Long-term efficacy and safety of lamivudine, entecavir, and tenofovir for treatment of hepatitis B virus-related cirrhosis.
OBJECTIVE
Data are limited on the efficacy and safety of tenofovir and entecavir when given for more than 1 year to patients with hepatitis B-related cirrhosis. We investigated the long-term safety and efficacy of these antiviral drugs in patients with chronic hepatitis B virus (HBV) infection, with compensated or decompensated cirrhosis, and compared results with those from lamivudine.


METHODS
We performed a retrospective analysis of data from 227 adult patients with chronic HBV infection who were diagnosed with cirrhosis, beginning in 2005, at 18 centers throughout Turkey. There were 104 patients who had decompensated cirrhosis, and 197 patients were treatment naive before. Seventy-two patients received tenofovir (followed up for 21.4 ± 9.7 mo), 77 patients received entecavir (followed up for 24.0 ± 13.3 mo), and 74 patients received lamivudine (followed up for 36.5 ± 24.1 mo). We collected data on patient demographics and baseline characteristics. Laboratory test results, clinical outcomes, and drug-related adverse events were compared among groups.


RESULTS
Levels of HBV DNA less than 400 copies/mL were achieved in 91.5%, 92.5%, and 77% of patients receiving tenofovir, entecavir, or lamivudine, respectively. Levels of alanine aminotransferase normalized in 86.8%, 92.1%, and 71.8% of patients who received tenofovir, entecavir, and lamivudine, respectively. Child-Turcotte-Pugh scores increased among 8.5% of patients who received tenofovir, 15.6% who received entecavir, and 27.4% who received lamivudine. Frequencies of complications from cirrhosis, including hepatic encephalopathy, variceal bleeding, hepatocellular carcinoma, and mortality, were similar among groups. Lamivudine had to be changed to another drug for 32.4% of the patients.


CONCLUSIONS
Tenofovir and entecavir are effective and safe for long-term use in patients with compensated or decompensated cirrhosis from HBV infection.
Department of Gastroenterology, Hacettepe University School of Medicine, Ankara, Turkey. gskoklu@yahoo.com
Seyfettin
S
Köklü
Yaşar
Y
Tuna
Murat Taner
MT
Gülşen
Mehmet
M
Demir
Aydin Şeref
AŞ
Köksal
Muhammet Cem
MC
Koçkar
Cem
C
Aygün
Sahin
S
Coban
Kamil
K
Ozdil
Hüseyin
H
Ataseven
Ebru
E
Akin
Tuğrul
T
Pürnak
Ilhami
I
Yüksel
Hilmi
H
Ataseven
Mehmet
M
Ibiş
Beytullah
B
Yildirim
Işilay
I
Nadir
Metin
M
Küçükazman
Erdem
E
Akbal
Osman
O
Yüksel
Omer
O
Başar
Erhan
E
Alkan
Ozlem
O
Baykal
D000225:Adenine / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives*; D000328:Adult; D000368:Aged; D000410:Alanine Transaminase / Q000097:blood; D000998:Antiviral Agents / Q000008:administration & dosage* / Q000009:adverse effects; D001774:Blood Chemical Analysis; D004359:Drug Therapy, Combination / Q000009:adverse effects* / Q000379:methods; D064420:Drug-Related Side Effects and Adverse Reactions / Q000453:epidemiology; D005260:Female; D006147:Guanine / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives*; D006515:Hepatitis B virus / Q000302:isolation & purification; D019694:Hepatitis B, Chronic / Q000150:complications*; D006801:Humans; D019259:Lamivudine / Q000008:administration & dosage* / Q000009:adverse effects; D008103:Liver Cirrhosis / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D063065:Organophosphonates / Q000008:administration & dosage* / Q000009:adverse effects; D012189:Retrospective Studies; D000068698:Tenofovir; D016896:Treatment Outcome; D014421:Turkey
D000998:Antiviral Agents; D063065:Organophosphonates; D019259:Lamivudine; C413685:entecavir; D006147:Guanine; D000068698:Tenofovir; D000410:Alanine Transaminase; D000225:Adenine