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See full PI, including BOXED WARNING.","importantText","VEMLIDY® (tenofovir alafenamide) | HCP site \n\nThis information is intended for US healthcare professionals.[Continue](#) Not a US healthcare professional? [**Go to Patient Site**](https://www.vemlidy.com)\n\n [![VEMLIDY® (tenofovir alafenamide) Logo](/media/images/vemlidy-tenofovir-alafenamide-logo.svg)](/)Toggle navigation\n\nVEMLIDY is indicated for the treatment of chronic hepatitis B virus (HBV) infection in adults with compensated liver disease.\n\n[Important Safety Information](/important-safety-information/) | [Prescribing Information](https://www.gilead.com/~/media/files/pdfs/medicines/liver-disease/vemlidy/vemlidy_pi.pdf?la=en) | [Patient Website](https://www.vemlidy.com)\n\n* [Treating Chronic Hep B](#)\n \n ##### Treating Chronic Hep B\n \n * [Renal & Bone Risk Factors](/treatment-renal-bone-risk-factors/)\n * [Disease Progression](/disease-progression/)\n * [Treatment Evolution](/treatment-evolution/)\n * [Treatment Guidelines](/treatment-guidelines/)\n \n* [Mechanism of Action](#)\n \n ##### Mechanism of Action\n \n * [Mechanism of Action](/mechanism-of-action/)\n \n* [Efficacy](#)\n \n ##### Efficacy\n \n * [Trial Designs](/clinical-trial-design/)\n * [Viral Suppression](/taf-vs-tdf-virologic-response/)\n * [ALT Normalization](/taf-vs-tdf-alt-normalization/)\n * [Resistance](/drug-resistance/)\n * [Cirrhosis & Fibrosis Data](/efficacy-cirrhosis/)\n \n* [Safety](#)\n \n ##### Safety\n \n * [Adverse Reactions](/adverse-reactions/)\n * [Renal Profile](/renal-safety-profile/)\n * [Bone Profile](/bone-mineral-density-profile/)\n \n* [Dosing](#)\n \n ##### Dosing\n \n * [Dosage & Administration](/dosage-information/)\n \n* [Resources](#)\n \n ##### Resources\n \n * [Co-pay & Access](/copay-patient-support/)\n * [Patient Education](/patient-education/)\n * [Clinical Resources](/clinical-resources/)\n \n\nVEMLIDY is indicated for the treatment of chronic hepatitis B virus (HBV) infection in adults with compensated liver disease.\n\n**See pivotal and 8-year [efficacy](/taf-vs-tdf-virologic-response/) and [safety](/adverse-reactions/) data for VEMLIDY**\n\n![](/media/images/Vemlidy-hero-image.png)\n\nVEMLIDY— \nproven results for the \nmoments that matter\n=======================================================\n\nEstablished efficacy and safety across a broad range of adult \nchronic HBV patients with compensated liver disease1-6\n\n[Explore pivotal and 8-year data](/taf-vs-tdf-virologic-response/)\n\nVEMLIDY is proven in robust global clinical trials1-5\n=====================================================\n\n[Study design](/clinical-trial-design/) [Renal safety parameters](/renal-safety-profile/) [Viral suppression](/taf-vs-tdf-virologic-response/) [Impact on bone mineral density](/bone-mineral-density-profile/) [ALT normalization rates](/taf-vs-tdf-alt-normalization/) [Adverse reactions](/adverse-reactions/) [Cirrhosis & fibrosis data\\*](/efficacy-cirrhosis/)\n\n\\*The data is not presented in the VEMLIDY label. \nALT=alanine aminotransferase.\n\nWatch hep B \nexperts discuss \nthe Simplified \nApproach to \nHepatitis B \nAlgorithm\n======================================================================================\n\nLearn how this approach may apply to your adult patients with chronic hep B\n\n[View now](/clinical-resources/)\n\nChoose VEMLIDY as a preferred first-line treatment option for \nadults with chronic HBV, recommended in 5 guidelines/algorithms7-11\n===================================================================================================================================\n\n![](/media/images/check-circle-yellow.svg)\n\n### **SABA** 2022\n\nSimplified Approach \nHepatitis B Algorithm\n\n![](/media/images/check-circle-yellow.svg)\n\n### **USTA** 2021\n\nUnited States Treatment \nAlgorithm\n\n![](/media/images/check-circle-yellow.svg)\n\n### **AATA** 2018\n\nAsian American \nTreatment Algorithm\n\n![](/media/images/check-circle-yellow.svg)\n\n### **AASLD** 2018\n\nAmerican Association for the \nStudy of Liver Diseases\n\n![](/media/images/check-circle-yellow.svg)\n\n### **EASL** 2017\n\nEuropean Association for \nthe Study of the Liver\n\n[Explore treatment guidelines/algorithms](/treatment-guidelines/)\n\nHelp your patients save on prescription costs\n=============================================\n\nEligible commercially insured patients can save with the VEMLIDY Co-pay Coupon Program.\n\n\\*For commercially insured eligible patients only. Restrictions apply. Subject to change; click \"See the details\" below for full terms and conditions. This is not health insurance. Only accepted at participating pharmacies.\n\n![As low as $0 co-pay](/media/images/0-dollar-co-pay.svg)\n\n\\*For commercially insured eligible patients only. Restrictions apply. Subject to change; click \"See the details\" below for full terms and conditions. This is not health insurance. Only accepted at participating pharmacies.\n\n[See the details](/copay-patient-support/)\n\nFor your patients: \nReal VEMLIDY \npatients share \ntheir stories\n==================================================================\n\nShare their journeys with your \npatients, and download other available patient resources\n\n[See more](/patient-education/)\n\nVEMLIDY offers convenient, patient-friendly dosing with a once-daily pill1\n--------------------------------------------------------------------------\n\nVEMLIDY is a 25-mg pill that’s 8 mm in diameter. _Pill image not to scale._\n\n[Learn more](/dosage-information/)\n\n![Close-up photo of a hand holding a VEMLIDY pill with GSI engraved on the surface](/media/images/Vemlidy-pill-in-hand.png)\n\nIMPORTANT SAFETY INFORMATION\n\nBOXED WARNING: POSTTREATMENT SEVERE ACUTE EXACERBATION OF HEPATITIS B\n\n* **Discontinuation of anti-hepatitis B therapy, including VEMLIDY, may result in severe acute exacerbations of hepatitis B. Hepatic function should be monitored closely with both clinical and laboratory follow-up for at least several months in patients who discontinue anti-hepatitis B therapy, including VEMLIDY. If appropriate, resumption of anti-hepatitis B therapy may be warranted.