Viread

Generic Name: Tenofovir Disoproxil Fumarate
Class: Nucleoside and Nucleotide Reverse Transcriptase Inhibitors
VA Class: AM800
Chemical Name: Bis(1 - methyl - ethyl)ester - (R) - 5 - [[2 - (6 - Amino - 9H - purin - 9 - yl) - 1 - methylethoxy]methyl] - 2,4,6,8 - tetraoxa - 5 - phosphanonanedioic acid 5-oxide (E)-2-butenedioate
Molecular Formula: C₉H₁₄N₅O₄P•H₂O
CAS Number: 202138-50-9

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  Lactic acidosis and severe hepatomegaly with steatosis (including some fatalities) reported rarely in patients receiving nucleoside reverse transcriptase inhibitors (NRTIs) alone or in conjunction with other antiretrovirals.^{1 7} (See Lactic Acidosis and Severe Hepatomegaly with Steatosis under Cautions.)

  
  


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  Severe acute exacerbations of hepatitis reported following discontinuance of tenofovir in patients with HBV infection.¹ Monitor hepatic function closely with both clinical and laboratory follow-up for at least several months after tenofovir is discontinued.¹ If appropriate, resumption of treatment for HBV infection may be warranted.¹

  
  

Introduction

Antiretroviral with antiviral activity against hepatitis B virus (HBV); nucleotide reverse transcriptase inhibitor.^{1 2 3 5}

Uses for Viread

Treatment of HIV Infection

Treatment of HIV-1 infection in conjunction with other antiretrovirals.^{1 6}

For purposes of therapeutic decisions, tenofovir is grouped with nucleoside reverse transcriptase inhibitor (NRTI) antiretrovirals.⁶

A preferred NRTI for use in multiple-drug antiretroviral regimens for initial therapy in adults.⁶

Fixed-combination preparation containing tenofovir and emtricitabine (Truvada) used in conjunction with other antiretrovirals.¹³ Can be used to decrease pill burden,⁶ but should not be used as a component of a triple NRTI regimen.¹³

Fixed-combination preparation containing efavirenz, emtricitabine, and tenofovir (Atripla) used alone or in conjunction with other antiretrovirals.²² Used to decrease pill burden and improve compliance.²²

Because of a high rate of virologic failure, triple NRTI regimens of tenofovir, abacavir, and lamivudine or tenofovir, didanosine, and lamivudine not recommended.^{6 9 12} Because of high rates of early virologic failure and rapid selection of resistant mutations, a regimen of tenofovir and didanosine not recommended for initial therapy.⁶

For patients coinfected with HBV, some experts recommend an NRTI combination of tenofovir and (emtricitabine or lamivudine); avoid use of regimens containing only 1 of these antiretrovirals (may increase risk of HBV resistance).⁶

Postexposure Prophylaxis of HIV

Postexposure prophylaxis of HIV infection† in health-care workers and others exposed occupationally via percutaneous injury or mucous membrane or nonintact skin contact with blood, tissues, or other body fluids associated with risk for transmission of the virus.²⁰ Used in conjunction with other antiretrovirals.²⁰

Postexposure prophylaxis of HIV infection† in individuals who have had nonoccupational exposure to blood, genital secretions, or other potentially infectious body fluids of a person known to be infected with HIV when that exposure represents a substantial risk for HIV transmission.¹⁷ Used in conjunction with other antiretrovirals.¹⁷

Chronic HBV Infection

Management of chronic HBV infection in adults with compensated liver function.¹

May be effective in both hepatitis B e antigen (HBeAg)-positive and HBeAg-negative patients.^{1 26}

Safety and efficacy not established in patients with decompensated liver disease.¹ Insufficient data in nucleoside-experienced patients and in those with lamivudine-associated mutations at study entry to establish efficacy in these patients.¹

Patients coinfected with both HBV and HIV who require treatment for HBV and who are not receiving antiretroviral therapy should receive an antiviral agent for HBV infection that does not have activity against HIV.^{6 28}

