EASL 綜述：乙肝“治愈”之路？低碳水化合物、高脂肪飲食治

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EASL 綜述：乙肝“治愈”之路？低碳水化合物、高脂肪飲食治療 T2D 的 NAFLD
— 來自歐洲肝臟研究協會年會的值得注意的研究

作者：Zaina Hamza，MedPage Today 特約撰稿人 2022 年 6 月 29 日
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在歐洲肝臟研究協會 (EASL) 年會上發表的值得注意的研究包括顯示難以治療的慢性丁型肝炎病毒患者對布列韋肽的持續反應、肝硬化與中風高風險之間的關聯，以及早期肝病檢測後生活方式的改善。以下是今年 EASL 會議的更多亮點。

貝匹羅韋森有望治療乙型肝炎

根據隨機 IIb 期 B-Clear 的中期結果，Bepirovirsen 是一種研究性反義寡核苷酸，可在慢性 HBV 患者中導致持續的病毒學應答和乙型肝炎病毒 (HBV) DNA 持續下降，而無需搶救藥物。學習。

據 Man-Fung Yuen 報導，在 457 名患者中，28% 服用核苷類似物的患者和 29% 未服用核苷類似物的患者在接受 300 mg 貝匹羅韋森治療後，在 24 週時達到無法檢測到的乙型肝炎表面抗原 (HBsAg) 和 HBV DNA 水平，香港大學醫學博士、博士。

“將乙型肝炎表面抗原和 HBV DNA 降低到定量下限以下有可能具有臨床意義並導致功能性治愈，”Yuen 說。

到治療結束時，68% 使用核苷類似物的患者和 65% 未使用核苷類似物的患者的 HBsAg 水平 <100 IU/mL。基線 HBsAg 低的患者病毒學應答較好。

使用核苷類似物的患者和未使用核苷類似物的患者中發生嚴重治療相關不良事件的比例<1%。

在 NAFLD/NASH 中瑞美替隆是安全的

III 期隨機 MAESTRO-NAFLD-1 試驗發現，瑞美替羅是一種選擇性甲狀腺激素受體-β 激動劑，在非酒精性脂肪肝病 (NAFLD) 和推測的非酒精性脂肪性肝炎 (NASH) 患者中是安全且耐受性良好的。

德克薩斯州聖安東尼奧市 Pinnacle 臨床研究中心的醫學博士 Stephen Harrison 報告說，在 52 週時，超過 1,100 名接受瑞美替隆 80 或 100 毫克每日一次的患者僅發生了輕度至中度不良事件。

在對 943 名患者進行的改良意向治療分析中，兩種劑量的瑞美替羅均顯著降低了所有關鍵的次要結局——通過 MRI 評估的肝臟脂肪-質子密度脂肪分數、受控衰減參數和致動脈粥樣硬化脂質（LDL-膽固醇） 、載脂蛋白 B 和甘油三酯）。

在這項研究中，1,143 名患者被隨機分配接受 80 毫克瑞美替羅、100 毫克瑞美替羅或安慰劑，而 171 名患者在 80 多個地點接受 100 毫克開放標籤瑞美替羅。

各治療組的嚴重治療出現的不良事件發生率相似：瑞美替羅 80 毫克組為 6.1%，100 毫克組為 7.4%，安慰劑組為 6.3%。

“作為 NASH 中第一個不依賴肝活檢來識別患者和測量治療反應的 III 期研究，MAESTRO-NAFLD-1 將有助於加速非侵入性成像和生物標誌物在 NASH 藥物開發中的作用，”哈里森指出。

低碳水化合物、高脂肪飲食對 NAFLD 和 2 型糖尿病有好處

根據開放標籤隨機 REDUCTION 試驗，低碳水化合物、高脂肪 (LCHF) 飲食改善了患有 2 型糖尿病的 NAFLD 患者的血糖控制並減少了疾病進展。

與低脂飲食相比，接受 LCHF 飲食的人在 6 個月時 HbA1c 水平顯著降低（-9.5 vs -3.4 mmol/mol）和 NAFLD 活動評分（NAS）改善（70% vs 49 %，P=0.028），丹麥歐登塞大學醫院的博士研究員 Camilla Dalby Hansen 報導。

在這項單中心試驗中，165 名患者（平均年齡 56 歲，58% 為女性）以 2:1 的比例隨機分配至不限制卡路里的 LCHF 飲食或低脂飲食。 “我們告訴參與者，‘請不要減肥，吃到飽，’”漢森說。

接受 LCHF 飲食的患者也經歷了更多的意外體重減輕（-5.8% 對 -1.8%）和 NAS 至少 2 個點的非顯著變化（22% 對 17%，P=0.587）。

    作者['full_name']

