Tenofovir Inchronic Hepatitis B – CMC Experience Over 3 Years

Background and aims: Tenofovir is a potent antiviral agent for hepatitis B with least risk of resistance. We evaluated the safety and efficacy of tenofovir use up to 3 years in patients with chronic hepatitis B (CHB).Methods: All patients (n=174) treated with tenofovir from year 2008 to 2012 were identified from a pharmacy database and those with at least six months follow up data (n=87) were included in this study. Case records were analyzed and serum HBV DNA, ALT and creatinine levels were analyzed at baseline and at follow up visits.Results: Eighty-four patients received tenofovir (chronic hepatitis-55% and cirrhosis-45%). Mean age was 42.67(±13.06) years and M: F= 3:1. Thirty patients (36%) were HBeAg positive. The mean baseline serum HBV DNA level was log10 5.06 (±2.28) IU/ml; median ALT 32 (10-119) IU/ml and creatinine1.0 (0.37- 1.3) mg/dl. Fifty patients were treatment naïve and the remaining 34 had been on either lamivudine (16%) or in combination with adefovir (26%). Twelve out of these 34 had treatment failure. Median duration of follow up was 16 months (6-36). At follow up mean DNA level was significantly low at log 10 2.02(±0.86) IU/ml (p=0.0001); ALT- 29 (7-61) IU/ml and creatinine- 1.08 (0.74-3.9) mg/dl. Twenty-two patients achieved undetectable viral load at median time period of6months (6 - 24). E antigen seroconversion was noted in 5 patients from 6 to 24 months. Significant virologic response (>5 log reduction) was also noted within a period of 12 months in all patients with treatment failure. No adverse effects were noted except mild elevation in serum creatinine (1 to 2 mg/dl) in one patient and acute renal failure in another patient.Conclusions: Tenofovir is an effective and safe option in patients with treatment failure as well as treatment naïve patients with CHB. Background and aims: Tenofovir is a potent antiviral agent for hepatitis B with least risk of resistance. We evaluated the safety and efficacy of tenofovir use up to 3 years in patients with chronic hepatitis B (CHB). Methods: All patients (n=174) treated with tenofovir from year 2008 to 2012 were identified from a pharmacy database and those with at least six months follow up data (n=87) were included in this study. Case records were analyzed and serum HBV DNA, ALT and creatinine levels were analyzed at baseline and at follow up visits. Results: Eighty-four patients received tenofovir (chronic hepatitis-55% and cirrhosis-45%). Mean age was 42.67(±13.06) years and M: F= 3:1. Thirty patients (36%) were HBeAg positive. The mean baseline serum HBV DNA level was log10 5.06 (±2.28) IU/ml; median ALT 32 (10-119) IU/ml and creatinine1.0 (0.37- 1.3) mg/dl. Fifty patients were treatment naïve and the remaining 34 had been on either lamivudine (16%) or in combination with adefovir (26%). Twelve out of these 34 had treatment failure. Median duration of follow up was 16 months (6-36). At follow up mean DNA level was significantly low at log 10 2.02(±0.86) IU/ml (p=0.0001); ALT- 29 (7-61) IU/ml and creatinine- 1.08 (0.74-3.9) mg/dl. Twenty-two patients achieved undetectable viral load at median time period of6months (6 - 24). E antigen seroconversion was noted in 5 patients from 6 to 24 months. Significant virologic response (>5 log reduction) was also noted within a period of 12 months in all patients with treatment failure. No adverse effects were noted except mild elevation in serum creatinine (1 to 2 mg/dl) in one patient and acute renal failure in another patient. Conclusions: Tenofovir is an effective and safe option in patients with treatment failure as well as treatment naïve patients with CHB.