**\n\nWarnings and Precautions\n\n* **Risk of Development of HIV-1 Resistance in HBV/HIV-1 Coinfected Patients:** Due to this risk, VEMLIDY alone should not be used for the treatment of HIV-1 infection. Safety and efficacy of VEMLIDY have not been established in HBV/HIV-1 coinfected patients. HIV antibody testing should be offered to all HBV-infected patients before initiating therapy with VEMLIDY, and, if positive, an appropriate antiretroviral combination regimen that is recommended for HBV/HIV-1 coinfected patients should be used.\n* **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 TAF-containing products. Patients with impaired renal function and/or taking nephrotoxic agents (including NSAIDs) are at increased risk of renal-related adverse reactions. Discontinue VEMLIDY in patients who develop clinically significant decreases in renal function or evidence of Fanconi syndrome. Monitor renal function in all patients – See Dosage and Administration.\n* **Lactic Acidosis and Severe Hepatomegaly with Steatosis:** Fatal cases have been reported with the use of nucleoside analogs, including tenofovir disoproxil fumarate (TDF). Discontinue VEMLIDY if clinical or laboratory findings suggestive of lactic acidosis or pronounced hepatotoxicity develop, including hepatomegaly and steatosis in the absence of marked transaminase elevations.\n\nAdverse Reactions\n\nMost common adverse reactions (incidence ≥5%; all grades) in clinical studies through week 144 were headache, upper respiratory tract infection, abdominal pain, cough, back pain, arthralgia, fatigue, nausea, diarrhea, dyspepsia, and pyrexia.\n\nDrug Interactions\n\n* Coadministration of VEMLIDY with drugs that reduce renal function or compete for active tubular secretion may increase concentrations of tenofovir and the risk of adverse reactions.\n* Coadministration of VEMLIDY is not recommended with the following: oxcarbazepine, phenobarbital, phenytoin, rifabutin, rifampin, rifapentine, or St. John’s wort. Such coadministration is expected to decrease the concentration of tenofovir alafenamide, reducing the therapeutic effect of VEMLIDY. Drugs that strongly affect P-glycoprotein (P-gp) and breast cancer resistance protein (BCRP) activity may lead to changes in VEMLIDY absorption.\n\nConsult the full prescribing information for VEMLIDY for more information on potentially significant drug interactions, including clinical comments.\n\nDosage and Administration\n\n* **Testing Prior to Initiation:** HIV infection.\n* **Prior to or When Initiating, and During Treatment:** On a clinically appropriate schedule, assess serum creatinine, estimated creatinine clearance, urine glucose, and urine protein in all patients. In patients with chronic kidney disease, also assess serum phosphorus.\n* **Dosage in Adults:** 1 tablet taken once daily with food.\n* **Renal Impairment:** Not recommended in patients with end stage renal disease (ESRD; eCrCl <15 mL/min) who are not receiving chronic hemodialysis; in patients on chronic hemodialysis, on hemodialysis days, administer VEMLIDY after completion of hemodialysis treatment.\n* **Hepatic Impairment:** Not recommended in patients with decompensated (Child-Pugh B or C) hepatic impairment.\n\nPregnancy and Lactation\n\n* **Pregnancy:** A pregnancy registry has been established for VEMLIDY. Available clinical trial data show no significant difference in the overall risk of birth defects for VEMLIDY compared with the background rate of major birth defects in the U.S. reference population.\n* **Lactation:** TAF and tenofovir can pass into breast milk. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for VEMLIDY and any potential adverse effects on the breastfed infant from VEMLIDY or from the underlying maternal condition.\n\nINDICATION\n\nVEMLIDY is indicated for the treatment of chronic hepatitis B virus (HBV) infection in adults with compensated liver disease.\n\nPlease [see full Prescribing Information for VEMLIDY](https://www.gilead.com/~/media/files/pdfs/medicines/liver-disease/vemlidy/vemlidy_pi.pdf?la=en), including **BOXED WARNING**.\n\n[SEE MORE ![](/media/images/plus-icon.svg)](#isi) \n\nIMPORTANT SAFETY INFORMATION\n\nBOXED WARNING: POSTTREATMENT SEVERE ACUTE EXACERBATION OF HEPATITIS B\n\n* **Discontinuation of anti-hepatitis B therapy, including VEMLIDY, may result in severe acute exacerbations of hepatitis B. Hepatic function should be monitored closely with both clinical and laboratory follow-up for at least several months in patients who discontinue anti-hepatitis B therapy, including VEMLIDY. If appropriate, resumption of anti-hepatitis B therapy may be warranted.**\n\n[TAP for **Important Safety Information**, including **Boxed Warning** on **posttreatment severe acute exacerbation of hepatitis B.**](#isi)\n\n**References:** **1.** VEMLIDY Prescribing Information. Foster City, CA: Gilead Sciences, Inc.; March 2024. **2.** Data on file. Gilead Sciences, Inc. **3.** Buti M, Lim Y-S, Chan HLY, et al. Eight-year efficacy and safety of tenofovir alafenamide for treatment of chronic hepatitis B virus infection: Final results from two randomised phase 3 trials. _Aliment Pharmacol Ther_. 2024;60(11-12):1573-1586. doi:10.1111/apt.18278 **4.