-positive patients ) In HBeAg-negative and in In HBeAg-positive patients who do not achieve HBe seroconversion, and patients, who do not achieve HBe seroconversion, and patients, a maintained a maintained undetectable HBV DNA level undetectable HBV DNA level on treatment on treatment with NUCs. with NUCs.

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• One year after the start of treatment the One year after the start of treatment the patients HBV DNA started to increase by patients HBV DNA started to increase by more than one log while her ALT levels are more than one log while her ALT levels are still normal in spite of her compliance to still normal in spite of her compliance to treatment.treatment.

• Shall we replace lamivudine or add Shall we replace lamivudine or add another drug?another drug?

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• Patient stopped treatment 3 years later Patient stopped treatment 3 years later after having persistent normal ALT and after having persistent normal ALT and undetectable HBV DNA for 2 years while undetectable HBV DNA for 2 years while her HBsAg was still + ve. The patient got her HBsAg was still + ve. The patient got married and pregnant. married and pregnant.

• Does she need to restart therapy?Does she need to restart therapy?• What precautions to be taken for the new What precautions to be taken for the new

born?born?

Page 49: HBV Guidelines and Cases Presentation

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Guidelines for mang. of pregnant females with Guidelines for mang. of pregnant females with HBVHBV

• Lamivudine, adefovir and entecavir are listed by Lamivudine, adefovir and entecavir are listed by the FDA as pregnancy the FDA as pregnancy category Ccategory C drugs, and drugs, and telbivudine and tenofovir as telbivudine and tenofovir as category B category B drugs. drugs. These classifications are based on the risk of These classifications are based on the risk of teratogenicity in preclinical evaluation.teratogenicity in preclinical evaluation.

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Guidelines for mang. of pregnant Guidelines for mang. of pregnant females with HBVfemales with HBV

• Recent reports suggest that lamivudine Recent reports suggest that lamivudine therapy during the last trimester of therapy during the last trimester of pregnancy in pregnant women with high pregnancy in pregnant women with high levels of viremia reduces the risk of intra-levels of viremia reduces the risk of intra-uterine and perinatal transmission of HBV uterine and perinatal transmission of HBV if given in addition to passive and active if given in addition to passive and active vaccination by HBIg and HBV vaccination.vaccination by HBIg and HBV vaccination.

• HBV-infected women should be monitored HBV-infected women should be monitored closely after delivery as exacerbations of closely after delivery as exacerbations of chronic hepatitis B may occurchronic hepatitis B may occur

J Viral Hepat 2008;15:37–41J Viral Hepat 2008;15:37–41

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–Ten years later the patient complained Ten years later the patient complained of enlarged cervical lymph nodes. Biopsy of enlarged cervical lymph nodes. Biopsy revealed Hodgkins lymphoma. She was revealed Hodgkins lymphoma. She was scheduled to receive chemotherapy.scheduled to receive chemotherapy.

•What to do ? What to do ?

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• Reactivation of HBV replication with increase Reactivation of HBV replication with increase

in serum HBV DNA and ALT level has been in serum HBV DNA and ALT level has been

reported in 20% to 50% of hepatitis B carriers reported in 20% to 50% of hepatitis B carriers

undergoing immunosuppressive or cancer undergoing immunosuppressive or cancer

chemotherapy.chemotherapy.

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• Prophylactic antiviral therapy should be Prophylactic antiviral therapy should be administered to hepatitis B carriers administered to hepatitis B carriers (regardless of baseline serum HBV DNA (regardless of baseline serum HBV DNA level)level) at the onset of cancer chemotherapy at the onset of cancer chemotherapy or a finite course of immunosuppressive or a finite course of immunosuppressive therapy, and maintained for 6 months therapy, and maintained for 6 months afterwardsafterwards..

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No No prophylaxisprophylaxis

Lamivudine Lamivudine prophylaxisprophylaxis

95% CI95% CIp>p>

HBV reactivation4141––100%100%00––40%40%8686––99%99%0.00010.0001

Liver failure2424––100%100%00––28%28%8585––95%95%0.00010.0001

Liver-related mortality0––50%0%55––91%0.0001

Chemotherapy withdrawal 1111––20%20%22––6%6%6060––90%90%0.00010.0001

All mortality6––100%0––35%38––76%0.0001

Katz Katz et alet al. . J Viral HepatJ Viral Hepat 2008; 15: 89 2008; 15: 89––102102..

A meta-analysis of LAM in HBsAg+ve subjects receiving chemotherapy

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