Tenofovir

近期，有关病原体RNA的研究取得了一些新的进展，主要是HBV RNA在LLV患者疾病进展中的预测价值、HBV RNA作为CHB患者恩替卡韦和替诺福韦治疗期间HBeAg血清转化的预测因子、HBV RNA和MELD联合评分对HBV相关慢加急性肝衰竭 (ACLF)死亡率的预测价值，这些崭新的研究为优化HBV患者的管理提供依据。3月，2025年亚太肝病会议在中国北京成功召开，在此为大家总结了有患HBV RNA的最新研究成果，主要是HBV RNA评估新药ALG-000184的数据以及在慢性乙型肝炎抗病毒治疗中的临床价值，这些崭新的研究成果为开发、研究HBV治疗策略注入了新鲜的血液。1Specific association and independent predictive value of HBV RNA in the disease progression of hepatitis B with low-level viremia[HBV RNA在乙型肝炎低水平病毒血症疾病进展中的特异性关联和独立预测价值]发表期刊：Clinics and Research in Hepatology and Gastroenterology研究机构：南京市第二医院文章作者：Liang Xu, Bin Yin, Dandan Chen, Xia Xiong, Yongfeng Yang , Xuping Wu内容摘要背景与目的：HBV RNA在肝脏内是cccDNA的下游转录产物。本研究首次探讨了血清HBV RNA对HBV低水平病毒血症（LLV）的诊断意义。阐明血清HBV RNA、HBV DNA和HBsAg之间的相互关系。方法：选取南京市第二医院514例乙型肝炎低病毒血症（LLV）患者为研究对象，分为四组：无症状HBV携带者（ASC）、慢性乙型肝炎（CHB）、肝硬化（LC）和肝细胞癌(HCC)。所有患者均进行了HBV RNA、HBV DNA、HBsAg、HBeAg和肝功能检测及分析。采用全自动核酸检测分析系统对HBV RNA进行定量检测，试剂盒由上海仁度生物科技股份有限公司提供。结果：HBV RNA、HBV DNA与HBsAg均呈正相关（r = 0.405, P < 0.001；r = 0.198, P <0.001）。HBV RNA与HBsAg的相关性强于HBV DNA与HBsAg的相关性，根据疾病进展阶段对患者进行分层后，这种差异变得更加明显。进一步进行多因素logistic回归分析结果显示，RNA在ASC组和CHB组有较强的统计学意义（P < 0.001）。结论：监测HBV RNA水平对LLV患者评估抗病毒治疗效果、预测疾病进展及临床结局展有一定价值。2Serum HBV RNA as a predictive biomarker for HBeAg seroconversion during entecavir and tenofovir disoproxil fumarate therapy in chronic hepatitis B patients[血清HBV RNA作为慢性乙型肝炎患者恩替卡韦和富马酸替诺福韦二氧吡酯治疗期间HBeAg血清转化的预测性生物标志物]发表期刊： The Spanish Journal of Gastroenterology 研究机构：福建医科大学孟超肝胆医院文章作者：Shu Wu，Huiling Kang，Er Huang，Wennan Wu，Lijuan Liu， Ronghua Chen内容摘要背景与目的：慢性乙型肝炎（CHB）影响全球数百万人肝硬化和肝细胞癌的主要病因。核苷类似物（NAs），如恩替卡韦（ETV）和富马酸替诺福韦二吡酯（TDF）有效抑制HBV复制。然而，功能性治愈，由HBsAg是否清除来定义仍然具有挑战性，需要可靠的生物标志物来预测治疗结果。方法：回顾性分析293例接受TDF或ETV治疗的HBeAg阳性CHB患者。血清HBsAg，HBeAg，HBV DNA和HBV RNA从基线开始，在24个月内，每6个月测量一次。采用Meier和Cox回归分析来评价HBV RNA水平与HBeAg血清转化之间的关系。采用RNA实时荧光恒温扩增检测技术（HBV-SAT）对血清中的HBV RNA进行定量，HBV-SAT试剂盒由上海仁度生物科技股份有限公司提供。结果：129例患者发生HBeAg血清转化，中位时间为14个月。较低的基线和6个月HBV RNA水平与较高的HBeAg血清转化率成正相关。多变量分析证实HBV RNA是独立的血清学转化预测因子。ROC分析显示HBV RNA水平在基线和6个月水平达到最高的预测准确性，在预测结果方面优于其他指标。结论：HBV RNA是一种很有前景的预测HBeAg血清学转化的生物标志物，它的使用可以优化慢性乙型肝炎患者的个性化治疗策略。3Prognostic Value of Combined HBV pgRNA and MELD Score for Mortality in HBV‐Related Acute‐on‐Chronic Liver Failure：A Single‐Center Retrospective Study[HBV RNA和MELD联合评分对HBV相关慢加急性肝衰竭(ACLF)死亡率的预测价值：一项单中心回顾性研究]发表期刊：Health Science Reports研究机构：复旦大学附属中山医院文章作者：Shu Wu，Huiling Kang，Er Huang，Wennan Wu，Lijuan Liu，Ronghua Chen内容摘要背景与目的：乙型肝炎病毒相关慢加急性肝衰竭（HBV-ACLF）患者的快速预后评估对优化临床干预至关重要。本研究旨在探讨乙型肝炎病毒前基因组RNA（HBV RNA）联合终末期肝病模型（MELD）评分对HBV-ACLF患者短期预后的临床价值。方法：这项回顾性研究纳入2016年7月至2024年7月福建福清医院的220例HBV-ACLF患者。收集患者的临床数据，包括HBV RNA水平、血常规、C反应蛋白、生化指标、凝血参数及MELD评分。根据90天结局将患者分为生存组与死亡组，通过二元逻辑回归分析确定死亡的独立危险因素。结果：90天随访期间，90例患者死亡，130例存活。与非存活者相比，存活者的HBV RNA水平显著更低（4.12[3.81-5.06] log10 IU/mL vs. 6.07[5.62-6.71]，Z=-10.14, p<0.001），MELD评分更低（21.27[18.50-23.14] vs. 31.88[27.82-34.66]，Z=-12.03, p<0.001）。多变量分析显示，HBV RNA（OR=12.38, 95%CI=2.68-57.25）和MELD评分（OR=3.20, 95%CI=1.33-7.70）均为90天死亡的独立预测因子（均p<0.01）。联合模型的ROC曲线下面积（AUC）达0.988（95%CI=0.978-0.998），显著优于单独使用HBV RNA（AUC=0.902, Z=4.487, p<0.001）或MELD评分（AUC=0.977, Z=2.012, p=0.044）。RNA-MELD评分（公式：-42.253+2.516×log10 pgRNA+1.165×MELD）的最佳截断值为0.302（约登指数=0.967），评分≥0.302的患者生存率显著降低（χ²=253.09, p<0.01）。结论：新型HBV RNA-MELD评分能有效预测HBV-ACLF患者的短期预后，其临床实用性优于单一模型，可为临床治疗决策提供及时指导。往期回顾前沿速递 |6月病原体RNA研究新进展前沿速递 | 5月病原体RNA研究新进展前沿速递| 2025 APASL HBV RNA精彩荟萃（二）前沿速递| 2025 APASL HBV RNA精彩荟萃（一）免责声明：本篇文章使用的图片等素材均源于互联网，我们尊重所有原创作者的权益权利，如果存在侵权，请及时联系我们删除。关于仁度上海仁度生物科技股份有限公司（股票代码：688193）成立于2007年，是国内最早一批专注于RNA分子诊断技术和产品的生命科学企业之一，致力于开发临床需求尚未满足的创新诊断技术和产品。公司拥有RNA实时荧光恒温扩增（SAT）的独家专利技术平台，以该技术平台为基础自主研发了一系列分子诊断试剂和设备一体化产品，专注于为生殖、呼吸、消化、血液、食品、环境安全等领域病原体的精准诊断、有效防控和个性化诊疗提供解决方案。仁爱生命 度衡健康专注病原体RNA临床检测