** Chan HLY, Fung S, Seto WK, et al; GS-US-320-0110 investigators. Tenofovir alafenamide versus tenofovir disoproxil fumarate for the treatment of HBeAg-positive chronic hepatitis B virus infection: a randomised, double-blind, phase 3, non-inferiority trial. _Lancet Gastroenterol Hepatol_. 2016;1(3):185-195. doi:10.1016/S2468-1253(16)30024-3 **5.** Chan HLY, Lim YS, Seto WKW, et al. 3-year efficacy and safety of tenofovir alafenamide compared with tenofovir disoproxil fumarate in HBeAg-negative and -positive patients with chronic hepatitis B. Poster presented at: AASLD 2018; November 9-13, 2018; San Francisco, CA. Poster 381. **6.** Agarwal K, Brunetto M, Seto WK, et al. 96 weeks treatment of tenofovir alafenamide vs tenofovir disoproxil fumarate for hepatitis B virus infection. _J Hepatol_. 2018;68(4):672-681. doi:10.1016/j.jhep.2017.11.039 **7.** Dieterich D, Graham C, Wang S, et al. It is time for a simplified approach to hepatitis B elimination. _Gastro Hep Advances_. 2023;2(2):209-218. doi:10.1016/j.gastha.2022.10.004 **8.** Martin P, Nguyen MH, Dieterich DT, et al. Treatment algorithm for managing chronic hepatitis B virus infection in the United States: 2021 update. _Clin Gastroenterol Hepatol_. 2021;S1542-3565(21)00818-1. doi:10.1016/j.cgh.2021.07.036 **9.** Tong MJ, Pan CQ, Han SB, et al. An expert consensus for the management of chronic hepatitis B in Asian Americans. _Aliment Pharmacol Ther_. 2018;47:1181-1200. **10.** Terrault NA, Lok ASF, McMahon BJ, et al. Update on prevention, diagnosis, and treatment of chronic hepatitis B: AASLD 2018 hepatitis B guidance. _Hepatology_. 2018;67(4):1560-1599. doi:10.1002/hep.29800 **11.** European Association for the Study of the Liver. EASL 2017 Clinical practice guidelines on the management of hepatitis B virus infection. _J Hepatol_. 2017;67(2):370-398. doi:10.1016/j.jhep.2017.03.021\n\n [![](/media/images/triangle.svg) TOP OF PAGE](#)\n\n* [![](/media/images/footer-accordion-arrow.svg)\n \n #### TREATING CHRONIC HEP B\n \n ](#collapse-1)\n \n #### TREATING CHRONIC HEP B\n \n * [Renal & Bone Risk Factors](/treatment-renal-bone-risk-factors/)\n * [Disease Progression](/disease-progression/)\n * [Treatment Evolution](/treatment-evolution/)\n * [Treatment Guidelines](/treatment-guidelines/)\n* [![](/media/images/footer-accordion-arrow.svg)\n \n #### MECHANISM OF ACTION\n \n ](#collapse-2)\n \n #### MECHANISM OF ACTION\n \n * [Mechanism of Action](/mechanism-of-action/)\n* [![](/media/images/footer-accordion-arrow.svg)\n \n #### EFFICACY\n \n ](#collapse-3)\n \n #### EFFICACY\n \n * [Trial Designs](/clinical-trial-design/)\n * [Viral Suppression](/taf-vs-tdf-virologic-response/)\n * [ALT Normalization](/taf-vs-tdf-alt-normalization/)\n * [Resistance](/drug-resistance/)\n * [Cirrhosis & Fibrosis Data](/efficacy-cirrhosis/)\n* [![](/media/images/footer-accordion-arrow.svg)\n \n #### SAFETY\n \n ](#collapse-4)\n \n #### SAFETY\n \n * [Adverse Reactions](/adverse-reactions/)\n * [Renal Profile](/renal-safety-profile/)\n * [Bone Profile](/bone-mineral-density-profile/)\n* [![](/media/images/footer-accordion-arrow.svg)\n \n #### DOSING\n \n ](#collapse-5)\n \n #### DOSING\n \n * [Dosage & Administration](/dosage-information/)\n* [![](/media/images/footer-accordion-arrow.svg)\n \n #### RESOURCES\n \n ](#collapse-6)\n \n #### RESOURCES\n \n * [Co-pay & Access](/copay-patient-support/)\n * [Patient Education](/patient-education/)\n * [Clinical Resources](/clinical-resources/)\n\n[![Gilead Sciences, Inc. Logo](/media/images/gilead-logo.png)](https://www.gilead.com)\n\n[Terms of Use](https://www.gilead.com/terms) | [Privacy Policy](https://www.gilead.com/privacy-statements/website-privacy-statement) | [Consumer Health Data Privacy Policy](https://www.gilead.com/privacy-statements/consumer-health-data-privacy-policy) | [Contact Us](https://www.gilead.com/contact)\n\nThe information contained on this site is intended for audiences in the United States only. The content on this site may not apply to non-US audiences as regulatory control, legal requirements, and/or medical practices may vary in other countries.\n\nVEMLIDY, the VEMLIDY Logo, GSI, SUPPORT PATH, GILEAD, and the GILEAD Logo are trademarks of Gilead Sciences, Inc., or its related companies. All other trademarks referenced herein are the property of their respective owners.\n\n©2025 Gilead Sciences, Inc. All rights reserved. US-VEMP-0275 05/25\n\nYou are about to leave VemlidyHCP.com. Gilead is not responsible for the content of the site you are about to visit.\n--------------------------------------------------------------------------------------------------------------------\n\nClick \"Continue\" to leave this site and come back to visit us another time.\n\nClick \"Cancel\" to return to VemlidyHCP.com.\n\n[Continue](#) Cancel\n\n**Meet Betsy,** a treatment-naive patient with chronic hepatitis B taking VEMLIDY\n---------------------------------------------------------------------------------\n\n**Meet Frank,** a patient with chronic hepatitis B who switched to VEMLIDY\n--------------------------------------------------------------------------\n\nDr Doug Dieterich and Dr Duke Nguyen discuss the Simplified Approach Hepatitis B Algorithm (SABA)\n-------------------------------------------------------------------------------------------------\n\nNavigate to different chapters of this video by clicking the chapter button (next to Settings).\n\nTranscript\n\n\\[Dieterich\\]\n\nHello everyone, I’m Dr Douglas Dieterich. My colleagues in this presentation are Dr Duke Nguyen and Dr Carrie Frenette.\n\n\\[Nguyen\\]\n\nThank you, Dr Dieterich. It’s great to be here today.\n\n\\[Frenette\\]\n\nYes, thank you. We are excited about sharing this timely information with you!\n\n\\[Dieterich\\]\n\nThat’s wonderful.