Abstract
Tenofovir disoproxil fumarate (TDF) monotherapy has proven superior antiviral efficacy in chronic hepatitis B (CHB) patients; however, whether the combination of TDF and emtricitabine (FTC) exerts a significant advantage remains controversial. A meta-analysis was performed to comprehensively compare the therapeutic effects of FTC/TDF combination with TDF alone in CHB patients. Five studies involving 614 patients were identified, and subgroup analysis was performed based on the nucleos(t)ide treatment history. Our results revealed that in patients with nucleos(t)ide-naïve treatment, there were no significant differences between the treatment groups with TDF alone and FTC/TDF combination after 12 and 24 weeks; however, the FTC/TDF combination showed better viral suppression efficacy versus TDF alone after 48 (OR = 2.16, 95% CI = 1.06–4.41, P = 0.03), 96 (OR = 2.76, 95% CI = 1.29–5.92, P = 0.009) and 192 weeks (OR = 2.60, 95% CI = 1.21–5.56, P = 0.01). In patients with nucleos(t)ide treatment history, no differences were noted between the two treatment groups after 12, 24, 48 and 96 weeks. Our results indicated that FTC/TDF combination showed better viral suppression efficacy versus TDF alone in CHB patients with nucleos(t)ide-naïve treatment, while both treatments provided similar viral suppression efficacy in CHB patients with nucleos(t)ide treatment history.
Highlights
Hepatitis B virus (HBV) infection remains a major global health problem
A recent meta-analysis[24] indicated that the combined therapy of adefovir dipivoxil (ADV) and LAM did not show obvious therapeutic superiority when administered in a short duration, but had a great advantage over monotherapy in term of both virological and biochemical responses after the long-term administration
The in vitro study demonstrated that the combination of FTC and Tenofovir disoproxil fumarate (TDF) could induce a synergistic effect on anti-HBV activity[18]
Summary
Hepatitis B virus (HBV) infection remains a major global health problem. It is a leading cause of chronic liver disease and chronic infection that may progress to liver cirrhosis and liver cancer[1,2]. The major goal of drug treatment for patients with chronic hepatitis B (CHB) is to improve quality of life and survival by preventing progression of the disease to cirrhosis, decompensated cirrhosis, end-stage liver disease, liver cancer and death[4,5]. This goal can be achieved if HBV replication can be suppressed in a sustained manner[5]. In 5-year clinical trials conducted in naïve CHB patients, TDF treatment showed well-tolerated and produced a significant improvement in hepatic fibrosis, durable suppression of HBV replication and delayed development of resistance[8,11]. Whether the combination of TDF and FTC provides a significantly predominant advantage over TDF monotherapy in CHB patients remains controversial
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