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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
 

 

 

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Initial ART Regimen

05-06-2008
Considerations before starting ART

  • Effectiveness of regimen
  • Potential for serious adverse effects and toxicity
  • Side effects and tolerability
  • Potential for interactions with other drugs
  • Potential for treatment options should the initial drug combination fail
  • Cost and availability
  • Patient readiness and likelihood of adequate adherence
  • Presence of pregnancy or the risk of becoming pregnant
  • Presence of tuberculosis and other illnesses -anaemia, peripheral neuropathy, kidney disease, hepatitis
  • Ability of the patient to return for regular and reliable follow-up
Recommended Regimens (for patients initiating therapy up to new 2007 guidelines)

  • 1st line: (AZT or d4T) + 3TC + (EFV or NVP). For women with exposure to NVP for PMTCT within 6 months, do not use NVP.
  • 2nd line: (TDF/FTC* or ABC/ddI**) + LPV/r. TDF/FTC preferred. If unable to tolerate LPV/r, consult HIV specialist.
  • *FTC or 3TC used in 2nd line regimen because resistance mutations decrease replication capacity and increase susceptibility to TDF and AZT.
  • **3TC resistance reduces efficacy of ABC, so ddI used instead.
New Recommended Regimens

  • New recommendations based on availability of TDF/FTC +/- EFV as fixed-dose combination which can be given od; proven potency of TDF; more favorable mutation pathway; lower incidence of anemia
  • 1st line: TDF/FTC + (EFV or NVP). If creatine clearance <50, use ABC + 3TC instead of TDF/FTC. For women with exposure to NPV for PMTCT within 6 months, do not use NVP.
  • 2nd line, preferred: AZT + (3TC* or TDF**/FTC*) + LPV/r***. AZT + 3TC + LPV/r is preferred 2nd line regimen for patients failing TDF-based 1st line regimen.
  • 2nd line, alternative: d4T/3TC* + LPV/r***. d4T associated with long term toxicity; should be used in 2nd line only if AZT cannot be taken
  • *FTC or 3TC used in 2nd line regimen because resistance mutations decrease replication capacity and increase susceptibility to TDF and AZT.
  • **TDF mutations can increase susceptibility to AZT and may increase AZT efficacy, while TDF may retain some activity
  • ***If unable to tolerate LPV/r refer to HIV specialist
Practical Hints in Choosing a Specific Regimen:

  • AZT may worsen anemia because of bone marrow suppression. Not recommended in patients with Hgb <10. Delay ART until anemia treated or use alternative NRTI combination.
  • Avoid d4T in patients with peripheral neuropathy (numbness, tingling, or burning sensations in extremities) and those being treated with INH, as it may worsen their symptoms.
  • Women with CD4 >250 and men with CD4 have greater risk of NVP hepatotoxicity; avoid starting NVP in these patients. (CD4 increase above these thresholds on NVP-based therapy is a desired outcome, and does not require change of therapy).
  • Use of single-dose NVP for perinatal prophylaxis not associated with hepatotoxicity
  • Use 2 week lead-in NVP dose (200mg od) before increasing to full dose (200 mg bid) to reduce risk of skin rash and hepatotoxicity
  • EFV associated with serious birth defects; avoid in women of reproductive age who are not using effective and consistent contraception, who are trying to get pregnant, or who are in 1st trimester of pregnancy
  • EFV associated with CNS side effects (drowsiness, insomnia, abnormal dreams, impaired concentration, etc.); these generally occur with first few doses and diminish or disappear after 2-4 weeks. Avoid with severe untreated psychiatric illness.
  • EFV is the recommended NNRTI to be used in HIV/TB co-infection treatment with rifampicin
  • Consider potential drug-drug interactions or additive toxicity if initiating ART in patients on certain other drugs, e.g. INH and d4T (peripheral neuropathy); cotrimoxazole and NVP or EFV (skin rash); INH and NVP or EFV (hepatotoxicity). In these situations, consider alternate ARV agent or close clinical and/or laboratory monitoring.
  • NNRTIs (NVP, EFV) do not effectively treat HIV-2 infection: use PI based regimen
  • With decreased creatinine clearance there is need for dose adjustment of TDF, 3TC, FTC, and d4T; AZT dose adjustment is required only with "severe" renal impairment or patient on dialysis (refer to links to drugs for details)
Special Considerations During Transition Period to New Recommendations:

  • Continue stable patients without signs of toxicity or clinical failure on current regimen: (AZT or d4T) + 3TC + (NVP or EFV)
  • Switch patients with signs of toxicity but not clinical failure to proposed first line regimen: TDF/FTC + either NVP or EFV
  • Switch patients with signs of clinical failure from AZT- or d4T-containing regimen to TDF/FTC + LPV/r
  • Pediatric patients transitioning to adult care follow above recommendations for stable patients, patients with toxicity, and patients with clinical failure
  • Patients will be transitioned to new 2nd line regimen as follows:
  • -TDF + ddI + LPV/r should be switched to TDF/FTC + LPV/r
  • -ABC + ddI with either LPV/r or NFV should be switched to TDF/FTC + LPV/r unless renal insufficiency present
  • -TDF + ddI + NFV should be switched to TDF/FTC + LPV/r
  • -d4T/3TC + IDV or AZT/3TC + IDV should be switched to TDF/FTC + LPV/r
  • -d4T/3TC + ABC or AZT/3TC/ABC: consult with provincial HIV specialist for transition
  • -d4T/3TC + LPV/r or AZT/3TC + LPV/r: consult with provincial HIV specialist for transition
  • -Other combinations not covered above: consult with provincial HIV specialist for transition

 
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Zambia HIV National Guidelines

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