\n\n\\[Dieterich\\]\n\nWe are here today to discuss the latest expert guidance regarding the management of chronic hepatitis B. This is a non-CME educational video which is sponsored by Gilead Sciences.\n\n\\[Dieterich\\]\n\nToday we are going to talk about the prevalence and the unmet needs for chronic hepatitis B in the US, an overview of the Simplified Approach Hepatitis B Algorithm, a treatment overview, and then some regional information on chronic hepatitis B in New York and California. We will then conclude with additional resources.\n\n\\[Dieterich\\]\n\nFirst, let’s take a look at the impact of chronic hepatitis B in the whole United States.\n\n\\[Dieterich\\]\n\nHepatitis B virus infection is the most common chronic viral infection in the world, causing 780,000 hepatocellular carcinoma and liver-related deaths each year.\n\nHere in the US, it is estimated that more than 600,000 people have been diagnosed with chronic hepatitis B infection, putting these people at risk for serious liver disease.\n\n\\[Dieterich\\]\n\nDespite the seriousness of this disease, chronic hepatitis B is undermanaged and undertreated. For example, approximately 70% of patients who are diagnosed with chronic hepatitis B are not receiving antiviral treatment. Moreover, approximately 65% of patients who have chronic hepatitis B and cirrhosis are not receiving antiviral treatment.\n\nWe also know that more than 60% of patients with chronic hepatitis B are not receiving regular monitoring of their chronic hepatitis B or more importantly screening for their liver cancers.\n\nThese statistics are particularly troubling when you consider that 20 to 30% of adults with chronic hepatitis B will develop complications such as cirrhosis and liver cancer.\n\n\\[Dieterich\\]\n\nOne of the most serious complications that can occur due to hepatitis B is liver cancer. The hepatitis B virus is classified as a Group 1 carcinogen, meaning that it can cause cancer in humans. Hepatitis B virus carries the same carcinogen classification as tobacco smoking and asbestos, highlighting the carcinogenic potential of hepatitis B. Persons with hepatitis B are at a 25- to 37-fold increased risk of liver cancer compared to non-infected people.\n\n\\[Dieterich\\]\n\nHepatitis B increases the risk of liver cancer through both direct and indirect mechanisms, which may occur at early stages of the disease and during any phase of the hepatitis B infection. Studies have shown that even untreated patients in the immune-tolerant phase of chronic hepatitis B are at increased risk of liver cancer.\n\nHepatitis B drives liver cancer development by several processes, including integration of DNA into the host genome, chromosomal instability, necroinflammation, and fibrosis development. It is estimated that approximately 20% of HCC occurs in patients who do not have cirrhosis.\n\nI have seen this in my practice, as I have a female patient with chronic hepatitis B who presented at the age of 29 with no cirrhosis but with a liver cancer.\n\nOne of the key determinants of the oncogenicity of hepatitis B infection is the level of HBV DNA. Studies have shown that HBV DNA levels above 2000 are associated with an increased risk of HCC and this risk is present even in patients without elevated ALT levels.\n\nThese parameters are important to keep in mind as we consider which patients with chronic hepatitis B should be recommended for antiviral therapy.\n\n\\[Dieterich\\]\n\nNow, I’d like to introduce you to the latest expert guidance for chronic hepatitis B treatment, the Simplified Approach Hepatitis B Algorithm, or SABA.\n\n\\[Dieterich\\]\n\nThe current HBV guidelines and algorithms are directed toward specialists and can be rather complex. As we reviewed in the introduction, data show there are significant gaps in care for patients with hepatitis B.\n\nBecause of this, a group of 7 other experts and myself, spanning hepatology, infectious disease, primary care developed a streamlined algorithm of hepatitis B intervention, encouraging earlier treatment for appropriate patients.\n\nOur publication includes the rationale for the algorithm along with recommendations on screening for hepatitis B infection, diagnostic work up, antiviral treatment, and monitoring of patients.\n\n\\[Dieterich\\]\n\nThe members of our expert panel, shown here, included Drs Agarwal, Kwo, and Lim, who are hepatologists; Dr Graham and Sulkowski, who are infectious disease specialists; and Drs Liu and Wang, who are primary care physicians. We published our recommendations in _Gastro Hep Advances_. If you scan this QR code, it will take you to our published article.\n\n\\[Dieterich\\]\n\nThe goal of our global expert panel was to gain consensus on a streamlined approach to hepatitis B care in order to facilitate implementation of hepatitis B intervention and treatment, especially in the primary care setting.\n\n\\[Dieterich\\]\n\nNotably, our approach was to assume that all patients with chronic hepatitis B need to be treated, and then to exclude those who do not ‘qualify’ for treatment, rather than the currently prevailing, reverse perspective. The goal is to reduce the number of patients who are not receiving appropriate treatment.\n\n\\[Dieterich\\]\n\nHere is the treatment algorithm that we developed. First, all patients with compensated cirrhosis and any HBV DNA should receive antiviral treatment, regardless of ALT levels.\n\n\\[Dieterich\\]\n\nIn addition, patients who are at least 30 years old, with HBV DNA >2000 IUs should receive antiviral treatment, regardless of ALT level.\n\n\\[Dieterich\\]\n\nFor adults who are younger than 30 years old, the recommendation is to start treatment if they have HBV DNA >2000 plus ALT above the upper limit of normal, which we defined as 30 for men and 19 for women.