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Vemlidy: FDA Expands Approval to Kids with Hepatitis B

Christina DeBusk
Apr 12th, 2024
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What is the active ingredient in the brand-name drug Vemlidy, and how does it help children who have hepatitis B?

In 2015, the U.S. Food and Drug Administration (FDA) approved the drug Vemlidy for the treatment of hepatitis B. At that point, it was only available for patients 12 and older. (1) This has now changed. On March 28, 2024, Gilead – the manufacturer of the drug – announced that the FDA has expanded its approval, now making this treatment available to kids as young as six with chronic hepatitis B infection. (2) This is important because this disease can have different consequences if developed earlier in life.

Hepatitis B Impacts Kids Differently

Hepatitis B is a liver infection caused by the hepatitis B virus. While it is more common in adults, children can contract this disease through transmission from their mother before birth. They may also contract it by coming into contact with bodily fluids from another person infected with the virus.

The Centers for Disease Control and Prevention reports that when younger people get infected with hepatitis B, there is a greater risk that their infection will be chronic, which is not necessarily the case for adults. (3) While there is no cure for this virus, treatment can help ease its effects. That’s where Vemlidy comes into play.

What Is Vemlidy and How Does It Help with Hepatitis B?

Vemlidy comes in tablet form and is taken once daily with food. The active ingredient in this brand-name drug is tenofovir alafenamide. Tenofovir alafenamide is an antiviral medicine that can be found in several drugs used to treat a variety of virus-based conditions, such as HIV. (4)

One of the studies involving Vemlidy was a 96-week Phase 2 clinical trial and involved kids aged 6 to 12. Those in the treatment group received 25 mg of Vemlidy while the control group received a placebo. Kids receiving the active drug had greater rates of viral suppression. The drug was also found to be safe and tolerable for this age group. (2)

Potential Vemlidy Side Effects

Medications can affect adults differently. The same is true for kids. Although Vemlidy appears to be well-tolerated in kids aged 6 to 12, some may experience side effects with this drug.

In the 96-week study, 5% or fewer of the pediatric subjects experienced adverse effects, some of the most common being:

• Swelling of the nasal passages
• Fever
• Headaches
• Diarrhea
• Respiratory infections
• Cough
• Upper abdominal pain

When Vemlidy May Not Be Recommended

Vemlidy isn’t right for everyone. For example, it is not recommended for patients with end-stage renal disease who are not receiving hemodialysis. Those receiving hemodialysis may be able to take this medication; they just have to take it after treatment on hemodialysis days versus before.

Vemlidy may also interact negatively with other medications, including those designed to reduce renal function and anticonvulsants. It may even interact with natural substances, such as St. John’s wort. (2) For this reason, it’s always best to consult with the child’s pediatrician to learn whether Vemlidy is a safe option for them.

Next Steps in Treating Hepatitis B in Children

While Vemlidy is not the end-all-be-all in hepatitis B treatment for children, it is a step in the right direction. The more treatment options that exist for treating this infection, the more options children and their families have for managing their condition.

Again, the child’s healthcare provider can help determine whether Vemlidy or some other treatment is best for them. Working closely with their pediatrician can help you both make the best decisions for your child while also addressing their hepatitis B.

(1) U.S. Food and Drug Administration. (2022, October). Highlights of Prescribing Information. Retrieved April 04, 2024, from https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/208464s014lbl.pdf

(2) Gilead. (2024, March 28). Press Releases: FDA Expands Indication for Gilead’s Vemlidy (Tenofovir Alafenamide) to Treat Chronic HBV Infection in Pediatric Patients as Young as Six. Retrieved April 04, 2024, from https://www.gilead.com/news-and-press/press-room/press-releases/2024/3/fda-expands-indication-for-gileads-vemlidy-tenofovir-alafenamide-to-treat-chronic-hbv-infection-in-pediatric-patients-as-young-as-six

(3) Centers for Disease Control and Prevention. (2023, March 09). Viral Hepatitis: Hepatitis B. Retrieved April 04, 2024, from https://www.cdc.gov/hepatitis/hbv/index.htm

(4) HIV.gov. (2023, April 27). Drug Database: Tenofovir Alafenamide. Retrieved April 04, 2024, from https://clinicalinfo.hiv.gov/en/drugs/tenofovir-alafenamide/patient

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About the Author

Christina DeBusk

Christina M. DeBusk is a health writer and editor who specializes in natural wellness, disease prevention and treatment options. She is also a Certified Nutrition Specialist, Personal Trainer, and Transformation Specialist. You can find her articles in a variety of health-related publications, both online and in print.

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