The CDC estimates that there were around 14,000 cases of acute hepatitis B (HBV) in the United States in 2020. Because many people may not have significant symptoms or know they are infected, only 2,157 cases were reported. There are many more people (around 880,000) estimated to have long-term, chronic HBV infection in the US alone. Worldwide, over 296 million people, including over 6 million children under 5 years of age are infected with chronic HBV. While we have vaccines that can help prevent HBV, currently there is no cure for HBV. There are medications such as Vemlidy (tenofovir alafenamide) that help prevent complications such as serious liver damage (cirrhosis) and liver cancer when taken for chronic HBV. Clinical trials are ongoing trying to find a cure for those already infected with HBV.
What are the symptoms of hepatitis B?
While some people experience no symptoms, some common symptoms of acute (short-term) HBV include fever, loss of appetite, tiredness, nausea/vomiting, stomach pain, dark-colored urine, joint pain, clay-colored stool, and yellowing of the skin or eyes. These symptoms will typically resolve on their own in a short period of time.
However, for those with chronic (long-term) HBV, symptoms can be serious and life-threatening. Some people with chronic HBV do not know they have it until the disease has significantly affected their liver. About 25% of those who develop chronic HBV during childhood and about 15% of those who developed it after childhood will one day die from severe complications such as cirrhosis or liver cancer.
Has anyone been cured of hepatitis B?
While there is no cure for hepatitis B, it typically goes away on its own within 1 to 2 months. Many people have no symptoms after they have been infected so they don’t even know they had it. They can still transmit the virus to others even if they do not have symptoms.
If symptoms do occur, they usually begin about 3 months after being exposed to the virus, but they can appear anywhere between 2 months to 5 months after exposure. They tend to only last a few weeks, but for some people, they may feel sick for as long as 6 months.
For those with chronic HBV, many will require medications such as Vemlidy for the rest of their lives. These medications can help protect the liver but will rarely get rid of the virus completely.
Vemlidy FAQs
What does Vemlidy treat?
Vemlidy is a brand-name prescription drug manufactured by Gilead Sciences, Inc. It was originally approved for the treatment of chronic hepatitis B virus infection in adults with stable (compensated) liver disease by the U.S. Food and Drug Administration (FDA).
More recently, Vemlidy was approved to treat pediatric patients 12 years of age and older. This was based on a 24-week clinical trial comparing treatment with Vemlidy 25 mg to placebo among treatment-naïve and treatment-experienced patients in this age group. The study met its primary endpoint of the percentage of patients (21%) with HBV DNA levels below 20 IU/mL after 24 weeks of treatment. This was compared to 0% of the patients reaching this level that were treated with a placebo.
Currently, Vemlidy is one of the preferred first-line oral antiviral therapies for chronic HBV as recommended by the American Association for the Study of Liver Diseases (AASLD). Other first-line treatment options include tenofovir disoproxil fumarate (TDF) and entecavir.
How does Vemlidy work?
The active ingredient in Vemlidy is tenofovir alafenamide which is also known as TAF. TAF belongs to the nucleoside analog reverse transcriptase inhibitor drug class. It is a prodrug of tenofovir that was designed to be able to travel to the liver before becoming active. Once it reaches the liver, most of the TAF is activated within cells of the liver. This means TAF works right where the hep B virus is located to help stop or slow its growth and prevent liver damage and other complications.
What doses of Vemlidy are available?
Vemlidy is available as an oral 25 mg tablet that should be taken with food.
What are the side effects of Vemlidy?
The most common possible side effects of Vemlidy include:
-
Headache
-
Cough
-
Nausea
-
Fatigue
-
Abdominal pain
-
Diarrhea
-
Joint pain
Rarely, Vemlidy may cause some more serious side effects such as:
-
Serious, life-threatening allergic reactions (hives, trouble breathing, swelling of your face, tongue, or throat)
-
Lactic acidosis (build-up of lactic acid in the blood)
-
Pancreatitis
-
New or worsening kidney disease
-
Severe liver problems with symptoms including upper stomach pain, unusual tiredness, loss of appetite, dark urine, and jaundice (yellowing of your skin or eyes)
Contact your healthcare professional for medical advice about any possible adverse effects you experience while taking Vemlidy. You can report your adverse effects to the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Are there any drug interactions with Vemlidy?
When Vemlidy is taken with other drugs, it can change how they work or make some side effects more likely or severe. You should ask your healthcare provider if any of the prescription medications, over-the-counter (OTC) drugs, vitamins, or supplements you take may interact with Vemlidy, including certain seizure medications (carbamazepine, oxcarbazepine, and phenytoin), antibacterials (rifabutin, rifampin, and rifapentine), and St. John’s wort.
Who should not take Vemlidy?
Vemlidy carries a Boxed Warning from the FDA that cautions against stopping treatment for HBV infections. Stopping medications such as Vemlidy may cause severe flare-ups of HBV. If your healthcare provider decides to stop Vemlidy, they should do blood tests regularly for several months to check your liver function. If needed, treatment should be restarted to prevent complications.
You should also make sure your healthcare provider is aware of your medical conditions before starting Vemlidy, including:
-
HIV-1 infection
-
End-stage renal disease (ESRD)
-
Liver disease
-
Pancreatitis
-
Are pregnant or plan to become pregnant
-
Are breastfeeding
Related Medications
Sources
-
https://www.gilead.com/-/media/files/pdfs/medicines/liver-disease/vemlidy/vemlidy_patient_pi.pdf
-
https://www.gilead.com/~/media/files/pdfs/medicines/liver-disease/vemlidy/vemlidy_pi.pdf?la=en
-
https://reference.medscape.com/drug/vemlidy-tenofovir-af-1000007
-
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