About VIREAD (VEER ee ad)
This section can help answer the following questions:
Why should I take VIREAD?
What does it do?
How well does it work?
What is resistance?
Can resistance stop VIREAD from working?
What are the possible side effects?
What other important information do I need to know?
VIREAD can help control chronic hepatitis B
If left untreated, the virus can multiply within your liver
VIREAD may help lower the amount of HBV in your body by lowering the ability of the virus to multiply and infect new liver cells.1
VIREAD has been shown to work well in adults with chronic hepatitis B
In two important studies (102 and 103), 426 people with chronic hepatitis B were treated with VIREAD and 215 people were treated with another medicine for 48 weeks (1 year). The levels of virus in the blood and the damage to the liver were measured.1
In both studies, most people who took VIREAD had low levels of the hepatitis B virus AND reduced liver inflammation within 1 year.1
Most of the people in the studies had never taken medicine for hepatitis B. It is important to note that the numbers of people in the studies who HAD taken medicine before were too small to determine if VIREAD worked well for them.1
Two different studies were done because of the hepatitis B e antigen (a viral protein). Some people with chronic hepatitis B have the e antigen and some do not. People with the e antigen may respond differently to medicines than those who don’t have the e antigen.1
Resistance can stop medicines from working well
Even if you are being treated for chronic hepatitis B, the amount of virus in your blood can start to go up. Resistance happens when the virus changes or “mutates” in a way that stops medicines from working well.1 It is important to be treated with a medicine that has a low rate of resistance.2
No resistance to VIREAD
was seen at 1 year1
While no resistance to VIREAD was seen at 1 year, it is not known how long VIREAD may help your chronic hepatitis B.1
Stay under a doctor’s care when taking VIREAD. Do not change your treatment or stop treatment without first talking with your doctor.
Possible side effects1
Studies in patients with chronic hepatitis B: The most common side effect of VIREAD is nausea. Less common side effects include abdominal pain, diarrhea, headache, dizziness, fatigue, nasopharyngitis, back pain, and skin rash.
Studies in patients with HIV-1: The most common side effects of VIREAD are rash, headache, pain, diarrhea, depression, weakness, and nausea. Less common side effects include vomiting, dizziness, and intestinal gas.
Some patients treated with VIREAD have had kidney problems. If you have had kidney problems in the past, or need to take another drug that can cause kidney problems, your healthcare provider may need to perform additional blood tests.
Laboratory tests show changes in the bones of patients treated with VIREAD. If you have had bone problems in the past, your healthcare provider may need to perform additional tests or may suggest additional medication. Additionally, bone pain and softening of the bone (which may contribute to fractures) may occur as a consequence of kidney problems.
Some patients taking antiviral drugs like VIREAD have developed a condition called lactic acidosis (a buildup in the blood of lactic acid, the same substance that causes your muscles to burn during heavy exercise). Symptoms of lactic acidosis include:
- Nausea
- Unusual or unexpected stomach discomfort
- Vomiting
- Weakness
If you notice these symptoms or if your medical condition changes suddenly, call your healthcare provider right away.
Changes in body fat have been seen in some patients taking anti-HIV-1 medicine. These changes may include increased amount of fat in the upper back and neck (“buffalo hump”), breast, and around the main part of your body (trunk). Loss of fat from the legs, arms, and face may also happen. The cause and long-term health effects of these conditions are not known at this time.
In some patients with advanced HIV infection (AIDS), signs and symptoms of inflammation from previous infections may occur soon after anti-HIV treatment is started. It is believed that these symptoms are due to an improvement in the body’s immune response, enabling the body to fight infections that may have been present with no obvious symptoms. If you notice any symptoms of infection, please inform your doctor immediately.
If you have HBV infection or HIV and HBV infection together, you may have a “flare-up” of hepatitis B, in which the disease suddenly returns in a worse way than before if you stop taking VIREAD. Do not stop taking VIREAD without your doctor’s advice. After stopping VIREAD, tell your doctor immediately about any new, unusual, or worsening symptoms that you notice after stopping treatment. After you stop taking VIREAD, your doctor will still need to check your health and take blood tests to check your liver for several months.
References: 1. VIREAD (tenofovir disoproxil fumarate) Prescribing Information. Foster City, CA: Gilead Sciences, Inc.; November 2008. 2. Lok ASF,McMahon BJ. Chronic hepatitis B (AASLD practice guidelines). Hepatology. 2007;45(2):507-539.
