02.02 adult art initiation gsn


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02.02 adult art initiation gsn

  1. 1. Module 2: Anti Retroviral Therapy in Adults and Adolescent Unit 2: When to initiate Highly Active Anti Retroviral Therapy (HAART)
  2. 2. UNIT 2: Objectives <ul><li>Understand the principles and goal of successful antiretroviral therapy (ART) </li></ul><ul><li>Understand the components of a Highly Active Anti Retroviral Therapy (HAART) regimen and the rationale for use of national standardized ART regimens </li></ul><ul><li>Understand when ART should be initiated and who should be started on ART </li></ul><ul><li>Understand drug and non-drug related considerations prior to initiating ART </li></ul>
  4. 4. The comprehensive care team managing the patient Spouse/partner Other family and friends Community services Spiritual Care givers Occupational therapist Physiotherapist Doctors Nurses Counsellor Nutritionist
  5. 5. ART is part of the comprehensive care of HIV infection <ul><li>Clinical care of HIV involves – Multidisplinary team effort </li></ul><ul><ul><li>Counseling and continued support </li></ul></ul><ul><ul><ul><li>Diagnosis </li></ul></ul></ul><ul><ul><ul><li>Nutritional counseling </li></ul></ul></ul><ul><ul><ul><li>Adherence </li></ul></ul></ul><ul><ul><ul><li>Chronic illness with impact on lifestyle </li></ul></ul></ul><ul><ul><ul><li>Care of the dying and bereavement </li></ul></ul></ul><ul><ul><li>Management of OIs </li></ul></ul><ul><ul><ul><li>Screening </li></ul></ul></ul><ul><ul><ul><li>Prophylaxis </li></ul></ul></ul><ul><ul><ul><li>Treatment </li></ul></ul></ul><ul><ul><li>Reproductive health care </li></ul></ul><ul><ul><ul><li>Prevention and treatment of STIs </li></ul></ul></ul><ul><ul><ul><li>Contraception </li></ul></ul></ul><ul><ul><ul><li>Cervical Cytology </li></ul></ul></ul><ul><ul><ul><li>Pre and post natal care </li></ul></ul></ul><ul><ul><li>ART </li></ul></ul>
  6. 6. <ul><li>Develop a treatment partnership with your patient. </li></ul><ul><li>Focus on your patient’s concerns and priorities. </li></ul><ul><li>Use the 5 A’s: A ssess, A dvise, A gree, A ssist, A rrange. </li></ul><ul><li>Educate patient on disease and support patient self-management. </li></ul><ul><li>Or ganize proactive follow-up. </li></ul><ul><li>Involve peer educators and support staff in your health facility. </li></ul><ul><li>Link the patient to community-based resources and support. </li></ul><ul><li>Use written information—registers, Treatment Plan, treatment cards and written information for patients—to document, monitor, and remind. </li></ul><ul><li>Work as a clinical team. </li></ul><ul><li>Assure continuity of care. </li></ul>
  7. 7. AIM OF ART <ul><li>Improve symptom free longevity by </li></ul><ul><li>maximal, sustainable & durable suppression of viral replication (<50 copies/ml) </li></ul>
  8. 8. Principles of ART <ul><li>Antiretroviral treatment is part of the comprehensive care of HIV infection </li></ul><ul><li>Treatment should be planned and started in good time </li></ul><ul><li>Regular follow up and monitoring is essential </li></ul><ul><li>Treatment should be stopped/changed when necessary </li></ul><ul><li>The choice of drugs should take into account </li></ul><ul><ul><li>Efficacy </li></ul></ul><ul><ul><li>Tolerability </li></ul></ul><ul><ul><li>Dose Schedule </li></ul></ul><ul><ul><li>Affordability and availability </li></ul></ul>
