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©2013 UpToDate ® Print Email Responses to approved antiviral therapies among treatment-naive patients with HBeAg-positive chronic hepatitis B Placebo/control groups from multiple studies, percent Standard IFN-α 5 MU daily or 10 MU three times per week for 12-24 weeks, percent Lamivudine 100 mg daily for 48-52 weeks, percent Adefovir 10 mg daily for 48 weeks, percent Entecavir 0.5 mg daily for 48 weeks, percent Tenofovir 300 mg daily for 48 weeks, percent Telbivudine 600 mg daily for 52 weeks, percent PegIFNα 180 mcg once weekly for 48 weeks, percent Peg IFNα 180 mcg once weekly + Lamivudine 100 mg daily for 48 weeks, percent Loss of serum HBV DNA* 0-17 37 40-44 21 67 76 60 25 69 Loss of HBeAg 6-12 33 17-32 24 22 NA 26 30/34• 27/28• HBeAg seroconversion 4-6 Difference of 18 16-21 12 21 21 22 27/32• 24/27• Loss of HBsAg 0-1 7.80 1 0 2 3.2 0 3 3 Normalization of ALT 7-24 Difference of 23 41-75 48 68 68 77 39 46 Histologic improvement NA NA 49-56 53 72 74 65 38Δ 41Δ Durability of response 80-90 50-80◊ ∼90◊ 69◊ NA ∼80 NA NA NA: not available. * Hybridization or branched chain DNA assays (lower limit of detection 20,000-200,000 international units/mL or 5-6 log copies/mL) in standard IFN-α studies and some lamivudine studies, and PCR assays (lower limit of detection approximately 50 international units/mL or 250 copies/mL) in other studies. • Responses at week 48/week 72 (24 weeks after stopping treatment). Δ Post-treatment biopsies obtained at week 72. ◊ Lamivudine and entecavir - no or short duration of consolidation treatment, Adefovir and telbivudine - most patients had consolidation treatment. Reproduced with permission from: Lok ASF, McMahon BJ. Chronic hepatitis B: Update 2009. Hepatology 2009; 50:661. Available online at file://publish.aasld.org/Pages/Default.aspx. Accessed September 8th 2009. Copyright © 2009 American Association for the Study of Liver Diseases. Responses to approved antiviral therapies among treatment-naive patients with HBeAG-negative chronic hepatitis B Control/placebo groups from multiple studies, percent Standard IFN-α 5 MU daily or 10 MU three times per week for 6-12 months, percent Lamivudine 100 mg daily for 48-52 weeks, percent Adefovir 10 mg daily for 48 weeks, percent Entecavir 0.5 mg daily for 48 weeks, percent Telbivudine 600 mg daily for 52 weeks, percent Tenofovir 300 mg daily for 48 weeks, percent PegIFNα 180 mcg once weekly for 48 weeks, percent

Standard IFN-α 5 MU daily or 10 MU three times per week for 6-12 months, percent Lamivudine 100 mg daily for 48-52 weeks, percent Adefovir 10 mg daily for 48 weeks, percent Entecavir 0.5 mg daily for 48 weeks, percent Telbivudine 600 mg daily for 52 weeks, percent Tenofovir 300 mg daily for 48 weeks, percent PegIFNα 180 mcg once weekly for 48 weeks, percent Peg IFNα 180 mcg once weekly + Lamivudine 100 mg daily for 48 weeks, percent Loss of serum HBV DNA* 0-20 60-70 60-73 51 90 88 93 63 87 Normalization of ALT 10-29 60-70 60-79 72 78 74 76 38 49 Histologic improvement 33 NA 60-66 64 70 67 72 48 38• Durability of response Control 10-20 <10 ~5 3 NA NA ~20 ~20 NA: not available. * Hybridization or branched chain DNA assays (lower limit of detection 20,000-200,000 international units/mL or 5-6 log copies/mL) in standard IFN-α studies and some lamivudine studies, and PCR assays (lower limit of detection approximately 50 international units/mL or 250 copies/mL) in other studies. • Post-treatment biopsies obtained at week 72. Reproduced with permission from: Lok ASF, McMahon BJ. Chronic hepatitis B: Update 2009. Hepatology 2009; 50:661. Available online at file://publish.aasld.org/Pages/Default.aspx. Accessed September 8th 2009. Copyright © 2009 American Association for the Study of Liver Diseases. Comparison of approved treatments of chronic hepatitis B Pegylated IFNα Lamivudine Adefovir Entecavir Telbivudine Tenofovir Indications HBeAg+, normal ALT Not indicated Not indicated Not indicated Not indicated Not indicated Not indicated HBeAg+ chronic hepatitis Indicated Indicated* Indicated • Indicated Indicated* Indicated HBeAg- chronic hepatitis Indicated Indicated* Indicated • Indicated Indicated* Indicated Duration of treatment HBeAg+ chronic hepatitis 1 year ≥1 yearΔ ≥1 yearΔ ≥1 yearΔ ≥1 yearΔ ≥1 yearΔ HBeAg- chronic hepatitis 1 year >1 year◊ >1 year◊ >1 year◊ >1 year◊ >1 year◊ Route Subcutaneous Oral Oral Oral Oral Oral Side effects Many Negligible Potential nephrotoxicity Negligible Negligible Potential nephrotoxicity Drug resistance - ∼20 percent, year 1 None, year 1 ∼1 percent up to year 6§ ∼25 percent up to year 2 None, up to year 5¥ ∼70 percent, year 5 29 percent, year 5 Cost������ High Low Intermediate High Intermediate Intermediate