Viread Dosage and Administration

Administration

Oral Administration

Administer single-entity preparation (Viread) or fixed-combination preparation (Truvada) orally without regard to meals.^{1 6 13} Administer fixed-combination preparation (Atripla) orally once daily on an empty stomach, preferably at bedtime.²²

Because dosage of tenofovir and emtricitabine cannot be adjusted individually, the fixed combination containing tenofovir and emtricitabine (Truvada) should not be used in pediatric patients or patients with severe renal impairment (Cl_cr <30 mL/minute).¹³

Because dosage of efavirenz, emtricitabine, and tenofovir cannot be adjusted individually, the fixed-combination containing efavirenz, emtricitabine, and tenofovir (Atripla) should not be used in patients with moderate to severe renal impairment (Cl_cr <50 mL/minute).²²

Dosage

Available as tenofovir disodium fumarate; dosage expressed in terms of tenofovir disodium fumarate.¹

Dosage of Truvada and Atripla expressed as number of tablets.^{13 22}

For treatment of HIV infection, Viread and Truvada must be given in conjunction with other antiretrovirals.^{1 6 13} Atripla may be used alone or in conjunction with other antiretrovirals.²²

If used with atazanavir, adjustment in treatment regimen necessary.¹⁰ If used with didanosine, adjustment of didanosine dosage necessary.^{1 6} (See Specific Drugs under Interactions.)

Pediatric Patients

Treatment of HIV Infection†

Oral

Children 2–8 years of age: 8 mg/kg once daily under investigation.¹⁵

Children >8 years of age: Median dose 210 mg/m² (maximum 300 mg) once daily under investigation.¹⁵

Adults

Treatment of HIV Infection

Oral

300 mg once daily.^{1 6}

Truvada: 1 tablet once daily.^{13 6}

Atripla: 1 tablet once daily.²²

Postexposure Prophylaxis of HIV†

Occupational Exposure†

Oral

300 mg once daily.²⁰

Initiate postexposure prophylaxis as soon as possible following exposure (within hours rather than days) and continue for 4 weeks, if tolerated.²⁰

Nonoccupational Exposure†

Oral

300 mg once daily.¹⁷

Initiate postexposure prophylaxis as soon as possible following exposure (preferably ≤72 hours after exposure) and continue for 28 days.¹⁷

Chronic HBV Infection

Oral

300 mg once daily.¹

Optimal duration of treatment unknown.¹

Special Populations

Hepatic Impairment

Treatment of HIV Infection and Chronic HBV Infection

Oral

Dosage adjustment not needed.¹

Renal Impairment

Treatment of HIV Infection and Chronic HBV Infection

Adjust dosage if Cl_cr <50 mL/minute.¹ Dosage adjustment not necessary in patients with Cl_cr of 50–80 mL/minute.¹

Viread Dosage in Adults with Renal Impairment1

Clcr (mL/min)	Dosage
30–49	300 mg once every 48 hours
10–29	300 mg every 72–96 hours
Hemodialysis patients	300 mg once every 7 days or after a total of approximately 12 hours of hemodialysis (assuming 3 hemodialysis sessions/week each lasting approximately 4 hours)

Manufacturer states dosage recommendations not available for patients with Cl_cr <10 mL/minute who are not undergoing hemodialysis.¹

Truvada Dosage in Adults with Renal Impairment13

Clcr (mL/minute)	Dose and Dosing Interval
≥50	One tablet every 24 hours
30–49	One tablet every 48 hours (monitor clinical response and renal function since dosage has not been evaluated clinically)
<30 (including hemodialysis patients)	Not recommended

Atripla: Dosage adjustment not necessary in patients with Cl_cr ≥50 mL/minute.²² Not recommended in patients with Cl_cr< 50 mL/minute.²²

Geriatric Patients

Select dosage with caution because of age-related decreases in hepatic, renal, and/or cardiac function and concomitant disease and drug therapy.¹

Cautions for Viread

Contraindications

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  Manufacturer states none known.¹

  
  