CONTACTS: Blair Baumwell, Media public_affairs@gilead.com Jacquie Ross, Investors investor_relations@gilead.com U.S. FDA APPROVES NEW BIKTARVY® INDICATION FOR PEOPLE WITH HIV WHO ARE TREATMENT-EXPERIENCED AND RESTARTING ANTIRETROVIRAL TREATMENT – Biktarvy Now First and Only Single Tablet Regimen to Receive FDA-Approved Label Expansion for Use in People with HIV with an ART History Who Are Not Virologically Suppressed – Foster City, Calif., July 30, 2025 – Gilead Sciences, Inc. (Nasdaq: GILD) today announced that the U.S. Food and Drug Administration (FDA) has granted a new approval for a novel indication for Biktarvy (bictegravir 50 mg/emtricitabine 200 mg/tenofovir alafenamide 25 mg tablets, B/F/TAF). This new indication expands Biktarvy’s label to include the treatment of people with HIV (PWH) with an antiretroviral treatment (ART) history who are not virologically suppressed, with no known or suspected resistance to the integrase strand inhibitor (INSTI) class, emtricitabine or tenofovir. The approval of this supplemental New Drug Application (sNDA) will help bridge an unmet public health need in PWH who are viremic and restarting ART given the limited treatment options approved by the FDA for this population to date. “Continuous scientific discoveries and person-centric advances in HIV care have helped transform the treatment landscape,” said Jared Baeten, MD, PhD, Senior Vice President, Virology Therapeutic Area Head. “At the same time, not everyone is achieving long-term HIV treatment success, especially when someone experiences an interruption in their HIV care. With this new indication, Biktarvy can now support an even broader range of PWH in reaching their long-term treatment goals, including those who are not virologically suppressed and who are restarting treatment. We are proud to take another step toward fulfilling Gilead’s commitment to end the HIV epidemic through a person-centered approach to treatment research that seeks to expand choices and enhance outcomes for those with HIV.” In the United States, this new indication for Biktarvy helps address a critical unmet need. Currently only 65% of PWH are estimated to be virally suppressed at any point in time, and many interrupt and later need to restart treatment. Research has shown that HIV transmission is highest among those who are not engaged in care or virally suppressed. Gaps in care account for nearly 80% of new HIV diagnoses, underscoring the need to focus on re-engagement in care and restarting treatment to help reduce the potential transmission of HIV. According to the U.S. Department of Health and Human Services, when PWH take their treatment as prescribed, and achieve and maintain an undetectable viral load for at least six months, it prevents sexual transmission of HIV to their partners. “For PWH who have stopped treatment or fallen out of care and are not virally suppressed, re-engagement and restarting treatment are crucial for preventing the spread of the virus and supporting individual long-term outcomes,” said Paul E. Sax, MD, Clinical Director of the Division of Infectious Diseases, Brigham and Women’s Hospital. “This expanded indication can now help healthcare providers more confidently support an even broader range of PWH, including PWH who are not virologically suppressed and are restarting HIV treatment.” FDA granted this new indication based on a scientific justification supported