Long-term outcomes in Chinese patients with chronic hepatitis B receiving nucleoside/nucleotide analogue therapy in real-world clinical practice: 5-year results from the EVOLVE study.

BACKGROUND In China, the optimal management of individuals living with chronic HBV infection remains an unmet need. The EVOLVE was a 5-year prospective, longitudinal, observational study that compared the clinical outcomes in treatment-naive CHB patients receiving entecavir (ETV) or lamivudine (LAM)-based therapies. METHODS Males or females aged ≥18 years, diagnosed with CHB regardless of cirrhosis or HBeAg status were enrolled from Tier 2 city hospitals (between 2012-2014). The choice of initial therapy and subsequent treatment modifications was at the discretion of treating physicians. Key outcomes included treatment modifications, virologic response (HBV DNA <300copies/mL), and HBV disease progression. RESULTS Of the 3408 patients enrolled, 1807 and 628 received ETV and LAM-based therapy, respectively. The mean age was 39.5 years, 74% were male, and 22.9% had cirrhosis. The rate of treatment modification was higher in the LAM-based vs ETV group (25.9% vs 13.7%); viral breakthrough was the most common reason in LAM-based group vs financial reasons in ETV group. At week 240, the virologic response rate was 73% in both treatment groups. Compared with LAM-based therapy, ETV was associated with a significantly lower incidence of viral breakthrough (12.6% vs 2.1%) and genotypic resistance (10.1% vs 1.2%; p<0.0001 for both); significantly lower risk of HBV disease progression (14.0% vs 10.7%; p=0.0113); and lower rates of progression to decompensated cirrhosis (9.6% vs 6.4%) and hepatocellular carcinoma (1.9% vs 0.8%). CONCLUSIONS This real-world, longitudinal study demonstrated a significantly lower risk of HBV-related disease progression, viral breakthrough, and resistance with ETV vs LAM-based therapy.