Warnings/Precautions

Warnings

Lactic Acidosis and Severe Hepatomegaly with Steatosis

Possible lactic acidosis and severe hepatomegaly with steatosis (potentially fatal).^{1 6 7} Reported mostly in women; obesity and long-term therapy with NRTIs also may be risk factors.^{1 6} Has been reported in patients with no known risk factors.¹

Cautious use recommended in patients with known risk factors for liver disease.¹

Interrupt therapy if there are clinical or laboratory findings suggestive of lactic acidosis or pronounced hepatotoxicity (e.g., hepatomegaly and steatosis even in the absence of marked increases in serum aminotransferase concentrations).¹

Exacerbation of Hepatitis

Severe acute exacerbations of hepatitis reported following discontinuance of HBV therapy in patients with HBV infection.¹

Closely monitor hepatic function at repeated intervals with both clinical and laboratory follow-up for several months or longer after tenofovir is discontinued.¹ If appropriate, resumption of anti-HBV therapy may be warranted.¹

Patients Coinfected with HBV and HIV

Test all HIV-infected patients for presence of HBV before initiating tenofovir.¹

Test all HBV-infected patients for HIV before initiating tenofovir.¹

Use tenofovir with other highly active antiretroviral agents in individuals coinfected with HBV and HIV.¹

Renal Toxicity

Renal impairment, including acute renal failure and Fanconi syndrome (renal tubular injury with hypophosphatemia) reported.¹

Avoid use in patients who are or have recently received nephrotoxic drugs.¹

Obtain Cl_cr before starting tenofovir; monitor periodically thereafter.¹ Monitor Cl_cr and serum phosphorus in those at risk for renal dysfunction.¹

General Precautions

Do not use multiple tenofovir-containing preparations concomitantly.¹

Use of Fixed Combinations

When used in fixed combination with emtricitabine (Truvada), consider the cautions, precautions, and contraindications associated with emtricitabine.¹³

When used in fixed combination with emtricitabine and efavirenz (Atripla), consider the cautions, precautions, and contraindications associated with the concomitant agents.²²

Adipogenic Effects

Possible redistribution or accumulation of body fat, including central obesity, dorsocervical fat enlargement (“buffalo hump”), peripheral wasting, facial wasting, breast enlargement, and general cushingoid appearance.¹

Immune Reconstitution Syndrome

During initial treatment, patients who respond to antiretroviral therapy may develop an inflammatory response to indolent or residual opportunistic infections (e.g., Mycobacterium avium complex [MAC], M. tuberculosis, cytomegalovirus [CMV], Pneumocystis jiroveci [formerly P. carinii]); this may necessitate further evaluation and treatment.¹

Bone Effects

Decreases from baseline in bone mineral density (BMD) at lumbar spine and hip, increases in biochemical markers of bone metabolism, and increased serum parathyroid hormone reported in patients receiving tenofovir with lamivudine and efavirenz; clinical importance unclear.¹

Osteomalacia associated with proximal renal tubulopathy reported during postmarketing surveillance.¹

Consider supplementation with calcium or vitamin D; the effect of such supplementation has not been studied.¹

Consider monitoring BMD in those with a history of pathologic bone fracture and in those at substantial risk for osteopenia.¹ If bone abnormalities are suspected, obtain appropriate consultation.¹

Early Virologic Failure in HIV Infection

Triple NRTI regimens associated with early virologic failure and high rates of resistance.¹ Use with caution; consider modifying the regimen.¹

Specific Populations

Pregnancy

Category B.¹ Antiretroviral Pregnancy Registry at 800-258-4263.^{1 18}

Because of lack of data and concerns regarding potential fetal bone effects, experts recommend the drug be used in pregnant women only after careful consideration of other alternatives.¹⁸

Lactation

Distributed into milk in rats; not known whether distributed into human milk.¹

Instruct HIV-infected women not to breast-feed because of risk of HIV transmission and risk of adverse effects in the infant.¹

Pediatric Use

Safety and efficacy of single entity (Viread) or fixed-combination (Truvada, Atripla) not established in children^{1 15} <18 years of age.^{1 7 22}

