ARV Treatment Guidelines for a Public Health Approach
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ARV Treatment Guidelines for a Public Health Approach Product Selection for HIV Treatment Vincent Habiyambere January 2006. Outline Unit 1 Treatment. Therapeutic & clinical goals in HIV/AIDS treatment Treatment of HIV infections in various population groups

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ARV Treatment Guidelines for a Public Health Approach

Product Selection for HIV Treatment

Vincent HabiyambereJanuary 2006

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Outline Unit 1Treatment

  • Therapeutic & clinical goals in HIV/AIDS treatment

  • Treatment of HIV infections in various population groups

  • when to start treatment ; WHO Clinical Staging for adults and adolescents

  • Treatment of Opportunistic Infections (OI)

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Outline Unit 2Product Selection

  • Basic elements of the selection process

  • Selection of ARVs based on treatment protocols

  • Public health considerations of 1st line regimens

  • Major problems of 2nd line regimens

  • WHO recommended 1st & 2nd line regimens for adults and adolescents

  • WHO recommended 1st & 2nd line regimens for children

  • Simplified guidelines

  • Dosages of ARVs for Adults and adolescents

  • Non ARV essential commodities

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Unit 1Treatment

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Global summary of the HIV and AIDS epidemic, December 2005

Number of people living with HIV in 2005 Total 40.3 million Adults 38.0 million Women 17.5 million Children under 15 years 2.3 million

People newly infected with HIV in 2005 Total 4.9 million Adults 4.2 million Children under 15 years 700 000

AIDS deaths in 2005 Total 3.1 million Adults 2.6 million Children under 15 years 570 000

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1.1 Goals in HIV/AIDS Treatment

  • Reduction of HIV related morbidity and mortality

  • Improved health status, quality of life with effects for the individual, the family and the society

  • Restoration and preservation of immunology functions

  • Maximal and durable suppression of viral replication

  • Reduced need for medical intervention and support

  • Prevention/reduction of drug resistant strains of HIV and OI’s

  • Reduction and control of drug side effects and support for adherence

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Pre-Conditions for Treatment

  • Adequate social support and patient care taker available

  • Adequate food supplies

  • Adequate health facilities nearby

  • Appropriate education for the patient re: adherence and side effect issues

  • Adequate testing and monitoring available

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Basic Components of HIV/AIDS Treatment

  • Use of Antiretrovirals to prevent replication of the Human Immunodeficiency Virus (HIV) in cells

  • Treatment of Opportunistic Infections caused by a weakened immune system

  • Monitoring, evaluation and adjustment of treatment to prevent drug resistance; to maximize effects of ART and to minimize consequences of toxicity and side effects.

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1.2 Treatment of HIV Infections in Various Population Groups

  • Adults and adolescents

  • Pregnant women or women of child-bearing age

  • Children

  • People with TB & HIV Co-infection

  • Health and emergency workers after occupational exposure

  • Victims of sexual assault

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ARV Therapy: A Public Health Approach

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The new WHO ARV Guidelines

  • Standardization of ARV therapy will allow for more rapid implementation:

    • easier to train professionals

    • easier to procure ARVs, reduce stock outs

    • easier to evaluate effectiveness

    • easier to monitor patients

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A public health approach to antiretroviral therapy

Key technical questions:

  • When should treatment be started?

  • What treatments can be used?

  • When and how should treatments be changed?

  • How should treatments be monitored?

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1. When to Start ARV in Adults/Adolescents

  • If CD4 testing available:

    • WHO stage IV disease, regardless of CD4 counts

    • WHO stage III disease, consider ART* using CD4 cell counts <350/mm3 to assist decision-making

    • WHO stage I or II if CD4 cell counts</=200/mm3

      * In this situation, the decision to start or defer ARV treatment should take in consideration not only the CD4 cell count and its evolution, but also concomitant clinical conditions

  • If CD4 testing not available*:

    • WHO stages IV & III disease, regardless of total lymphocyte count (TLC)

    • WHO stage II disease with TLC </=1200/mm3

      * TLC=total lymphocyte count; only useful in symptomatic patients; in absence of CD4 testing, would not treat stage I asymptomatic adult

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WHO Clinical Stages for adults and adolescents

  • WHO Clinical Stage I (Asymptomatic)

    • HIV positive, no weight loss

    • No symptoms or only generalized lymphadenopathy

    • Able to do normal activities

  • WHO Clinical Stage II (Mild disease)

    • Mild weight loss (5-10%), minor disease symptoms: sores or cracks around lips, itching rash, H. Zoster, recurrent upper RI, sinusitis, recurrent mouth ulcers

    • Still able to do normal activities

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WHO Clinical Stages for adults and adolescents(Cont'd)

  • WHO Clinical Stage III (Moderate disease)

    • Weight loss >10%, oral thrush (oral leukoplakia), over 1 month diarrhea or fever, pulmonary TB, severe bacterial infections (pneumonia, muscle infection), TB lymphadenopathy, acute necrotizing ulcerative gingivitis/periodontitis, other bacterial infections

    • May be bedridden <50% per day over a one month period

  • WHO Clinical Stage IV (Severe disease: AIDS)

    • AIDS defining illnesses: wasting syndrome, oesophageal thrush, >1 month H. simplex ulcerations, lymphoma, Kaposi sarcoma, invasive cervical cancer, Pneumocystis pneumonia, CMV retinitis, extrapulmonary TB, toxoplasma brain abscess, cryptococcal meningitis, HIV encephalopathy, visceral leishmaniasis.

