Tenofovir Disoproxil Fumarate (Viread)

Tenofovir Disoproxil Fumarate is an antiviral drug that is used to treat patients with chronic Hepatitis B and HIV infections.

Indications of Tenofovir:

  • Chronic hepatitis B:

    • It is used for the treatment of chronic hepatitis B virus in patients ≥2 years of age weighing ≥10 kg.
  • Treatment of HIV-1 infection:

    • It is indicated for the treatment of HIV-1 infection in patients ≥2 years of age weighing ≥10 kg, in combination with other antiretroviral agents.
  • Off Label Use of Tenofovir disoproxil fumarate in Adults:

    • HIV-1 nonoccupational postexposure prophylaxis; HIV-1 occupational postexposure prophylaxis.

Tenofovir disoproxil fumarate dose in Adults

  • Hepatitis B infection:

    • 300 mg per oral once daily.
  • Treatment duration:

    • Tenofovir is influenced by HBeAg status, duration of HBV suppression, and presence of cirrhosis/decompensation.

Tenofovir Disoproxil Fumarate use in patients without cirrhosis:

  • Hepatitis B e antigen-positive immune-active chronic hepatitis:

    • The duration of therapy is generally a minimum of 12 months of persistently normal ALT and undetectable serum HBV DNA levels after HBeAg seroconversion
  • HBeAg-negative immune-active chronic hepatitis:

    • Duration of therapy is indefinite, discontinuation may be considered in patients with loss of HBsAg.

Tenofovir Disoproxil Fumarate in Patients with Cirrhosis:

  • HBeAg-positive immune-active chronic hepatitis:

    • Treatment should be continued indefinitely in seroconversion unless there is a strong reason for discontinuation.
  • HBeAg-negative immune-active chronic hepatitis:

    • Treatment discontinuation is not recommended due to the potential for decompensation and death.

Tenofovir Disoproxil Fumarate Dose in HIV-1 infection:

  • Treatment:

    • 300 mg per oral once-daily concurrently with other antiretrovirals.
  • HIV-1 nonoccupational postexposure prophylaxis (off-label use):

    • 300 mg per oral once daily for 28 days concurrently with other antiretroviral agents.
    • Therapy should be started within 72 hours of exposure.
  • HIV-1 occupational postexposure, prophylaxis (off-label use):

    • 300 mg per oral once daily in combination with emtricitabine and raltegravir.
    • Therapy should be started within 72 hours and continued for one month.

Tenofovir Disoproxil Fumarate Dose in Children:

Tenofovir Disoproxil Fumarate Dose in HIV-1 infection:

  • Treatment - Weight-directed dosing:

    • Children ≥2 years weighing ≥10 kg and Adolescents: 8 mg/kg per oral once daily
    • maximum daily dose: 300 mg/day
  • Dosage form specific fixed dosing:

    • Oral powder: Children ≥2 years weighing ≥10 kg and Adolescents:

Note: Only measure with the provided scoop. One level scoop = 40 mg tenofovir disoproxil fumarate

  • 10 to <12 kg:

    • 80 mg (2 scoops)per oral once daily
  • 12 to <14 kg:

    • 100 mg (2.5 scoops) per oral once daily
  • 14 to <17 kg:

    • 120 mg (3 scoops) per oral once daily
  • 17 to <19 kg:

    • 140 mg (3.5 scoops) per oral once daily
  • 19 to <22 kg:

    • 160 mg (4 scoops) per oral once daily
  • 22 to <24 kg:

    • 180 mg (4.5 scoops) per oral once daily
  • 24 to <27 kg:

    • 200 mg (5 scoops) per oral once daily
  • 27 to <29 kg:

    • 220 mg (5.5 scoops)per oral once daily
  • 29 to <32 kg:

    • 240 mg (6 scoops) per oral once daily
  • 32 to <34 kg:

    • 260 mg (6.5 scoops) per oral once daily
  • 34 to <35 kg:

    • 280 mg (7 scoops) per oral once daily
  • ≥35 kg:

    • 300 mg (7.5 scoops)per oral once daily
  • Oral tablets: Children ≥2 years weighing ≥17 kg and Adolescents:

    • 17 to <22 kg:

      • 150 mg once daily
    • 22 to <28 kg:

      • 200 mg once daily
    • 28 to <35 kg:

      • 250 mg once daily
    • ≥35 kg:

      • 300 mg once daily
  • HIV-1 nonoccupational postexposure prophylaxis:

    • Children ≥2 years:

      • Oral: Age- and weight-appropriate dosing (see HIV-1 infection, treatment above) for 28 days in combination with other antiretroviral agents.
      • Initiate therapy within 72 hours of exposure.
    • Adolescents:

