Comparative Meta-Analysis of Tenofovir Disoproxil Fumarate versus Emtricitabine and Tenofovir Disoproxil Fumarate as Treatments for Patients with Chronic Hepatitis B

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.

Figure 1. Flow diagram of literature search strategies.

Figure 2. Forest plot displaying the primary outcomes of viral suppression efficacy for CHB patients at different time points after treatments with TDF alone and FTC/TDF combination, respectively.

Forest plot showed viral suppression efficacy for CHB patients with nucleos(t)ide-(or naïve) treatment history after (a) 12 weeks, (b) 24 weeks, (c) 48 weeks, (d) 96 weeks and (e) 192 weeks of treatments with TDF alone and FTC/TDF combination, respectively.

Figure 3. Forest plot displaying the secondary outcomes of serological responses for CHB patients at different time points after treatments with TDF alone and FTC/TDF combination, respectively.

Forest plots showed the comparison of (a) HBeAg loss and (b) HBeAg seroconversion in CHB patients after 48, 96 and 192 weeks of treatments with TDF alone and FTC/TDF combination, respectively.

Figure 4. Forest plot displaying the secondary outcomes of safety assessment for CHB patients after treatments with TDF alone and FTC/TDF combination, respectively.

Forest plot showed the comparison of (a) overall AE, (b) drug-related AE, (c) SAE and (d) drug-related SAE for CHB patients after treatments with TDF alone and FTC/TDF combination, respectively.

Figure 5. Risk of bias in all included studies was assessed using the Cochrane Collaboration’s tool.

(a) Risk of bias graph: each risk of bias item was presented as percentages in all included studies; (b) Risk of bias summary: each risk of bias item was presented in each included study.