Before starting treatment, the FDA strongly recommends hepatitis B testing. If Viread is discontinued, people with hepatitis B should be closely monitored and, if needed, provided anti-hepatitis B drugs to reduce the risk of a severe flare-up.
Viread belongs to a class of drugs known as nucleoside reverse transcriptase inhibitors (NRTIs). It works by blocking the action of an enzyme that HIV-1 and the hepatitis B virus (HBV) both use to make copies of themselves. By doing so, it reduces the viral population to undetectable levels.
Viread is available as a tablet or powder and can be used in adults and children as young as 2 years old. Viread is also available as a generic under the drug name tenofovir disoproxil fumarate.
Tenofovir disoproxil fumarate (TDF) is a component of several combination HIV drugs, including Truvada (emtricitabine/TDF) and Atripla (efavirenz/emtricitabine/TDF).
What Is Viread Used for?
The Food and Drug Administration (FDA) approved Viread for the treatment of:
Brand Name(s): Viread
Administration Route(s): Oral
Drug Availability: Prescription
Therapeutic Classification: Antiretroviral agent
Available Generically: Yes
Controlled Substance: N/A
Active Ingredient: Tenofovir disoproxil fumarate.
Dosage Form(s): Tablet, powder
HIV-1: Used in combination with at least two other antiretroviral drugs in adults and children aged 2 years and over who weigh at least 22 pounds (10 kilograms) Chronic hepatitis B infection: Used on its own in adults and children aged 2 years and over who weigh at least 22 pounds (10 kilograms)
Viread does not cure HIV-1 or hepatitis B. It works by suppressing the virus to where it is below the level of detection in blood tests, thereby slowing the progression of the disease.
People coinfected with HIV-1 and HBV can also use Viread but only as part of a combination antiretroviral treatment plan.
How to Take Viread
Viread is available as an oral tablet in four different strengths: 150 milligrams (mg), 200 milligrams, 250 milligrams, and 300 milligrams. The tablet is taken by mouth with or without food.
If you’re unable to swallow tablets, there is a powder form of Viread available for mixing into soft foods. Scoop the powder from the bottle using the dosing scoop included in the package. Only mix the powder with 2 to 4 ounces of soft foods, such as applesauce, baby food, or yogurt. Do not mix it with liquid. Ingest the mixture immediately to avoid a bitter taste.
Storage
You can store Viread tablets safely at room temperature (between 60 and 77 degrees F). Avoid storing the pills on a sunny windowsill and in a glove compartment where temperatures can be excessive.
Keep the tablets tightly sealed in their original light-resistant container. Discard any drugs that have expired.
Off-Label Uses
Although not formally approved by the FDA for such use, Viread can be used to prevent HIV-1 infection either before exposure or immediately following exposure to the virus. This is known as off-label use.
Pre-Exposure Prophylaxis (PrEP)
TDF is an ingredient in the drug Truvada. In addition to treating HIV-1, Truvada is widely used in a preventive strategy known as HIV pre-exposure prophylaxis (PrEP). For people who do not have HIV, taking Truvada once daily can reduce the risk of getting HIV-1 by as much as 99%.
Although the combination of Viread and another drug called Emtriva (emtricitabine) have the same ingredients as Truvada, neither are approved for PrEP. However, Viread and Emtriva are sometimes used as short-term substitutes if Truvada is not available. However, they must be taken together. Viread is not used on its own for PrEP.
Post-Exposure Prophylaxis (PEP)
Viread can also be used for another preventive strategy known as HIV post-exposure prophylaxis (PEP) PEP aims to prevent an infection after accidental exposure to HIV, either through condomless sex, sharing needles, or healthcare exposure (such as a needlestick injury).
PEP must be started within 72 hours of exposure—ideally less—and taken for 28 consecutive days. According to the U.S. Public Health Service, Viread used in combination with the HIV drug Isentress (raltegravir) is the preferred option for PEP in healthcare exposure.
What Are the Side Effects of Viread?
As with all drugs, Viread can cause side effects. Most are relatively mild and temporary, usually resolving within several days or weeks. However, Viread has been known to trigger potentially severe complications affecting the liver or kidneys in some people.