      • The combination product is recommended (see Emtricitabine and Tenofovir Disoproxil Fumarate monograph)

Tenofovir Disoproxil Fumarate dose in the treatment of Chronic Hepatitis B infection:

  • Children ≥2 years weighing ≥10 kg and Adolescents:

    • 8 mg/kg per oral once daily
    • The maximum daily dose: 300 mg/day

Pregnancy Risk Category: B

  • Tenofovir can cross the human placenta, increasing the risk of stillbirth, preterm delivery, low birth weight and small for gestational infants.
  • If viral suppression is successful and the regimen is well tolerated, Tenofovir may be continued during pregnancy.
  • It should be administered postpartum, with dose modification in HIV.
  • It can be administered at 28-32 weeks gestation, and stopped between 1 and 3 months after delivery. Continuous monitoring of ALT is recommended.
  • Infants who have been exposed to antiretroviral medication should be followed up for a long time.
  • Children with heart or CNS abnormalities and children with mitochondrial dysfunction should also be evaluated.
  • Mothers who gave birth to tenofovir disoproxil fumarate during pregnancy could have lactic acidosis or hepatic steroids, and decreased bone mineral content.

Tenofovir disoproxil fumarate use during breastfeeding:

  • Tenofovir can be excreted in milk but is not recommended for acute HIV infection in breastfeeding women.
  • If the infection is confirmed, breastfeeding should be stopped.
  • Postnatal HIV transmission is still possible even with maternal antiretroviral treatment.
  • Besides, a multi-class-resistant virus has been detected in breastfeeding infants despite maternal therapy.

Tenofovir Disoproxil Fumarate Dose adjustment in renal disease:

  • Manufacturer's labeling:

    • Creatinine clearance ≥50 mL/minute:

      • No dosage adjustment necessary.
    • Creatinine clearance 30 to 49 mL/minute:

      • 300 mg every 48 hours
    • Creatinine clearance 10 to 29 mL/minute:

      • 300 mg every 72 to 96 hours
    • Creatinine clearance <10 mL/minute:

      • There are no dosage adjustments provided in the manufacturer's labeling.
    • Hemodialysis:

      • 300 mg following dialysis every 7 days or after a total of 12 hours of dialysis (usually once weekly assuming 3 dialysis sessions lasting about 4 hours each).
  • Alternate recommendations (IDSA):

    • Creatinine clearance <50 mL/minute (and not on hemodialysis) or GFR <60 mL/minute/1.73 m²:

      • Avoid use.
    • Peritoneal dialysis:

      • Use with caution; dose reduction recommended.

Tenofovir Disoproxil Fumarate Dose adjustment in liver disease:

No dosage adjustment is necessary.

Common Side Effects of Tenofovir Disoproxil Fumarate:

  • Central Nervous System:

    • Insomnia
    • Headache
    • Pain
    • Dizziness
    • Depression
  • Dermatologic:

    • Skin Rash
    • Pruritus
  • Endocrine & Metabolic:

    • Hypercholesterolemia
    • Increased Serum Triglycerides
  • Gastrointestinal:

    • Abdominal Pain
    • Nausea
    • Diarrhea
    • Vomiting
  • Neuromuscular & Skeletal:

    • Decreased Bone Mineral Density
    • Increased Creatine Phosphokinase
    • Weakness
  • Miscellaneous:

    • Fever

Rare Side Effects of Tenofovir Disoproxil Fumarate:

  • Cardiovascular:

    • Chest Pain
  • Central Nervous System:

    • Fatigue
    • Anxiety
    • Peripheral Neuropathy
  • Dermatologic:

    • Diaphoresis
  • Endocrine & Metabolic:

    • Weight Loss
    • Glycosuria
    • Hyperglycemia
    • Lipodystrophy
  • Gastrointestinal:

    • Increased Serum Amylase
    • Anorexia
    • Dyspepsia
    • Flatulence
  • Genitourinary:

    • Hematuria
  • Hematologic & Oncologic:

    • Neutropenia
  • Hepatic:

    • Increased Serum ALT
    • Increased Serum AST
    • Increased Serum Transaminases
    • Increased Serum Alkaline Phosphatase
  • Neuromuscular & Skeletal:

    • Back Pain
    • Arthralgia
    • Myalgia
  • Renal:

    • Increased Serum Creatinine
    • Renal Failure
  • Respiratory:

    • Sinusitis
    • Upper Respiratory Tract Infection
    • Nasopharyngitis
    • Pneumonia

