06b arv treatment guidelines (national)

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  • 8/10/2019 06b ARV Treatment Guidelines (National)

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    Perform Adherence Counseling

    95% adherence rate is required to prevent the

    development of drug resistance.

    Pretreatment education- give IEC materials

    Pre-treatment counseling

    Identify potential barriers to adherence and resolve

    incorporate cART in patients daily routine

    resolve issues regarding work schedules andtravel

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    1. Complete Blood Count (CBC)

    2. TB Screening: sign and symptoms, chest x-

    ray, sputum smear and/or gene expert

    3. Pregnancy test for females of reproductive

    age

    4. Hepatitis B screening (HBsAg)

    5. CD4 cell count

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    Recommended regiment for Adults and adolescents (> 10 years of age)

    1. First line regimen: 2 NRTI + 1 NNRTI

    i. Preferred first line NRTIs : Zidovudine (AZT) + Lamivudine (3TC)

    ii. Alternative first line NRTI: Tenofovir (TDF) + Lamivudine (3TC)

    iii. First line NNRTI: Nevirapine (NVP) or Efavirenz (EFV)

    In the Philippines, 70-75% PLHIV tolerates Nevirapine (NVP) thus patients

    with thorough understanding of the implications of both drugs in terms of

    immediate and long-term effects has option to choose whether he will be

    initiated with either NVP or EFV as first-line NNRTL History of allergy or atopy

    does not correlate to hypersensitivity to NVP.

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    Recommended first line combination antiretroviral therapy (cART)

    i. Normal hemoglobin, no rifampicin: AZT + 3TC + (NVP or EFV)

    ii. Normal hemoglobin, with rifampicin: AZT + 3TC + EFV

    iii. Low hemoglobin, no rifampicin: TDF + 3TC + ( NVP or EFV)

    iv. Low hemoglobin, with rifampicin: TDF + 3TC + EFV

    v. With hepatitis B needing treatment: TDF + 3TC + EFV

    Low hemoglobin

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    Monitoring for ARV Toxicity

    1. For AZT-containing regimen:

    CBC (after 2, 4,8 ,12 weeks and then every 6 months or as

    indicated

    2. For TDF-containing regimen:

    Serum creatinine within 6 months of initiation then every 12 months

    or as indicated

    3. For PI-containing regimen:

    Baseline lipid profile and FBS within 6 months then every 12 months

    or as indicated

    4. For EFV-containing regimen:Baseline lipid profile within 6 months then every 12 months or as

    indicated

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    Monitor response to treatment

    1. Clinical Response

    Frequency of clinical monitoring with depend on patients

    response to ART. Patients should be followed-up on the

    minimum, at 2,4,8, and 12 weeks after starting ART and every

    six months one patient has been assessed to be stable.

    Reassessment of clinical stage and assessment of symptoms ofdrug toxicities should be made every visit. For patients with good

    compliance to ARV therapy, clinical response is recommended

    to be used together with CD4 count and viral load determination

    (whenever feasible) to detect treatment failure.

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    Clinical failure is defined as a new or recurrent clinical

    event indicating severe immunodeficiency (WHO clinicalstage 4) after 6 months of effective treatment. This

    should be differentiated from Immune Reconstitution

    Inflammatory Syndrome (IRIS) wherein exacerbation of

    previously subclinical coexisting infections (e.g. TB) may

    occur, resulting in an apparent worsening of disease after

    initiating ART. IRIS, the switching of ART would be

    inappropriate.

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    2. Immunologic Response

    Patients who initiated therapy with very low baseline CD4 T cell count

    may have less response to therapy. As a general rule, new and

    progressive severe immunodeficiency as demonstrated by declining

    CD4 cell counts should trigger a switch in therapy. However, any

    measurement that may indicate the need to consider switching should

    be repeated and the low level confirmed before any change is

    implemented. Where resources are available, CD4 T cell count may be

    done every sic months for mentoring.

    Reasonable working definitions of immunological failure are:

    1. CD4 count fails to the baseline (or below) or

    2. Persistent CD4 level below 100 cells/mm3

    3. No concomitant or recent infection to cause a transient decline in theCD4 cell count

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    3. Virologic Response

    Virologic failure is defines as plasma viral load above1,000 copies/ml based on two consecutive viral load

    measurement after 4-8 weeks, with adherent support.

    An individual must be taking ART for at least 6

    months before it can determined that a regimen has

    failed. If treatment failure is considered viral assay

    must be done before any change or shift on ART

    regimen. Where resources are available, viral load

    assay may be done on the first 12-month of regimen

    and every 12 month thereafter.

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    F. Change of Treatment Regimen

    1. Drug toxicity and side effects (See Annex 2)

    Antiretroviral drugs are substituted with drugs belonging to the same ARV class (eg.

    TDF for AZT where anemia occurs, or efavirenz for nevirapine for hypersensitivity

    reactions). Delaying substitutions or switches in drugs when there are signs of

    adverse drug effects may cause harm and may affect adherence, leading to drugresistance and treatment failure.

    2. Treatment failure

    It is very important to regularly assess patients for treatment failure, determine the

    reasons for these and institute appropriate management immediately. If poor

    compliance is the cause of treatment failure, counseling for adherence must be

    intensified and the current regimen continued. Viral load test must be done 4-8

    weeks after to reassess response to treatment.

    3. Patients who are candidates for second-line ARV must be managed in close

    coordination with the Research Institute for Tropical Medicine.

    4. Drug interactions

    The physician should be aware of all the drugs that the patient is taking when

    initiating ART and during treatment maintenance.

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    G. Lifelong ARV for HIV infected women

    Once ARV therapy is initiated in HIV infected pregnant and breastfeeding women, it

    should be maintained as lifelong treatment even after the delivery and cessation of

    breastfeeding

    I. Manage HIV and TB co-infection:All PLHIV should be regularly screened for TB co-infection based on the revised

    policies and guidelines in the Collaborative Approach of TB and HIV Prevention and

    Control. TB Diagnosis and treatment follow the National Tuberculosis Program (NTP)

    Guidelines.

    Anti-tuberculosis treatment should be initiated first, followed by ART as soon aspossible after the first two weeks of TB treatment. Patients should be monitored

    closely for signs and symptoms of hepatotoxicity.

    J. Manage HIV and Hepatitis B and C Co-infection:

    Hepatitis B and C treatment follows the existing international guidelines. However,

    the patients should be followed up more closely because of the major risk of drug-

    related interactions of some ARV with anti-HCV drugs