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Tenofovir alafenamide and emtricitabine: Pediatric drug information

Tenofovir alafenamide and emtricitabine: Pediatric drug information
2024© UpToDate, Inc. and its affiliates and/or licensors. All Rights Reserved.
ALERT: US Boxed Warning
HIV-1 and hepatitis B coinfection:

Severe acute exacerbations of hepatitis B (HBV) have been reported in HBV-infected individuals who have discontinued products containing emtricitabine and/or tenofovir disoproxil fumarate, and may occur with discontinuation of emtricitabine/tenofovir alafenamide. Hepatic function should be monitored closely with both clinical and laboratory follow-up for at least several months in individuals who are infected with HBV and discontinue emtricitabine/tenofovir alafenamide. If appropriate, anti-HBV therapy may be warranted.

Risk of drug resistance with use for preexposure prophylaxis:

Emtricitabine/tenofovir alafenamide used for HIV-1 preexposure prophylaxis (PrEP) must only be prescribed to individuals confirmed to be HIV-negative immediately prior to initiating and at least every 3 months during use. Drug-resistant HIV-1 variants have been identified with the use of emtricitabine/tenofovir disoproxil fumarate for HIV-1 PrEP following undetected acute HIV-1 infection. Do not initiate emtricitabine/tenofovir alafenamide for HIV-1 PrEP if signs or symptoms of acute HIV-1 infection are present unless negative infection status is confirmed.

Brand Names: US
  • Descovy
Brand Names: Canada
  • Descovy
Therapeutic Category
  • Antiretroviral, Reverse Transcriptase Inhibitor, Nucleoside (Anti-HIV);
  • Antiretroviral, Reverse Transcriptase Inhibitor, Nucleotide (Anti-HIV)
Dosing: Pediatric

Note: Multiple tablet strengths are available and contain different amounts of each component; use caution.

HIV-1 infection, treatment

HIV-1 infection, treatment: Note: In patients weighing <35 kg, efficacy has not been established for coadministration with an HIV protease inhibitor administered with either ritonavir or cobicistat. Gene mutation and antiretroviral resistance patterns should be evaluated (refer to https://www.iasusa.org for more information) when necessary.

Children weighing 14 to <25 kg: Oral: Emtricitabine 120 mg and tenofovir alafenamide 15 mg per tablet: One tablet once daily.

Children and Adolescents weighing ≥25 kg: Oral: Emtricitabine 200 mg and tenofovir alafenamide 25 mg per tablet: One tablet once daily.

HIV-1 infection, preexposure prophylaxis in uninfected high-risk individuals

HIV -1 infection, preexposure prophylaxis (PrEP) in uninfected high-risk individuals:

Note: Patients should be confirmed HIV-negative immediately prior to initiation of therapy and screened again at least once every 3 months and upon diagnosis of any other sexually transmitted infections; adherence should also be closely monitored (Ref).

Adolescents weighing ≥35 kg: Oral: Emtricitabine 200 mg and tenofovir alafenamide 25 mg per tablet: One tablet once daily.

Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.

Dosing: Kidney Impairment: Pediatric

Children and Adolescents weighing ≥14 kg:

CrCl ≥30 mL/minute: No dosage adjustment necessary.

CrCl <30 mL/minute: Use is not recommended.

Dosing: Hepatic Impairment: Pediatric

Children and Adolescents weighing ≥14 kg:

Mild to moderate impairment: No dosage adjustment necessary.

Severe impairment: There are no dosage recommendations in the manufacturer's labeling (has not been studied).

Dosing: Adult

(For additional information see "Tenofovir alafenamide and emtricitabine: Drug information")

HIV-1 infection, treatment

HIV-1 infection, treatment: Oral: One tablet (emtricitabine 200 mg/tenofovir alafenamide 25 mg) once daily, in combination with other antiretroviral agents.

HIV-1 infection, preexposure prophylaxis in men and transgender women

HIV-1 infection, preexposure prophylaxis in men and transgender women:

Note: Some experts reserve use for those with or at risk of renal dysfunction (CrCl 30 to <60 mL/minute), osteopenia, or osteoporosis (Ref).

