September 2026

PDR Drug Update 

Promising New Management for Chronic Hepatitis Delta Virus

Chronic hepatitis delta virus (HDV) infection is relatively uncommon but severe. It occurs exclusively in individuals with chronic hepatitis B virus (HBV) infection since it requires hepatitis B surface antigen (HBsAg) to complete its life cycle. The condition causes acceleration of hepatic fibrosis that substantially increases the risk for cirrhosis, hepatic decompensation, hepatocellular carcinoma (HCC), and liver-related mortality. It is therefore considered an aggressive disease that is critical to manage effectively.

Current estimates show that approximately 12 million people worldwide have HDV infection. It occurs in two principal manners, the first being when an individual acquires HBV and HDV simultaneously, and the second when HDV infects a person who already has chronic HBV. Some acute HBV/HDV coinfections resolve, whereas superinfection of an established HBV carrier has a much higher probability (up to 80%) of progression to chronic HDV infection. These patients have an increased risk of hepatic complications and are twice as likely to need a liver transplant.

Transmission of HDV is the same as it is with HBV. Contact with infected bodily fluids can pass along these viruses, such as through sexual intercourse, sharing syringes or other objects that may have infected blood on them, or (rarely) from a mother to her baby during birth. Patients with chronic HDV may be asymptomatic despite ongoing hepatic injury, particularly early in the disease. Others present with fatigue, malaise, anorexia, nausea, abdominal discomfort, or biochemical evidence of hepatocellular inflammation. As fibrosis advances, portal hypertension and hepatic insufficiency may begin to emerge.

Clinical methods for diagnosis are used to identify HDV exposure in an individual who is HBsAg-positive. The presence of anti-HDV antibodies establishes exposure, while quantitative or qualitative HDV RNA testing can confirm active, viremic infection. If a chronic infection is determined to exist, clinicians will need to view the HDV as a progressive chronic liver disease requiring longitudinal assessment rather than simply as an additional viral laboratory diagnosis. Treatment decisions depend heavily on fibrosis stage, disease activity, comorbidities, and treatment eligibility. Accelerated trajectory toward advanced disease, cirrhosis, portal hypertension, hepatic decompensation, and hepatocellular carcinoma can be expected.

As a severe condition with very few treatment options and limited prevalence in the US, chronic HDV is considered an orphan disease. Strategies for treatment have relied on pegylated interferon alfa, but unfortunately it offers only modest response rates and has significant contraindications and potential toxicity for patients. However, the therapeutic landscape for treating chronic HDV is currently undergoing substantial changes as new clinical trial data addressing the treatment of persons living with HBV monoinfection and HBV/HDV coinfection have fueled excitement among clinicians regarding the prospect of cures.

One of the most recent changes is the landmark approval of Hepcludex (bulevirtide-gmod) for injection, for subcutaneous use. It is the first FDA-approved therapy indicated specifically for chronic HDV in adults without cirrhosis or with compensated cirrhosis. The acceptance of bulevirtide introduces a well-defined antiviral mechanism, clinically meaningful virologic and biochemical responses, and an alternative for patients for whom interferon is unsuitable. Bulevirtide targets the viral life cycle at a point distinct from that of interferon therapy. The drug is a synthetic lipopeptide that binds and inhibits NTCP, thereby preventing HBV and HDV entry into hepatocytes. The FDA indication excludes patients with decompensated cirrhosis, and durable off-treatment virologic control will need to be further studied. Nevertheless, it transforms chronic HDV from a disease with extremely limited therapeutic options into one with an FDA-approved, directly targeted, non-interferon mechanism.

HDV treatment recommendations are expected to evolve rapidly following the latest approval of bulevirtide. Continued long-term studies are needed to establish whether it will be able to reverse cirrhosis or prevent hepatocellular carcinoma. The future of HDV management will likely depend on combinations of entry inhibitors, prenylation inhibitors, HBsAg-targeting agents, nucleic acid therapies, and immune-based interventions to achieve sustained virologic control or a functional cure. Stay informed about emergent drug information, including treatment options for HDV, by exploring PDR by ConnectiveRx. You can also stay current by using the official PDR app, mobilePDR, which is available for free from your preferred app store.

