Drug class
Nucleoside reverse transcriptase inhibitor; NRTI, “nuke”
Manufacturer
GlaxoSmithKline
AWP
$578.00 / month; generic: $359.00 / month
Dosage
Adult: One 100 mg tablet once daily, with or without food.
Pediatric (ages 2–17): 3 mg per kg of weight, for no more than 100 per day. Oral solution (liquid) for dosages less than 100 mg.
Dose adjustments needed for individuals with kidney disease. See below and consult a medical provider for more detail. Take your missed dose as soon as possible, unless it is closer to the time of your next dose. Never double your dose.
Generic available.
What are the potential side effects and adverse events?
Overall, Epivir-HBV is a very well-tolerated medication with minimal side effects. When side effects do occur, they include headache, nausea, fatigue, and diarrhea. Nasal symptoms and cough can occur, too. Insomnia, dizziness and muscular pain may also occur. There are two potential serious side effects when taking Epivir-HBV: (1) Lactic acidosis: The buildup of lactic acid in the blood that 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; (2) 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).
What are the 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, and inform them of any changes as they happen. Epivir-HBV has no significant drug interactions. Epivir-HBV should not be taken with full strength Epivir for HIV treatment. It should not be taken with the following HIV combination medications, as they already contain Epivir or other related medications: Atripla, Combivir, Complera, Descovy, Emtriva, Epzicom, Genvoya, Hepsera, Odefsey, Stribild, Triumeq, Trizivir, or Truvada.
More information
Don’t confuse Epivir-HBV with Epivir for the treatment of HIV: Epivir-HBV is 100mg while the Epivir for the treatment of HIV is 300mg. If you are co-infected with HBV/HIV, you should take the 300mg dose. If you are co-infected, you should not treat HBV without also treating HIV: Resistance can develop if that occurs. Another HIV medicine—Viread—also works against both HIV and HBV, and is another option for treatment. Taken together, they can help decrease the risk of HBV drug resistance. If your HIV becomes resistant to Epivir, it does not mean your HBV did (and vice versa). If you have HBV, and need to switch from any Epivir-containing regimens, there is a risk of an HBV flare-up with signs and symptoms of acute HBV infection. For individuals with HBV/HCV co-infection, or those at risk of HBV reactivation while undergoing HCV DAA treatment, Epivir-HBV is one of the medications you could be prescribed to prevent it from happening.
Dosage of Epivir-HBV in adult patients with renal impairment
|
Creatinine clearance (mL/min) |
Recommended dosage |
|---|---|
|
50 or greater |
100 mg once daily |
|
30–49 |
100 mg first dose, then 50 mg once daily |
|
15–29 |
100 mg first dose, then 25 mg once daily |
|
5–14 |
35 mg first dose, then 15 mg once daily |
|
less than 5 |
35 mg first dose, then 10 mg once daily |
Drug class
Nucleoside reverse transcriptase inhibitor; NRTI, “nuke”
Manufacturer
Gilead Sciences
AWP
$1,991.00 / month
Dosage
One 10 mg tablet once daily, with or without food.
What are the potential side effects and adverse events?
Hepsera is a well-tolerated medication, with the following side effects: asthenia (weakness), headaches, abdominal pain, nausea, excessive gas, diarrhea, and dyspepsia (indigestion). These tend to be mild and manageable. As Hepsera is processed by the kidneys, there is some risk of kidney toxicity. Before starting it, patients should have their creatinine clearance (CrCl) assessed. Routine monitoring of glucose and protein in the urine, and of serum phosphorus should be standard of care, too. There are two potential serious side effects when taking Hepsera: (1) Lactic acidosis: The buildup of lactic acid in the blood that 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; (2) 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).
What are the 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, and inform them of any changes as they happen. Do not take Hepsera with the HIV/HBV treatments Viread or Vemlidy, including any combination medications that include either of them: Atripla, Complera, Descovy, Odefsey, Stribild, Genvoya, or Truvada. Hepsera 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).
