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Studies of VIREAD in Patients New to Treatment

VIREAD has been shown to work well in adults who:

  • Are infected with chronic hepatitis B
  • Are new to treatment
  • Have normal functioning livers

In two studies (Studies 102 and 103), VIREAD was shown to help lower the amount of the hepatitis B virus (HBV) in adults. It's important to know that these studies focused on people with chronic hepatitis B but whose liver was still able to perform its necessary functions (compensated liver disease). Additionally, most of the patients in the studies had never taken hepatitis B medication (treatment-naïve).1

Two studies were done based on whether patients had or did not have the hepatitis B e antigen (a viral protein). People with the e antigen may respond differently to medicine than those who don’t have the e antigen.1

Benefits

In Studies 102 and 103 a combined 641 total patients were evaluated. Out of the 641, 426 patients with chronic hepatitis B were treated with VIREAD and 215 were treated with another medicine for the first year. Thereafter, all patients received VIREAD.

389 total patients completed 3 years of taking VIREAD. 235 of them were e antigen negative patients and 154 were e antigen positive patients. Results showed that approximately 9 out of 10 (88%) e antigen negative patients, and 3 out of 4 (75%) e antigen positive patients, maintained low levels of hepatitis B after taking VIREAD for 3 years.

Approximately 9 out of 10 patients (88%) who took VIREAD had low levels of HBV at 3 years (Study 102, e antigen negative). Approximately 3 out of 4 patients (75%) who took VIREAD had low levels of HBV at 3 years (Study 103, e antigen positive).

Resistance can stop medicine from working well

Even if you are being treated for CHB, 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 144 weeks1

Zero Percent Resistance At One Year

While no resistance to VIREAD was seen at 144 weeks in patients new to treatment (Studies 102 and 103), we do not know how long VIREAD may help your hepatitis. Sometimes viruses change in your body and medicines no longer work. This is called drug resistance.

Stay under a doctor's care when taking VIREAD. Do not change your treatment or stop treatment without first talking with your doctor.

Side Effects1

In these studies, 9% of patients treated with VIREAD experienced nausea versus 2% treated with another medicine. Other side effects reported in >5% of patients treated with VIREAD included: stomach pain, diarrhea, headache, dizziness, fatigue, common cold symptoms such as sore throat and runny nose, back pain, and skin rash.

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.
  • 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.
    • 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.
  • 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.
  • Bone problems can happen in some people who take VIREAD. Bone problems include bone pain, softening or thinning (which may lead to fractures). Your healthcare provider may need to do additional tests to check your bones.

For additional risk information for VIREAD, including boxed WARNINGS, please click here. Also, please see FDA-Approved Patient Labeling and Full Prescribing Information.

References:

  1. VIREAD (tenofovir disoproxil fumarate) Prescribing Information. Foster City, CA: Gilead Sciences, Inc.; October 2010.
  2. Lok ASF, McMahon BJ. Chronic hepatitis B (AASLD practice guidelines). Hepatology. 2007;45(2):507-539.