Oral: One tablet (emtricitabine 200 mg/tenofovir alafenamide 25 mg) once daily (Ref).

Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.

Dosing: Kidney Impairment: Adult

The renal dosing recommendations are based upon the best available evidence and clinical expertise. Senior Editorial Team: Bruce Mueller, PharmD, FCCP, FASN, FNKF; Jason A. Roberts, PhD, BPharm (Hons), B App Sc, FSHP, FISAC; Michael Heung, MD, MS.

Dose adjustments for altered kidney function prior to treatment initiation :

Note: Kidney function may be estimated using the Cockcroft-Gault formula for dosage adjustment purposes. Although the manufacturer’s labeling of individual agent emtricitabine suggests adjustments to the dosing interval when CrCl <50 mL/minute, clinical and pharmacokinetic studies suggest that it can be used at usual recommended doses/intervals when CrCl ≥30 mL/minute and in patients receiving hemodialysis; monitor for GI (eg, nausea) and CNS-related adverse effects (Ref).

Altered kidney function: Oral:

CrCl ≥30 mL/minute: No dosage adjustment necessary (Ref).

CrCl <30 mL/minute: Use is not recommended (Ref).

Augmented renal clearance (measured urinary CrCl ≥130 mL/minute/1.73 m2): Augmented renal clearance (ARC) is a condition that occurs in certain critically ill patients without organ dysfunction and with normal serum creatinine concentrations. Younger patients (<55 years of age) admitted post trauma or major surgery are at highest risk for ARC, as well as those with sepsis, burns, or hematologic malignancies. An 8- to 24-hour measured urinary CrCl is necessary to identify these patients (Ref).

Oral: No dosage adjustment necessary (Ref).

Hemodialysis, intermittent (thrice weekly): Emtricitabine (~30% removed over 3 hours); tenofovir alafenamide (no data on % removed):

Oral: No dosage adjustment necessary. When a scheduled dose falls on a hemodialysis day, administer after hemodialysis (Ref).

Peritoneal dialysis: Oral: Use not recommended (has not been studied) (Ref).

CRRT: Drug clearance is dependent on the effluent flow rate, filter type, and method of renal replacement. Recommendations are based on high-flux dialyzers and effluent flow rates of 20 to 25 mL/kg/hour (or ~1,500 to 3,000 mL/hour) and minimal residual kidney function unless otherwise noted. Appropriate dosing requires consideration of adequate drug concentrations. Close monitoring of response and adverse reactions due to drug accumulation is important.

Oral: There are no data available in patients on CRRT (has not been studied). Although some removal of emtricitabine and tenofovir are expected based on physicochemical characteristics, no dosage adjustment is likely to be necessary (Ref).

PIRRT (eg, sustained, low-efficiency diafiltration): Drug clearance is dependent on the effluent flow rate, filter type, and method of renal replacement. Appropriate dosing requires consideration of adequate drug concentrations. Close monitoring of response and adverse reactions due to drug accumulation is important.

Oral: There are no data available in patients on PIRRT (has not been studied). Although some removal of emtricitabine and tenofovir are expected based on physicochemical characteristics, no dosage adjustment is likely to be necessary. When a scheduled dose falls on a PIRRT day, administer after PIRRT session (Ref).

Nephrotoxicity during treatment:

Tenofovir alafenamide has been associated with acute kidney injury, proximal tubular nephropathy, and Fanconi syndrome. Although kidney injury is less common with tenofovir alafenamide than tenofovir disoproxil fumarate, discontinue use in patients who develop clinically significant decreases in kidney function or evidence of Fanconi syndrome (Ref).

Dosing: Hepatic Impairment: Adult

Mild-to-moderate impairment (Child-Pugh class A or B): No dosage adjustment necessary.

Severe impairment (Child-Pugh class C): There are no dosage adjustments provided in the manufacturer's labeling (has not been studied).

Adverse Reactions

The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified. Reported adverse reactions are for HIV-1 preexposure prophylaxis in adults. Also see individual agents.