Route Subcutaneous Oral Oral Oral Oral Oral Side effects Many Negligible Potential nephrotoxicity Negligible Negligible Potential nephrotoxicity Drug resistance - ∼20 percent, year 1 None, year 1 ∼1 percent up to year 6§ ∼25 percent up to year 2 None, up to year 5¥ ∼70 percent, year 5 29 percent, year 5 Cost������ High Low Intermediate High Intermediate Intermediate * Not preferred drug due to high rate of resistance. • Not preferred drug due to weak antiviral activity. Δ Treatment for at least 12 months after anti-HBe seroconversion. ◊ Treatment continued until HBsAg loss. § Entecavir resistance 1.2 percent up to six years in nucleoside naïve patients but 1.0 mg dose used from year 3 onward, resistance ~50 percent at year five in patients with prior lamivudine resistance. ¥ Patients with detectable HBV DNA at week 72 eligible to receive additional treatment with emtricitabine and ~70% of such patients elected to do so. ‡ Based on treatment duration of 1 year. Adapted with permission from: Lok ASF, McMahon BJ. Chronic hepatitis B: Update 2009. Hepatology 2009; 50:661. Available online at file://publish.aasld.org/Pages/Default.aspx. Accessed September 8th 2009. Copyright © 2009 American Association for the Study of Liver Diseases.

©2013 UpToDate ® Print Email Responses to approved antiviral therapies among treatment-naive patients with HBeAg-positive chronic hepatitis B Placebo/control groups from multiple studies, percent Standard IFN-α 5 MU daily or 10 MU three times per week for 12-24 weeks, percent Lamivudine 100 mg daily for 48-52 weeks, percent Adefovir 10 mg daily for 48 weeks, percent Entecavir 0.5 mg daily for 48 weeks, percent Tenofovir 300 mg daily for 48 weeks, percent Telbivudine 600 mg daily for 52 weeks, percent PegIFNα 180 mcg once weekly for 48 weeks, percent Peg IFNα 180 mcg once weekly + Lamivudine 100 mg daily for 48 weeks, percent Loss of serum HBV DNA* 0-17 37 40-44 21 67 76 60 25 69 Loss of HBeAg 6-12 33 17-32 24 22 NA 26 30/34• 27/28• HBeAg seroconversion 4-6 Difference of 18 16-21 12 21 21 22 27/32• 24/27• Loss of HBsAg 0-1 7.80 1 0 2 3.2 0 3 3 Normalization of ALT 7-24 Difference of 23 41-75 48 68 68 77 39 46 Histologic improvement NA NA 49-56 53 72 74 65 38Δ 41Δ Durability of response 80-90 50-80◊ ∼90◊ 69◊ NA ∼80 NA NA NA: not available. * Hybridization or branched chain DNA assays (lower limit of detection 20,000-200,000 international units/mL or 5-6 log copies/mL) in standard IFN-α studies and some lamivudine studies, and PCR assays (lower limit of detection approximately 50 international units/mL or 250 copies/mL) in other studies. • Responses at week 48/week 72 (24 weeks after stopping treatment). Δ Post-treatment biopsies obtained at week 72. ◊ Lamivudine and entecavir - no or short duration of consolidation treatment, Adefovir and telbivudine - most patients had consolidation treatment. Reproduced with permission from: Lok ASF, McMahon BJ. Chronic hepatitis B: Update 2009. Hepatology 2009; 50:661. Available online at file://publish.aasld.org/Pages/Default.aspx. Accessed September 8th 2009. Copyright © 2009 American Association for the Study of Liver Diseases.