by the strength of evidence for Biktarvy from treatment naïve studies 1489 and 1490 which demonstrated rapid and durable viral suppression, an established long-term safety and tolerability profile and zero cases of treatment-emergent resistance to Biktarvy through five years. Please see below for U.S. Indication and Important Safety Information, for Biktarvy, including Boxed Warning. There is no cure for HIV or AIDS. For an overview of anticipated regulatory scientific milestones for Gilead' HIV treatment pipeline please visit: https://www.gilead.com/science/pipeline. About Biktarvy Biktarvy is a complete HIV treatment that combines three powerful medicines to form the smallest 3-drug, INSTI-based STR available, offering simple once-daily dosing with or without food, with a limited drug interaction potential and a high barrier to resistance. Biktarvy combines the novel, unboosted INSTI bictegravir, with the F/TAF backbone. Biktarvy is a complete STR and should not be taken with other HIV medicines. U.S. Indication for Biktarvy BIKTARVY is indicated as a complete regimen for the treatment of HIV-1 infection in adult and pediatric patients weighing ≥14 kg with no antiretroviral treatment history; or with an ARV treatment history and not virologically suppressed, with no known or suspected substitutions associated with resistance to the integrase strand inhibitor class, emtricitabine, or tenofovir; or to replace the current ARV regimen in those who are virologically suppressed (HIV-1 RNA <50 copies per mL) on a stable ARV regimen with no known or suspected substitutions associated with resistance to bictegravir or tenofovir. U.S. Important Safety Information for Biktarvy BOXED WARNING: POST TREATMENT ACUTE EXACERBATION OF HEPATITIS B • Severe acute exacerbations of hepatitis B have been reported in patients with HIV-1 and HBV who have discontinued products containing emtricitabine (FTC) and/or tenofovir disoproxil fumarate (TDF) and may occur with discontinuation of BIKTARVY. Closely monitor hepatic function with both clinical and laboratory follow-up for at least several months in patients with HIV-1 and HBV who discontinue BIKTARVY. If appropriate, anti-hepatitis B therapy may be warranted. Contraindications • Coadministration: Do not use BIKTARVY with dofetilide or rifampin. Warnings and precautions • Drug interactions: See Contraindications and Drug Interactions sections. Consider the potential for drug interactions prior to and during BIKTARVY therapy and monitor for adverse reactions. • Immune reconstitution syndrome, including the occurrence of autoimmune disorders with variable time to onset, has been reported. • New onset or worsening renal impairment: Postmarketing cases of renal impairment, including acute renal failure, proximal renal tubulopathy (PRT), and Fanconi syndrome have been reported with tenofovir alafenamide (TAF)–containing products. Do not initiate BIKTARVY in patients with estimated creatinine clearance (CrCl) <30 mL/min except in virologically suppressed adults <15 mL/min who are receiving chronic hemodialysis. Patients with impaired renal function and/or taking nephrotoxic agents (including NSAIDs) are at increased risk of renal-related adverse reactions. Discontinue BIKTARVY in patients who develop clinically significant decreases in renal function or evidence of Fanconi syndrome. Renal monitoring: Prior to or when initiating BIKTARVY and during therapy, assess serum creatinine, CrCl, urine glucose, and urine protein in all patients