    • Bedridden >50% /day over one month period

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Treatment of Opportunistic Infections (OI)

  • Treat promptly in accordance with national protocols, even when ARV’s are not available

  • National protocols for the management of OIs required

  • Uninterrupted supply of Medicines for OIs required

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2.1 Basic Elements of the Selection Process

  • Selection committee is multi-disciplinary

    • representatives of AIDS council, national drug formulary committee, HIV specialists (doctors, nurses pharmacists, procurement specialists) & PLWHA

  • Drug selection should be based on pre-determined criteria

  • Fixed dose combination should be considered to optimize adherence

  • Important to use INNs (int'l nonproprietary names instead of brand names)

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2.2 Selection of ARV’s Based on National Treatment Protocols

  • First line ARV treatment

  • Second line ARV treatment

  • PMTCT

  • Post Exposure prophylaxis

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First line regimens: the principle Protocols

2 Nucleosides

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1 Non-nucleoside

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List of ARVs found in the WHO EDL Protocols

Nucleoside Reverse Transcriptase Inhibitors

  • abacavir (ABC)

  • didanosine (ddI)

  • lamivudine (3TC)

  • stavudine (d4T)

  • zidovudine (ZDV or AZT)

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List of ARVs found in the WHO EDL Protocols

Non - nucleoside Reverse Transcriptase Inhibitors

  • efavirenz (EFV or EFZ)

  • nevirapine (NVP)

    Protease Inhibitors (PI)

  • indinavir (IDV)

  • lopinavir+ritonavir (LPV/r)

  • nelfinavir (NFV)

  • saquinavir (SQV)

  • ritonavir (booster for IDV, LPV, SQV)

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Fixed Dose Combinations of Antiretrovirals intended for use in HIV+ Adults and Adolescents available at the end of 2003

Three-Drug Fixed Dose Combinations

d4T (30 mg) + 3TC (150 mg) + NVP (200 mg)

d4T (40 mg) + 3TC (150 mg) + NVP (200 mg)

ZDV (300 mg) + 3TC (150 mg) + NVP (200 mg)

ZDV (300 mg) + 3TC (150 mg) + ABC (300 mg)

Two-Drug Fixed Dose Combinations

(for use with a third ARV and for NVP lead-in dosing)

d4T (30 mg) + 3TC (150 mg)

d4T (40 mg) + 3TC (150 mg)

ZDV (300 mg) + 3TC (150 mg)

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2.3 Considerations that Informed the Choice of First-Line ARV Regimens

  • Potency

  • Side effect profile

  • Maintenance of future options

  • Predicted adherence

  • Availability of fixed dose combinations of antiretrovirals

  • Coexistent medical conditions (TB, and pregnancy or risk thereof)

  • Concomitant medications

  • Presence of resistant viral strain

  • Cost and availability

  • Limited infrastructure

  • Rural delivery

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2.4 Problems with second-line ARV regimens ARV Regimens

  • Multiple resistance mutations

  • High pill burden

  • Limited experience

  • TDF availability

  • ABC hypersensitivity

  • Cold chain for RTV

  • High cost

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First-Line Regimen ARV Regimens

Second-Line Regimen

d4T or ZDV

TDF or ABC

Plus

Plus

3TC

ddI

Plus

Plus

NVP or EFZ

Protease inhibitor:

LPV/r or SQV/r *

2.5 WHO Recommended First and Second-Line ARV Regimens for HIV Treatment in Adults/Adolescents

* NFV in places without cold chain

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First-Line Regimen ARV Regimens

Second-Line Regimen

d4T or ZDV

ABC *

Plus

Plus

3TC

ddI

Plus

Plus

NVP or EFZ

Protease inhibitor:

LPV/r or NFV,

or SQV/r if wt >25 kg

2.6 WHO Recommended First and Second-Line ARV Regimens for Treatment in Children

* Insufficient PK data on TDF in children to recommend it as

alternative NRTI, and concerns re: bone toxicity of TDF

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2.7 SIMPLIFIED GUIDELINES FOR ARV TREATMENT ARV Regimens(HIV-1 INFECTION)

