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>Antimicrobial Agents>
HIV Guide Home PageEmail this module to a friend

Valganciclovir

Paul A. Pham Pharm.D. and John G. Bartlett M.D.
11-29-2010

Zambia Specific Information

  • Available formulation in Zambia: tablet:  450 mg  
  • Oral valganciclovir equivalent to IV ganciclovir for treatment of CMV disease.
  • Due to additive bone marrow suppression, avoid co-administration with AZT.
Zambia Information Author: Paul A. Pham, Pharm.D.

INDICATIONS

FDA

  • Treatment of CMV retinitis in pts with AIDS.
  • Prevention of CMV disease in kidney, heart, and kidney-pancreas transplant pts at high risk for CMV disease (e.g., donor positive, recipient negative). Not indicated in liver transplant pts.
NON-FDA APPROVED USES

  • Prevention of CMV retinitis of the contralateral eye in pts treated with intraocular ganciclovir implant.
  •  Treatment of GI CMV disease (in pts tolerating PO intake). 

FORMS

brand 
name
 
generic 
Mfg 
brand 
forms
 
cost* 
Valcyte ValganciclovirRocheoral
tablet
450 mg
$46.99

*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

  • CMV retinitis (induction): 900 mg PO twice-daily with food x 3 wks (plus ganciclovir implant)
  • CMV retinitis (maintenance): 900 mg PO once-daily with food until immune reconstitution (CD4 >150 x 3-6 mos w/ ophthalmology consultation confirming quiescence).
  • Gastrointestinal CMV disease: 900 mg twice-daily with food x 3-6 wks (consider maintenance therapy with severe disease and/or with relapse)
  • Prevention of CMV disease in kidney, heart, and kidney-pancreas transplant pts at high risk for CMV disease (e.g., donor [+] CMV/recipient negative): 900 mg daily with food beginning within 10 days of transplantation and continuing through day 100 post-transplantation.
  • Monitor CBC 2-3x/wk. Discontinue drug or add G-CSF if ANC <500. Discontinue if platelet count <25,000 or consider D/C if Hgb <8g/dL.

RENAL DOSING

DOSING FOR GLOMERULAR FILTRATION OF 50-80

>60 ml/min: 900 mg (induction); 900 mg once-daily (maintenance).

DOSING FOR GLOMERULAR FILTRATION OF 10-50

40-59 ml/min: 450 mg twice-daily (induction) then 450mg once-daily (maintenance). 25-39 ml/min: 450 mg once-daily (induction) then 450 mg every other day (maintenance). 10-24 ml/min: 450 mg every other day (induction) then 450 mg twice weekly (maintenance).

DOSING FOR GLOMERULAR FILTRATION OF <10 ML/MIN

Not recommended by manufacturer.

DOSING IN HEMODIALYSIS

Not recommended by manufacturer (HD removes approx. 50% of GCV). Consider using 1.25 mg/kg IV ganciclovir post-HD (induction)

DOSING IN PERITONEAL DIALYSIS

No data.

DOSING IN HEMOFILTRATION

No data.

ADVERSE DRUG REACTIONS

COMMON

OCCASIONAL

  • Anemia
  • Fever
  • Rash
  • Headache
  • Seizures
  • Confusion
  • Mental status changes
RARE

  • Hepatoxicity

DRUG INTERACTIONS

  • ddI (buffered or EC): not studied with valganciclovir but ddI levels may be increased. PK study with ddI (buffered) and ganciclovir (GCV) resulted in a 111% increase in ddI AUC. GCV AUC decreased by 21%. Monitor closely for ddI toxicity. Consider ddI dose reduction or alternative NRTI.
  • Drug Interactions with PIs, NNRTIs, RAL, MVC, and ENF unlikely.
  • Myelosuppressive drugs (e.g., AZT, interferon, 5-FC, pyrimethamine, etc.): may increase risk of hematologic toxicity. Monitor closely with co-administration. Consider alternative agents or support with GCSF.
  • Probenecid: may increase GCV serum levels. Monitor for GCV toxicity.
  • Trimethoprim: may increase GCV serum levels. Monitor for GCV toxicity.

SPECTRUM

CMV, HSV-1, HSV-2, EBV, VZV, HHV-8, and HHV-6.

PHARMACOLOGY

Pharmacology

COMMENTS

Oral valganciclovir has 10-fold better absorption than oral GCV. AUC of oral valganciclovir 900 mg comparable to GCV 5mg/kg IV. Oral valganciclovir equivalent to IV GCV for treatment of CMV retinitis in HIV+ pts and is preferred due to oral administration. Contraindicated by manufacturer in pts with severe neutropenia (ANC <500/dL), thrombocytopenia (<25,000/dL), severe anemia (Hgb <8 g/dL) and renal failure. Neutropenia and anemia generally responsive to G-CSF and erythropoietin.

Basis for Recommendations

  • Recommendations of the National Institutes of Health (NIH), the Centers for Disease Control and Prevention (CDC), and the HIV Medicine Association of the Infectious Diseases Society of America (HIVMA/IDSA) ; Guidelines for Prevention and Treatment of Opportunistic Infections in HIV-Infected Adults and Adolescents ; http://AIDSinfo.nih.gov   ; 2008 ; Vol.
    Rating: Basis for recommendation
    Comments:In pts tolerating PO intake, oral valganciclovir + ganciclovir implant is recommended for the treatment of CMV retinitis.

REFERENCES


 
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