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 Zambia HIV National Guidelines
 


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 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>
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Lamivudine

Paul A. Pham, Pharm.D. and John G. Bartlett, M.D.
10-21-2010

Zambia Specific Information

  • Available formulation in Zambia: Oral liquid: 50 mg/5 ml; Tablet: 150 mg. AZT 300 mg/3TC 150 mg combination tab. AZT 300 mg/3TC 150 mg/NVP 200 mg combination tab
  • Co-formulations with 3TC: AZT+3TC (300 mg+150 mg); AZT+3TC+NVP (300 mg+150 mg+200 mg); d4T+3TC+NVP (30 mg+150 mg+200 mg). Dose: 1 tablet twice daily.
  • Active against HBV, but should be co-administered with TDF in HBV co-infected patients to prevent emergence of 3TC resistance.
  • AZT /3TC plus NVP no longer first-line ARV regimen in ARV-naïve patients. TDF/FTC/EFV now preferred due to long-term efficacy, favorable mutation pathway, and lower incidence of anemia.
  • After TDF/FTC/EFV failure, AZT/3TC plus LPV/r is recommended second line regimen.
Zambia Information Author: Paul A. Pham, Pharm.D.

INDICATIONS

FDA

  • Treatment of HIV infection in combination with other antiretrovirals.
  • Treatment of HBV (Epivir HB)
NON-FDA APPROVED USES

  • Treatment of hepatitis in HIV-HBV co-infected pts.

FORMS

brand 
name
 
generic 
Mfg 
brand 
forms
 
cost* 
Epivir Lamivudine (3TC)GlaxoSmithKlineoral
tablet
150 mg, 300 mg
$7.63; $15.27
      oral
solution
10 mg/mL (240 mL)
$122.14
Epivir HB (for HBV infection)Lamivudine (3TC)GlaxoSmithKlineoral
tablet
100 mg
$13.66
      oral
solution
5 mg/mL (240 mL)
$163.97
Combivir Lamivudine (3TC)/Zidovudine (AZT)GlaxoSmithKlineoral
tablet
150 mg 3TC/300 mg AZT
$16.55
     

Trizivir Lamivudine (3TC)/Zidovudine (AZT)/Abacavir (ABC) GlaxoSmithKlineoral
tablet
ABC 300 mg + AZT 300 mg + 3TC 150 mg
$26.81
Epzicom Lamivudine (3TC)/Abacavir (ABC) GlaxoSmithKline oral
tablet
ABC 600 mg + 3TC 300 mg
$35.78
Kivexa (brand name available in Europe)ABC + 3TCGlaxoSmithKlineoral
tablet
ABC 600 mg + 3TC 300 mg
variable

*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: 1-2 tabs once-daily

  • As Epivir: 3TC 300 mg PO once-daily or 150 mg PO twice-daily
  • As Combivir or Trizivir: 1 tab PO twice-daily
  • As Epzicom: 1 tab PO once-daily

RENAL DOSING

DOSING FOR GLOMERULAR FILTRATION OF 50-80

300 mg once-daily or 150 mg PO twice-daily. 

DOSING FOR GLOMERULAR FILTRATION OF 10-50

Cr Clearance 30-49 mL/min: 150 mg PO once-daily ; Cr Clearance 15-29 mL/min: 150 mg x1 then 100 mg once-daily.

DOSING FOR GLOMERULAR FILTRATION OF <10 ML/MIN

150 mg x1 then 25-50 mg once-daily.

DOSING IN HEMODIALYSIS

150 mg x1, then 25-50 mg once-daily (post HD).

DOSING IN PERITONEAL DIALYSIS

150 mg x1, then 25-50 mg once-daily (limited data).

DOSING IN HEMOFILTRATION

No data consider 150 mg PO once-daily.

ADVERSE DRUG REACTIONS

One of the best tolerated NRTIs with side effect profile comparable to placebo in hepatitis trials.

OCCASIONAL

  • Headache, nausea, diarrhea, abdominal pain, and insomnia (association unclear; may be due to co-administered ARVs).
  • Hepatitis flare or fulminant hepatitis (in HBV co-infected pts if 3TC withdrawn or with development 3TC-resistant HBV)
RARE

  • Lactic Acidosis: listed as NRTI class effect, but unlikely to be caused by 3TC. In vitro, 3TC, along with TDF, FTC, and ABC, are not associated with mitochondrial toxicity.
  • Pancreatitis (reported in pediatric pts).

DRUG INTERACTIONS

No pertinent drug interactions since it is not a substrate, inhibitor, or inducer of CYP450 isoforms.

Drug-to-Drug Interactions

Drug-to-Drug Interaction

DrugEffect of InteractionRecommendations/Comments
Abacavir 3TC AUC decreased by 15%; Cmax decreased by 35%.Not clinically significant. Use standard dose.
Trimethoprim/ Sulfamethoxazole 3TC AUC increased by 44%.Not clinically significant. Use standard dose.
Methadone 3TC: No reported interaction. Methadone: No change.Not clinically significant. Use standard dose.
Nelfinavir No effect on 3TC AUC.Not clinically significant. Use standard doses of both.

SPECTRUM

HIV and HBV

RESISTANCE

  • 184V: selected by 3TC, resulting in high-level resistance to 3TC and FTC, slight decrease in susceptibility to ddI and ABC, and enhanced susceptibility to AZT, d4T, and TDF.
  • TAMs (41L, 210W, 215Y/F, 219Q/E, 67N, 70R): resistance likely with multiple TAMs.
  • T69S: high-level resistance.
  • Q151M complex: high-level resistance.
  • K65R: intermediate resistance.
  • 44D and 119I: increase 3TC resistance in combination with TAMs.

PHARMACOLOGY

Pharmacology

COMMENTS

  • Pros: very well tolerated; active against HBV; convenient coformulations available;  once-daily dosing with low pill burden (1 tab once-daily); resistance (184V mutation) increases susceptibility to AZT, d4T, and TDF, and delays accumulation of TAMs; 3TC or FTC are essential components of all recommended initial regimens; coformulated with AZT (Combivir), ABC (Epzicom), and AZT + ABC (Trizivir). Decreased fitness with 184V mutation, which may result in partial antiviral activity.
  • Cons: high-level resistance with single point mutation (184V); risk of hepatitis flare or fulminant hepatitis if 3TC withdrawn or if resistance develops in co-infected pts; high rate of HBV resistance with prolonged therapy if not used in combination with other anti-HBV agent (typically TDF); shorter intracellular half-life compared to FTC; more frequent emergence of 184V with AZT/3TC than TDF/FTC in GS934 study.

REFERENCES

REFERENCED WITHIN THIS GUIDE


 
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