Standard DoseAdults (age 16 and older): Treatment-naïve with no resistance, one 0.5 mg tablet once daily. If lamivudine (Epivir) or telbivudine (Tyzeka, discontinued since December 2016) resistant, one 1 mg tablet once daily. Adults with decompensated liver disease (Child-Pugh B or C): one 1 mg tablet once daily. Baraclude should always be taken on an empty stomach (no food 2 hours before, or 2 hours after taking pill).
Dose adjustments needed for individuals with kidney disease (see chart below). Baraclude is safe to use in children ages 2 years and older, weighing at least 22 pounds (10 kg) or more. Dosing for children is based on weight and should be done in consultation with an experienced medical provider. An oral solution (0.05 mg/mL) is also available for children or as reduced doses in people with kidney disease.
AWPBRAND: 0.5 mg and 1 mg tablets—$1,647 / month
GENERIC: 0.5 mg and 1 mg tablets—$1,332–1,800 / month
Potential Side Effects and Toxicity
Baraclude is a very well-tolerated medication with minimal side effects. When side effects do occur, they include headache, fatigue, dizziness, and nausea. Baraclude may lead to lactic acidosis, a buildup of lactic acid in the blood, which could be fatal. Signs and symptoms of lactic acidosis include feeling very weak or excessively fatigued, difficulty breathing, stomach pain with nausea and vomiting, feeling cold and chills (especially in arms and legs), dizziness and light-headedness, fast or irregular heartbeat, or unusual muscle pain. If you experience any of these symptoms contact your medical provider immediately. Two liver conditions—hepatomegaly (enlarged liver) or steatosis (fatty liver)—may occur. Signs and symptoms of these liver conditions include: yellowing of the eyes and/or skin (jaundice), dark colored urine, light colored stools, nausea, loss of appetite, and pain, achiness or tenderness of the liver (lower right side of the belly, below the ribcage and next to the belly button).
Potential Drug Interactions
Be sure to tell your medical provider or pharmacist about all the medications, supplements, and herbs you take, whether they are prescribed, over-the-counter, or illicit, before starting this regimen. Report any changes to your medications as they happen. Baraclude is safe to take with all HIV medications, with no drug interactions. Baraclude is eliminated by the kidneys, so it should be avoided with any medications that could negatively affect the kidneys, including chronic use or high doses of NSAIDS (non-steroidal anti-inflammatory drugs, such as Advil, Aleve, ibuprofen, naproxen, or Motrin).
Baraclude will not cure HBV—currently, no HBV medication will cure you—but it can decrease your risk of long-term complications such as cirrhosis or liver cancer. Baraclude is one of several preferred medications, including Vemlidy, Viread, and pegylated interferon, for the treatment of HBV in both mono- and HBV/HIV co-infected persons. If you are dually diagnosed with HBV/HIV, you should not treat HBV without also treating your HIV. You should be checked for resistance to Epivir (lamivudine) before starting Baraclude. Epivir resistance decreases the effectiveness of Baraclude at the 0.5 mg dose, and it must be increased to 1 mg daily. For individuals with HBV/HCV co-infection, or people at risk of HBV reactivation while undergoing HCV DAA treatment, Baraclude may be one of the medications you could be prescribed to prevent it from happening and is safe to use while being treated for HCV. See HBV Reactivation for more information and consult your medical provider. (Black Box Warning)
Abrupt discontinuation of Baraclude may cause a severe, acute exacerbation of hepatitis B, which can result in hepatic decompensation and liver failure. If Baraclude is discontinued, your doctor should closely monitor you for symptoms of exacerbation. Do not stop this medication without talking to your doctor first.