More information
Hepsera was the second medication approved for treating HBV. Hepsera will not cure you of HBV (no HBV medication will cure you), but it can decrease your risk of long-term complications like cirrhosis or liver cancer. Although Hepsera is not an HIV medication, it does have some activity against HIV and should not be taken by itself if you are HIV-positive. If your HBV is resistant to Epivir HBV (lamivudine), use Hepsera with Epivir HBV. If your HBV viral load does not fall below 1000 copies/ml with this combination, you and your medical provider should consider alternative treatments. Hepsera is not to be used in people with decompensated cirrhosis.
If you have kidney disease and/or are on hemodialysis, Hepsera can be taken safely, but with the following dose adjustments:
|
Creatinine clearance (mL/min) |
Recommended dosage and schedule |
|---|---|
|
50 or greater |
10 mg every 24 hours |
|
30-49 |
10 mg every 48 hours |
|
10-29 |
10 mg every 72 hours |
|
Hemodialysis patients |
10 mg every 7 days following dialysis |
Drug class
Nucleoside reverse transcriptase inhibitor; NRTI, “nuke”
Manufacturer
Bristol-Myers Squibb
AWP
$1,728 / month, generic $977 / month, prices for both 0.5 mg and 1 mg tablets
Dosage
Adult (age 16 and older): Treatment-naïve with no resistance, one 0.5 mg tablet once daily on an empty stomach (no food 2 hours before or 2 hours after taking pill); if lamivudine or telbivudine (brand name Tyzeka, discontinued for use since December 2016) resistant, 1 mg once daily on an empty stomach. Adult with decompensated liver disease: 1 mg once per day. Dose adjustments needed for individuals with kidney disease. See drug page and consult a medical provider for more detail.
Pediatric (age 2–15): Weight-based dosing required. See below for more detail and consult your medical provider. Take your missed dose as soon as possible, unless it is closer to the time of your next dose. Never double your dose.
What are the potential side effects and adverse events?
Baraclude is a very well-tolerated medication with minimal side effects. When side effects do occur, they include headache, fatigue, dizziness, and nausea. There are two potential serious side effects when taking Baraclude: (1) Lactic acidosis: The build-up of lactic acid in the blood that 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; (2) 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).
What are the 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, and inform them of any changes 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).
More information
Baraclude will not cure you of HBV (no HBV medication will cure you), but it can decrease your risk of long-term complications like cirrhosis or liver cancer. Baraclude is one of three preferred medications (including Viread and pegylated interferon) for the treatment of HBV in both mono- and HBV/HIV co-infected persons. Although Baraclude is not an HIV medication, it does have some activity against HIV. It should not be taken by itself if you are HIV-positive. If you are co-infected with HBV/HIV, you should not treat HBV without also treating 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 must be increased to 1 mg.
For patients with kidney disease, the following chart reviews the dosage requirements:
|
Creatinine clearance (mL/min) |
Prescribed Dose: 0.5 mg |
Dose for lamivudine-refractory or patients with decompensated |
|
50 or greater |
0.5 mg once per day |
1 mg once per day |
|
30 to 49 |
0.25 mg once per day or 0.5 mg every 48 hours |
0.5 once per day or 1 mg every 48 hours |
|
10 to 29 |
0.15 mg once per day or 0.5 mg every 72 hours |
0.3 mg once per day or 1 mg every 72 hours |
|
Less than 10 or on dialysis |
0.05 mg once per day or 0.5 mg every 7 days |
0.1 mg once per day or 1 mg every 7 days |
Drug class
Nucleoside reverse transcriptase inhibitor; NRTI, “nuke”
Manufacturer
Gilead Sciences
AWP
$1,281.00 / month
Dosage
One 25 mg tablet once per day, with food. Take your missed dose as soon as possible, unless it is closer to the time of your next dose. Never double your dose.