This is not a complete list of side effects and others may occur. A healthcare provider can advise you on side effects. If you experience other effects, contact your pharmacist or a healthcare provider. You may report side effects to the FDA at fda.gov/medwatch or 1-800-FDA-1088.
Common Side Effects
Viread is generally well tolerated and may not cause any side effects. If side effects do occur, they most commonly involve (by the general order of frequency):
HeadacheRash (usually mild)Body achesDiarrheaDepressionBack painNauseaFever (usually mild)Stomach upsetWeaknessAnxietyVomitingJoint pain
Side effects tend to be mild to moderate and resolve without treatment. Call your healthcare provider if side effects persist, worsen, or seem unusual.
Severe Side Effects
Viread can cause severe side effects in some people. People with advanced liver or kidney disease are at the greatest risk.
Hepatitis B
Viread carries a Black Box warning advising consumers about the risk of a severe flare-up of hepatitis B symptoms in people who discontinue treatment. Stopping treatment with Viread can cause the hepatitis B virus to rebound. In people with advanced liver disease (including cirrhosis), this could potentially lead to liver failure.
Before starting treatment, the FDA strongly recommends hepatitis B testing in the event an infection is undiagnosed. People with hepatitis B who are stopping treatment with Viread should be closely monitored and, if needed, provided antihepatitis B drugs to reduce the risk of a severe flare-up.
Kidney Disease
Viread may also pose risks to people with kidney disease, in some cases leading to the onset of acute kidney failure. Although older people (aged 65 years and older) with chronic kidney disease or diabetes are at the greatest risk, people with no history of kidney disease have been known to experience this uncommon side effect. Most cases are reversible once the treatment is stopped.
Before starting treatment, your provider will test your kidney function—most specifically the creatinine clearance (CrCl)—and continue monitoring your blood and urine to see if there is any decline. People with a CrCl below 50 milliliters per minute (mL/min) may require a dose adjustment.
Call your healthcare provider right away if you have serious side effects after using Viread. Call 911 if your symptoms feel life-threatening or if you think you’re having a medical emergency.
These include symptoms of acute kidney failure, such as:
Decreased urine output Swelling of the legs, ankles, or feet Shortness of breath Irregular heartbeats Fatigue Nausea and vomiting Chest pains Confusion Seizures
Long-Term Side Effects
TDF-associated kidney failure is concerning, but it remains relatively uncommon in the United States due to the routine monitoring of kidney function and the management of drug interactions. Even so, studies suggest that ongoing exposure to TDF can lead to kidney problems. This only highlights the need for the routine testing of anyone taking TDF-containing medications, including Viread. Talk to your healthcare provider if you have any questions or concerns.
Dosage: How Much Viread Should I Take?
Modifications
In people with moderate to severe kidney disease, defined as creatinine clearance (CrCl) of 50 milliliters per minute or less, the Viread dose should be modified as follows:
If you experience a serious side effect, you or your provider may send a report to the FDA’s MedWatch Adverse Event Reporting Program or by phone (800-332-1088).
The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.
For oral dosage forms (oral powder or tablets): For treatment of HIV infection: Adults and children 2 years of age and older and weighs 35 kilograms (kg) or more—300 milligrams (mg) once a day. Children 2 years of age and older and weighing 28 to less than 35 kg—Dose is based on body weight and must be determined by your doctor. The dose is one 250 mg tablet once a day. Children 2 years of age and older and weighing 22 to less than 28 kg—Dose is based on body weight and must be determined by your doctor. The dose is one 200 mg tablet once a day. Children 2 years of age and older and weighing 17 to less than 22 kg—Dose is based on body weight and must be determined by your doctor. The dose is one 150 mg tablet once a day. Children younger than 2 years of age and weighing less than 10 kg—Use and dose must be determined by your doctor. For treatment of chronic hepatitis B infection: Adults and children 2 years of age and older weighing 35 kilograms (kg) or more—Dose is based on body weight and must be determined by your doctor. The dose is 300 milligrams (mg) (7. 5 scoops) once a day. Children 2 years of age and older and weighing 34 to less than 35 kg—Dose is based on body weight and must be determined by your doctor. The dose is 280 mg (7 scoops) once a day. Children 2 years of age and older and weighing 32 to less than 34 kg—Dose is based on body weight and must be determined by your doctor. The dose is 260 mg (6. 