  9. 9. Principles of ART cont’d <ul><li>ARV drugs are associated with adverse events and drug-drug interactions </li></ul><ul><li>Adherence is key to successful treatment </li></ul><ul><li>Treatment may fail despite patient’s and carer’s best efforts </li></ul><ul><li>There should be commitment to continued support of patient (and family) </li></ul>
  10. 10. Characteristics of good HAART <ul><li>Potent: should bring down viral load to an undetectable level within 3-4 months of therapy </li></ul><ul><li>Acceptable regimen to maximize adherence </li></ul><ul><li>- simple </li></ul><ul><li>- tolerable side effects </li></ul><ul><li>- patient commitment for life-long therapy </li></ul><ul><li>Reasonable options for future therapy </li></ul><ul><li>Affordable and sustainable </li></ul>
  11. 11. HAART…….Cont. <ul><li>HAART does not cure HIV but halts viral replication,thus prevent further disease progression and immune system damage </li></ul>
  12. 12. HISTORY OF ART <ul><li>1980 - 1987 - NO THERAPY </li></ul><ul><li>1987 - 1994 - MONO THERAPY </li></ul><ul><li>1994 - 1999 - COMBINATION THERAPY (HAART) </li></ul><ul><li>1999 - 2002 - COMPLICATED THERAPY </li></ul><ul><li>2002 - 2005 - SIMPLIFIED THERAPY </li></ul>
  13. 13. Goals of ART <ul><li>1. Maximal suppression of HIV replication </li></ul><ul><li>2. Restoration and preservation of immune function </li></ul><ul><li>3. Improved Quality of Life </li></ul><ul><li>4. Reduction of HIV related Morbidity and Mortality </li></ul>
  14. 14. 1. Suppression of HIV Replication <ul><li>ARVs must be taken in combination of at least 3 drugs </li></ul><ul><li>Strict adherence to treatment is of the utmost importance </li></ul><ul><ul><li><95% adherence allows the rapid development of viral resistance </li></ul></ul><ul><ul><li>Poor adherers do badly </li></ul></ul><ul><ul><ul><li>Fail treatment much earlier </li></ul></ul></ul>
  15. 15. 2. Immune Reconstitution <ul><li>ART prevents CD4 destruction by HIV </li></ul><ul><li>CD4 cell count can recover </li></ul><ul><li>Improved function of CD4 cells </li></ul><ul><li>CD4 cells are central to the immune system </li></ul><ul><ul><li>So there is improved overall function of the immune system </li></ul></ul><ul><ul><li>It takes from 6 to 8 weeks for this to become evident clinically </li></ul></ul>
  16. 16. 3. Improvement of QOL <ul><li>Decreased hospitalizations </li></ul><ul><li>Decreased risk of illnesses </li></ul><ul><li>Increased general well-being </li></ul><ul><li>Reversal of weight loss </li></ul><ul><li>Ability to return to work </li></ul>
  17. 17. Take-home Messages about ART <ul><li>Not an emergency treatment </li></ul><ul><ul><li>Benefits take 6 to 8 weeks </li></ul></ul><ul><ul><li>Should not be initiated while an inpatient </li></ul></ul><ul><li>Treat opportunistic infections first </li></ul><ul><ul><li>OI’s cause >90% of morbidity in HIV </li></ul></ul><ul><ul><li>>90% of OI’s are simple to treat </li></ul></ul><ul><li>ART is only one part of HIV Care </li></ul><ul><ul><li>All who require ART should first be on CPT first </li></ul></ul><ul><li>Optimize nutrition </li></ul>