1% to 10%:

Gastrointestinal: Abdominal pain (2%), diarrhea (5%), nausea (4%)

Nervous system: Fatigue (2%), headache (2%)

Neuromuscular & skeletal: Decreased bone mineral density (≥5% decrease at lumbar spine: 4%; ≥7% decrease at femoral neck: 1%)

Frequency not defined:

Endocrine & metabolic: Increased serum triglycerides

Hepatic: Exacerbation of hepatitis B

Postmarketing:

Dermatologic: Skin rash, urticaria

Endocrine & metabolic: Fanconi’s syndrome

Genitourinary: Proximal tubular nephropathy

Hypersensitivity: Angioedema

Renal: Acute kidney injury, renal tubular necrosis

Contraindications

As preexposure prophylaxis in patients with unknown or HIV-1 positive status.

Canadian labeling: Additional contraindications (not in US labeling): Hypersensitivity to emtricitabine, tenofovir alafenamide, or any component of the formulation.

Warnings/Precautions

Concerns related to adverse effects:

• Immune reconstitution syndrome: Patients may develop immune reconstitution syndrome resulting in the occurrence of an inflammatory response to an indolent or residual opportunistic infection during initial HIV treatment or activation of autoimmune disorders (eg, Graves disease, polymyositis, Guillain-Barré syndrome, autoimmune hepatitis) later in therapy; further evaluation and treatment may be required.

• Lactic acidosis/hepatomegaly: Lactic acidosis and severe hepatomegaly with steatosis, sometimes fatal, have been reported with use of nucleoside analogues, alone or in combination with other antiretrovirals. Suspend treatment in any patient who develops clinical or laboratory findings suggestive of lactic acidosis or pronounced hepatotoxicity (marked transaminase elevation may/may not accompany hepatomegaly and steatosis).

• Renal toxicity: Renal toxicity (acute renal failure, Fanconi syndrome, and/or proximal renal tubulopathy) has been reported with use of tenofovir prodrugs; patients with impaired renal function and those with concurrent or recent nephrotoxic therapy (including nonsteroidal anti-inflammatory drug use) are at an increased risk. Discontinue use in patients who develop clinically significant decreases in renal function or evidence of Fanconi syndrome.

Disease-related concerns:

• Chronic hepatitis B: [US Boxed Warning]: Acute, severe exacerbations of hepatitis B virus (HBV) have been reported in HBV-infected patients following discontinuation of antiretroviral therapy. Closely monitor hepatic function with clinical and laboratory follow-up for at least several months in patients infected with HBV who discontinue this therapy. If appropriate, anti-HBV therapy may be warranted, especially in patients with advanced hepatic disease or cirrhosis (post-treatment HBV exacerbations may lead to hepatic decompensation and liver failure). All patients with HIV should be tested for HBV prior to or when initiating treatment; HBV-uninfected patients should be offered vaccination.

• Comprehensive prevention program: Preexposure prophylaxis (PrEP) should be accompanied by a comprehensive HIV-1 prevention program (eg, risk reduction counseling, consistent and correct condom use, regular sexually transmitted infection testing), with particular emphasis on medication adherence.

• Renal impairment: Use is not recommended in patients with CrCl <30 mL/minute (unless receiving hemodialysis). Safety and efficacy of concurrent administration with an HIV-1 protease inhibitor plus ritonavir or cobicistat has not been established in patients with CrCl <15 mL/minute (with or without hemodialysis).

• Resistance risk with preexposure prophylaxis: [US Boxed Warning]: Confirm HIV-1 negative status immediately before and at least every 3 months during therapy, and upon diagnosis of any other sexually transmitted infection. Do not start PrEP if signs or symptoms of acute HIV-1 infection are present unless HIV-1 negative status is confirmed by a test approved by the Food and Drug Administration (FDA) as an aid to detect HIV-1 infection (including acute or primary infection). Risk of drug resistant HIV-1 variants with PrEP use if patient had undetected acute HIV-1 infection: Some HIV-1 tests do not detect acute HIV-1 infection. Screen PrEP candidates for signs/symptoms of acute HIV-1 infection and potential exposure events within 1 month of starting PrEP. If signs/symptoms or potential exposure events exist, use a test approved by the FDA for diagnosing acute or primary HIV-1 infection before initiating PrEP. During use of PrEP, if a screening test indicates possible HIV-1 infection or if symptoms of acute HIV-1 infection develop after a potential exposure, convert the HIV-1 PrEP regimen to an HIV-1 treatment regimen until negative infection status is confirmed.

