Effects of Tenofovir Disoproxil Fumarate in Hepatitis B e Antigen-Positive Patients With Normal Levels of Alanine Aminotransferase and High Levels of Hepatitis B Virus DNA
Little is known about the benefit of antiviral therapy for hepatitis B e antigen (HBeAg)−positive patients with high viral load and normal levels of alanine aminotransferase. We evaluated the effects of single and combination therapies in immune-tolerant patients with chronic hepatitis B. In a doubl...
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| Published in | Gastroenterology (New York, N.Y. 1943) Vol. 146; no. 5; pp. 1240 - 1248 |
|---|---|
| Main Authors | , , , , , , , , , , , , , , |
| Format | Journal Article |
| Language | English |
| Published |
United States
Elsevier Inc
01.05.2014
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| Subjects | |
| Online Access | Get full text |
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| Abstract | Little is known about the benefit of antiviral therapy for hepatitis B e antigen (HBeAg)−positive patients with high viral load and normal levels of alanine aminotransferase. We evaluated the effects of single and combination therapies in immune-tolerant patients with chronic hepatitis B.
In a double-blind study, nucleos(t)ide-naïve patients with high levels of hepatitis B virus (HBV) DNA who were positive for HBeAg and had normal levels of alanine aminotransferase were randomly assigned to groups given either oral tenofovir disoproxil fumarate (TDF, 300 mg) and placebo (n = 64) or a combination of TDF (300 mg) and emtricitabine (200 mg, n = 62) for 192 weeks. The primary end point was proportion of patients with serum levels of HBV DNA <69 IU/mL at week 192.
The study population (mean age was 33 years; 89% were Asian) was predominantly infected with HBV genotypes B and C (93%), 99% were HBeAg positive with a mean baseline level of HBV DNA of 8.41 log10 IU/mL. At week 192, 55% of patients (35 of 64) in the TDF+placebo group and 76% of patients (47 of 62) in the TDF+emtricitabine group had levels of HBV DNA <69 IU/mL (P = .016). No patients were found to have viral resistance to therapy. HBeAg seroconversion occurred in 3 patients (5%), all in the TDF+placebo group; no patient had loss of hepatitis B surface antigen. In multivariate analysis, female sex (odds ratio = 7.05; P = .002) and TDF+emtricitabine treatment (odds ratio = 3.9; P = .01) were associated with a favorable response. Both regimens were well tolerated.
In HBeAg-positive patients with chronic HBV infection, high viral loads, normal levels of alanine aminotransferase, and therapy with the combination of TDF and emtricitabine provided better viral suppression than TDF alone, although rates of HBeAg seroconversion and hepatitis B surface antigen loss were low. |
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| AbstractList | Little is known about the benefit of antiviral therapy for hepatitis B e antigen (HBeAg)−positive patients with high viral load and normal levels of alanine aminotransferase. We evaluated the effects of single and combination therapies in immune-tolerant patients with chronic hepatitis B.
In a double-blind study, nucleos(t)ide-naïve patients with high levels of hepatitis B virus (HBV) DNA who were positive for HBeAg and had normal levels of alanine aminotransferase were randomly assigned to groups given either oral tenofovir disoproxil fumarate (TDF, 300 mg) and placebo (n = 64) or a combination of TDF (300 mg) and emtricitabine (200 mg, n = 62) for 192 weeks. The primary end point was proportion of patients with serum levels of HBV DNA <69 IU/mL at week 192.
The study population (mean age was 33 years; 89% were Asian) was predominantly infected with HBV genotypes B and C (93%), 99% were HBeAg positive with a mean baseline level of HBV DNA of 8.41 log10 IU/mL. At week 192, 55% of patients (35 of 64) in the TDF+placebo group and 76% of patients (47 of 62) in the TDF+emtricitabine group had levels of HBV DNA <69 IU/mL (P = .016). No patients were found to have viral resistance to therapy. HBeAg seroconversion occurred in 3 patients (5%), all in the TDF+placebo group; no patient had loss of hepatitis B surface antigen. In multivariate analysis, female sex (odds ratio = 7.05; P = .002) and TDF+emtricitabine treatment (odds ratio = 3.9; P = .01) were associated with a favorable response. Both regimens were well tolerated.