Clinical studies underway to evaluate investigational tablets and oral solution of tenofovir in HIV-infected children ≥2 years of age†.¹⁵

Geriatric Use

Insufficient experience in those ≥65 years of age to determine whether they respond differently than younger adults; select dosage with caution.¹

Hepatic Impairment

Limited data indicate dosage adjustment not needed in patients with hepatic impairment.¹

Renal Impairment

Tenofovir principally eliminated by kidneys; pharmacokinetics likely to be affected.¹

Monitor Cl_cr and serum phosphorus in patients with mild renal impairment (Cl_cr 50–80 mL/minute).¹

Dosage adjustments necessary in those with Cl_cr <50 mL/minute.^{1 6} Closely monitor clinical response and renal function; safety and efficacy of reduced dosages not evaluated in clinical studies.¹ (See Renal Impairment under Dosage and Administration.)

Common Adverse Effects

HIV Infection: Nausea, diarrhea, rash, headache, pain, depression, asthenia.¹

HBV Infection: Nausea.¹

Interactions for Viread

Tenofovir and its prodrug are not substrates of CYP enzymes;¹ tenofovir does not inhibit CYP3A4, 2D6, 2C9, or 2E1, but may have a slight inhibitory effect on 1A.¹

Drugs Affecting or Metabolized by Hepatic Microsomal Enzymes

Pharmacokinetic interactions with drugs that are inhibitors or substrates of hepatic microsomal enzymes unlikely.¹

Nephrotoxic Drugs or Drugs Eliminated by Renal Excretion

Potential increased plasma concentrations of tenofovir or the concomitant drug when used with drugs that reduce renal function or compete for active tubular secretion (e.g., acyclovir, adefovir dipivoxil, cidofovir, ganciclovir, valacyclovir, valganciclovir).¹ Monitor for dose-related toxicities.⁶