If severe anemia

If severe CNS symptoms or pregnancy

Substitute ZDV to d4T

1st Line Regimen

ZDV/3TC + EFV

Substitute EFV to NVP

If hepatitis or severe rash

If severe anemia and neuropathy or pancreatitis

Therapeutic Failure

Substitute EFV to NFV

Substitute ZDV to ddI (or ABC)

If severe dislipidemia

2nd Line Regimen

TDF + ddI + LPV/r

If renal failure

SubstituteLPV/r to NFV (or ATV/r)

Substitute TDF to ABC

TB/HIV

If severe GI intolerance

Substitute LPV/r to SQV/r

DISTRICT/REGIONAL LEVEL

LOCAL LEVEL

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Substitute ddI to ABC


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HIV-infected pregnant women without indications for ARV treatment

Alternative regimens (not in any order of preference)

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HIV-infected pregnant women with indications for ARV treatment

  • Women

  • Follow the treatment guidelines as for non-pregnant adults except that EFV should not be given in the first trimester

  • First-line regimens:

    • ZDV + 3TC + NVP or

    • d4T + 3TC + NVP

  • Consider delaying initiating ARV treatment until after the first trimester, although for severely ill women the benefits of initiating treatment early clearly outweigh the potential risks

  • Infants

    • ZDV for one week or

    • single-dose NVP or

    • single-dose NVP plus ZDV for one week

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    Post-exposure prophylaxis (PEP) treatment

    • Start PEP as soon as possible after exposure to HIV (within 72 H) for a duration of 28 days (4 weeks).

    • Most commonly used for PEP:

      • Bitherapy: AZT + 3 TC (Zidovudine, Lamivudine) (combivir)

      • 300mg AZT+150mg 3TC twice per day for 28 days

      • Triple combination: AZT + 3 TC + IDV

      • Twice per day Combivir and 3 times IDV 800mg per day

      • or other PI such as NFV, LPV/r

    • If drug resistant HIV strain is suspected referral to a specialist is necessary

    • Consider also psychological support, prevention of STIs & unwanted pregnancy

      • Clinical Management of Rape Survivors, WHO & UNHCR, 2004: Revised Edition

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    Drug class/drug treatment

    Nucleoside RTIs

    Abacavir (ABC)

    Didanosine (ddl)

    Lamivudine (3TC)

    Stavudine (d4T)

    Zidovudine (ZDV)

    Nucleotide RTI

    Tenofovir (TDF)

    Dose

    300 mg twice daily

    400 mg once daily

    (250 mg once daily if <60 kg)

    (250 mg once daily if administered with TDF)

    150 mg twice daily or 300 mg once daily

    40 mg twice daily

    (30 mg twice daily if <60 kg)

    300 mg twice daily

    300 mg once daily

    (Note: drug interaction with ddl necessitates dose reduction

    of latter)

    2.8 Dosages of Antiretroviral Drugs for Adults and Adolescents

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    Drug class/drug treatment

    Non-nucleoside RTIs

    Efavirenz (EFV)

    Nevirapine (NVP)

    Protease inhibitors

    Indinavir/ritonavir (IDV/r)

    Lopinavir/ritonavir

    Nelfinavir (NFV)

    Saquinavir/ritonavir (SQV/r)

    Dose

    600 mg once daily

    200 mg once daily for 14 days, then 200 mg twice daily

    800 mg/100 mg twice daily

    400 mg/100 mg twice daily

    533 mg/133 mg twice daily when combined with EFV or NVP)

    1250 mg twice daily

    1000 mg/100 mg twice daily or 1600 mg/200 mg once daily

    Dosages of Antiretroviral Drugs for Adults and Adolescents

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    2.9 Non ARV’s Essential commodities for care of PLWHA treatment

    • Essential HIV and related testing materials and reagents

    • Essential medicines for Opportunistic Infections

    • Medicines for pain relief, palliative care, and mental health problems

    • Condoms

    • Medical supplies: gloves, syringes, needles

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    Conclusion: MAJOR QUESTIONS IN WHO ART GUIDELINES treatment

    WHEN TO START

    WHICH ARVs

    WHEN TO SUBSTITUTE

    WHO GLOBAL RECOMMENDATIONS

    REGIONAL AND COUNTRY CRITERIA

    WHEN TO SWITCH

    WHEN TO STOP

    DRUG FORMULARY

    1ST AND 2ND REGIMENS

    BASIC INFO FOR FORECASTING AND PROCUREMENT

    SPECIAL SITUATIONS

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    Major references treatment

    • Scaling up ARV Therapy in resource limited settings: Treatment guidelines for a public Health Approach – WHO, 2003

    • WHO Model List of Essential Medicines – WHO, March 2005(14th Edition)

    • Clinical Management of Rape Survivors - UNHCR and WHO 2004.

      Available on CD rom and more information on the AMDS website:

      http://www.who.int/3by5/amds/en/

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