  18. 18. Take-home Messages about ART <ul><li>Adherence counselling essential </li></ul><ul><li>Patients should be able to demonstrate an understanding of: </li></ul><ul><ul><li>Importance of strict adherence </li></ul></ul><ul><ul><li>Their ability to afford drugs long term </li></ul></ul><ul><ul><li>Life-long treatment, monthly follow-up </li></ul></ul><ul><li>The Kenyan National Guidelines should be followed </li></ul><ul><ul><li>“ If you don’t agree with them, campaign for a </li></ul></ul><ul><ul><li>change rather than ignoring them!” </li></ul></ul>
  19. 19. Antiretroviral drugs: best practice <ul><li>Minimum combination of three drugs from at least 2 different classes drugs </li></ul><ul><ul><li>2 NRTIs + NNRTI </li></ul></ul><ul><ul><li>2 NRTIs + 2 PIs* </li></ul></ul><ul><ul><li>2 NRTIs + PI </li></ul></ul><ul><li>Never use mono- or dual- therapy </li></ul><ul><ul><li>Do not adequately suppress viral replication </li></ul></ul><ul><ul><li>Allow resistance to develop rapidly </li></ul></ul><ul><ul><ul><li>may adversely affect use of class of drugs involved </li></ul></ul></ul><ul><li>Triple nucleoside therapy (ABC+3TC+AZT) </li></ul><ul><ul><li>Best avoided especially in absence of viral load tests, treatment-experienced </li></ul></ul><ul><ul><li>Utility mainly in some cases of treatment simplification/rare cases of drug interactions* </li></ul></ul>
  20. 20. PROTOCOL FOR ART REGIMEN <ul><li>Confirmation of HIV diagnosis </li></ul><ul><li>Counseling for ART </li></ul><ul><li>Baseline investigations </li></ul><ul><li>Indications of therapy </li></ul><ul><li>Selection of regimens </li></ul><ul><li>Monitoring of ART </li></ul><ul><li>Switching of regimens </li></ul><ul><li>Resistance testing </li></ul>
  21. 21. BASELINE INVESTIGATIONS <ul><li>To Rule Out </li></ul><ul><li>Underlying O.Is </li></ul><ul><li>X-ray chest </li></ul><ul><li>Montoux test </li></ul><ul><li>Sputum for AFB </li></ul><ul><li>USG abdomen </li></ul><ul><li>FNAC/Biopsy of lymphnodes </li></ul><ul><li>VDRL </li></ul><ul><li>HbsAg </li></ul>For Monitoring ARV Hb CBC LFT RFT Blood sugar Urine Stool & S. Cholesterol S.Triglycerides S. Uric acid S.Creatinine S. Lactic acid S. Amylase Prognostic Investigations CD4 lymphocyte enumeration Plasma Viral load assays
  22. 22. When to Start ART in Adults and Adolescents <ul><li>Where CD4 Testing NOT available </li></ul><ul><li>WHO III & IV regardless of total Lymphocyte count </li></ul><ul><li>WHO II when total lymphocyte count <1200/mm3 </li></ul>
  23. 23. When to Start ART in Adults and Adolescents <ul><li>Where CD4 testing available </li></ul><ul><li>WHO I& II when CD4 < 250/mm 3 </li></ul><ul><li>WHO stage III when CD4 count < 350/mm3 </li></ul><ul><li>WHO stage IV irrespective of CD4 level </li></ul>
  24. 24. Guidance on Clinical Criteria <ul><li>In symptomatic patients with stage 3 and 4 disease CD4 is not essential for initiating treatment </li></ul><ul><li>The cut-off levels of CD4 count are not </li></ul><ul><ul><li>A sick, deteriorating patient with a CD4 of 210 should not be excluded from ART if otherwise able and keen to begin </li></ul></ul><ul><ul><li>A very well, stable patient with a CD4 of 180 could reasonably opt for close follow up and deferral of ART to a later date </li></ul></ul>
  25. 25. TB/HIV Co-infected Patients <ul><li>Always give TB treatment priority </li></ul><ul><li>All patients should be on cotrimoxazole prophylaxis </li></ul><ul><li>Optimum time to start ART in TB/HIV co-infected patients is not known </li></ul><ul><ul><li>Consider the risk of HIV progression if ART is delayed </li></ul></ul><ul><ul><li>Balance against risk of having to discontinue therapies because of toxicities, side effects, paradoxical reactions or unforeseen drug/drug interactions if ART is started </li></ul></ul>