In HBeAg-positive patients with chronic HBV infection, high viral loads, normal levels of alanine aminotransferase, and therapy with the combination of TDF and emtricitabine provided better viral suppression than TDF alone, although rates of HBeAg seroconversion and hepatitis B surface antigen loss were low. Little is known about the benefit of antiviral therapy for hepatitis B e antigen (HBeAg)-positive patients with high viral load and normal levels of alanine aminotransferase. We evaluated the effects of single and combination therapies in immune-tolerant patients with chronic hepatitis B.BACKGROUND & AIMSLittle is known about the benefit of antiviral therapy for hepatitis B e antigen (HBeAg)-positive patients with high viral load and normal levels of alanine aminotransferase. We evaluated the effects of single and combination therapies in immune-tolerant patients with chronic hepatitis B.In a double-blind study, nucleos(t)ide-naïve patients with high levels of hepatitis B virus (HBV) DNA who were positive for HBeAg and had normal levels of alanine aminotransferase were randomly assigned to groups given either oral tenofovir disoproxil fumarate (TDF, 300 mg) and placebo (n = 64) or a combination of TDF (300 mg) and emtricitabine (200 mg, n = 62) for 192 weeks. The primary end point was proportion of patients with serum levels of HBV DNA <69 IU/mL at week 192.METHODSIn a double-blind study, nucleos(t)ide-naïve patients with high levels of hepatitis B virus (HBV) DNA who were positive for HBeAg and had normal levels of alanine aminotransferase were randomly assigned to groups given either oral tenofovir disoproxil fumarate (TDF, 300 mg) and placebo (n = 64) or a combination of TDF (300 mg) and emtricitabine (200 mg, n = 62) for 192 weeks. The primary end point was proportion of patients with serum levels of HBV DNA <69 IU/mL at week 192.The study population (mean age was 33 years; 89% were Asian) was predominantly infected with HBV genotypes B and C (93%), 99% were HBeAg positive with a mean baseline level of HBV DNA of 8.41 log10 IU/mL. At week 192, 55% of patients (35 of 64) in the TDF+placebo group and 76% of patients (47 of 62) in the TDF+emtricitabine group had levels of HBV DNA <69 IU/mL (P = .016). No patients were found to have viral resistance to therapy. HBeAg seroconversion occurred in 3 patients (5%), all in the TDF+placebo group; no patient had loss of hepatitis B surface antigen. In multivariate analysis, female sex (odds ratio = 7.05; P = .002) and TDF+emtricitabine treatment (odds ratio = 3.9; P = .01) were associated with a favorable response. Both regimens were well tolerated.RESULTSThe study population (mean age was 33 years; 89% were Asian) was predominantly infected with HBV genotypes B and C (93%), 99% were HBeAg positive with a mean baseline level of HBV DNA of 8.41 log10 IU/mL. At week 192, 55% of patients (35 of 64) in the TDF+placebo group and 76% of patients (47 of 62) in the TDF+emtricitabine group had levels of HBV DNA <69 IU/mL (P = .016). No patients were found to have viral resistance to therapy. HBeAg seroconversion occurred in 3 patients (5%), all in the TDF+placebo group; no patient had loss of hepatitis B surface antigen. In multivariate analysis, female sex (odds ratio = 7.05; P = .002) and TDF+emtricitabine treatment (odds ratio = 3.9; P = .01) were associated with a favorable response. Both regimens were well tolerated.In HBeAg-positive patients with chronic HBV infection, high viral loads, normal levels of alanine aminotransferase, and therapy with the combination of TDF and emtricitabine provided better viral suppression than TDF alone, although rates of HBeAg seroconversion and hepatitis B surface antigen loss were low.CONCLUSIONSIn HBeAg-positive patients with chronic HBV infection, high viral loads, normal levels of alanine aminotransferase, and therapy with the combination of TDF and emtricitabine provided better viral suppression than TDF alone, although rates of HBeAg seroconversion and hepatitis