Warnings: Additional Pediatric Considerations

Emtricitabine-associated hyperpigmentation may occur at a higher frequency in pediatric patients compared to adults (children: 32%; adults: 2% to 6%).

Through disruption in vitamin D metabolism, decreases in bone mineral density (BMD) have been observed with tenofovir alafenamide (TAF) after 48 weeks of treatment; however, the incidence and negative impact on BMD is less than that observed with tenofovir disoproxil fumarate (TDF). Additionally, TAF is associated with less renal toxicity than TDF but equal antiviral efficacy. A higher incidence of dyslipidemia has been reported with TAF than TDF. TAF is preferred over TDF whenever possible; do not use TAF and TDF concomitantly (HHS [pediatric] 2019).

Dosage Forms: US

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Tablet, Oral:

Descovy: Emtricitabine 120 mg and tenofovir alafenamide 15 mg

Descovy: Emtricitabine 200 mg and tenofovir alafenamide 25 mg [contains fd&c blue #2 (indigo carm) aluminum lake]

Generic Equivalent Available: US

No

Pricing: US

Tablets (Descovy Oral)

120-15 mg (per each): $88.09

200-25 mg (per each): $88.09

Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.

Dosage Forms: Canada

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Tablet, Oral:

Descovy: Emtricitabine 200 mg and tenofovir alafenamide 10 mg

Descovy: Emtricitabine 200 mg and tenofovir alafenamide 25 mg [contains fd&c blue #2 (indigo carm) aluminum lake]

Administration: Pediatric

Oral: Administer with or without food.

Administration: Adult

Oral: Administer with or without food.

Storage/Stability

Store below 30°C (86°F). Dispense in original container.

Medication Guide and/or Vaccine Information Statement (VIS)

An FDA-approved patient medication guide, which is available with the product information and as follows, must be dispensed with this medication:

Descovy: https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/208215s019lbl.pdf#page=37

Use

Treatment of HIV-1 infection in combination with other antiretroviral agents (FDA approved in pediatric patients weighing ≥35 kg and adults); treatment of HIV-1 infection in combination with other antiretroviral agents (other than protease inhibitors that require a CYP3A inhibitor) (FDA approved in pediatric patients weighing ≥14 to <35 kg); Note: HIV treatment regimens consisting of three antiretroviral agents from at least two classes are strongly recommended; preexposure prophylaxis to reduce the risk of sexually acquired HIV-1 infection in at-risk individuals (FDA approved in adolescents weighing ≥35 kg and adults); Note: Not indicated for individuals at risk from receptive vaginal sex (has not been studied).

Metabolism/Transport Effects

Refer to individual components.

Drug Interactions

Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the drug interactions program by clicking on the “Launch drug interactions program” link above.

Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the drug interactions program

Acyclovir-Valacyclovir: May increase the serum concentration of Tenofovir Products. Tenofovir Products may increase the serum concentration of Acyclovir-Valacyclovir. Risk C: Monitor therapy

Adefovir: May diminish the therapeutic effect of Tenofovir Products. Adefovir may increase the serum concentration of Tenofovir Products. Tenofovir Products may increase the serum concentration of Adefovir. Risk X: Avoid combination

Aminoglycosides: May increase the serum concentration of Tenofovir Products. Tenofovir Products may increase the serum concentration of Aminoglycosides. Risk C: Monitor therapy

Atidarsagene Autotemcel: Antiretroviral Agents may diminish the therapeutic effect of Atidarsagene Autotemcel. Risk X: Avoid combination

Betibeglogene Autotemcel: Antiretroviral Agents may diminish the therapeutic effect of Betibeglogene Autotemcel. Risk X: Avoid combination

Cabozantinib: MRP2 Inhibitors may increase the serum concentration of Cabozantinib. Risk C: Monitor therapy

CarBAMazepine: May decrease the serum concentration of Tenofovir Alafenamide. Risk X: Avoid combination

Cidofovir: May increase the serum concentration of Tenofovir Products. Tenofovir Products may increase the serum concentration of Cidofovir. Risk C: Monitor therapy