FDA New Approvals

Garzulys

The FDA has approved Garzulys (insulin aspart-fsan), a rapid-acting insulin analog to improve glycemic control in adults and pediatric patients with diabetes mellitus. Learn more about Garzulys

Genglycos

The FDA has approved Genglycos (pariglasgene brecaparvovec-opnr) to reduce daily cornstarch intake as an adjunct to nutritional management in adult and pediatric patients 8 years of age and older with glycogen storage disease type Ia. Learn more about Genglycos

Gwyn Lo

The FDA has approved Gwyn Lo (norelgestromin and ethinyl estradiol transdermal system). Gwyn Lo is a new combined hormonal contraceptive patch with low-dose estrogen. Learn more about Gwyn Lo

Jideytro

The FDA has approved Jideytro (zidesamtinib), a ROS1 selective inhibitor, for the treatment of adult patients with locally advanced or metastatic ROS1-positive non-small cell lung cancer who received a prior ROS1 kinase inhibitor. Learn more about Jideytro

Lytenava

The FDA has approved Lytenava (bevacizumab-vikg) for the treatment of neovascular age-related macular degeneration (nAMD), commonly known as wet AMD. Learn more about Lytenava

Mflusiva

The FDA has approved Mflusiva (influenza vaccine, mRNA) for active immunization for the prevention of influenza disease caused by influenza virus subtypes A and B represented in the vaccine. Mflusiva is approved for use in persons 50 years of age and older. Learn more about Mflusiva

Orzeyful

The FDA has approved Orzeyful (oveporexton), an oral orexin receptor 2 agonist, for the treatment of narcolepsy type 1 (NT1, narcolepsy with cataplexy) in adults. Learn more about Orzeyful

Pasatru

The FDA has approved Pasatru (garetosmab-grts) to reduce new heterotopic ossification (bone formation outside the skeleton) and reduce clinician-assessed disease flare-ups in adults with fibrodysplasia ossificans progressiva. Learn more about Pasatru

Simtriyo

The FDA has approved Simtriyo (centanafadine), a once-daily extended-release capsule for the treatment of attention-deficit hyperactivity disorder in adults and pediatric patients aged 6 years and older weighing at least 20kg. Learn more about Simtriyo

Tauklarify

The FDA has approved Tauklarify (florquinitau F 18 injection), a radiodiagnostic agent indicated for positron emission tomography of the brain in adults with cognitive impairment who are being evaluated for Alzheimer’s disease to identify patients with tau neurofibrillary tangle pathology. Learn more about Tauklarify

Tudriqev

The FDA has approved Tudriqev (vusolimogene oderparepvec-wtpg) in combination with nivolumab for the treatment of adults with unresectable advanced cutaneous melanoma who experienced disease progression on an anti-PD-1 antibody-based regimen. Learn more about Tudriqev

Zenbexus

The FDA has approved Zenbexus (iberdomide) in combination with daratumumab and hyaluronidase-fihj and dexamethasone for the treatment of adult patients with multiple myeloma who have received at least one prior line of therapy including a proteasome inhibitor and an immunomodulatory agent. Learn more about Zenbexus

FDA New Indications

Pluvicto

The FDA has approved Pluvicto (lutetium Lu 177 vipivotide tetraxetan) in combination with an androgen receptor pathway inhibitor for patients with prostate-specific membrane antigen-positive metastatic androgen pathway modulation-naive/sensitive prostate cancer, commonly known as metastatic hormone-sensitive prostate cancer. Learn more about Pluvicto

FDA Labeling Changes

Lerochol

The FDA has approved an autoinjector for Lerochol (lerodalcibep-liga) injection 300mg/1.2mL, a third-generation PCSK9 inhibitor. The FDA also approved an update to the drug’s indication statement in its prescribing information reflecting the reduction of risk for major adverse cardiovascular events achieved in adults via LDL-C lowering with statins or with monoclonal antibody PCSK9 inhibitors used as an add-on to statin therapy. Learn more about Lerochol