Specific Drugs

Drug	Interaction	Comments
Abacavir	Pharmacokinetic interaction unlikely1 In vitro evidence of additive or synergistic antiretroviral effects1
Adefovir		Manufacturer of tenofovir states that tenofovir should not be used with adefovir for treatment of HBV infection1
Atazanavir	Atazanavir: Decreased plasma concentrations and AUC of atazanavir (minimum concentrations decreased 40%); increased plasma concentrations and AUC of tenofovir1 6 10 Ritonavir-boosted atazanavir: Decreased plasma concentrations and AUC of atazanavir (minimum concentrations decreased 23%); increased plasma concentrations and AUC of tenofovir; 1 6 In vitro evidence of additive antiretroviral effects21	Do not use tenofovir in conjunction with atazanavir without low-dose ritonavir1 6 Regimen of atazanavir 300 mg, ritonavir 100 mg, and tenofovir disoproxil fumarate 300 mg once daily with food recommended1 6 10 Monitor for tenofovir toxicity;1 discontinue tenofovir if adverse effects occur1 If used concomitantly with atazanavir and a histamine H2-receptor antagonist in treatment-experienced patients, a regimen of atazanavir 400 mg, tenofovir disoproxil fumarate 300 mg, and ritonavir 100 mg once daily with food is recommended21
Darunavir	Ritonavir-boosted darunavir: Increased plasma concentrations of tenofovir; no change in plasma concentrations of darunavir6 24	Experts state clinical importance unknown6 Manufacturer of darunavir states usual dosage of ritonavir-boosted darunavir and tenofovir can be used;24 monitor for tenofovir toxicity6
Didanosine	Increased plasma concentrations and AUC of didanosine; no effect on tenofovir pharmacokinetics1 6 Early virologic failure and rapid selection of resistant mutations reported6 Increased risk of didanosine-associated adverse effects (e.g., pancreatitis, neuropathy)1 In vitro evidence of additive or synergistic antiretroviral effects1	Concomitant use of didanosine and tenofovir: Not recommended for initial therapy6 Caution advised; reduce didanosine dosage; closely monitor for didanosine-associated adverse effects; discontinue didanosine if necessary1 In patients weighing ≥60 kg with Clcr ≥60 mL/minute, reduce didanosine dosage to 250 mg (delayed-release capsules) once daily; in patients weighing <60 kg with Clcr ≥60 mL/minute, reduce didanosine dosage to 200 mg (delayed-release capsules) once daily; administer without food or with a light meal1 6 14 19
Emtricitabine	No evidence of clinically important pharmacokinetic interactions1 13 In vitro evidence of additive or synergistic antiretroviral effects13
Entecavir	No evidence of clinically important pharmacokinetic interaction1
Estrogens/Progestins	Hormonal contraceptives containing ethinyl estradiol and norgestimate: Pharmacokinetic interaction unlikely1
Histamine H2-receptor antagonists	Alterations in atazanavir concentrations possible with concomitant use of a histamine H2-receptor antagonist, tenofovir, and atazanavir (with or without ritonavir)21	If used concomitantly with atazanavir and a histamine H2-receptor antagonist in treatment-experienced patients, a regimen of atazanavir 400 mg, tenofovir disoproxil fumarate 300 mg, and ritonavir 100 mg once daily with food is recommended;21
Indinavir	Slight alterations in indinavir and tenofovir concentrations;1 6 not clinically important1 In vitro evidence of additive or synergistic antiretroviral effects1	No dosage adjustment needed6
Lamivudine	Pharmacokinetic interaction not clinically important;1 in vitro evidence of additive or synergistic antiretroviral effects1
Lopinavir and ritonavir	Increased peak plasma concentration and AUC of tenofovir; decreased peak plasma concentration and AUC of lopinavir; decreased peak plasma concentration and AUC of ritonavir1 6	Clinical importance unknown6 Monitor for tenofovir toxicity6
Methadone	Pharmacokinetic interaction unlikely1
Nelfinavir	Pharmacokinetic interaction unlikely1 In vitro evidence of additive or synergistic antiretroviral effects1
Nonnucleoside reverse transcriptase inhibitors (NNRTIs)	No evidence of pharmacokinetic interaction with efavirenz1 In vitro evidence of additive or synergistic antiretroviral effects with delavirdine, efavirenz, or nevirapine1
Ribavirin	Pharmacokinetic interaction unlikely1
Ritonavir	In vitro evidence of additive or synergistic antiretroviral effects1
Saquinavir	Ritonavir-boosted saquinavir (saquinavir 1 g twice daily and ritonavir 100 mg twice daily): No clinically important change in saquinavir concentrations with tenofovir 300 mg once daily1 In vitro evidence of additive or synergistic antiretroviral effects1	Ritonavir-boosted saquinavir: Dosage adjustment not needed 1
Stavudine	In vitro evidence of additive or synergistic antiretroviral effects1
Tacrolimus	No evidence of clinically important pharmacokinetic interaction1
Tipranavir	Ritonavir-boosted tipranavir: Decreased tenofovir concentrations; decreased tipranavir concentrations6 16 In vitro evidence of additive antiretroviral effects16	Clinical importance unknown6
Zidovudine	In vitro evidence of additive or synergistic antiretroviral effects1

Viread Pharmacokinetics

Absorption

Bioavailability

Tenofovir disoproxil fumarate is a diester prodrug of tenofovir.¹ Oral bioavailability approximately 25%; peak plasma concentrations attained in about 1 hour in fasting patients.¹

Fixed-combination tablet containing emtricitabine 200 mg and tenofovir disoproxil fumarate 300 mg (Truvada) is bioequivalent to a 200-mg emtricitabine capsule and a 300-mg tenofovir disoproxil fumarate tablet given simultaneously.¹³

Fixed-combination tablet containing efavirenz 600 mg, tenofovir disoproxil fumarate 300 mg, and emtricitabine 200 mg (Atripla) is bioequivalent to a 600-mg efavirenz tablet, a 300-mg tenofovir disoproxil fumarate tablet, and a 200-mg emtricitabine capsule given simultaneously.²²

