OUTCOMES OF ENTECAVIR (ETV) AND TENOFOVIR (TDF) COMBINATION THERAPY IN CHRONIC HEP-B PATIENTS WITH PREVIOUS TREATMENT FAILURE
Reported by Jules Levin
Prof. Muzaffar Lateef Gill
Background: ETV and TDF are the most effective /nucelos(t)ide analogues for the treatment of chronic hepatitis B. There are not many published studies about the safety and efficacy of this combination therapy for patients with chronic hepatitis B who have viral break through with combination of Lamuvidine (LAM) and Adefovir( ADV) .we wanted to study the efficacy and safety of this combination therapy in this cohort.
Methods: We enrolled 60 patients with chronic Hepatitis B who have received LAM and ADV combination therapy for at least 2 years and were found to have viral breakthrough (Hep B PCR positive) HB-DNA>6logIU/ml 6 months after cessation of therapy. The enrollment period was between February 2010 to April 2010. These patients were given ETV 0.5mg and TDF 300mg daily for 96 weeks. Study endpoints were complete HBV suppression at week 24, long term HBV suppression and safety profile especially renal functions. Patients with decompensated cirrhosis were excluded from this study. These patients were seen in outpatient every 8 weeks. They had baseline CBC, LFTS, BUN/Creatinine, and quantitative HB-DNA.They had ALT, BUN/CREATININE on every visit.HB-DNA was done every three month basis.
Results: We are reporting the interim analysis of this cohort after 12 months of therapy. out of 60 patients 40 were male, 20 female. Median ALT was 85 median HB-DNA 7 logIU/ml. After 3, 6 and 12 months of ETV+TDF therapy the viral load was undetectable in 50%, 60% and 75% patients respectively. These patients are continuing therapy for total of 96 weeks and they are in close F/U.
Conclusion: ETV and TDF combined therapy has an excellent efficacy and safety who had viral break through with LAM and ADV combination therapy. Our study has a limitation we do not have resources to check resistant mutation. It was an empirical treatment.