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INITIAL MANAGEMENT OF THE PATIENT LIVING WITH HIV PART 3 INITIATING THERAPY

INITIAL MANAGEMENT OF THE PATIENT LIVING WITH HIV PART 3 INITIATING THERAPY. Objectives. After completing this session the participant should be able to: Discuss the goals of HIV treatment. Understand when resistance testing should be performed.

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INITIAL MANAGEMENT OF THE PATIENT LIVING WITH HIV PART 3 INITIATING THERAPY

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  1. INITIAL MANAGEMENT OF THE PATIENT LIVING WITH HIVPART 3INITIATING THERAPY

  2. Objectives • After completing this session the participant should be able to: • Discuss the goals of HIV treatment. • Understand when resistance testing should be performed. • Discuss the potential benefits and concerns for early treatment initiation.

  3. Goals of Treatment • Reduce HIV-related morbidity; prolong duration and quality of survival • Restore and/or preserve immunologic function • Maximally and durably suppress HIV viral load • Prevent HIV transmission AETC NRC http://www.aidsetc.org February, 2013

  4. Tools to Achieve Treatment Goals • Selection of ARV regimen • Maximizing adherence • Pretreatment resistance testing AETC NRC http://www.aidsetc.org February, 2013

  5. Improving Adherence • Support and reinforcement • Simplified dosing strategies • Reminders, alarms, timers, and pillboxes • Ongoing patient education • Trust in primary care provider AETC NRC http://www.aidsetc.org February, 2013

  6. Use of CD4 Cell Levels to Guide Therapy Decisions • CD4 count • The major indicator of immune function • Most recent CD4 count is best predictor of disease progression • A key factor in determining urgency of ART or need for OI prophylaxis • Important in determining response to ART • Adequate response: CD4 increase 50-150 cells/µL per year • CD4 monitoring • Check at baseline (x 2) and at least every 3-6 months* * May consider every 6-12 months in clinically stable patients on ART with sustained HIV RNA suppression and CD4 status well above threshold for opportunistic infection risk. AETC NRC http://www.aidsetc.org February, 2013

  7. Use of HIV RNA Levels to Guide Therapy Decisions • HIV RNA • May influence decision to start ART and help determine frequency of CD4 monitoring • Critical in determining response to ART • Goal of ART: HIV RNA below limit of detection (i.e., <20-75 copies/mL, depending on assay) • Commercially available assays do not detect HIV-2 AETC NRC http://www.aidsetc.org February, 2013

  8. Use of HIV RNA Levels to Guide Therapy Decisions(2) • RNA monitoring • Check at baseline (x 2) • Immediately before initiating ART • 2-4 weeks (not more than 8 weeks) after start or change of ART, then every 4-8 weeks until suppressed to <200 copies/mL • Every 3-4 months with stable patients; may consider every 6 months for stable adherent patients with VL suppression >2-3 years • Isolated “blips” may occur (transient low-level RNA, typically <400 copies/mL), are not thought to predict virologic failure • ACTG defines virologic failure as confirmed HIV RNA >200 copies/mL AETC NRC http://www.aidsetc.org February, 2013

  9. Testing for Drug Resistance • Before initiation of ART: • Transmitted resistance in 6-16% of HIV-infected patients • In absence of therapy, resistance mutations may decline over time and become undetectable by current assays, but may persist and cause treatment failure when ART is started • Identification of resistance mutations may optimize treatment outcomes • Resistance testing (genotype) recommended for all at entry to care • Recommended for all pregnant women • Patients with virologic failure: • Perform while patient is taking ART, or ≤4 weeks after discontinuing therapy • Interpret in combination with history of ARV exposure and ARV adherence AETC NRC http://www.aidsetc.org February, 2013

  10. Drug Resistance Testing: Recommendations AETC NRC http://www.aidsetc.org February, 2013

  11. Drug Resistance Testing: Recommendations (2) AETC NRC http://www.aidsetc.org February, 2013

  12. Drug Resistance Testing: Recommendations (3) AETC NRC http://www.aidsetc.org February, 2013

  13. Drug Resistance Testing: Recommendations (4) AETC NRC http://www.aidsetc.org February, 2013

  14. Other Assessment and Monitoring Studies • HLA-B*5701 screening • Recommended before starting ABC, to reduce risk of hypersensitivity reaction (HSR) • HLA-B*5701-positive patients should not receive ABC • Positive status should be recorded as an ABC allergy • If HLA-B*5701 testing is not available, ABC may be initiatedafter counseling and with appropriate monitoring for HSR • Coreceptor tropism assay • Should be performed when a CCR5 antagonist is being considered • Phenotype assays have been used; genotypic test now available but has been studied less thoroughly • Consider in patients with virologic failure on a CCR5 antagonist (though does not rule out resistance to CCR5 antagonist) AETC NRC http://www.aidsetc.org February, 2013

  15. Rationale for ART • Effective ART with virologic suppression improves and preserves immune function in most patients, regardless of baseline CD4 count • Earlier ART may result in better immunologic responsesand clinical outcomes • Reduction in AIDS- and non-AIDS-associated morbidity and mortality • Reduction in HIV-associated inflammation and associated complications • ART strongly indicated for all patients with low CD4 count or symptoms • ART can significantly reduce risk of HIV transmission • Recommended ARV combinations are effective andwell tolerated AETC NRC http://www.aidsetc.org February, 2013