Contraindication to Tenofovir Disoproxil Fumarate:

Hypersensitivity to tenofovir and any component of the formulation

Warnings and precautions

  • Reduced bone mineral density

    • Tenofovir has been associated with decreases in bone mineral density and increased serum parathyroid hormone and 1,25 vitamin D levels in adults and children were also higher.
    • Supplementation with Vitamin D and calcium should be provided. It is also important to monitor bone density in adults and children who have had a history of fractures.
  • Immune reconstitution syndrome:

    • Immune reconstitution syndrome can occur in patients who have an inflammatory response to residual HIV infection.
    • Patients may also develop autoimmune disorders like Graves' disease or polymyositis later in therapy.
  • Lactic acidosis/ hepatomegaly:

    • Life-threatening conditions include severe hepatomegaly and lactic acidosis.
  • Osteomalacia, renal dysfunction

    • Osteomalacia may be caused by proximal renal tubeopathy. This can manifest as bone pain, extreme pain, fractures and weakness.
  • Toxicity in the renal system:

    • May cause renal toxicity such as acute renal failure and/or Fanconi syndrome and the risk factor is increased with NSAIDs.
    • Guidelines from IDSA recommend replacing tenofovir by alternate therapy for HIV-infected persons with a >25% decrease of GFR from baseline.
    • This includes a level of 60mL/minute/1.73m2 during treatment, as well as euglycemic, increased urinary and phosphorus excretion, hypophosphatemia and proteinuria.
  • Chronic Hepatitis B: [US-Boxed Warning]

    • Hepatitis B exacerbation may occur after treatment has been stopped.
    • This can lead to hepatic dysfunction and hepatic failure in patients with advanced hepatic diseases or cirrhosis.
    • After stopping therapy, LFTs should continue to be monitored for longer periods.

Monitoring parameters:

  • CBC
  • LFTS
  • RFTS
  • Creatinine kinase
  • Urine glucose and protein
  • Serum phosphorus
  • CD4 count/HIV RNA levels
  • bone density
  • testing for HBV
  • HIV status

How to administer Tenofovir disoproxil fumarate (Viread)?

  • Tablets can be given without regard to food.
  • The powder should be mixed with 2 to 4 ounces of soft food (applesauce, baby food, yogurt) and swallowed immediately, do not mix in liquid (powder may float on top of the liquid even after stirring).
  • The powder should be measured using only the supplied dosing scoop.

Mechanism of action of Tenofovir disoproxil fumarate:

  • Tenofovir diproxil fumarate, also known as TDF, is a nucletide reverse transcriptase inhibitor.
  • It is analogous to adenosine 5’-monophosphate. It inhibits viral replication by interfering the HIV viral DNA dependent polymerase. 
  • Hydrolysis converts tenofovir disoproxil fumarate to tenofovir, and then phosphorylates it to the active form of tenofovir. Tenofovir inhibits HBV replication by inhibiting HBV polymerase.

Protein binding:

  • <7% to serum proteins


  • Tenofovir disoproxil fumarate (TDF) is converted intracellularly by hydrolysis (by non-CYP enzymes) to tenofovir, then phosphorylated to the active tenofovir diphosphate


  • Tablets: ~25% (fasting); increases ~40% with high-fat meal
  • Powder: Peak serum concentrations are 26% lower compared to the tablet, but the mean AUCs are similar

Half-life elimination:

  • Serum: 17 hours
  • intracellular: 10 to 50 hours

Time to peak serum concentration:

  • Fasting: 36 to 84 minutes
  • With high-fat meal: 96 to 144 minutes


  • Urine (70% to 80%) via filtration and active secretion, primarily as unchanged tenofovir within 72 hours; after multiple oral doses (administered with food): 32% ± 10% is excreted in the urine within 24 hours


  • Total body clearance is decreased in patients with renal impairment

Tenofovir disoproxil fumarate Brand Names (International):

  • APO-Tenofovir
  • Auro-Tenofovir
  • JAMP-Tenofovir
  • MYLAN-Tenofovir Disoproxil
  • NAT-Tenofovir
  • PMSTenofovir
  • TEVA-Tenofovir
  • Viread
  • Dipovir
  • Forvic
  • Foviral
  • Glonovir
  • Ricovir
  • Tefostad T300
  • Tenof
  • Tenofir
  • Tenofo-B
  • Tenolam
  • Tenozet
  • Tenvir
  • Tenvira
  • Tenvor
  • Viraday
  • Viread
  • Xynovir

Tenofovir disoproxil fumarate Brand Names in Pakistan:

Brands in Pakistan will be updated later.


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