Studies of VIREAD in Patients with Advanced Liver Disease
VIREAD may help in patients with serious liver damage
In a small study (Study 108), VIREAD was shown to help lower the amount of the hepatitis B virus (HBV) in patients with serious liver damage that prevents the liver from functioning normally (decompensated liver disease).1
Benefits and side effects
In this study, 45 total patients with chronic hepatitis B and decompensated liver disease were treated with VIREAD for 48 weeks. The results from the study showed that 31 out of 44 patients (70%) of those who took VIREAD had low levels of the hepatitis B virus at week 48.1
The most common side effects experienced by patients who participated in this study are:
- Stomach pain
- Nausea
- Sleeplessness
- Itching
- Vomiting
- Dizziness
- Fever
Four of 45 patients (9%) experienced a decline in kidney function. Three of these patients developed kidney failure.
New or worse kidney problems can happen in some people who take VIREAD. If you have had kidney problems in the past or need to take another medicine that can cause kidney problems, your healthcare provider may need to do blood tests to check your kidneys during your treatment with VIREAD.1
IMPORTANT RISK INFORMATION
VIREAD can cause serious side effects, including:
- Build-up of an acid in your blood (lactic acidosis): Lactic acidosis can happen in some people who take VIREAD or similar (nucleoside analog) medicines. Lactic acidosis is a serious medical emergency that can lead to death. Lactic acidosis can be hard to identify early, because the symptoms could seem like symptoms of other health problems. Call your healthcare provider right away if you get the following symptoms which could be signs of lactic acidosis: feeling very weak or tired, have unusual muscle pain, have trouble breathing, have stomach pain with nausea/vomiting, feel cold, especially in your arms and legs, feel dizzy or lightheaded, have a fast or irregular heartbeat.
- Severe liver problems: Severe liver problems can happen in people who take VIREAD or similar medicines. In some cases these liver problems can lead to death. Your liver may become large (hepatomegaly) and you may develop fat in your liver (steatosis) when you take VIREAD. Call your healthcare provider right away if you have any of the following symptoms of liver problems: Your skin or the white part of your eyes turn yellow (jaundice), dark “tea-colored” urine, light-colored bowel movements, loss of appetite for several days or longer, nausea, stomach pain.
- You may be more likely to get lactic acidosis or severe liver problems if you are female, very overweight (obese), or have been taking VIREAD or a similar medicine for a long time
- Worsening of your Hepatitis B infection: Your hepatitis B virus (HBV) infection may become worse (flare up) if you take VIREAD and then stop it. A “flare-up” is when your HBV infection suddenly returns in a worse way then before. Do not let your VIREAD run out. Do not stop taking VIREAD without first talking to your healthcare provider. If you stop taking VIREAD, your healthcare provider will need to check your health often and do regular blood tests to check your HBV infection. Tell your healthcare provider about any new or unusual symptoms you may have after you stop taking VIREAD.
For additional risk information for VIREAD, including boxed WARNINGS, please click here. Also, please see FDA-Approved Patient Labeling and Full Prescribing Information.
Reference:
- VIREAD (tenofovir disoproxil fumarate) Prescribing Information. Foster City, CA: Gilead Sciences, Inc.; October 2010.