Cladribine: Agents that Undergo Intracellular Phosphorylation may diminish the therapeutic effect of Cladribine. Risk X: Avoid combination

Cobicistat: May increase the serum concentration of Tenofovir Alafenamide. Risk C: Monitor therapy

Elivaldogene Autotemcel: Antiretroviral Agents may diminish the therapeutic effect of Elivaldogene Autotemcel. Management: Avoid use of antiretroviral medications for at least one month, or for the amount of time required for elimination of the retroviral medication, prior to stem cell mobilization and until the all apheresis cycles are finished Risk X: Avoid combination

Fosphenytoin-Phenytoin: May decrease the serum concentration of Tenofovir Alafenamide. Risk X: Avoid combination

Ganciclovir-Valganciclovir: Tenofovir Products may increase the serum concentration of Ganciclovir-Valganciclovir. Ganciclovir-Valganciclovir may increase the serum concentration of Tenofovir Products. Risk C: Monitor therapy

Lovotibeglogene Autotemcel: Antiretroviral Agents may diminish the therapeutic effect of Lovotibeglogene Autotemcel. Risk X: Avoid combination

Lumacaftor and Ivacaftor: May increase the serum concentration of P-glycoprotein/ABCB1 Substrates (High risk with Inhibitors or Inducers). Lumacaftor and Ivacaftor may decrease the serum concentration of P-glycoprotein/ABCB1 Substrates (High risk with Inhibitors or Inducers). Risk C: Monitor therapy

Nirmatrelvir and Ritonavir: May increase the serum concentration of Tenofovir Alafenamide. Risk C: Monitor therapy

Nonsteroidal Anti-Inflammatory Agents: May enhance the nephrotoxic effect of Tenofovir Products. Management: Seek alternatives to these combinations whenever possible. Avoid use of tenofovir with multiple NSAIDs or any NSAID given at a high dose due to a potential risk of acute renal failure. Diclofenac appears to confer the most risk. Risk D: Consider therapy modification

Nonsteroidal Anti-Inflammatory Agents (Topical): May enhance the nephrotoxic effect of Tenofovir Products. Risk C: Monitor therapy

Orlistat: May decrease the serum concentration of Antiretroviral Agents. Risk C: Monitor therapy

OXcarbazepine: May decrease the serum concentration of Tenofovir Alafenamide. Risk X: Avoid combination

P-glycoprotein/ABCB1 Inducers: May decrease the serum concentration of Tenofovir Alafenamide. Management: Consider alternatives to the use of P-gp inducers with tenofovir alafenamide. If combined, monitor for reduced tenofovir alafenamide concentrations and efficacy, and for the development of resistance. Risk D: Consider therapy modification

PHENobarbital: May decrease the serum concentration of Tenofovir Alafenamide. Risk X: Avoid combination

Primidone: May decrease the serum concentration of Tenofovir Alafenamide. Risk X: Avoid combination

Rifabutin: May decrease the serum concentration of Tenofovir Alafenamide. Risk X: Avoid combination

RifAMPin: May decrease the serum concentration of Tenofovir Alafenamide. Risk X: Avoid combination

Rifapentine: May decrease the serum concentration of Tenofovir Alafenamide. Risk X: Avoid combination

Ritonavir: May increase the serum concentration of Tenofovir Alafenamide. Risk C: Monitor therapy

St John's Wort: May decrease the serum concentration of Tenofovir Alafenamide. Risk X: Avoid combination

Tacrolimus (Systemic): Tenofovir Products may enhance the nephrotoxic effect of Tacrolimus (Systemic). Risk C: Monitor therapy

Tipranavir: May decrease the serum concentration of Tenofovir Alafenamide. Risk X: Avoid combination

Reproductive Considerations

The Health and Human Services (HHS) perinatal HIV guidelines consider emtricitabine and tenofovir alafenamide preferred agents for use in patients with HIV who are not yet pregnant but are trying to conceive (HHS [perinatal] 2023).

Refer to individual monographs for additional information.

