Clinical Management Guidelines 2012

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Central American Course Monitoring and Evaluation for HIV/AIDS Policy and Program Management 1 2 3 4 Module 1 Unit 1 Clinical Management Guidelines 2012 National TB, HIV/AIDS & other STIs Programme Ministry of Health

Comprehensive Care HIV as a chronic disease All patients should enter care at the earliest stage possible T&C VCT and PITC Risk reduction interventions pre-art SRH for other STIs, pregnancy Nutritional counseling Mental health directly associated to HIV, some cases not

ART as prevention -? Early ART Maximizes treatment response Minimizes treatment complications (IRIS) Direct link to reduced morbidity and mortality ART as prevention reduced viral load

Predictors of Inadequate Adherence Regimen complexity and pill burden Low literacy level Active drug use or alcoholism Stigma Mental illness (especially depression) Cognitive impairment Lack of patient education Medication adverse effects Treatment fatigue

Predictors of Inadequate Adherence Age, race, sex, educational level, socioeconomic status, and a past history of alcoholism or drug use do NOT reliably predict suboptimal adherence Higher socioeconomic status and education levels and lack of history of drug use do NOT reliably predict optimal adherence

Predictors of Good Adherence Emotional and practical supports Convenience of regimen Understanding of the importance of adherence Belief in efficacy of medications Feeling comfortable taking medications in front of others Keeping clinic appointments Severity of symptoms or illness

Improving Adherence Establish readiness to start therapy Provide education on medication dosing Review potential side effects Anticipate and treat side effects Use educational aids including pictures, pillboxes, and calendars Simplify regimens, dosing, and food requirements Engage family, friends Utilize team approach with nurses, pharmacists, and peer counselors Provide accessible, trusting health care team

Screening / laboratory pre-art Tests Initial 6 months Annually Confirmation of HIV positive antibody status Physical examination, including height, weight, BMI, blood pressure, waist circumference CD4 count and % (optional: CD8 count and %) HIV RNA (viral load) Complete blood count AST, ALT, Alk phosphatase, calcium, phosphate, creatinine clearance Antibody tests for Hepatitis B, C and syphilis (if previously negative) Fasting blood glucose and lipids to include total LDL & HDL cholesterol and triglycerides Complete urinalysis Cardiovascular risk assessment Sexually Transmitted Infection (STI) screening (including anal swab) PSA Cervical Pap smear PPD - Negative PPD does not exclude active or latent tuberculosis.

Screening/Laboratory Monitoring (on ART) Tests Treatment Initiation 6 months Annually CD4 count and % (optional: CD8 count and %) HIV RNA (viral load) Complete blood count AST, ALT, Alk phosphatase, calcium, phosphate, creatinine clearance Antibody tests for Hepatitis B, C and syphilis (if previously negative) Fasting blood glucose and lipids to include total LDL & HDL cholesterol and triglycerides Complete urinalysis Cardiovascular risk assessment (according to ART) Sexually Transmitted Infection (STI) screening (including anal swab) Cervical Pap smear PPD - Negative PPD does not exclude active or latent tuberculosis.

Belize 2012 Guidelines:When to start? 1. It is recommended to treat all patients with CD4 counts of 350 cells/mm 3 irrespective of the WHO clinical stage. 2. It is recommended to treat all patients with WHO clinical stage 3 and 4 irrespective of CD4 count. In making these recommendations, the National HIV/AI DS Programme place high value on avoiding death, disease progression and the likely risk of HIV transmission over and above cost and feasibility. *Special consideration to the initiation of ART for those under 500 should be made on and individual basis. If patient is willing, understands the implications and is ready for ART Rapidly decreasing CD4 count (drop of 50 / 6 months) High viral load (>100,000 copies)

What to start? Zidovudine + lamivudine + Efavirenz zidovudine + lamivudine + Nevirapine Tenofovir + emtricitabine + efavirenz Tenofovir + emtricitabine + nevirapine

Selection of the 2 nd line regimen 1. A boosted protease inhibitor (bpi) plus two nucleoside analogues (NRTIs) are recommended for second-line ART. (Strong recommendation, moderate quality of evidence) 2. ATV/r and LPV/r are the recommended bpis for second-line ART, in Belize we will use LPV/r as the second line option (Strong recommendation, moderate quality of evidence) 3. Simplification of second NRTI options is recommended. oif d4t or AZT has been used in first-line therapy, use TDF + (3TC or FTC) as the NRTI backbone in second- line therapy. oif TDF has been used in first-line therapy, use AZT + 3TC as the NRTI backbone in second- line therapy. (Strong recommendation, moderate quality of evidence) 12