TDF tenofovir disoproxil fumarate
Standard DoseOne 300 mg tablet once daily, without regard to food.
For adults and children at least 2 years old weighing at least 21 pounds (10 kg). Viread tablets are also available in the following dosages: 150 mg, 200 mg, and 250 mg tablets, and oral powder (40 mg/g in 60 g packets). Viread tablets can be disintegrated in water, grape juice, or orange juice with minor stirring and pressure from a spoon. In children, Viread is dosed based on body weight. See package insert for specific weight-based dosing. Must be taken in combination with another antiretroviral(s).
Take missed dose as soon as possible, unless it is closer to the time of your next dose. Do not double up on your next dose. Dosing frequency needs to be adjusted for adults and children with decreased kidney function (for creatinine clearance, or CrCl, less than 50 mL/min). See package insert for guidance on dosing in the setting of kidney impairment. FDA approved for chronic hepatitis B virus (HBV) in patients 12 years and older weighing at least 77 pounds (35 kg).
- Generic available.
- See package insert for more complete information on potential side effects and interactions.
ManufacturerGilead Sciences, Inc.
(800) GILEAD-5 (445-3235)
AWP300 mg tablets: $1,504.20/month
generic 300 mg tablets: $1,215.94/month
Potential Side Effects and Toxicity
Generally well tolerated, but some people may experience nausea, diarrhea, vomiting, and gas. Decreases in bone mineral density (BMD) have been observed. BMD monitoring should be considered for people who have a history of bone fracture due to bone disease or are at risk for osteopenia or osteoporosis. Viread may cause kidney toxicities. Creatinine clearance (CrCl) should be assessed before initiating treatment.
In addition to CrCl, glucose and protein in the urine and serum phosphorus should be monitored more often in patients at risk for kidney problems. Tell your provider about any pain in extremities, persistent or worsening bone pain and fractures, with or without muscular pain or weakness, as well as any concerning changes in urinary habits, as these could be signs of bone or kidney problems. Prior to initiation, people should be tested for hepatitis B virus (HBV) infection. Severe exacerbations of hepatitis B have been reported in people co-infected with hepatitis B who have discontinued Viread (because TDF also treats HBV). Monitor liver enzymes closely in people co-infected with hepatitis B and, if appropriate, initiation of anti-hepatitis B therapy may be warranted upon Viread discontinuation. Call your health care provider right away if you develop any of the following signs or symptoms of hepatitis: yellowing of the skin or whites of the eyes; dark or tea-colored urine; pale-colored bowel movements; nausea or vomiting; loss of appetite; or pain, aching, or tenderness on the right side below the ribs. The Viread formulation contains lactose, which can cause some abdominal discomfort, especially in patients sensitive to lactose. See weight discussion in “More information;” go to positivelyaware.com/articles/weighty-concerns and positivelyaware.com/articles/fatty-tissues.
Potential Drug Interactions
Do not take with Cimduo or Temixys, Descovy, Hepsera, Truvada, or Vemlidy, all used for the treatment of hepatitis B. Viread decreases levels of Reyataz; therefore, Reyataz 300 mg must be boosted with Norvir 100 mg or Tybost 150 mg (taken together with food) when used in combination with TDF. Kaletra, Prezista/Norvir, and Reyataz/Norvir increase Viread levels, but there is no dose adjustment needed. Patients taking Kaletra, Prezista/Norvir, or Reyataz/Norvir with TDF should be monitored for Viread side effects (including kidney disorders) due to the higher TDF levels. Do not take Viread with adefovir. Avoid taking Viread with drugs that negatively affect the kidneys, including chronic use or high doses of NSAIDS (non-steroidal anti-inflammatory drugs) for pain, such as Advil or Motrin (ibuprofen) and Aleve (naproxen). Viread may be used with hepatitis C drugs such as Harvoni or Zepatier, depending on the other components in the HIV regimen. Monitor for tenofovir toxicities if used with Epclusa. Tell your provider or pharmacist about all medications, herbals, and supplements you are taking or thinking of taking, prescribed or not.
TDF with emtricitabine (as Truvada) and TDF with lamivudine (as Cimduo or Temixys) are recommended NRTI combinations by DHHS HIV treatment guidelines for first-time therapy. Tenofovir alafenamide (TAF) has replaced TDF in certain fixed-dose combinations. Biktarvy, Genvoya, Odefsey, and Symtuza are four single-tablet regimens containing TAF instead of TDF. Descovy is similar to Truvada, but it combines emtricitabine with TAF instead of TDF. In clinical trials, TAF had fewer kidney and bone issues than TDF. The NIH reported infants exposed in the womb to TDF may have lower bone mineral content than those exposed to other antivirals. Weight gain is being more commonly recognized as a potential side effect of TAF. In the community, enlargement of the stomach and waist area can be distressing. According to the DHHS HIV treatment guidelines, “Weight gain has been associated with initiation of ART [antiretroviral therapy] and subsequent viral suppression.
The increase appears to be greater with INSTIs than with other drug classes. Greater weight increase has also been reported with TAF than with TDF, and greater with DOR than EFV.” Other factors have been associated with weight gain in addition to medication used, including race, sex, and previous overweight status. There is no word yet on reversibility, but the race is on to find more answers. Tenofovir DF was approved in 2012 as part of Truvada for HIV prevention as PrEP (pre-exposure prophylaxis; see Truvada for PrEP page). TDF is part of the single-tablet regimens Atripla, Symfi, Symfi Lo, Complera, Delstrigo, and Stribild. Truvada, Cimduo, and Temixys are recommended by DHHS as part of the preferred NRTI combination components of an ART regimen during pregnancy.
Dr. Melanie Thompson:
Tenofovir disoproxil fumarate (TDF) revolutionized the nuke “backbones” when introduced in 2001. It was potent, more tolerable in the short term than the old standards AZT, ddI, ddC, and d4T, very durable, and a once daily drug. Its primary companion has been FTC, but now that TDF is off-patent, it is also coformulated with 3TC in drugs such as Cimduo/Temixys, as well as in Delstrigo (along with doravirine.)
TDF can affect kidney function, so laboratory monitoring is necessary. It also causes a slow but predictable decrease in bone density over the course of months, but rarely to a dangerous degree in persons who begin with normal bone density. These side effects appear to be more frequent in the presence of boosters such as ritonavir or cobicistat.
TDF has the interesting side effect of lowering cholesterol levels.
TDF is also potent against hepatitis B and if the drug is stopped, a hepatitis flair can occur.
Activist Bridgette Picou:
Tenofovir disoproxil fumarate (TDF), or Viread, is a component of many STRs, and is in Truvada. Monitor your kidneys and bone health while taking Viread, as it is known to affect them over time. Symptoms will often disappear after the medication is stopped.