\n\n\\[Dieterich\\]\n\nThese treatment criteria are based on research that shows that patients who are older than 30 and have elevated DNA are at risk for liver disease progression. This age cut off of 30 years old is also recommended by the World Health Organization as a treatment criterion for antiviral therapy.\n\nIn addition, there is clinical evidence demonstrating that HBV DNA levels of >2000 IUs are associated with an increased risk of HCC or progression to cirrhosis, regardless of e antigen status or ALT level.\n\nIn discussions with healthcare providers about this algorithm, I’ve been asked if I have concerns about treatment adherence, especially in such young patients, but in my experience, even patients who are in their 20s and 30s remain adherent when they understand the seriousness of hepatitis B.\n\nI will now turn this over to my colleague, Dr Nguyen.\n\n\\[Nguyen\\]\n\nNow, we would like to discuss the use of VEMLIDY.\n\nVEMLIDY is indicated for the treatment of chronic hepatitis B infection in adults with compensated liver disease.\n\nVEMLIDY carries a Boxed Warning for posttreatment severe acute exacerbation of hepatitis B.\n\nDiscontinuation of anti-hepatitis B therapy, including VEMLIDY, may result in severe acute exacerbations of hepatitis B. Hepatic function should be monitored closely with both clinical and laboratory follow-up for at least several months in patients who discontinue anti-hepatitis B therapy, including VEMLIDY. If appropriate, resumption of anti-hepatitis B therapy may be warranted.\n\nPlease stay tuned at the end of this video Dr Carrie Frenette will review additional important safety considerations for VEMLIDY.\n\n\\[Nguyen\\]\n\nVEMLIDY is recommended as a first-line hepatitis B therapy by the Simplified Approach to Hepatitis B Algorithm, and by the guidelines from the American Association for the Study of Liver Diseases, the US Treatment Algorithm, the Asian American Treatment Algorithm, and the guidelines from the European Association for the Study of the Liver.\n\n\\[Nguyen\\]\n\nThe guidelines and algorithms recommend VEMLIDY as a first-line therapy because it has proven efficacy, 0 resistance, and demonstrated reduced impact on long-term renal and bone safety parameters. Although, long-term clinical significance of these have not yet been fully quantified.\n\nTherefore, VEMLIDY can be considered in patients with, or at risk for, renal dysfunction and bone disease.\n\nPostmarketing cases of renal impairment, including acute renal failure and proximal renal tubulopathy, have been reported. In all patients, monitor renal function and discontinue treatment in those who exhibit significant reductions in renal function or evidence of Fanconi syndrome.\n\nVEMLIDY is not recommended in patients with end stage renal disease, who are not receiving chronic hemodialysis. In patients on chronic hemodialysis, on dialysis days, VEMLIDY should be administered after the completion of hemodialysis.\n\n\\[Nguyen\\]\n\nSo Dr Dieterich, can you tell us more about your experiences with hepatitis B in your region and your management of these patients?\n\n\\[Dieterich\\]\n\nSure, Duke.\n\n\\[Dieterich\\]\n\nMy practice is in New York City, and many people don’t realize that approximately 22% of the people in New York are immigrants, including people from places with higher endemicity of chronic hepatitis B, such as Asia and Africa. More than half of New Yorkers live in households with at least one immigrant.\n\n\\[Dieterich\\]\n\nAbout 3% of New York City residents are living with hepatitis B. As shown in this graph, the boroughs with the highest incidence are Brooklyn and Queens, followed by the Bronx, Manhattan, and last, Staten Island. In addition, it has been estimated that 46% of New York City residents with hepatitis B remain undiagnosed. So as you can see, chronic hepatitis B has an important impact in New York.\n\n\\[Dieterich\\]\n\nThe SABA recommendations are particularly applicable to my practice in New York. For example, I regularly see patients with chronic hepatitis B who are in their 30s and have elevated hepatitis B DNA, but have normal ALT levels. My recommendation is to treat these patients with antiviral therapy, as described in the overview of the SABA algorithm.\n\nI have a discussion with my patients about the importance of antiviral therapy and how oral antivirals can fit well with their routine. With the appropriate understanding and motivation, the majority of my patients remain on therapy as indicated, including younger patients, such as adults younger than 30 years old. For example, I have an 18-year-old male patient with chronic hepatitis B who is so dedicated to taking his medicine that he proactively told me about his plans for taking his VEMLIDY during a week-long ski vacation.\n\nFor all my patients, I ensure that they understand the potential adverse reactions for VEMLIDY, with headaches being the most common.\n\n\\[Dieterich\\]\n\nBefore initiating therapy, I make sure to set expectations with my patients for testing and monitoring.\n\nThis includes before starting treatment with VEMLIDY, and during treatment, patients should have their creatinine levels, urine glucose, and urine protein tested. For those with chronic kidney disease they should also have their serum phosphorus assessed. If patients discontinue VEMLIDY treatment, it's important to closely monitor their hepatic function for at least several months after stopping treatment.\n\nIn addition to these monitoring requirements, the expert panel recommends that patients come in for a clinic visit every 3 months until viral suppression is achieved, then every 6 months thereafter. Every 6 months we conduct a liver ultrasound and test their level of alpha-fetoprotein. We also regularly assess their creatinine clearance.