Food

Food delays time to peak plasma concentrations by approximately 1 hour.¹ Administration with a high-fat meal increases oral bioavailability (14% increase in peak plasma concentrations; 40% increase in AUC);¹ pharmacokinetics not appreciably affected by administration with a light meal.¹

Distribution

Extent

Crosses the human placenta.¹⁸ Not known whether tenofovir is distributed into human milk.¹

Plasma Protein Binding

In vitro binding to plasma or serum proteins is <0.7 or 7.2%, respectively, over tenofovir concentrations of 0.01–25 mcg/mL.¹

Elimination

Metabolism

Tenofovir disoproxil fumarate requires initial diester hydrolysis for conversion to tenofovir and subsequent phosphorylation by cellular enzymes to form the active tenofovir diphosphate.¹

Tenofovir and its prodrug are not substrates of CYP enzymes.¹

Elimination Route

Eliminated principally by kidneys using glomerular filtration and active tubular secretion; approximately 32% of an oral dose excreted in urine within 24 hours.¹

Half-life

Approximately 17 hours.¹

Special Populations

No substantial changes in tenofovir pharmacokinetics in individuals with moderate to severe hepatic impairment compared with those with normal hepatic function.¹

Moderate or severe renal impairment results in increased plasma concentrations; dosage adjustment necessary if Cl_cr <50 mL/minute.¹ (See Renal Impairment under Dosage and Administration.)

Stability

Storage

Oral

Tablets, Film-coated

Viread: 25°C (may be exposed to 15–30°C).¹

Truvada: 25°C (may be exposed to 15–30°C).¹³

Atripla: 25°C (may be exposed to 15–30°C).²²

Actions and SpectrumActions

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  Tenofovir disoproxil fumarate is a prodrug and is inactive until the drug is hydrolyzed in vivo to tenofovir which is then phosphorylated to the active metabolite (tenofovir diphosphate).^{1 2 3 5}

  
  


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  Active in vitro and in vivo against HIV-1^{1 5} and HBV;^{1 6 26} some activity against HIV-2.¹

  
  


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  Inhibits replication of retroviruses, including HIV-1, by interfering with viral RNA-directed DNA polymerase (reverse transcriptase).^{1 2 3 5}

  
  


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  Inhibits HBV replication through competitive inhibition of viral DNA polymerase.²⁹

  
  


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  Weak inhibitor of mammalian DNA α- and β-polymerases and mitochondrial DNA γ-polymerase.^{1 4 5} Low potential to induce mitochondrial toxicity.^{4 5}

  
  


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  HIV-1 resistant to tenofovir can be selected in vitro and have been reported in clinical isolates.^{1 5}

  
  


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  Cross-resistance between tenofovir and some NRTIs reported.¹ Cross-resistance with HIV protease inhibitors (PIs) or nonnucleoside reverse transcriptase inhibitors (NNRTIs) unlikely.⁷

  
  

Advice to Patients

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  Critical nature of HIV therapy compliance.¹ Importance of using tenofovir in conjunction with other antiretrovirals—not for monotherapy.¹

  
  


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  Antiretroviral therapy is not a cure for HIV infection, and opportunistic infections still may occur.¹ HIV transmission via sexual contact or sharing needles is not prevented by antiretrovirals.¹

  
  


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  Advise patient of the risks and benefits of tenofovir and other alternatives for treatment of HBV infection.¹

  
  


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  Importance of reading patient package insert from manufacturer.¹

  
  


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  Redistribution/accumulation of body fat may occur, with as yet unknown long-term health effects.¹

  
  


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  Importance of informing clinicians of concomitant medical problems such as renal or hepatic impairment.¹

  
  


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  Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs and dietary or herbal products.¹

  
  


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  Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.¹

  
  


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  Importance of advising patients of other important precautionary information.¹ (See Cautions.)