    Zaina Hamza 是今日 MedPage 的特約撰稿人，報導胃腸病學和傳染病。她常駐芝加哥。

StephenW

EASL Roundup: Path to 'Cure' in Hep B? Low-Carb, High-Fat Diet for NAFLD With T2D
— Noteworthy research from the European Association for the Study of the Liver annual meeting

by Zaina Hamza, Staff Writer, MedPage Today June 29, 2022
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Notable research presented at the European Association for the Study of the Liver (EASL) annual meeting included studies that showed a sustained response to bulevirtide among patients with difficult-to-treat chronic hepatitis delta virus, the association between liver cirrhosis and higher risk of stroke, and an increase in lifestyle improvements after early liver disease detection. Below are a few more highlights from this year's EASL meeting.

Bepirovirsen Promising for Hepatitis B

Bepirovirsen, an investigational antisense oligonucleotide, led to sustained virologic response and a sustained decrease in hepatitis B virus (HBV) DNA, without the need for rescue medication, in patients with chronic HBV, according to interim results of the randomized phase IIb B-Clear study.

Among 457 patients, 28% of those taking nucleoside analogues and 29% of those not taking nucleoside analogues who received bepirovirsen 300 mg achieved undetectable levels of hepatitis B surface antigen (HBsAg) and HBV DNA levels at 24 weeks, reported Man-Fung Yuen, MD, PhD, of the University of Hong Kong.

"The reduction in hepatitis B surface antigen and HBV DNA to below the lower limit of quantification has the potential to be clinically meaningful and lead to functional cure," Yuen said.

By the end of treatment, 68% of those on nucleoside analogues and 65% of those not on nucleoside analogues had HBsAg levels <100 IU/mL. Better virologic response occurred in those with low baseline HBsAg.

Serious treatment-related adverse events occurred in <1% of patients on nucleoside analogues and 1% of those not on nucleoside analogues.

Resmetirom Safe in NAFLD/NASH

Resmetirom, a selective thyroid hormone receptor-beta agonist, was safe and well tolerated among patients with nonalcoholic fatty liver disease (NAFLD) and presumed nonalcoholic steatohepatitis (NASH), the phase III randomized MAESTRO-NAFLD-1 trial found.

At 52 weeks, only mild to moderate adverse events had occurred in over 1,100 patients receiving resmetirom 80 or 100 mg once daily, reported Stephen Harrison, MD, of Pinnacle Clinical Research in San Antonio, Texas.

In a modified intent-to-treat analysis of 943 patients, both doses of resmetirom led to significant reductions in all key secondary outcomes -- liver fat assessed by MRI-proton density fat fraction, controlled attenuation parameter, and atherogenic lipids (LDL-cholesterol, apolipoprotein B, and triglycerides).

In this study, 1,143 patients were randomized to receive either resmetirom 80 mg, resmetirom 100 mg, or placebo, while 171 patients received 100 mg of open-label resmetirom, across over 80 sites.

Rates of serious treatment-emergent adverse events were similar across the treatment groups: 6.1% with 80-mg resmetirom, 7.4% with 100 mg, and 6.3% with placebo.

"As the first phase III study in NASH that does not rely on liver biopsy to identify patients and measure treatment response, MAESTRO-NAFLD-1 will help accelerate the role of non-invasive imaging and biomarkers in NASH drug development," Harrison noted.

Low-Carb, High-Fat Diet Shows Benefits in NAFLD and Type 2 Diabetes

The low-carbohydrate, high-fat (LCHF) diet improved glycemic control and reduced disease progression among NAFLD patients with type 2 diabetes, according to the open-label randomized REDUCTION trial.

Those who followed the LCHF diet compared with a low-fat diet had a significantly greater reduction in HbA1c levels (-9.5 vs -3.4 mmol/mol) and an improvement in the NAFLD activity score (NAS) at 6 months (70% vs 49%, P=0.028), reported Camilla Dalby Hansen, a PhD fellow at Odense University Hospital in Denmark.

In this single-center trial, 165 patients (mean age 56 years, 58% women) were randomized 2:1 to a calorie-unrestricted LCHF diet or a low-fat diet. "We told participants, 'please do not lose any weight, eat until you're full,'" Hansen said.

Patients on the LCHF diet also experienced more unintended weight loss (-5.8% vs -1.8%) and a non-significant change in NAS by at least 2 points (22% vs 17%, P=0.587).

    author['full_name']

    Zaina Hamza is a staff writer for MedPage Today, covering Gastroenterology and Infectious disease. She is based in Chicago.