\n\nSome of my colleagues have asked about insurance access or coverage for VEMLIDY. I’ve been able to get insurance coverage for my patients on VEMLIDY, although coverage can differ for other providers and patients. If my patients have questions about how to access VEMLIDY, I point them to the VEMLIDY.com website where they can learn about the co-pay program and Support Path.\n\n\\[Dieterich\\]\n\nNow, I’d like to pass things over to Dr Nguyen to tell us about chronic hepatitis B in California and his experience in managing patients there.\n\n\\[Nguyen\\]\n\nThank you, Dr Dieterich. Although New York and California are on opposite sides of the country, we in California do share a lot in common with you in New York as it relates to chronic hepatitis B being an important health concern.\n\n\\[Nguyen\\]\n\nCalifornia is home to almost 11 million immigrants, which represents approximately 25% of the first-generation immigrants in the US. This includes people from high hepatitis B endemic areas, such as Asia and Africa.\n\n\\[Nguyen\\]\n\nThe prevalence of chronic hepatitis B is particularly high in California, with Asian Pacific Islanders being especially at risk. In San Francisco Bay Area, hepatitis B-related hepatocellular carcinoma is a leading cause of death among Asian Pacific Islanders. In addition, the prevalence of people with chronic hepatitis B is estimated to be more than 2-fold higher in the Los Angeles County compared with the US overall.\n\nSo, just as hepatitis B infection is an important public health concern globally, this is also true for California.\n\n\\[Nguyen\\]\n\nMy practice is in Fountain Valley, in southern California, where we see many patients with chronic hepatitis B, including some with hepatocellular carcinoma without signs of cirrhosis. These are the 20% of patients that Dr Dieterich mentioned earlier, which is what makes this a particularly insidious disease.\n\nI think we’re fortunate in our area that we have many physicians who are very passionate about hepatitis B therapy, including primary care providers who have been educated throughout the years and some of them have taken it upon themselves to help in the management.\n\nThis is a segue to one of my favorite English sayings, if you give a man a fish, you will feed him for a day. Teach a man to fish, you will feed him for a lifetime.\n\nSo I educate my primary care providers to be comfortable to treat hepatitis B so they can take care of their patients. If they are not comfortable, I will manage the patient with them.\n\nI believe the Simplified Approach to Hepatitis B Algorithm will support antiviral therapy for many adult patients who would benefit from it and who may not otherwise be recommended based on other guidance. This is a step forward for our chronic hepatitis B patients.\n\n\\[Nguyen\\]\n\nIn my personal experience, patients have had success obtaining insurance coverages for VEMLIDY when we have prescribed it.\n\nI have referred patients to the VEMLIDY Co-pay Coupon Program. For some eligible patients, their co-pays were as low as $0.\n\nAnd now, I would like to introduce Dr Carrie Frenette who will provide more information on these resources. Dr Frenette.\n\n\\[Frenette\\]\n\nThank you, Dr Nguyen.\n\n\\[Frenette\\]\n\nGilead has support resources for patients with chronic hepatitis B. With the VEMLIDY Co-pay Coupon Program, eligible patients with commercial insurance may pay as low as a $0 co-pay for out-of-pocket costs for VEMLIDY, up to $6000 per year with no monthly limit.\n\nSupport Path can help patients to understand their coverage and identify financial support options. To learn more, visit mysupportpath.com, and for multilingual assistance, call 1-855-769-7284, Monday through Friday, between 9 am and 8 pm Eastern Standard Time. These are subject to change and restrictions apply. See the full terms and conditions at mysupportpath.com/providers.\n\n\\[Frenette\\]\n\nNow, let’s review some additional Important Safety Information for VEMLIDY.\n\n\\[Frenette\\]\n\nWarnings and Precautions\n\nRisk of Development of HIV-1 Resistance in HBV/HIV-1 Coinfected Patients: Due to this risk, VEMLIDY alone should not be used for the treatment of HIV-1 infection. Safety and efficacy of VEMLIDY has not been established in HBV/HIV-1 coinfected patients. HIV antibody testing should be offered to all HBV-infected patients before initiating therapy with VEMLIDY, and, if positive, an appropriate antiretroviral combination regimen that is recommended for HBV/HIV-1 coinfected patients should be used.\n\nNew 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 TAF-containing products. Patients with impaired renal function and/or taking nephrotoxic agents (including NSAIDs) are at increased risk of renal-related adverse reactions. Discontinue VEMLIDY in patients who develop clinically significant decreases in renal function or evidence of Fanconi syndrome. Monitor renal function in all patients – See Dosage and Administration.\n\nLactic Acidosis and Severe Hepatomegaly with Steatosis: Fatal cases have been reported with the use of nucleoside analogs, including tenofovir disoproxil fumarate (TDF). Discontinue VEMLIDY if clinical or laboratory findings suggestive of lactic acidosis or pronounced hepatotoxicity develop, including hepatomegaly and steatosis in the absence of marked transaminase elevations.\n\n\\[Frenette\\]\n\nAdverse Reactions\n\nThe most common adverse reactions (incidence ≥5%; all grades) in clinical studies through week 144 were headache, upper respiratory tract infection, abdominal pain, cough, back pain, arthralgia, fatigue, nausea, diarrhea, dyspepsia, and pyrexia.\n\nDrug Interactions\n\nCoadministration of VEMLIDY with drugs that reduce renal function or compete for active tubular secretion may increase concentrations of tenofovir and the risk of adverse reactions.