  16. When to Start ART • Exact CD4 count at which to initiate therapy not known, but evidence points to starting at higher counts • Current recommendation: ART for all AETC NRC http://www.aidsetc.org February, 2013

  17. Recommendations for Initiating ART • ART is recommended for treatment: • “ART is recommended for all HIV-infected individuals to reduce the risk of disease progression.” • The strength of this recommendation varies on the basis of pretreatment CD4 count (stronger at lower CD4 levels) AETC NRC http://www.aidsetc.org February, 2013

  18. Recommendations for Initiating ART • ART is recommended for prevention: • “ART also is recommended for HIV-infected individuals for the prevention of transmission of HIV.” AETC NRC http://www.aidsetc.org February, 2013

  19. Rating Scheme for Recommendations • Strength of recommendation: • Strong • Moderate • Optional • Quality of evidence: • ≥1 randomized controlled trials • ≥1 well-designed nonrandomized trials or observational cohort studies with long-term clinical outcomes • Expert opinion AETC NRC http://www.aidsetc.org February, 2013

  20. Recommendations for Initiating ART: CD4 Count or Clinical Category AETC NRC http://www.aidsetc.org February, 2013

  21. Recommendations for Initiating ART: Prevention AETC NRC http://www.aidsetc.org February, 2013

  22. Recommendations for Initiating ART: Considerations AETC NRC http://www.aidsetc.org February, 2013

  23. Potential Benefits of Early Therapy • Untreated HIV may be associated with development of AIDS and non-AIDS-defining conditions • Earlier ART may prevent HIV-related end-organ damage; deferred ART may not reliably repair damage acquired earlier • Increasing evidence of direct HIV effects on various end organs and indirect effects via HIV-associated inflammation • End-organ damage occurs at all stages of infection AETC NRC http://www.aidsetc.org February, 2013

  24. Potential Benefits of Early Therapy (2) • Potential decrease in risk of many complications, including: • HIV-associated nephropathy • Liver disease progression from hepatitis B or C • Cardiovascular disease • Malignancies (AIDS defining and non-AIDS defining) • Neurocognitive decline • Blunted immunological response owing to ART initiation at older age • Persistent T-cell activation and inflammation AETC NRC http://www.aidsetc.org February, 2013

  25. Potential Benefits of Early Therapy: Supporting data • CD4 count 350 cells/µL or history of AIDS-defining illness: • Randomized control trial (RCT) data show decreased morbidity and mortality with ART • CD4 count 350-500 cells/µL: • RCT data as well as nonrandomized trials and cohort data support morbidity and perhaps mortality benefit of ART AETC NRC http://www.aidsetc.org February, 2013

  26. Potential Benefits of Early Therapy: Supporting data (2) • CD4 count >500 cells/µL • Cohort study data are not consistent; some show survival benefit if ART initiated • Other considerations (eg, potential benefit of ART on non-AIDS complications, HIV transmission risk) support recommendation for ART AETC NRC http://www.aidsetc.org February, 2013

  27. Potential Concerns about Early Therapy • ARV-related toxicities • Nonadherence to ART • Drug resistance • Cost AETC NRC http://www.aidsetc.org February, 2013

  28. Consider More-Rapid Initiation of ART • Pregnancy • AIDS-defining condition • Acute opportunistic infection • Lower CD4 count (eg, <200 cells/µL) • Acute/recent infection • Rapid decline in CD4 • Higher viral load (eg, >100,000 copies/mL) • HIVAN • HBV coinfection • HCV coinfection AETC NRC http://www.aidsetc.org February, 2013

  29. Consider Deferral of ART • Clinical or personal factors may support deferral of ART • If CD4 count is low, deferral should be considered only in unusual situations, and with close follow-up • When there are significant barriers to adherence • If comorbidities complicate or prohibit ART • “Elite controllers” and long-term nonprogressors AETC NRC http://www.aidsetc.org February, 2013

  30. Current ARV Medications * EVG currently available only in coformulation with cobicistat (COBI)/TDF/FTC AETC NRC http://www.aidsetc.org February, 2013

  31. Case Study Discussion

  32. Case 1 • A 32 year old woman presents for FU care. She was dx 8 mo ago. After returning for the confirmatory results she has missed her next 2 appointments. She admits to THC use and states she last had a beer 4 days ago. She is anxious, talkative, and smells of ETOH. Her CD4 count is 448 and the HIV RNA is 88,375. The Genotype indicates no drug resistance. She has Medicaid and states she is eager to start medication today. • Discuss your concerns for this patient and how you would address them. • How do you address her eagerness to start ARV’s.

  33. Websites to Access the Guidelines • http://aidsinfo.nih.gov • http://www.aidsetc.org AETC NRC http://www.aidsetc.org February, 2013

  34. Howard University HURB 1 1840 7th Street NW, 2nd Floor Washington, DC 20001 202-865-8146 (Office) 202-667-1382 (Fax) www.capitolregiontelehealth.org www.aetcnmc.org

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