What are the potential side effects and adverse events?
Vemlidy is a very well-tolerated medication with minimal side effects. The most commonly reported side effects were headache, abdominal pain, fatigue, cough, nausea, and back pain. Not everyone experiences side effects, and among those who did, approximately 1% had to stop taking Vemlidy. As Vemlidy is processed by the kidneys, there is some risk of kidney toxicity. Before starting it, patients should have their creatinine clearance (CrCl) assessed. Routine monitoring of glucose and protein in the urine, and of serum phosphorus should be standard of care, too. If you experience any pain in the extremities, persistent or worsening bone achiness/pain, or fractures with or without muscular pain, consult your medical provider immediately. Vemlidy may lead to lactic acidosis: The buildup of lactic acid in the blood that 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).
What are the 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, and inform them of any changes as they happen. As Vemlidy is related to Viread (tenofovir DF), the two medications cannot be taken together. Similarly, it cannot be taken with any of the following HIV combination medications, as they contain Tenofovir DF: Atripla, Complera, Descovy, Odefsey, Stribild, Genvoya, or Truvada. If taken with the anticonvulsant carbamazepine, Vemlidy dosage should be increased to two tablets once per day. Vemlidy should not be taken with oxcarbazepine, phenobarbital, or phenytoin. Vemlidy should not be taken with the antimycobacterial medications rifabutin, rifampin, and rifapentine. Vemlidy should not be taken with St. John’s wort.
More information
Vemlidy was approved for HIV in 2015 and then for HBV in 2016. It’s related to Viread, using a smaller dose that is more efficiently delivered so the risks of kidney disease and loss of bone density appear to be less. If you are co-infected with HBV/HIV, you should not treat HBV without also treating HIV. If you have HBV/HIV, and need to switch from any tenofovir-containing regimens, there is a risk of an HBV flare-up with signs and symptoms of acute HBV infection. For individuals with HBV/HCV co-infection, or those at risk of HBV reactivation while undergoing HCV DAA treatment, Vemlidy is one of the medications you could be prescribed to prevent it from happening. Vemlidy should not be used in patients with severe kidney disease who have a creatinine clearance below 15 mL per minute. Vemlidy should not be used in patients with decompensated cirrhosis (Child-Pugh B or C).
Drug class
Nucleoside reverse transcriptase inhibitor; NRTI, “nuke”
Manufacturer
Gilead Sciences
AWP
$1, 571.00 / month
Dosage
One 300 mg tablet once per day, with or without food. Take your missed dose as soon as possible, unless it is closer to the time of your next dose. Never double your dose.
What are the potential side effects and adverse events?
Viread is a very well-tolerated medication with minimal side effects. The most commonly reported side effects are diarrhea, nausea, asthenia (muscle weakness), headache, depression, and abdominal pain. Other, more rarely reported side effects include rash, excessive gas, and generalized pain and achiness, including back pain. Nervous system side effects include depression, insomnia, peripheral neuropathy, and dizziness. Viread may lead to decreases in bone mineral density (BMD), and patients should be monitored for osteoporosis or osteopenia. As Viread is processed by the kidneys, there is some risk of kidney toxicity. Before starting it, patients should have their creatinine clearance (CrCl) assessed. Routine monitoring of glucose and protein in the urine, and of serum phosphorus should be standard of care, too. If you experience any pain in the extremities, persistent or worsening bone achiness/pain, or fractures with or without muscular pain, consult your medical provider immediately. There are two potential serious side effects when taking Viread: (1) Lactic acidosis: The buildup of lactic acid in the blood that 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; (2) 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).