  26. 26. ART and TB: When to start Start anti-TB treatment Consider clinical status: start ART as appropriate CD4 count not available Start anti-TB treatment Start ART after completion of TB treatment CD4 count 200-350/mm 3 Start anti-TB treatment Start ART after intensive phase CD4 count 100-200/mm 3 Start anti-TB treatment Start ART as soon as possible CD4 <100/mm 3 Treatment Recommendation CD4 Count
  27. 27. ART and TB <ul><li>ART is recommended for all patients with TB with CD4 counts < 200/mm 3 and should be considered in patients with CD4 counts < 350/mm 3 </li></ul><ul><li>In the absence of CD4 counts, ART is recommended for all patients with TB </li></ul>
  28. 28. Rationale Behind Standardized ARV Therapy <ul><li>Success of TB treatment program </li></ul><ul><li>Simplicity of prescribing </li></ul><ul><li>Preservation of certain ARV’s on a population level </li></ul><ul><li>Simple sequencing of 1 st to 2 nd line </li></ul><ul><li>Increased efficiency in drug procurement </li></ul><ul><li>Cost and availability of FDC’s </li></ul>
  29. 29. National Standard 1 st Line Regime for Adults and Adolescents <ul><li>Lamivudine </li></ul><ul><li>+ </li></ul><ul><li>Stavudine/ </li></ul><ul><li>Zidovudine </li></ul><ul><li>+ </li></ul><ul><li>Nevirapine </li></ul><ul><li>Lamivudine </li></ul><ul><li>+ </li></ul><ul><li>Stavudine/ </li></ul><ul><li>Zidovudine </li></ul><ul><li>+ </li></ul><ul><li>Efavirenz </li></ul>or
  30. 30. Standard 2nd Line Regime for Adults and Adolescents <ul><li>Didanosine (ddI) </li></ul><ul><li>+ </li></ul><ul><li>Abacavir (ABC) </li></ul><ul><li>+ </li></ul><ul><li>Lopinavir/ritonavir </li></ul><ul><li>(LPV/r) </li></ul><ul><li>Tenofovir (TDF) </li></ul><ul><li>+ </li></ul><ul><li>Abacavir (ABC) </li></ul><ul><li>+ </li></ul><ul><li>Lopinavir/ritonavir </li></ul><ul><li>(LPV/r) </li></ul>or
  31. 31. For Patients on Non-standard 1 st line Regimes… <ul><li>1 st Line </li></ul><ul><li>D4T+ddI+NNRTI </li></ul><ul><li>AZT+3TC+PI </li></ul><ul><li>AZT+3TC+ABC </li></ul><ul><li>2 nd Line </li></ul><ul><li>AZT /ABC+ 3TC+LPV/r </li></ul><ul><li>NNRTI+ABC+ddI </li></ul><ul><li>NNRTI/LPV/r+ TDF+ d4T </li></ul>
  32. 32. A note on Fixed Dose Combinations (FDC’s) <ul><li>WHO Approved FDC’s are available for: </li></ul><ul><ul><li>d4T/3TC/NVP </li></ul></ul><ul><ul><li>D4T/3TC </li></ul></ul><ul><ul><li>AZT/3TC </li></ul></ul><ul><li>Advantages </li></ul><ul><ul><li>Decreased pill burden </li></ul></ul><ul><ul><li>Increased adherence </li></ul></ul><ul><ul><li>Mono or duo-therapy not possible </li></ul></ul><ul><ul><li>Lower cost </li></ul></ul><ul><ul><li>Simplify stock control and forcasting </li></ul></ul><ul><li>GoK has chosen these for the National roll-out </li></ul>
  33. 33. Pregnancy and ART <ul><li>Not a contraindication for ART </li></ul><ul><li>In general, best to defer to after the first trimester (after organogenesis) </li></ul><ul><li>EFV contraindicated </li></ul><ul><li>ART greatly decreases vertical transmission </li></ul><ul><li>Also allows mother to remain well to care for her child </li></ul><ul><li>Avoid d4T and DDI together; increased risk of lactic acidosis </li></ul>
