Johns Hopkins POC-IT: Point of Care Information Technology [Home]
HIV Guide
 Zambia HIV National Guidelines
 


Introduction  

HIV Counseling and Testing  

Sexually Transmitted Infections (STIs)  

General Principles of Antiretroviral Therapy for Chronic HIV Infection in Adults and Adolescents  

When to Start ARV Therapy for Chronic HIV Infection in Adults and Adolescents  

Initial Regimen for ARV Therapy  

Adherence  

Baseline evaluation and Monitoring  

Calculations: Ideal Body Weight, Body Mass Index and Creatinine Clearance  

ARV Therapy for Individuals with Tuberculosis Co-Infection  

Adverse Effects and Toxicity  

Immune Reconstitution Inflammatory Syndrome (IRIS)  

Changing or Stopping ART  

Treatment Failure  

Stopping ARV Therapy  

Post Exposure Prophylaxis  

Cotrimoxazole Prophylaxis  

WHO Staging in Adults and Adolescents  

Nutrition Care and Support  

Palliative Care in HIV and AIDS  

 Guide Editors
 Editor In Chief
    Joel E. Gallant, MD, MPH

Pharmacology Editor
    Paul Pham, PharmD, BCPS

Zambia Guideline Team
   Peter Mwaba MMed PhD FRCP
   Alywn Mwinga MMed
   Isaac Zulu MMed MPH
   Velepie Mtonga MMed
   Albert Mwango MBChB
   Jabbin Mulwanda MMed FCS
 

 

 

Drugs>Antiretrovirals>
HIV Guide Home PageEmail this module to a friend

Emtricitabine

Paul A. Pham, Pharm.D. and John G. Bartlett, M.D.
06-11-2009

Zambia Specific Information

  • Available formulation in Zambia: Capsule: 200 mg; Oral liquid: 10 mg/ml. TDF 300 mg/FTC 200 mg combination tab EFV 600 mg/TDF 300 mg/FTC 200 mg combination tab
  • FTC/TDF plus EFV or NVP is now preferred firstline regimen due to long-term potency and favorable mutation pathway.
  • Refrigerate FTC solution. Solution can be kept out at room temperature for 3 months only.
Zambia Information Author: Paul A. Pham, Pharm. D.

INDICATIONS

FDA

  • Treatment of HIV infection in combination with other antiretroviral agents.
NON-FDA APPROVED USES

  • Treatment of hepatitis B in HIV-HBV co-infected pts. or in HBV mono-infected patients.

FORMS

brand 
name
 
generic 
Mfg 
brand 
forms
 
cost* 
Emtriva Emtricitabine (FTC)GileadOral
capsule
200 mg
$13.70 per cap
      Oral
solution
10 mg/mL (170mL)
$97.00 (170 mL bottle)
Truvada Emtricitabine (FTC)+ Tenofovir DF (TDF)GileadOral
tablet
FTC200 mg/TDF 300 mg
$38.34 per tab
Atripla Emtricitabine (FTC)+ Tenofovir DF (TDF) + Efavirenz (EFV) Bristol-Myers Squibb / Gilead Oral
tablet
FTC200mg/TDF300 mg/EFV 600 mg
$55.11 per tab

*Prices represent cost per unit specified and are representative of "Average Wholesale Price" (AWP). AWP Prices were obtained and gathered by Lakshmi Vasist Pharm D using the Red Book, manufacturer's information, and the McKesson database.

^Dosage is indicated in mg unless otherwise noted.

USUAL ADULT DOSING

Pill burden: 1 cap or tab once-daily.

  • FTC 200 mg - 1 tab once-daily. with or without food.
  • Can be administered as a co-formulated product with tenofovir DF (Truvada) 1 tab PO once-daily with or without food and TDF/EFV (Atripla) 1 tab once-daily. Evening dosing on an empty stomach recommended with initial Atripla therapy to decrease EFV-associated side effects.

RENAL DOSING

DOSING FOR GLOMERULAR FILTRATION OF 50-80

200 mg q24hrs.

DOSING FOR GLOMERULAR FILTRATION OF 10-50

30-49 mL/min: FTC 200 mg every other day or TDF/FTC co-formulation (Truvada) 1 tab every other day;15-29 mL/min: FTC 200 mg every 3 days. TDF/FTC (Truvada) not recommended with GFR <30 ml/min. EFV/TDF/FTC co-formulation (Atripla) not recommended with GFR <50 ml/min.

DOSING FOR GLOMERULAR FILTRATION OF <10 ML/MIN

<15 mL/min: 200 mg every 4 days. TDF/FTC (Truvada) and EFV/TDF/FTC co-formulation (Atripla) not recommended.

DOSING IN HEMODIALYSIS

200 mg every 4 days post-HD (30% of dose removed with 3-hr HD). TDF/FTC (Truvada) not recommended with GFR <30ml/min . EFV/TDF/FTC co-formulation (Atripla) not recommended with GFR <50 ml/min).

DOSING IN PERITONEAL DIALYSIS

No data. Consider dose reduction. TDF/FTC (Truvada) not recommended with GFR <30ml/min and EFV/TDF/FTC co-formulation (Atripla) not recommended with GFR <50 ml/min).

DOSING IN HEMOFILTRATION

No data. Consider dose reduction.

ADVERSE DRUG REACTIONS

GENERAL

  • Generally well tolerated. For Atripla, see EFV for EFV-associated side effects and TDF for TDF-associated side effects
OCCASIONAL

  • Mild asymptomatic skin hyperpigmentation on the palm and/or soles noted in 3% of pts, with increased frequency in dark-skinned individuals.
  • Asymptomatic and transient CPK elevation.
  • Headache, diarrhea, nausea, asthenia, and rash that required discontinuation in approx. 1% of pts.
RARE

  • Lactic acidosis (categorized as NRTI class adverse effect, but not expected to occur frequently with FTC).

DRUG INTERACTIONS

Not a substrate, inhibitor, or inducer of any CYP450 isoforms. No clinically significant drug interactions.

Drug-to-Drug Interactions

Drug-to-Drug Interaction

DrugEffect of InteractionRecommendations/Comments
AZT No significant drug interaction.Use standard dose.
FoodFTC AUC was not affected by food.Administer FTC with or without food
TDF Tenofovir Cmin was increased by 20%; AUC was unchanged.Interaction not significant. Use standard dose.

SPECTRUM

RESISTANCE

  • 184V: High-level resistance.
  • T69ins: High-level resistance.
  • Q151M complex: Unknown data, but low-level resistance likely.
  • TAMs (41L, 210W, 215Y/F, 219Q/E, 44D, 67N, 70R, 118I): high level resistance with multiple TAMs.

PHARMACOLOGY

Pharmacology

COMMENTS

  • Pros: Activity against HBV; well tolerated; once-daily dosing; co-formulation with TDF; similar to 3TC with respect to activity, tolerability, and resistance profile
  • Cons: Hyperpigmentation in some pts; less clinical data than for 3TC.

REFERENCES

REFERENCED WITHIN THIS GUIDE


 
Diagnosis
 


Complications of Therapy


Malignancies


Miscellaneous


Opportunistic Infections


Organ System

Drugs
 


Antimicrobial Agents


Antiretrovirals


Miscellaneous

Guidelines
 


Zambia HIV National Guidelines

Management
 


Antiretroviral Therapy


Laboratory Testing


Miscellaneous

Pathogens
 


Bacteria


Fungi


Parasites


Viruses

View All Modules
 
Index
 
 
Contacts    Help    Copyright    Acknowledgments    Abbreviations