5 scoops) once a day. Children 2 years of age and older and weighing 29 to less than 32 kg—Dose is based on body weight and must be determined by your doctor. The dose is 240 mg (6 scoops) once a day. Children 2 years of age and older and weighing 27 to less than 29 kg—Dose is based on body weight and must be determined by your doctor. The dose is 220 mg (5. 5 scoops) once a day. Children 2 years of age and older and weighing 24 to less than 27 kg—Dose is based on body weight and must be determined by your doctor. The dose is 200 mg (5 scoops) once a day. Children 2 years of age and older and weighing 22 to less than 24 kg—Dose is based on body weight and must be determined by your doctor. The dose is 180 mg (4. 5 scoops) once a day. Children 2 years of age and older and weighing 19 to less than 22 kg—Dose is based on body weight and must be determined by your doctor. The dose is 160 mg (4 scoops) once a day. Children 2 years of age and older and weighing 17 to less than 19 kg—Dose is based on body weight and must be determined by your doctor. The dose is 140 mg (3. 5 scoops) once a day. Children 2 years of age and older and weighing 14 to less than 17 kg—Dose is based on body weight and must be determined by your doctor. The dose is 120 mg (3 scoops) once a day. Children 2 years of age and older and weighing 12 to less than 14 kg—Dose is based on body weight and must be determined by your doctor. The dose is 100 mg (2. 5 scoops) once a day. Children 2 years of age and older and weighing 10 to less than 12 kg—Dose is based on body weight and must be determined by your doctor. The dose is 80 mg (2 scoops) once a day. Children younger than 2 years of age and weighing less than 10 kg—Use and dose must be determined by your doctor.
CrCl 30 to 49 milliliters per minute: 300 milligrams every 48 hoursCrCl 10 to 29 milliliters per minute: 300 milligrams every 72 to 96 hours
People on hemodialysis may need to take 300 milligrams every seven days or 300 milligrams around 12 hours after completion of a dialysis session.
If you have kidney problems, discuss the appropriate course of action with your healthcare provider.
Missed Dose
If you miss a dose of Viread, take it as soon as you remember. If it is almost time for your next dose, skip the original dose and continue as normal. Never double up doses.
Overdose: What Happens If I Take Too Much Viread?
Because of its effect on the kidneys, a Viread overdose may cause severe kidney injury.
If a Viread overdose were to occur, seek emergency medical care. Treatment may involve hemodialysis. Supportive care can help treat nausea, vomiting, and other symptoms.
Precautions
What Are Reasons I Shouldn’t Take Viread?
You may need to explore other treatment options if you have had a severe allergic reaction to Viread (or any other TDF-containing drug). However, severe allergic reactions to TDF are rare.
If someone collapses, has a seizure, has trouble breathing, or can’t wake up after taking too much Viread, call 911 immediately.
Do not use this medicine if you or your child are also taking adefovir, Atripla®, Biktarvy®, Complera®, Descovy®, Genvoya®, Hepsera®, Odefsey®, Stribild®, Truvada®, or Vemlidy®. Tell your doctor right away if you or your child are using any of these medicines. Do not start using tenofovir until your doctor tells you to.
Two rare but serious reactions to this medicine are lactic acidosis (build-up of acid in the blood) and liver toxicity. These are more common if you are female, very overweight (obese), or have been taking antiviral medicines for a long time. Call your doctor right away if you or your child have stomach discomfort or cramping, nausea, vomiting, diarrhea, a decreased appetite, general feeling of discomfort, muscle cramping or pain, unusual tiredness or weakness, trouble breathing, or yellow skin or eyes.
Do not change your dose or stop using this medicine, even for a short time, without talking to your doctor.
This medicine may increase your risk of having broken bones (fractures). Ask your doctor if you or your child have any concerns about this.
This medicine may increase the risk for kidney problems, including kidney failure. To reduce this risk, be sure to follow up with all blood tests your doctor may order, and avoid other medications that may injure the kidneys, such as certain other antiviral medicines or NSAID pain medicines.
Your immune system may get stronger when you start using HIV medicines. Tell your doctor right away if you or your child notice any changes in your health. Sometimes the immune system will start to fight infections that were hidden in your body, such as pneumonia or tuberculosis. Autoimmune disorders (eg, Graves’ disease, polymyositis, and Guillain-Barré syndrome) may also occur.