\n\nCoadministration of VEMLIDY is not recommended with the following: oxcarbazepine, phenobarbital, phenytoin, rifabutin, rifampin, rifapentine, or St. John’s wort. Such coadministration is expected to decrease the concentration of tenofovir alafenamide, reducing the therapeutic effect of VEMLIDY. Drugs that strongly affect P-glycoprotein (P-gp) and breast cancer resistance protein (BCRP) activity may lead to changes in VEMLIDY absorption.\n\nConsult the full prescribing information for VEMLIDY for more information on potentially significant drug interactions, including clinical comments.\n\nDosage and Administration\n\nTesting Prior to Initiation: should include HIV infection.\n\nPrior to or When Initiating, and During Treatment: On a clinically appropriate schedule, assess serum creatinine, estimated creatinine clearance, urine glucose, and urine protein in all patients. In patients with chronic kidney disease, also assess serum phosphorus.\n\nThe Dosage in Adults: is 1 tablet taken once daily with food.\n\nRenal Impairment: It’s not recommended in patients with end stage renal disease (ESRD; estimated creatinine clearance <15 mL/min) who are not receiving chronic hemodialysis; in patients on chronic hemodialysis, on hemodialysis days, administer VEMLIDY after completion of hemodialysis treatment.\n\nHepatic Impairment: Not recommended in patients with decompensated (Child-Pugh B or C) hepatic impairment.\n\n\\[Dieterich\\]\n\nThank you for joining us today for this discussion about SABA recommendations and how earlier treatment may be an option for your appropriate adult chronic hepatitis B patients.\n\n\\[Nguyen\\]\n\nThanks, Doug. And yes, thank you for joining us, we hope that today’s video will aid you in the management of your chronic hepatitis B patients.\n\n\\[Frenette\\]\n\nThanks so much for joining us!\n\n![VEMLIDY® (tenofovir alafenamide) Logo](/media/images/vemlidy-tenofovir-alafenamide-logo.svg)\n\nSABA 2022 Simplified Approach Hepatitis B Algorithm1\n----------------------------------------------------\n\nCHB patients with compensated cirrhosis and detectable HBV DNA, regardless of ALT levels, \nshould be treated\n\n![Chart1](/media/images/vem-saba-chart1.svg) ![Chart1](/media/images/vem-saba-chart1-mobile.svg)\n\n* Refer to a specialist if HIV coinfection exists\n* VEMLIDY is not indicated for patients with decompensated (Child-Pugh B or C) hepatic impairment and has not been tested in this population\n\nExpert panel recommendations for monitoring patients with CHB1\n\nNewly diagnosed patients not eligible for treatmentb\n\n![Chart2](/media/images/vem-saba-chart2.svg) ![Chart2](/media/images/vem-saba-chart2-mobile.svg)\n\nPatients starting treatment\n\n![Chart3](/media/images/vem-saba-chart3.svg) ![Chart3](/media/images/vem-saba-chart3-mobile.png)\n\nSee full Prescribing Information for monitoring requirements specific to VEMLIDY.\n\nVEMLIDY can be considered in patients with, or at risk for, renal dysfunction and bone disease1,b,c\n\n**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 TAF-containing products. Patients with impaired renal function and/or taking nephrotoxic agents (including NSAIDs) are at increased risk of renal-related adverse reactions. Discontinue VEMLIDY in patients who develop clinically significant decreases in renal function or evidence of Fanconi syndrome. Monitor renal function in all patients - See Dosage and Administration.6\n\n\\*HBV DNA <2000 IU/mL OR if age <30 and HBV DNA >2000 IU/mL and ALT ≤ULN, then re-evaluate for treatment eligibility in 6 months.a,d\n\naALT ULN = 30 U/L for men and 19 U/L for women.\n\nbVEMLIDY is indicated for the treatment of chronic hepatitis B virus (HBV) infection in adults with compensated liver disease.6\n\nc**VEMLIDY is not recommended in patients with end-stage renal disease (ESRD; eCrCl <15mL/min) who are not receiving chronic hemodialysis; in patients on chronic hemodialysis, on hemodialysis days, administer VEMLIDY after completion of hemodialysis treatment.6**\n\n****\n\ndAssess ALT and HBV DNA every 6 months for 2 years, then annually if no change; assess HBsAg every 2 years.\n\neTo help assess fibrosis, the SABA recommends the use of the aspartate aminotransferase-to-platelet ratio index (APRI), the Fibrosis-4 index (FIB-4), or transient elastography.\n\n****\n\n****\n\n![VEMLIDY® (tenofovir alafenamide) Logo](/media/images/vemlidy-tenofovir-alafenamide-logo.svg)\n\nUSTA 2021 United States Treatment Algorithm2\n--------------------------------------------\n\nCHB patients with compensated cirrhosis and detectable HBV DNA, regardless of ALT levels, should be treated\n\n![Chart1](/media/images/vem-usta-chart1.svg) ![Chart1](/media/images/vem-usta-chart1-mobile.svg)\n\naThe upper limits of normal for serum ALT concentrations are 30 IU/L for men and 19 IU/L for women.\n\nbUpon initial diagnosis, monitor every 3 months for 1 year to ensure stability.\n\nc**VEMLIDY is not recommended in patients with end-stage renal disease (ESRD; eCrCl <15 mL/min) who are not receiving chronic hemodialysis; in patients on chronic hemodialysis, on hemodialysis days, administer VEMLIDY after completion of hemodialysis treatment.6**\n\nVEMLIDY is the only oral antiviral for adults with CHB that doesn’t require a dose adjustment for renal impairment6-8,13\n\n![VEMLIDY® (tenofovir alafenamide) Logo](/media/images/vemlidy-tenofovir-alafenamide-logo.svg)\n\nAATA 2018 Asian American Treatment Algorithm3\n---------------------------------------------\n\nCHB patients with compensated cirrhosis and detectable HBV DNA, regardless of ALT levels, should be treated\n\n![Chart1](/media/images/vem-aata-chart1.webp) ![Chart1](/media/images/vem-aata-chart1-mobile.webp)\n\naALT ULN is based on local laboratory range.