FDA New Dosing

Furoscix

The FDA has approved Furoscix ReadyFlow (furosemide) injection for the treatment of edema in adults with heart failure (HF) or chronic kidney disease (CKD). Furoscix (furosemide) injection delivered via an on-body infusor is currently available and was approved for adult patients with edema in HF in 2022 and in CKD in 2025. Learn more about Furoscix

FDA Recalls

American Regent Papaverine HCl

American Regent, Inc. is conducting a nationwide voluntary recall of a single lot of papaverine HCl injection, USP, 60mg/2mL single dose vial to the consumer level. The product is being recalled due to the presence of particulate matter identified as glass and/or paraformaldehyde. Learn more about the American Regent papaverine HCl recall

B. Braun Excel Lactated Ringer’s

B. Braun Medical Inc. is voluntarily recalling one lot of Excel Lactated Ringer’s injection, 1000mL to the hospital/healthcare facility level, due to the presence of particulate matter in the solution identified primarily as cellulose cotton fibers, with individual particles also identified as cellulose wood fiber and polystyrene. Learn more about the B. Braun Excel Lactated Ringer’s recall

Baxter Cefazolin in Dextrose

Baxter International Inc. is voluntarily recalling Lot LD175708, Exp 14-Feb 2027 of cefazolin in dextrose injection due to a report of particulate matter found in the solution identified as cardboard. Learn more about the Baxter cefazolin in dextrose recall

Fresenius Kabi Morphine Sulfate

Fresenius Kabi, an operating company of the Fresenius Group, is voluntarily recalling one lot of morphine sulfate injection USP, Simplist 2mg/1mL due to a label mix-up. The MicroVault labeled as morphine 2mg/1mL, may contain a prefilled syringe of Dilaudid 0.5mg/0.5mL. This recall is being conducted to the user level. Learn more about the Fresenius Kabi morphine sulfate recall

Fresenius Kabi Tyenne

Fresenius Kabi, an operating company of the Fresenius Group, is recalling one lot of Tyenne (tocilizumab-aazg) injection, 400mg/20mL (20mg/mL), 20mL vials, to the user level. An internal investigation at the firm found the product to contain glass particles. Learn more about the Fresenius Kabi Tyenne recall

Liebel-Flarsheim Company Optiray

Liebel-Flarsheim Company, LLC is recalling one lot of Optiray Imaging Bulk Package 350, 500mL in vial, (Ioversol Injection 74% 350mg iodine/mL) for intra-arterial or intra-venous use to the user level (hospitals, imaging centers, healthcare facilities and clinics, and other potential users of the product) due to the presence of particulate matter comprising polyethylene and other plastic materials, stainless steel and glass. Learn more about the Liebel-Flarsheim Company Optiray recall

Optimal Balance Pharmacy Glutathione

Optimal Balance Pharmacy is voluntarily recalling one lot of compounded glutathione 200mg/mL 30mL multi-dose vials to the patient level. The product is being recalled because pharmacy testing identified elevated bacterial endotoxin levels. Learn more about the Optimal Balance Pharmacy glutathione recall

Sunny Pharmtech Cyclophosphamide

Sunny Pharmtech, Inc is voluntarily recalling three lots of cyclophosphamide for injection, USP, 1g/vial and 2g/vial, to the user level due to the presence of particulate matter identified as steel. No adverse events or injuries associated with this particulate matter issue have been reported. Learn more about the Sunny Pharmtech cyclophosphamide recall

Victory Medical Center Pharmacy Compounded Glutathione

Victory Medical Center Pharmacy is voluntarily recalling certain lots of compounded glutathione 200mg/mL multi-dose vials to the patient level. The product is being recalled because pharmacy testing identified elevated bacterial endotoxin levels. Learn more about the Victory Medical Center Pharmacy compounded glutathione recall

FDA REMS

Zenbexus

The FDA has approved a REMS for Zenbexus (Iberdomide). The goal of the Zenbexus REMS is to mitigate the risk of embryo-fetal toxicity. Learn more about Zenbexus

Labeling Updates - No updates this month