as clinically appropriate. In patients with chronic kidney disease, assess serum phosphorus. • Lactic acidosis and severe hepatomegaly with steatosis: Fatal cases have been reported with the use of nucleoside analogs, including FTC and TDF. Discontinue BIKTARVY if clinical or laboratory findings suggestive of lactic acidosis or pronounced hepatotoxicity develop, including hepatomegaly and steatosis in the absence of marked transaminase elevations. Adverse reactions • Most common adverse reactions (incidence ≥5%; all grades) in clinical studies through week 144 were diarrhea (6%), nausea (6%), and headache (5%). Drug interactions • Prescribing information: Consult the full prescribing information for BIKTARVY for more information on Contraindications, Warnings, and potentially significant drug interactions, including clinical comments. • Enzymes/transporters: Drugs that induce P-gp or induce both CYP3A and UGT1A1 can substantially decrease the concentration of components of BIKTARVY. Drugs that inhibit P-gp, BCRP, or inhibit both CYP3A and UGT1A1 may significantly increase the concentrations of components of BIKTARVY. BIKTARVY can increase the concentration of drugs that are substrates of OCT2 or MATE1. • Drugs affecting renal function: Coadministration of BIKTARVY with drugs that reduce renal function or compete for active tubular secretion may increase concentrations of FTC and tenofovir and the risk of adverse reactions. Dosage and administration • Dosage: Adult and pediatric patients weighing ≥25 kg: 1 tablet containing 50 mg bictegravir (BIC), 200 mg emtricitabine (FTC), and 25 mg tenofovir alafenamide (TAF) taken once daily with or without food. Pediatric patients weighing ≥14 kg to <25 kg: 1 tablet containing 30 mg BIC, 120 mg FTC, and 15 mg TAF taken once daily with or without food. For children unable to swallow a whole tablet, the tablet can be split and each part taken separately as long as all parts are ingested within approximately 10 minutes. • Renal impairment: For patients weighing ≥25 kg, not recommended in patients with CrCl 15 to <30 mL/min, or <15 mL/min who are not receiving chronic hemodialysis, or <15 mL/min who are receiving chronic hemodialysis and have no antiretroviral treatment history. For patients weighing ≥14 kg to <25 kg, not recommended in patients with CrCl <30 mL/min. • Hepatic impairment: Not recommended in patients with severe hepatic impairment. • Prior to or when initiating: Test patients for HBV infection. • Prior to or when initiating, and during treatment: As clinically appropriate, assess serum creatinine, CrCl, urine glucose, and urine protein in all patients. In patients with chronic kidney disease, assess serum phosphorus. Pregnancy and lactation • Pregnancy: BIKTARVY is recommended in pregnant individuals who are virologically suppressed on a stable ARV regimen with no known substitutions associated with resistance to any of the individual components of BIKTARVY. Lower plasma exposures of BIKTARVY were observed during pregnancy; therefore, viral load should be monitored closely during pregnancy. • Lactation: Individuals with HIV-1 should be informed of the potential risks of breastfeeding. About Gilead HIV For more than 35 years, Gilead has been a leading innovator in the field of HIV, driving advances in treatment, prevention and cure research. Gilead researchers have developed 13 HIV medications, including the first single-tablet regimen to treat HIV, the first antiretroviral for pre-exposure prophylaxis (PrEP) to help reduce new HIV infections, and the first long-acting injectable HIV treatment medication administered twice-yearly. Our advances in medical research have helped to transform HIV into a treatable, preventable, chronic condition for millions of people. Gilead is committed to continued scientific innovation to provide solutions for the evolving needs of people affected by HIV around the world. Through partnerships, collaborations and charitable giving, the company also aims to improve education, expand access and address barriers to care, with the goal of ending the HIV epidemic for everyone, everywhere. Gilead was recognized as one of the leading philanthropic funders of HIV-related programs in a report released by Funders Concerned About AIDS. About Gilead Sciences Gilead Sciences, Inc. is a biopharmaceutical company that has pursued and achieved breakthroughs in medicine for more than three decades, with the goal of creating a healthier world for all people. The company is committed to advancing innovative medicines to prevent and treat life-threatening diseases, including HIV, viral hepatitis, COVID-19, cancer and inflammation. Gilead operates in more than 35 countries worldwide, with headquarters in Foster City, California. Forward-Looking Statements This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that are subject to risks, uncertainties and other factors, including Gilead’s ability to initiate, progress or complete clinical trials within currently anticipated timelines or at all, and the possibility of unfavorable results from ongoing or additional clinical trials, including those involving Biktarvy; uncertainties relating to regulatory applications and related filing and approval timelines, including potential applications for indications currently under evaluation, and the risk that any regulatory approvals, if granted, may be subject to significant limitations on use or subject to withdrawal or other adverse actions by the applicable regulatory authority; the risk that physicians may not see the benefits of prescribing Biktarvy for any approved indication; and any assumptions underlying any of the foregoing. These and other risks, uncertainties and factors are described in detail in Gilead’s Quarterly Report on Form 10-Q for the quarter ended March 31, 2025, as filed with the U.S. Securities and Exchange Commission. These risks, uncertainties and other factors could cause actual results to differ materially from those referred to in the forward-looking statements. All statements other than statements of historical fact are statements that could be deemed forward-looking statements. The reader is cautioned that any such forward-looking statements are not guarantees of future performance and involve risks and uncertainties and is cautioned not to place undue reliance on these forward-looking statements. All forward-looking statements are based on information currently available to Gilead, and Gilead assumes no obligation and disclaims any intent to update any such forward-looking statements. # # # Biktarvy, Gilead and the Gilead logo are trademarks of Gilead Sciences, Inc., or its related companies. U.S. Prescribing Information for Biktarvy, including BOXED WARNING, is available at www.gilead.com. For more information about Gilead, please visit the company’s website at www.gilead.com, follow Gilead on X (@Gilead Sciences) and LinkedIn), or contact Gilead Public Affairs at public_affairs@gilead.com, 1-800-GILEAD-5 or 1-650-574-3000.