What are the 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, and inform them of any changes as they happen. Do not take Viread with the HBV treatment Hepsera. Viread cannot be taken with any of the following HIV combination medications, as they contain Tenofovir DF: Atripla, Complera, Descovy, Odefey, Stribild, Genvoya, or Truvada. Viread reduces the levels of Reyataz, meaning that Reyataz 300mg must be boosted with Norvir 100 mg or Tybost 150 mg (taken together with food) when used together. Kaletra, Prezista/Norvir, and Reyataz/Norvir increase Viread levels, but do not require dose adjustments. This interaction may increase Viread-related side effects, and patients should be monitored for them (including kidney disorders). Viread 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). Viread is safe to take with HCV DAAs, but monitor for side effects if used with Epclusa.
More information
Viread (and its related drug Vemlidy) are also HIV medications. If you are co-infected with HBV/HIV, you should not treat HBV without also treating HIV. Another HIV medication—Epivir—also works against both HIV and HBV, and is another option for treatment. If you have HBV/HIV, and need to switch from any Viread-containing
regimens, there is a risk of an HBV flare-up with signs and symptoms of acute HBV infection. For individuals with HBV/HCV co-infection, or those at risk of HBV reactivation while undergoing HCV DAA treatment, Viread is one of the medications you could be prescribed to prevent it from happening.
Dosage
Pegasys
Adult: 180 mcg injected intramuscularly once per week, no food restrictions. Pediatric: Not recommended, but off-label use is possible. Consult with a medical provider for more information. Treatment length is 48 weeks.
Intron A
Adults and pediatrics (age 1 and older): 3 million IU/m2 three times a week (TIW) for the first week of therapy followed by dose escalation to 6 million IU/m2 TIW (maximum of 10 million IU TIW) injections. Treatment length is 16 weeks for adults and 16–24 weeks for pediatrics.
Take your missed dose as soon as possible on the same day or the next day and then continue on your regular dosing schedule; if multiple days are missed, check with your medical provider about what to do; never double dose or take doses too close together.
What are the potential side effects and adverse events?
Interferon has a large number of side effects associated with it: fatigue, headaches, nausea, chills, insomnia, anemia, pyrexia (fever), injection site reactions, loss of appetite, rash, myalgia (muscle pain), neutropenia, irritability, depression, alopecia (hair loss), dyspnea (shortness of breath), arthralgia (joint pain), pruritis (itching), flu-like feelings, dizziness, diarrhea, cough, weight loss, vomiting, unspecified pain, dry skin, anxiety, abdominal pain, leukopenia, and thrombocytopenia. In the case of the psychiatric/emotional side effects: interferon has been associated with depression, anxiety and, in rare cases, suicidal thoughts. If you have a history of any of these conditions, talk to your provider before starting HBV treatment (it does not mean you can’t take HBV treatment, you just want to watch for signs and be able to take preventative actions ahead of time). As an injectable, injection site reactions (redness, swelling, and/or itching) and inflammation are common. If you have autoimmune hepatitis, or are allergic to any of the ingredients in interferon, you should not take it.
What are the potential drug interactions?
There are few drug interactions with interferon: Be sure to tell your medical provider or pharmacist about all the medications and herbs you take, whether prescribed, over-the-counter, or illicit, before starting this drug. Caution is advised when taken with warfarin, phenytoin, or methadone. Methadone levels may increase due to interferon, so methadone levels and signs and symptoms of a stronger narcotic effect should be monitored.
More information
While interferon is no longer used in HCV treatment, there is still a potential role for it in HBV. That said, it is rarely used for HBV treatment. The World Health Organization does not include it in their HBV guidelines. It has some clinical advantages over the oral antivirals, as it’s a finite therapy and it doesn’t lead to HBV resistance, but it’s a hard medication to take. Other medications are easier to take with fewer side effects. The AASLD Guidelines for the Treatment of Hepatitis B does include pegylated interferon alfa (PEG-IFN-a), along with Baraclude (entecavir or ETV) and Viread (tenofovir disoproxil fumarate or TDF) as first-line agents in the treatment of HBV. If you need HBV treatment, talk to your medical provider about which option is best for you.