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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.

Abstract：

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-naïve 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.

journal_name

Antivir Ther

journal_title

Antiviral therapy

authors

Jia J,Shang J,Tang H,Jiang J,Ning Q,Dou X,Zhang S,Zhang M,Han T,Tan D,Zhou X,Chen G,Sheng J,Su Z,Chen H,Dai E,Ye Y,Guo Y,Shen Y,Yuan J,Wei Z,Zhu S,EVOLVE Study Group.

doi

10.3851/IMP3372

subject

Has Abstract

pub_date

2020-10-22 00:00:00

eissn

1359-6535

issn

2040-2058

pub_type

杂志文章

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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.