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Key New WHO Recommendations Dec 2009

Key New WHO Recommendations Dec 2009. Crossroads Hotel 7 th January 2010. REC 1: When to start.

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Key New WHO Recommendations Dec 2009

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  1. Key New WHO Recommendations Dec 2009 Crossroads Hotel 7th January 2010

  2. REC 1: When to start • All adolescents & adults with HIV infection & CD4 counts less than/equal to 350 cells/mm3, including pregnant women, should be started on ART immediately regardless of whether they have clinical symptoms • Individuals with severe or advanced clinical disease (WHO clinical stage 3 or 4) should start ART irrespective of CD4 cell count

  3. Proposed WHO 2009 Criteria for the ART Initiation in adults and adolescents(ART Guidelines Meeting, October/2009)

  4. REC 2: What to use in 1st line • First line therapy should consist of an NNRTI + two NRTIs, one of which should be AZT or TDF. • Countries using D4T in first line regimens should start phasing it out because of its long term toxicity Recommended regimens: • AZT + 3TC + EFV • AZT + 3TC + NVP • TDF + 3TC or FTC + EFV • TDF + 3TC or FTC + NVP

  5. REC 3: Pregnancy & ART 1. Start ART in all pregnant women with HIV and CD4 count<350 cells/mm3, irrespective of clinical symptoms. 2. CD4 testing is required to identify if pregnant women with HIV and WHO clinical stage 1 or 2 disease need to start antiretroviral treatment or prophylaxis. 3. Start ART in all pregnant women with HIV and WHO clinical stage 3 or 4, irrespective of CD4 count.

  6. Pregnancy cont’d • Benefits of NVP for women with CD4 cell count between 250 to 350/mm3 likely to outweigh risk of not treating. • EFV regimens preferred but the low risk of NTD (<1%) means should avoid starting in first trimester. • AZT regimens preferred in pregnancy but TDF acceptable.

  7. Pregnancy cont’d 4. Start one the following regimens in ART-naïve pregnant women eligible for treatment. • AZT + 3TC + EFV • AZT + 3TC + NVP • TDF + 3TC or FTC+ EFV • TDF + 3TC or FTC + NVP • 5. Do not start EFV during the first-trimester of pregnancy.

  8. REC 4: HIV/HBV co-infection Patients who require treatment for hepatitis B virus co-infection, should start ART immediately, regardless of CD4 cell count or WHO clinical stage. First and second line regimens for this group should contain TDF and either 3TC or FTC i.e. - TDF+3TC/FTC+ EFV or - TDF+3TC/FTC+ NVP

  9. REC 5: HIV/TB co-infection Regardless of their CD4-cell counts, patients co-infected with HIV and TB should be started on ART as soon as possible after starting TB treatment • EFV based regimens preferred initial options. • All active TB pts start ART as soon as tolerable. • Rifabutin in TB regimen if using concomitant PI regimen Regimen options: - AZT+3TC+EFV or - TDF+3TC/FTC+EFV

  10. d4T phase out plan towards AZT or TDF is recommended in settings where d4T regimens are used as the principal option to start ART. • ART should be initiated as soon as possible in all HIV/TB coinfected patients with active TB (within 8 weeks after start TB treatment).

  11. REC 6: What to use in 2nd line • Second line ART should consist of a Ritonavir-boosted PI plus two NRTIs (one of which should be AZT or TDF, considering what was used in 1st line) • Ritonavir-boosted Atazanavir and Lopinavir/ritonavir are the preferred PIs • Regimens: TDF + 3TC/FTC + LPV/r/ATZ/r or AZT + 3TC/FTC + LPV/r/ATZ/r

  12. REC 7: Lab Monitoring • All patients should have access to CD4 cell count testing to optimize Pre-ART and ART management. Viral load testing is recommended to confirm treatment failure. • Symptom directed or targeted use of lab tests is the preferred approach for drug toxicity monitoring

  13. ART laboratory monitoring 1 Recommended test in patients with high risk of adverse events associated with AZT (low CD4 or low BMI). 2 Recommended test in patients with high risk of adverse events associated with TDF (underlying renal disease, older age group, low BMI, diabetes, hypertension and concomitant use of a boosted PI or nephrotoxic drugs). 3 Recommended test in patients with high risk of adverse events associated with NVP ( ART naive HIV+ women with CD4 > 250 cells/mm3, HCV co-infection)

  14. REC 8: PMTCT • Pregnant women who don't need ART for their own health should start taking prophylaxis as soon as possible from 14 weeks gestation. • Either three-drug ART or infant prophylaxis should be given throughout the breastfeeding period if mothers do not need ART for their own health.

  15. PMTCT cont’d

  16. PMTCT – infant feeding

  17. The end I Thank you, Dr Zengani Chirwa – T/A Care Treatment & Support, HIV & AIDS Department - MOH

  18. Ministry of Health Department of HIV &AIDS

  19. Treatment Care & Support programme Crossroads hotel 7th January 2010

  20. Goal • To reduce mortality & morbidity in adults and children due to HIV and AIDS and mitigate the impact of HIV and AIDS in Malawi

  21. Eligibility for ART - current The eligibility criteria in Malawi includes: • CD4 <250 irrespective of WHO staging • TLC <1200mm3 for WHO stage 2 patients • WHO clinical stage 3 or 4 irrespective of CD4 • CD4 < 350 for pregnant women irrespective of WHO clinical stage Malawi current ART regimens First line regimen: Nevirapine+Stavudine+ Lamivudine (Triomune) Alternative first line includes: AZT & EFV based regimens

  22. Achievements • Through the scale up plan 2006-2010 the programme had cummulatively by end September 2009: • 253,154 patients ever started on ART • Out of which 183,147 are alive and on treatment representing 56% of those in immediate need • ART services are provided at 236 static sites which support over 100 mobile and outreach sites

  23. Achievements • Access: over 60% of the patients are female, while children make up 10% (<15yrs) • Current ART regimen: 94% are still on 1st line – NVP+3TC+D4T 5% are on one of the alternative first lines – AZT or EFV or both less than 1% are on second line While 1% are on non-standard regimens

  24. Challenges – ART programme • Human resources-HCW, lab technicians etc • Infrastructure: more sites required for service delivery and current sites require expansion/renovation • Equipment and reagents including DNA-PCR and CD4 machines • Funding to meet the extra cost of the recommendations • Sample transportation system (CD4 & DBS)

  25. The end • Thank you

  26. Issues

  27. Issues cont’d

  28. AZT vs TDF and NVP vs EFV

  29. CD4 & Viral load Point of care CD4 and Viral load when available will enable early initiation of ART using CD4 and VL monitoring for ART failure - Currently more feasible to roll out VL for ART failure than CD4 testing due to DBS for VL Monitoring of patients for ART failure currently will entail >200,000 viral loads per year Sample transportation systems will need to be strengthened /established

  30. Group Work 4 groups Group 1 – Earlier start & regimen change Group 2 – Phase out plan for D4T, lab monitoring, baseline, monitoring and ART failure Group 3 – ART in Pregnancy, HIV/TB, HIV/HBV Group 4 - PMTCT

  31. Conclusion • Trends: • Encourage earlier diagnosis • Treat earlier • Promote less toxic/ more friendly regimens • Monitor more strategically • But Will cost more • The major operational question is not if these recommendations should be followed or not, but how to do it safely, with equity… and how to fund it!!

  32. Thank you • Dr Zengani Chirwa

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