B surface antigen loss were low. Background & Aims Little is known about the benefit of antiviral therapy for hepatitis B e antigen (HBeAg)−positive patients with high viral load and normal levels of alanine aminotransferase. We evaluated the effects of single and combination therapies in immune-tolerant patients with chronic hepatitis B. Methods In a double-blind study, nucleos(t)ide-naïve patients with high levels of hepatitis B virus (HBV) DNA who were positive for HBeAg and had normal levels of alanine aminotransferase were randomly assigned to groups given either oral tenofovir disoproxil fumarate (TDF, 300 mg) and placebo (n = 64) or a combination of TDF (300 mg) and emtricitabine (200 mg, n = 62) for 192 weeks. The primary end point was proportion of patients with serum levels of HBV DNA <69 IU/mL at week 192. Results The study population (mean age was 33 years; 89% were Asian) was predominantly infected with HBV genotypes B and C (93%), 99% were HBeAg positive with a mean baseline level of HBV DNA of 8.41 log10 IU/mL. At week 192, 55% of patients (35 of 64) in the TDF+placebo group and 76% of patients (47 of 62) in the TDF+emtricitabine group had levels of HBV DNA <69 IU/mL ( P = .016). No patients were found to have viral resistance to therapy. HBeAg seroconversion occurred in 3 patients (5%), all in the TDF+placebo group; no patient had loss of hepatitis B surface antigen. In multivariate analysis, female sex (odds ratio = 7.05; P = .002) and TDF+emtricitabine treatment (odds ratio = 3.9; P = .01) were associated with a favorable response. Both regimens were well tolerated. Conclusions In HBeAg-positive patients with chronic HBV infection, high viral loads, normal levels of alanine aminotransferase, and therapy with the combination of TDF and emtricitabine provided better viral suppression than TDF alone, although rates of HBeAg seroconversion and hepatitis B surface antigen loss were low. Little is known about the benefit of antiviral therapy for hepatitis B e antigen (HBeAg)-positive patients with high viral load and normal levels of alanine aminotransferase. We evaluated the effects of single and combination therapies in immune-tolerant patients with chronic hepatitis B. In a double-blind study, nucleos(t)ide-naïve patients with high levels of hepatitis B virus (HBV) DNA who were positive for HBeAg and had normal levels of alanine aminotransferase were randomly assigned to groups given either oral tenofovir disoproxil fumarate (TDF, 300 mg) and placebo (n = 64) or a combination of TDF (300 mg) and emtricitabine (200 mg, n = 62) for 192 weeks. The primary end point was proportion of patients with serum levels of HBV DNA <69 IU/mL at week 192. The study population (mean age was 33 years; 89% were Asian) was predominantly infected with HBV genotypes B and C (93%), 99% were HBeAg positive with a mean baseline level of HBV DNA of 8.41 log10 IU/mL. At week 192, 55% of patients (35 of 64) in the TDF+placebo group and 76% of patients (47 of 62) in the TDF+emtricitabine group had levels of HBV DNA <69 IU/mL (P = .016). No patients were found to have viral resistance to therapy. HBeAg seroconversion occurred in 3 patients (5%), all in the TDF+placebo group; no patient had loss of hepatitis B surface antigen. In multivariate analysis, female sex (odds ratio = 7.05; P = .002) and TDF+emtricitabine treatment (odds ratio = 3.9; P = .01) were associated with a favorable response. Both regimens were well tolerated. In HBeAg-positive patients with chronic HBV infection, high viral loads, normal levels of alanine aminotransferase, and therapy with the combination of TDF and emtricitabine provided better viral suppression than TDF alone, although rates of HBeAg seroconversion and hepatitis B surface antigen loss were low. |
| Author | Mathurin, Philippe Flaherty, John F. Chan, Chi Kuen Poordad, Fred Lin, Lanjia Gane, Edward J. Chan, Henry L.Y. Gaggar, Anuj Chan, Sing Subramanian, G. Mani Chang, Ting-Tsung Hui, Aric Josun Lee, Sam Corsa, Amy McHutchison, John G. |