This medicine does not decrease the risk of transmitting the HIV infection to others through sexual contact or by contaminated blood. Make sure you understand and practice safe sex, even if your partner also has HIV. Avoid sharing needles with anyone.
Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.
What Other Medications Interact With Viread?
There are certain drugs you may need to avoid while taking Viread. This includes nephrotoxic drugs (drugs that are toxic to the kidneys). When taken with Viread, these drugs can increase the risk of kidney injury.
Nephrotoxic drugs of concern include, among others:
Aminoglycoside antibiotics like Gentak (gentamicin), neomycin, streptomycin, and Tobrex (tobramycin) Antiviral drugs like Cytovene (ganciclovir), Valcyte (valganciclovir), Valtrex (valacyclovir), Vistide (cidofovir), and Zovirax (acyclovir) Nonsteroidal anti-inflammatory drugs (NSAIDs) like Aleve (naproxen) and Celebrex (celecoxib) when taken in high doses
Other drug interactions can alter the concentration of Viread or the accompanying drug in the bloodstream. Decreased concentrations can reduce how well the drug works, while increased concentrations can enhance the risk of drug toxicity.
Let your provider know if you take any of the following:
HIV protease inhibitor drugs like Norvir (ritonavir), Kaletra (lopinavir/ritonavir), Prezcoxib (darunavir and cobicistat), or Reyataz (atazanavir) Hepatitis C direct-acting antivirals (DAAs) like Harvoni (ledipasvir/sofosbuvir), Epclusa (sofosbuvir/velpatasvir), or Vosevi (sofosbuvir/velpatasvir/voxilaprevir)
To avoid interactions, always tell your provider about any drugs you take, including all prescription, over-the-counter, herbal, nutritional, or recreational substances.
What Medications Are Similar?
Viread belongs to a class of drugs called NRTIs. They were the first class of drugs used to treat HIV and continue to be among the most effective and durable antiretroviral agents.
In addition to Viread, there are four other NRTIs used in combination HIV therapy:
Epivir (lamivudine) Retrovir (zidovudine) Ziagen (abacavir) Emtriva (emtricitabine)
There are also two NRTIs used solely for the treatment of chronic hepatitis B infection:
Baraclude (entecavir) Hepsera (adefovir)
Only Viread and Epivir are approved to treat HIV and chronic hepatitis B infection.
The “New” Tenofovir
In 2015, the FDA approved the first in a line of drugs made with an “improved” version of TDF called tenofovir alafenamide (TAF). TAF is labeled for use in hepatitis B and used off-label for HIV. Unlike TDF, TAF is a pro-drug, meaning that it is an inactive agent converted by the body into an active drug. Because of this, TAF requires a far lower dose than TDF and is less likely to cause kidney-related side effects.
One of the first TAF-containing drugs approved by the FDA was Descovy (emtricitabine/TAF).15 Others include Biktarvy (bictegravir/emtricitabine/TAF), Genvoya (elvitegravir/cobicistat/emtricitabine/TAF), Odefsey (emtricitabine/rilpivirine/TAF), and Symtuza (darunavir/cobicistat/emtricitbine/TAF).
How Can I Stay Healthy While Taking Viread?
Living with HIV-1 or chronic hepatitis B can be challenging, but you can live a long and healthy life with the appropriate treatment and lifestyle choices.
Today, people living with HIV-1 can live normal to near-normal life expectancies if diagnosed and treated early. Similarly, the improved diagnosis and treatment of chronic hepatitis B have also afforded longer life spans and prevented severe liver complications.
But it takes more than just pills to manage either disease. Positive lifestyle changes, including routine exercise, changes in diet, and quitting cigarettes, are just as important as they help reduce the risk of cancer and heart disease that are common in people with HIV-1 and hepatitis B. In people with chronic hepatitis B, avoiding alcohol is essential to preserving your liver function and maintaining your long-term health and well-being.
If prescribed medications like Viread to treat HIV-1 or hepatitis B, you must take them every day as prescribed. If you don’t, you run the risk of developing drug resistance in which your medications will become less and less effective. Speak with your healthcare team if you have problems taking your medications as prescribed. In some cases, combination drugs can be prescribed to reduce your daily pill burden to one pill per day.