\n\nbOther causes include medications, supplements, non-alcoholic fatty liver disease, alcohol intake, and other viral etiologies (ie, hepatitis A virus, hepatitis C virus, hepatitis D virus, HIV, Epstein-Barr virus, and cytomegalovirus).\n\nThe development of the 2018 AATA was supported, in part, by an independent grant from Gilead Sciences, Inc.\n\n“Based on \\[the\\] safety profile and non-inferiority of efficacy endpoints, \\[VEMLIDY\\] represents an attractive alternative to \\[TDF\\] in the treatment of CHB”3\n\n![VEMLIDY® (tenofovir alafenamide) Logo](/media/images/vemlidy-tenofovir-alafenamide-logo.svg)\n\nAASLD 2018 American Association for the Study of Liver Diseases4\n----------------------------------------------------------------\n\nCHB patients with compensated cirrhosis and detectable HBV DNA, regardless of ALT levels, should be treated\n\n![Chart1](/media/images/vem-aasld-chart1.webp) ![Chart1](/media/images/vem-aasld-chart1-mobile.png)\n\naThe upper limit of normal for serum ALT concentration is 35 U/L for men and 25 U/L for women.\n\nbLiver disease defined by noninvasive testing showing significant fibrosis (≥F2) or liver biopsy showing moderate/severe inflammation (A2 or A3) and/or significant fibrosis (≥F2).\n\n“\\[VEMLIDY\\] is more stable than TDF in plasma and delivers the active metabolite to hepatocytes more efficiently, allowing a lower dose to be used with similar antiviral activity \\[and\\] less systemic exposure.”4\n\nPivotal trials and open-label extension (OLE) design: 108 and 1101-3,6\n----------------------------------------------------------------------\n\nThe efficacy and safety of VEMLIDY 25 mg once daily in the treatment of chronic hepatitis B in adults with compensated liver disease were evaluated in 2 randomized, double-blind, active-controlled, noninferiority trials: Trial 108 (N=425 HBeAg– treatment-naïve and treatment-experienced patients) and Trial 110 (N=873 HBeAg+ treatment-naïve and treatment-experienced patients).\n\nThe primary endpoint for both studies was HBV DNA <29 IU/mL and noninferiority to tenofovir disoproxil fumarate (TDF) (10% margin; 95% confidence interval \\[CI\\] approach) at Week 48.\n\nAdditional efficacy endpoints evaluated at Week 48, Week 96, and Week 144 for both studies include:\n\n* Proportion of patients with HBV DNA <29 IU/mL\n* Alanine aminotransferase (ALT) normalization\n* Hepatitis B surface antigen (HBsAg) loss and seroconversion\n\nHepatitis B envelope antigen (HBeAg) loss and seroconversion were also assessed in Trial 110.\n\nThe original protocol was amended to extend the double-blind phase from 96 weeks to 144 weeks. However, before implementation of the protocol amendment, 540 patients entered the open‑label phase at Week 96 (360 patients remained on VEMLIDY and 180 patients switched from TDF to VEMLIDY).\n\nAt Week 144, all 1157 remaining HBeAg- and HBeAg+ patients (out of the original 1298) entered the open-label VEMLIDY phase. At Week 384, the full analysis set included 1298 patients who were enrolled in the study.\n\nThe 8-year analysis is not presented in the VEMLIDY full Prescribing Information.\n\n[See baseline characteristics](/clinical-trial-design/)\n\nContinue to data\n\nSwitch trial design: 40181,6\n----------------------------\n\nThe efficacy and safety of switching from TDF 300 mg once daily to VEMLIDY 25 mg once daily in virologically suppressed adults with CHB infection were evaluated in a randomized, double-blind, active-controlled trial: Trial 4018 (N=488).\n\nPatients must have been taking TDF 300 mg once daily for ≥12 months, with HBV DNA less than the Lower Limit of Quantitation by local laboratory assessment ≥12 weeks prior to screening and HBV DNA <20 IU/mL at screening. Patients were randomized in a 1:1 ratio to either switch to VEMLIDY (n=243) or stay on TDF (n=245). At baseline, the median duration of exposure to TDF prior to the trial was similar in both treatment groups (TAF=220.0 weeks, TDF=224.3 weeks).\n\nThe **primary endpoint** was the proportion of patients with plasma HBV DNA ≥20 IU/mL at Week 48.\n\nAdditional efficacy endpoints included:\n\n* Proportion of patients with HBV DNA <20 IU/mL\n* ALT normal and normalization, HBsAg loss and seroconversion\n* HBeAg loss and seroconversion\n\nAt Week 48, all patients who were randomized to TDF for the controlled portion of the trial were switched to VEMLIDY for the open-label extension through Week 96.\n\n[See baseline characteristics](/clinical-trial-design/switch-trial-4018-design/)\n\nContinue to data\n\nBaseline characteristics\n------------------------\n\n![](/media/images/trial_designs_chart_modal.png)\n\nTreatment-naïve patients had <12 weeks of previous treatment with any nucleoside/nucleotide analog. Treatment-experienced patients met all entry criteria (including HBV DNA ≥20,000 IU/mL and serum ALT criteria) and had ≥12 weeks of previous treatment with any nucleoside/nucleotide analog.1,2\n\nALT=alanine aminotransaminase; BMD=bone mineral density; TDF=tenofovir disoproxil fumarate.\n\na“Other” includes genotypes E, F, H, and unknown.3\n\nbExcludes patients with missing values.3\n\ncExcluding interferon and TDF. Patients may have been on more than one prior therapy.2\n\nd“Other” category included clevudine, tenofovir alafenamide, and other oral nucleoside/nucleotide agents.2\n\n****\n\n ![](https://px.deepintent.com/pixel.gif?id=4d9ce39a67) \n\nWe may utilize tracking technologies such as cookies and pixels to process personal data in order to enhance your experience on our site and to analyze performance and traffic. You may exercise your consumer right to opt-out by clicking the “Cookies Settings” link. 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