1. Sustained suppression of HBV replication

Decrease in serum HBV DNA to <105 copies/ml

Seroconversion HBeAg to anti-HBe; HBsAg to anti-HBs

2. Remission of liver disease; Normalization of serum

ALT levels

Decreased necro-inflammation in liver

3. Improvement in clinical outcome; Decreased risks of

developing cirrhosis, liver failure and HCC;

4. Increased survival

Patients who have

• Acute liver failure due to HBV

• ALT of >2 x UNL and or HBV DNA > 20,000 IU/ml

• Cirrhosis and clinical complications

• Cirrhosis or advanced fibrosis & HBV DNA in serum

• Reactivation of Chronic HBV after chemotherapy or immuno-suppression

• Infants born to women who are HBsAg-positive

• The immune-active phase who do not have advanced fibrosis or cirrhosis

Patients with

• Chronic hepatitis B in the immune-tolerant phase (with high levels of serum HBV DNA but normal serum ALT levels or little activity on liver biopsy)

• Patients in the inactive carrier or low replicative phase (with low levels of or no detectable HBV DNA in serum and normal serum ALT levels)

• Patients who have latent HBV infection (HBV DNA without HBsAg)

• High baseline ALT level

• Low Baseline HBV DNA level

• Mild-to-moderate histological activity

• Mild to Moderate stage Liver Dysfunction

• Genotype of the HBV – (A>B>C>D)

• Baseline HBeAg positivity (wild virus)

• Genetic barrier to resistance - Lamivudine, Telbivudine and to a lesser degree, Adefovir

• Persistently elevated HBV DNA

• Persistently elevated ALT (SGPT)

• HBV genotype C infection

• Male Gender, Older age

• Family history of HCC

• Co-infection with HCV or HIV or HDV

Obtain Baseline testsObtain Baseline tests

HBV DNA, ALTHBV Serology panel

Obtain Baseline testsObtain Baseline tests

HBV DNA, ALTHBV Serology panel

Endocrine

Hypothyroidism

Hyperthyroidism

Dermatologic

Rash, Dry skin, Pruritus

Thinning of Hair

Gastrointestinal

Anorexia, Nausea, Weight loss

Systemic

Fever (low grade), Fatigue

Myalgia and or Arthralgia

Mood Disturbances

Depression

Irritability, Insomnia

Hematologic

Neutropenia, Anemia

Thrombocytopenia

105 copies/ml(20,000 IU/ml)

• Emtricitabine

• Clevudine (l-FMAU)

• Therapeutic vaccines