  
  

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Tenofovir Disoproxil Fumarate

Routes	Dosage Forms	Strengths	Brand Names	Manufacturer
Oral	Tablets, film-coated	300 mg	Viread	Gilead

Tenofovir Disoproxil Fumarate Combinations

Routes	Dosage Forms	Strengths	Brand Names	Manufacturer
Oral	Tablets, film-coated	300 mg with Emtricitabine 200 mg	Truvada	Gilead
		300 mg with Emtricitabine 200 mg and Efavirenz 600 mg	Atripta	Bristol-Myers Squibb and Gilead

Comparative Pricing

This pricing information is subject to change at the sole discretion of DS Pharmacy. This pricing information was updated 03/2011. Actual costs to patients will vary depending on the use of specific retail or mail-order locations and health insurance copays.

Atripla 600-200-300MG Tablets (BRISTOL-MYERS SQUIBB/GILEAD): 30/$1795.72 or 90/$5154.14

Truvada 200-300MG Tablets (GILEAD SCIENCES): 30/$1071.69 or 90/$3180.65

Viread 300MG Tablets (GILEAD SCIENCES): 30/$771.97 or 90/$2196.03

Disclaimer

This report on medications is for your information only, and is not considered individual patient advice. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use.

The American Society of Health-System Pharmacists, Inc. and Drugs.com represent that the information provided hereunder was formulated with a reasonable standard of care, and in conformity with professional standards in the field. The American Society of Health-System Pharmacists, Inc. and Drugs.com make no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information and specifically disclaims all such warranties. Users are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and the information is provided for informational purposes only. The entire monograph for a drug should be reviewed for a thorough understanding of the drug's actions, uses and side effects. The American Society of Health-System Pharmacists, Inc. and Drugs.com do not endorse or recommend the use of any drug. The information is not a substitute for medical care.

AHFS Drug Information. © Copyright, 1959-2011, Selected Revisions November 2009. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.

† Use is not currently included in the labeling approved by the US Food and Drug Administration.

References

1. Gilead Sciences Inc. Viread (tenofovir disoproxil fumarate) tablets prescribing information. Foster City, CA; 2008 Nov.

2. Squires KE. Phase I/II trial of the pharmacokinetics, safety, and antiretroviral activity of tenofovir disoproxil fumarate in human immunodeficiency virus-infected adults. Antimicrob Agents Chemother. 2001; 45:2733-9. [IDIS 469675] [PubMed 11557462]

3. Srinivas RV, Kim C et al. Anti-human immunodeficiency virus activity and cellular metabolism of a potential prodrug of the acyclic nucleoside phosphonate 9-R-(2-phosphonomethoxypropyl)adenine (PMPA), Bis(isopropyloxymethylcarbonyl)PMPA. Antimicrob Agents Chemother. 1998; 42:612-7. [PubMed 9517941]

4. Birkus G, Hitchcock MJM, Cihlar T. Assessment of mitochondrial toxicity in human cells treated with tenofovir: comparison with other nucleoside reverse transcriptase inhibitors. Antimicrob Agents Chemother. 2002; 46:716-23 [PubMed 11850253]

5. Gilead Sciences, Inc. FDA advisory committee briefing document on Viread (tenofovir DF) for the treatment of HIV-1 infection in adults in combination with other antiretroviral agents. NDA 21-356. Aug 30, 2001. From the FDA website.

6. Panel on Antiretroviral Guidelines for Adults and Adolescents. Guidelines for the use of antiretroviral agents in HIV-1-infected adults and adolescents (November 3, 2008). From the US Department of Health and Human Services HIV/AIDS Information Services (AIDSinfo) website.

7. Gilead, Foster City, CA: Personal communication

8. Squires K, Pierone G, Berger D et al. Tenofovir DF: a 48-week final analysis from a phase III randomized, double blind placebo controlled study in antiretroviral experienced patients. Poster presented at the 9^th Conference on Retroviruses and Opportunistic Infections. Seattle, WA: 2002 Feb 24-28. Poster No. 413-W

9. Manion DJ. Dear healthcare provider letter: early virologic non-response in patients with HIV infection treated with lamivudine, abacavir, and tenofovir. GlaxoSmithKline; 2003 Jul. From FDA website.