  34. 35. Patient Preparation <ul><li>Issue of lifelong continuous treatment </li></ul><ul><li>Expected benefits </li></ul><ul><li>Potential side effects of treatment and what to do </li></ul><ul><li>Necessity for regular follow up </li></ul><ul><li>Adherence and relation to outcome, drug resistance </li></ul><ul><li>Adjusting to changes in lifestyle </li></ul><ul><li>Recreational drug use </li></ul><ul><li>Use of concomitant medication </li></ul><ul><li>Medication not to be shared </li></ul><ul><li>Point of contact if needed </li></ul>
  35. 36. Considerations prior to starting ART <ul><li>Logistics </li></ul><ul><ul><li>Availability of ARVs </li></ul></ul><ul><ul><li>Sustainability </li></ul></ul><ul><li>Drug related </li></ul><ul><ul><li>Drug Interactions </li></ul></ul><ul><ul><ul><li>Co-infections </li></ul></ul></ul><ul><ul><ul><li>Contraception </li></ul></ul></ul><ul><ul><ul><li>Combined toxicity Patient factors </li></ul></ul></ul><ul><ul><li>Body weight </li></ul></ul><ul><ul><ul><li>60kg key in determining dose of Stavudine and Didanosine </li></ul></ul></ul><ul><ul><ul><li>Kids </li></ul></ul></ul><ul><li>Patient factors </li></ul><ul><ul><li>Previous ART use by patient </li></ul></ul><ul><ul><li>Pregnancy </li></ul></ul><ul><ul><ul><li>Not a contraindication for ART </li></ul></ul></ul><ul><ul><ul><li>Effects of ARVs on pregnant woman and fetus- largely unknown </li></ul></ul></ul><ul><ul><ul><li>Delay starting ARVs until 2 nd trimester </li></ul></ul></ul><ul><ul><ul><li>Avoid Efavirenz during 1 st trimester (and in women of child bearing potential) </li></ul></ul></ul>
  36. 37. When to Start: Early Initiation of Antiretroviral Therapy <ul><li>Benefits </li></ul><ul><ul><li>Control of viral replication and mutation </li></ul></ul><ul><ul><li>Preservation of immune system </li></ul></ul><ul><ul><li>Decreased risk of selection of resistant virus </li></ul></ul><ul><ul><li>Possible decreased risk of viral transmission </li></ul></ul><ul><li>Risks </li></ul><ul><ul><li>Drug-related reduction in quality of life </li></ul></ul><ul><ul><li>Greater cumulative drug-related adverse events </li></ul></ul><ul><ul><li>Possible earlier development of drug resistance </li></ul></ul><ul><ul><li>Limitation of future treatment options </li></ul></ul>
  37. 38. When to Start: Delayed Initiation of Antiretroviral Therapy <ul><li>Benefits </li></ul><ul><ul><li>Avoid negative effects on QOL and drug-related adverse events </li></ul></ul><ul><ul><li>Delay development of drug resistance </li></ul></ul><ul><ul><li>Preserve future treatment options </li></ul></ul><ul><li>Risks </li></ul><ul><ul><li>Possible risk of irreversible immune system destruction </li></ul></ul><ul><ul><li>Possible greater difficulty in suppressing viral replication </li></ul></ul><ul><ul><li>Greater likelihood of adverse events </li></ul></ul><ul><ul><li>Co-infections and drug interactions </li></ul></ul><ul><ul><li>Immune reconstitution </li></ul></ul><ul><ul><li>Possible increased risk of HIV transmission </li></ul></ul>
  38. 39. Summary <ul><li>HAART should be started in good time </li></ul><ul><li>Patient understanding and acceptance for ART is of utmost importance </li></ul><ul><li>ADHERENCE to ART is success to ART </li></ul><ul><li>National ART should be used for better management of the patient (Easy referral from public-private-public set up) </li></ul>
  39. 40. <ul><li>THANK YOU </li></ul>