Tenofovir Disoproxil Fumarate (tenofovir disoproxil fumarate (TDF))
Also sold as: Tenvir, Viread, Tenof
Pregnancy
Cat B
Lactation
Avoid
Schedule
H1
Forms
Tablet 300mg +1
Indications
- HIV-1 infection (as part of combination antiretroviral therapy — ART)
- Chronic hepatitis B virus (HBV) infection
- HIV pre-exposure prophylaxis (PrEP) in high-risk adults
- HIV post-exposure prophylaxis (PEP) component
Adult Dosing
HIV-1 infection (ART component)
300mg once daily
Indefinitely as part of ART regimen; must be used with at least one other active antiretroviral agent
Always take with food — high-fat meal increases bioavailability by ~40%. Standard backbone of most WHO-preferred first-line HIV regimens (TDF + 3TC + DTG or EFV).
Chronic Hepatitis B (HBV)
300mg once daily
Indefinitely; duration guided by HBeAg status, viral suppression, and HBsAg status
First-line treatment for HBV. Highly effective with high barrier to resistance. Continue for ≥12 months after HBsAg seroconversion (rare); most patients require long-term therapy.
HIV Pre-Exposure Prophylaxis (PrEP)
300mg once daily (as TDF + FTC fixed-dose combination)
Ongoing; requires negative HIV test before initiation and every 3 months
Must be combined with emtricitabine (FTC) as Truvada or equivalent fixed-dose combination for PrEP.
Pediatric Dosing
For children 2 to <12 years, weight-based dosing with oral powder (40mg/g) mixed with food. Not recommended in infants <2 years or <10kg. Bone density monitoring particularly important in pediatric patients — TDF may impair bone mineral density in growing children. Consider tenofovir alafenamide (TAF) if available.
Renal Dose Adjustment
| CrCl / eGFR | Dose Adjustment |
|---|---|
| CrCl ≥50 mL/min | 300mg every 24 hours (standard dosing) |
| CrCl 30–49 mL/min | 300mg every 48 hours |
| CrCl 10–29 mL/min | 300mg every 72–96 hours |
| CrCl <10 mL/min (not on haemodialysis) | Not recommended — insufficient data; use only after specialist consultation |
| Haemodialysis (CrCl <10 mL/min) | 300mg every 7 days or after approximately 12 hours of haemodialysis; administer after session |
Pregnancy & Lactation
Pregnancy: Category B
TDF is extensively used in pregnancy for HIV treatment and HBV management. WHO recommends TDF as preferred backbone for HIV-positive pregnant women. No increased risk of adverse fetal outcomes identified in large cohort studies. TDF also used in the third trimester of HBV-infected mothers with high viral loads to prevent vertical transmission. Neonates born to HIV-positive mothers should receive appropriate antiretroviral prophylaxis.
Lactation: Avoid
Tenofovir is excreted in breast milk. WHO recommends that HIV-positive mothers in resource-limited settings consider benefits of breastfeeding vs HIV transmission risk — complex country-specific guidance applies. For HBV-only indication in HIV-negative women: avoid breastfeeding during therapy or pump and discard. Breastfed infants of mothers on TDF should be monitored for adverse effects.
Top Drug Interactions
| Interacting Drug | Effect | Severity |
|---|---|---|
| Atazanavir | TDF reduces atazanavir plasma levels by ~25%; must boost atazanavir with ritonavir (ATV/r 300/100mg) to maintain adequate exposure when co-administered with TDF | Major |
| Didanosine (ddI) | TDF significantly increases didanosine plasma levels (AUC +44–60%); increases risk of didanosine toxicity — lactic acidosis, pancreatitis, peripheral neuropathy; combination generally avoided | Major |
| NSAIDs (diclofenac, ibuprofen, naproxen) | Additive nephrotoxicity; NSAIDs reduce renal perfusion and glomerular filtration — increase risk of TDF-induced Fanconi syndrome and tubular dysfunction; avoid regular NSAID use | Moderate |
| Aminoglycosides (gentamicin, amikacin) | Additive nephrotoxicity; both independently cause proximal tubular injury; co-administration increases renal toxicity risk | Moderate |
| Lopinavir/ritonavir (LPV/r) | LPV/r increases tenofovir levels by ~32%; monitor renal function and watch for tenofovir toxicity (tubular dysfunction) | Moderate |
| Ledipasvir-sofosbuvir (for HCV co-infection) | Ledipasvir markedly increases tenofovir levels (TFV plasma AUC +98%); do not co-administer without ritonavir/cobicistat-boosted ART regimen — risk of TDF nephrotoxicity and reduced bone density | Major |
| Acyclovir / Valacyclovir / Ganciclovir | Compete for renal tubular secretion — may increase TDF levels in renal impairment; monitor renal function | Minor |