10. Hodder S. Dear healthcare provider letter: important new pharmacokinetic data for Reyataz (atazanavir sulfate) in combination with Viread (tenofovir disoproxil fumarate). Princeton, NJ: Bristol-Myers Squibb; 2003 Aug 8.

11. Gilead Sciences, Inc. Emtriva (emtricitabine) capsules prescribing information. Foster City, CA; 2005 Jul.

12. Toole J. Dear healthcare provider letter: high rate of virologic failure in patients with HIV infection treated with once-daily triple NRTI regimen containing didanosine, lamivudine, and tenofovir. Foster City, CA; 2003 Oct 14. From FDA website.

13. Gilead Sciences, Inc. Truvada (emtricitabine and tenofovir disoproxil fumarate) tablet prescribing information. Foster City, CA; 2008 May.

14. Bristol-Myers Squibb. Videx EC (didanosine) delayed-release capsules enteric-coated beadlets prescribing information. Princeton, NJ; 2006 Feb.

15. Working Group on Antiretroviral Therapy and Medical Management of HIV-infected Children of the National Resource Center at the François-Xavier Bagnoud Center, Health Resources and Services Administration (HRSA), and National Institutes of Health (NIH). Guidelines for the use of antiretroviral agents in pediatric HIV infection (February 23, 2009). From the US Department of Health and Human Services HIV/AIDS Information Services (AIDSinfo) website.

16. Boehringer Ingelheim. Aptivus (tipranavir) capsules prescribing information. Ridgefield, CT; 2005 Nov 11.

17. Center for Disease Control and Prevention. Antiretroviral postexposure prophylaxis after sexual, injection-drug use, or other nonoccupational exposure to HIV in the United States: Recommendations from the U.S. Department of Health and Human Services. MMWR Recomm Rep. 2005; 54(No. RR-2):1-19.

18. Perinatal HIV Guidelines Working Group. US Public Health Service Task Force recommendations for use of antiretroviral drugs in pregnant HIV-infected women for maternal health and interventions to reduce perinatal HIV-1 transmission in the United States (April 29, 2009). From the US Department of Health and Human Services HIV/AIDS Information Services (AIDSinfo) website.

19. Bristol-Myers Squibb. Videx (didanosine) chewable/dispersible buffered tablets and pediatric powder for oral solution prescribing information. Princeton, NJ; 2006 Feb.

20. Center for Disease Control and Prevention. Updated U.S. public health service guidelines for the management of occupational exposures to HIV and recommendations for postexposure prophylaxis. MMWR Recomm Rep. 2005; 54(No. RR-9):1-17.

21. Bristol-Myers Squibb. Reyataz(atazanavir sulfate) prescribing information. Princeton, NJ; 2008 Mar

22. Bristol-Myers Squibb and Gilead. Atripla (efavirenz 600 mg/emtricitabine 200mg /tenofovir disoproxil fumarate 300mg) tablets prescribing information. Foster City, CA; 2007 May.

23. Gallant JE, DeJesus E, Arribas JR et al. Tenofovir DF, emtricitabine, and efavirenz vs. zidovudine, lamivudine, and efavirenz for HIV. N Engl J Med. 2006; 354:251-60. [PubMed 16421366]

24. Tibotec. Prezista (darunavir) prescribing information. Raritan, NJ; 2006 Jun.

25. Hammer SM, Saag MS, Schechter M et al. Treatment of adult HIV infection: 2006 recommendations of the International AIDS Society–USA panel. JAMA. 2006; 296:827-43. [PubMed 16905788]

26. Marcellin P, Heathcote EJ, Buti M et al. Tenofovir disoproxil fumarate versus adefovir dipivoxil for chronic hepatitis. N Engl J Med.2008; 359:2442-55. [PubMed 19052126]

27. Lok AS, McMahon BJ. Chronic hepatitis B. Hepatology. 2007; 45:507-39. [PubMed 17256718]

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