1. Sustained suppression of HBV replication Decrease in serum HBV DNA to <10 5 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

Interferon  2B - 1992 Lamivudine - 1998 Adefovir - 2002 Peg Interferon - 2004 Entecavir - 2005 Telbivudine - 2006 Tenofovir - 2008

HBeAg Status HBV DNA IU/ml ALT level x UNL Recommendation Positive Positive > 20,000 > 20,000



2 times > 2 times

Do not treat Peg Inf, Adefovir, Entacavir

Negative Negative Negative > 20,000 > 2,000



2,000 > 2 times 1 to 2 times



1 time

Peg Inf, Adefovir, Entacavir Liver Bx. for Rx. decision Observe

HBV DNA, ALT HBV Serology panel Obtain Baseline tests

Obtain Baseline tests HBV DNA, ALT HBV Serology panel

Systemic Fever (low grade), Fatigue Myalgia and or Arthralgia Mood Disturbances Depression Irritability, Insomnia Hematologic Neutropenia, Anemia Thrombocytopenia Endocrine Hypothyroidism Hyperthyroidism Dermatologic Rash, Dry skin, Pruritus Thinning of Hair Gastrointestinal Anorexia, Nausea, Weight loss

10 5 copies/ml (20,000 IU/ml)

•

Emtricitabine

•

Clevudine (l-FMAU)

•

Therapeutic vaccines