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Side Effects
Common
- Nausea
- Diarrhoea
- Headache
- Dizziness
- Fatigue
- Flatulence
- Rash
- Mild decrease in bone mineral density (common with long-term use)
Serious / Discontinue If
- Nephrotoxicity — proximal renal tubulopathy, Fanconi syndrome (glucosuria without hyperglycaemia, phosphaturia, proteinuria, aminoaciduria, renal tubular acidosis)
- Acute renal failure
- Decreased bone mineral density — risk of osteoporosis and fragility fractures with long-term use
- Lactic acidosis — rare but life-threatening mitochondrial toxicity; more common with other NRTIs
- Severe acute exacerbation of hepatitis B upon discontinuation in HBV co-infected patients
- Immune reconstitution inflammatory syndrome (IRIS) — in HIV patients initiating ART
- Lipodystrophy with long-term ART (class effect)
Contraindications
- Hypersensitivity to tenofovir disoproxil or any component
- Significant renal impairment (CrCl <10mL/min) without haemodialysis — relative contraindication
- Co-administration with didanosine (generally — significantly increases ddI toxicity)
- HBV mono-infection in setting of decompensated cirrhosis — specialist guidance required
Available Indian Brands
| Brand | Manufacturer | Price (approx) |
|---|---|---|
| Tenvir 300mg | Cipla | ₹525 for 30 tablets |
| Viread 300mg | Gilead Sciences | ₹1,850 for 30 tablets |
| Tenof 300mg | Mylan (Viatris India) | ₹495 for 30 tablets |
Monitoring Required
- Renal function — serum creatinine and estimated GFR at baseline, then every 3 months; more frequently in high-risk patients (elderly, hypertensives, diabetics, concurrent nephrotoxins)
- Urine markers of tubular dysfunction quarterly: urinary glucose (without hyperglycaemia), urine protein (dipstick), phosphate (fractional excretion) — early Fanconi syndrome markers
- Serum phosphate — hypophosphataemia is an early sign of tubular toxicity
- Bone mineral density (DEXA scan) — at baseline and every 1–2 years, especially in patients with osteoporosis risk factors or children
- Vitamin D and calcium levels — supplement if deficient (particularly important given bone density effects)
- HIV viral load — every 3–6 months to confirm virological suppression
- CD4 count — every 6–12 months
- HBV DNA and LFTs — every 3–6 months in HBV-treated patients
- WARN: Monitor for severe HBV flare if TDF is stopped in HBV co-infected patients — LFTs can spike dramatically
- Lactate levels if symptoms of lactic acidosis (unexplained nausea, abdominal pain, dyspnoea, muscle weakness)
Patient Counseling Points
- Take tenofovir with food (a meal) — this significantly improves absorption and reduces stomach upset
- Take at the same time each day — consistency is critical for HIV treatment to maintain viral suppression
- NEVER stop tenofovir without consulting your doctor — abrupt discontinuation in hepatitis B patients can cause dangerous flare of liver disease
- Drink adequate water throughout the day — this helps protect kidneys
- Avoid regular use of painkillers like ibuprofen or diclofenac — these can damage kidneys when combined with tenofovir; use paracetamol instead
- You will need regular blood and urine tests to monitor kidney function and bone health — do not miss these
- Report any of these symptoms immediately: significant decrease in urination, bone pain, muscle weakness, swollen ankles (may indicate kidney problems)
- HIV: tenofovir does not cure HIV — it suppresses the virus to prevent disease progression; continue ART for life
- HBV: treatment for hepatitis B is usually lifelong; stopping without medical guidance can lead to severe hepatitis flare
- For HIV: continue using condoms and other HIV prevention measures — ART reduces but does not eliminate transmission risk
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Clinically reviewed by: Dr. Priya Ramachandran, MD (Medicine), DNB (Infectious Diseases), AIIMS New Delhi
Last reviewed: 2026-04-01
References
- WHO Consolidated Guidelines on HIV Prevention, Testing, Treatment, Service Delivery and Monitoring (2021)
- Gilead Sciences Viread (tenofovir disoproxil fumarate) US Prescribing Information
- EASL Clinical Practice Guidelines on the Management of Hepatitis B Virus Infection (2017)
- NACO (National AIDS Control Organisation) Antiretroviral Therapy Guidelines India (2023)
- UpToDate: Tenofovir disoproxil fumarate — an overview (2025)
- Micromedex Solutions — Tenofovir disoproxil monograph