In last Friday’s post, this blog reviewed 5-year data on tenofovir usage which showed that tenofovir could reverse fibrosis/cirrhosis. Another study using the same cohort examined the efficacy of tenofovir in patients with high viral load (HVL) at baseline (Hepatology 2013; 58: 505-13).
From an initial total of 641 patients enrolled in GS-US-174-0102 (n=375) and GS-US-174-0103 (n=266), the authors identified 129 (20%) with HVL. HVL was defined as having ≥9 log10 copies/mL. After an initial 48 weeks of randomization between tenofovir (HVL n=82) or adefovir (HVL n=47), patients received an additional 192 weeks of therapy with tenofovir in an open label extension.
Results:
- By week 240, 98.3% of HVL and 99.2% of non-HVL patients on treatment achieved HBV DNA <400 copies/mL
- High HVL patients took longer to achieve undetectable HBV DNA, but by week 96 the results were similar in both groups
- Patients who received tenofovir during the initial 48 weeks achieved undetectable HBV DNA quicker than those who had received adefovir initially
- There were similar rates of histologic regression in both HVL and non-HVL patients
This study evaluated only patients in the ‘immune clearance’ phase of HBV and therefore cannot be extrapolated to those in the immune tolerant phase.