Pregnancy Considerations

The Health and Human Services (HHS) perinatal HIV guidelines consider this combination to be a preferred nucleoside reverse transcriptase inhibitor backbone for initial therapy in antiretroviral-naive pregnant patients. In addition, this combination is preferred for use in pregnant patients with HIV who have had antiretroviral therapy (ART) in the past but are restarting, or who require a new ART regimen (due to poor tolerance or poor virologic response of current regimen). Patients who become pregnant while taking this combination may continue if viral suppression is effective and the regimen is well tolerated.

Emtricitabine and tenofovir alafenamide are recommended as part of a preferred regimen when early (acute/recent) HIV infection is detected during pregnancy; genotyping may be required if the person had prior use of long acting cabotegravir for pre-exposure prophylaxis (PrEP).

The HHS perinatal guidelines also recommend emtricitabine plus tenofovir alafenamide as a component of regimens for HIV/hepatitis B virus–coinfected patients who are pregnant (HHS [perinatal] 2023).

Refer to individual monographs for additional information.

Monitoring Parameters

HIV: Preexposure prophylaxis (PrEP): General recommendations: Refer to current guidelines for complete monitoring recommendations for patients receiving PrEP. Assessment should include risk behaviors and HIV testing (prior to initiation, at least once every 3 months, if recent exposures are suspected, upon diagnosis of other sexually transmitted infections, and if clinical symptoms consistent with acute HIV infection are present). Monitor CrCl (baseline, every 12 months or more frequently in some patients as clinically appropriate); weight, cholesterol, triglycerides (every 12 months). Screen for hepatitis B (baseline); for patients with hepatitis B coinfection, monitor hepatic function and hepatitis B viral load for several months after therapy is stopped (CDC 2021).

HIV: Treatment: General recommendations: Management of HIV infection requires extensive monitoring; refer to current guidelines (https://clinicalinfo.hiv.gov/en/guidelines) for additional guidance. Antiretroviral (ARV) drug-resistance testing is recommended before initiation of therapy in treatment-naive patients. After initiation of or change in ARV therapy regimen, pediatric patients should be evaluated for clinical adverse effects and treatment adherence at 1 to 2 weeks, and laboratory testing for drug toxicity should occur at 2 to 4 weeks; monitor for therapy adherence, effectiveness, and toxicities every 3 to 4 months.

Drug-specific monitoring: Frequency may vary based on several factors including age, concomitant therapy, and clinical response; refer to current guidelines for additional information.

Screen for hepatitis B prior to starting therapy (in patients who previously demonstrated no immunity to hepatitis B). For patients with hepatitis B coinfection, monitor hepatic function and hepatitis B viral load for several months after therapy is stopped. Serum electrolytes (including anion gap), SCr, urine protein/glucose, lipid profiles (baseline and periodically with therapy or if clinical presentation indicates need), serum phosphorus (in patients with chronic kidney disease), serum lactate (if clinical presentation indicates need).

Mechanism of Action

Nucleoside and nucleotide reverse transcriptase inhibitor combination; emtricitabine is a cytidine analogue while tenofovir alafenamide fumarate (TAF) is an analog of adenosine 5'-monophosphate. Each drug interferes with HIV viral RNA dependent DNA polymerase activities resulting in inhibition of viral replication.

Pharmacokinetics (Adult Data Unless Noted)

Protein binding: Emtricitabine: <4%; TAF: ~80%

Metabolism: Emtricitabine: Not significantly metabolized; TAF: Primarily intracellular metabolism; minimal extent by CYP3A

Half-life elimination: Emtricitabine: 10 hours; TAF: 0.51 hours

Time to peak, plasma: Emtricitabine: 3 hours; TAF: 1 hour

Excretion: Emtricitabine: Urine (70%); feces (13.7%); TAF: Urine (<1%), feces 31.7%)

Clearance: Emtricitabine and tenofovir may be eliminated by both glomerular filtration and active tubular secretion

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  5. Descovy (emtricitabine and tenofovir alafenamide) [prescribing information]. Foster City, CA: Gilead Sciences Inc; January 2022.
  6. Descovy (emtricitabine and tenofovir alafenamide) [product monograph]. Mississauga, Ontario, Canada: Gilead Sciences Canada Inc; August 2022.
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  14. Refer to manufacturer's labeling.
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