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Initial ART Regimen
05-06-2008
- 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
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1st line: (AZT or d4T) + 3TC + (EFV or NVP). For women with exposure to NVP for PMTCT within 6 months, do not use NVP.
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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 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
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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.
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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.
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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
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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
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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
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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.
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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)
- 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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