| Author_xml | – sequence: 1 givenname: Henry L.Y. surname: Chan fullname: Chan, Henry L.Y. email: hlychan@cuhk.edu.hk organization: Prince of Wales Hospital, The Chinese University of Hong Kong, Hong Kong – sequence: 2 givenname: Chi Kuen surname: Chan fullname: Chan, Chi Kuen organization: Queen Mary Hospital, University of Hong Kong, Hong Kong – sequence: 3 givenname: Aric Josun surname: Hui fullname: Hui, Aric Josun organization: Alice Ho Miu Ling Nethersole Hospital, Hong Kong – sequence: 4 givenname: Sing surname: Chan fullname: Chan, Sing organization: Chan, Sing Private Practice, Flushing, New York – sequence: 5 givenname: Fred surname: Poordad fullname: Poordad, Fred organization: Texas Liver Institute, San Antonio, TX – sequence: 6 givenname: Ting-Tsung surname: Chang fullname: Chang, Ting-Tsung organization: National Cheng Kung University Hospital, Tainan, Taiwan – sequence: 7 givenname: Philippe surname: Mathurin fullname: Mathurin, Philippe organization: Hôpital Claude Huriez, Lille, France – sequence: 8 givenname: John F. surname: Flaherty fullname: Flaherty, John F. organization: Gilead Sciences, Inc., Foster City, California – sequence: 9 givenname: Lanjia surname: Lin fullname: Lin, Lanjia organization: Gilead Sciences, Inc., Foster City, California – sequence: 10 givenname: Amy surname: Corsa fullname: Corsa, Amy organization: Gilead Sciences, Inc., Foster City, California – sequence: 11 givenname: Anuj surname: Gaggar fullname: Gaggar, Anuj organization: Gilead Sciences, Inc., Foster City, California – sequence: 12 givenname: G. Mani surname: Subramanian fullname: Subramanian, G. Mani organization: Gilead Sciences, Inc., Foster City, California – sequence: 13 givenname: John G. surname: McHutchison fullname: McHutchison, John G. organization: Gilead Sciences, Inc., Foster City, California – sequence: 14 givenname: Sam surname: Lee fullname: Lee, Sam organization: Heritage Medical Research Clinic, University of Calgary, Calgary, Ontario, Canada – sequence: 15 givenname: Edward J. surname: Gane fullname: Gane, Edward J. organization: Auckland General Hospital, University of Auckland, Auckland, New Zealand |
| BackLink | https://www.ncbi.nlm.nih.gov/pubmed/24462735$$D View this record in MEDLINE/PubMed |
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| Snippet | Little is known about the benefit of antiviral therapy for hepatitis B e antigen (HBeAg)−positive patients with high viral load and normal levels of alanine... Background & Aims Little is known about the benefit of antiviral therapy for hepatitis B e antigen (HBeAg)−positive patients with high viral load and normal... Little is known about the benefit of antiviral therapy for hepatitis B e antigen (HBeAg)-positive patients with high viral load and normal levels of alanine... |
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| SubjectTerms | Adenine - adverse effects Adenine - analogs & derivatives Adenine - therapeutic use Adolescent Adult Alanine Transaminase - blood Antiviral Agents - adverse effects Antiviral Agents - therapeutic use Biomarkers - blood Combination Therapy Deoxycytidine - analogs & derivatives Deoxycytidine - therapeutic use DNA, Viral - blood Double-Blind Method Drug Therapy, Combination Emtricitabine Female FTC Gastroenterology and Hepatology HBsAg Hepatitis B e Antigens - blood Hepatitis B virus - drug effects Hepatitis B virus - genetics Hepatitis B virus - immunology Hepatitis B, Chronic - blood Hepatitis B, Chronic - diagnosis Hepatitis B, Chronic - drug therapy Humans Immune Tolerance Immune Tolerant Male Middle Aged Multivariate Analysis Odds Ratio Phosphorous Acids - adverse effects Phosphorous Acids - therapeutic use Time Factors Treatment Outcome Viral Load Young Adult |
| Title | Effects of Tenofovir Disoproxil Fumarate in Hepatitis B e Antigen-Positive Patients With Normal Levels of Alanine Aminotransferase and High Levels of Hepatitis B Virus DNA |
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