ARV Treatment Rules for a General Wellbeing Approach Item Choice for HIV Treatment Vincent Habiyambere January 2006.

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ARV Treatment Guidelines for a Public Health Approach Product Selection for HIV Treatment Vincent Habiyambere January 2006 key

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Outline Unit 1 Treatment Therapeutic & clinical objectives in HIV/AIDS Treatment of HIV diseases in different populace bunches when to begin treatment ; WHO Clinical Staging for grown-ups and youths Treatment of Opportunistic Infections (OI) alluring

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Outline Unit 2 Product Selection Basic components of the choice procedure Selection of ARVs in view of treatment conventions Public wellbeing contemplations of 1 st line regimens Major issues of 2 nd line regimens WHO prescribed 1 st & 2 nd line regimens for grown-ups and teenagers WHO suggested 1 st & 2 nd line regimens for kids Simplified rules Dosages of ARVs for Adults and young people Non ARV fundamental wares attractive

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Unit 1 Treatment key

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Global synopsis of the HIV and AIDS pandemic, December 2005 Number of individuals 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 recently tainted with HIV in 2005 Total 4.9 million Adults 4.2 million Children under 15 years 700 000 AIDS passings in 2005 Total 3.1 million Adults 2.6 million Children under 15 years 570 000 . key

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1.1 Goals in HIV/AIDS Treatment Reduction of HIV related horribleness and mortality Improved wellbeing status, personal satisfaction with impacts for the individual, the family and the general public Restoration and protection of immunology capacities Maximal and tough concealment of viral replication Reduced requirement for medicinal mediation and bolster Prevention/diminishment of medication safe strains of HIV and OI\'s Reduction and control of medication reactions and backing for adherence key

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Pre-Conditions for Treatment Adequate social backing and patient guardian accessible Adequate sustenance supplies Adequate wellbeing offices close-by Appropriate instruction for the patient re: adherence and symptom issues Adequate testing and checking accessible key

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Basic Components of HIV/AIDS Treatment Use of Antiretrovirals to forestall replication of the Human Immunodeficiency Virus (HIV) in cells Treatment of Opportunistic Infections brought about by a debilitated insusceptible framework Monitoring, assessment and change of treatment to avoid drug resistance; to boost impacts of ART and to minimize results of lethality and reactions. applicable

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1.2 Treatment of HIV Infections in Various Population Groups Adults and youths Pregnant ladies or ladies of kid bearing age Children People with TB & HIV Co-contamination Health and crisis laborers after word related presentation Victims of rape key

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ARV Therapy: A Public Health Approach key

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The new WHO ARV Guidelines Standardization of ARV treatment will take into consideration more fast execution: simpler to prepare experts less demanding to get ARVs, diminish stock outs less demanding to assess adequacy less demanding to screen patients key

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A general wellbeing way to deal with antiretroviral treatment Key specialized inquiries: When ought to treatment be begun? What medications can be utilized? At the point when and in what capacity ought to medications be changed? In what capacity ought to medicines be observed? key

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1. At the point when to Start ARV in Adults/Adolescents If CD4 testing accessible: WHO stage IV illness, paying little respect to CD4 numbers WHO stage III malady, consider ART * utilizing CD4 cell checks <350/mm 3 to help basic leadership WHO stage I or II if CD4 cell counts</=200/mm 3 * In this circumstance, the choice to begin or concede ARV treatment ought to take in thought not just the CD4 cell tally and its advancement, additionally attendant clinical conditions If CD4 testing not available*: WHO stages IV & III infection, paying little heed to aggregate lymphocyte tally (TLC) WHO stage II sickness with TLC </=1200/mm 3 * TLC=total lymphocyte include; just valuable symptomatic patients; without CD4 testing, would not treat stage I asymptomatic grown-up key

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WHO Clinical Stages for grown-ups and young people WHO Clinical Stage I (Asymptomatic) HIV constructive, no weight reduction No manifestations or just summed up lymphadenopathy Able to do ordinary exercises WHO Clinical Stage II (Mild ailment) Mild weight reduction (5-10%), minor ailment side effects: bruises or breaks around lips, tingling rash, H. Zoster, repetitive upper RI, sinusitis, intermittent mouth ulcers Still ready to do ordinary exercises significant

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WHO Clinical Stages for grown-ups and youths (Cont\'d) WHO Clinical Stage III (Moderate malady) Weight misfortune >10%, oral thrush (oral leukoplakia), more than 1 month loose bowels or fever, aspiratory TB, serious bacterial contaminations (pneumonia, muscle disease), TB lymphadenopathy, intense necrotizing ulcerative gingivitis/periodontitis, other bacterial diseases May be disabled <50% every day over a one month time span WHO Clinical Stage IV (Severe ailment: AIDS) AIDS characterizing sicknesses: squandering disorder, oesophageal thrush, >1 month H. simplex ulcerations, lymphoma, Kaposi sarcoma, intrusive cervical growth, Pneumocystis pneumonia, CMV retinitis, extrapulmonary TB, toxoplasma cerebrum boil, cryptococcal meningitis, HIV encephalopathy, instinctive leishmaniasis. Laid up >50%/day more than one month time span applicable

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Treatment of Opportunistic Infections (OI) Treat speedily as per national conventions, notwithstanding when ARV\'s are not accessible National conventions for the administration of OIs required Uninterrupted supply of Medicines for OIs required key

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2. Item Selection; Which ARV to utilize? key

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2.1 Basic Elements of the Selection Process Selection board of trustees is multi-disciplinary delegates of AIDS gathering, national medication model advisory group, HIV authorities (specialists, attendants drug specialists, acquisition pros) & PLWHA Drug choice ought to be founded on pre-decided criteria Fixed measurement blend ought to be considered to improve adherence Important to utilize INNs (int\'l nonproprietary names rather than brand names) key

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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 key

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First line regimens: the guideline 2 Nucleosides + 1 Non-nucleoside key

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List of ARVs found in the WHO EDL Nucleoside Reverse Transcriptase Inhibitors abacavir (ABC) didanosine (ddI) lamivudine (3TC) stavudine (d4T) zidovudine (ZDV or AZT) key

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List of ARVs found in the WHO EDL 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 (promoter for IDV, LPV, SQV) key

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Fixed Dose Combinations of Antiretrovirals planned for use in HIV+ Adults and Adolescents accessible toward 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) . key

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2.3 Considerations that Informed the Choice of First-Line ARV Regimens Potency Side impact profile Maintenance of future choices Predicted adherence Availability of settled measurement mixes of antiretrovirals Coexistent medicinal conditions (TB, and pregnancy or hazard thereof) Concomitant meds Presence of safe viral strain Cost and accessibility Limited framework Rural conveyance key

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2.4 Problems with second-line ARV regimens Multiple resistance transformations High pill trouble Limited experience TDF accessibility ABC excessive touchiness Cold chain for RTV High cost key

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First-Line Regimen Second-Line Regimen d4T or ZDV TDF or ABC Plus 3TC ddI 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 spots without cool chain key

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First-Line Regimen Second-Line Regimen d4T or ZDV ABC * Plus 3TC ddI 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 information on TDF in kids to prescribe it as option NRTI, and concerns re: bone poisonous quality of TDF key

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2.7 SIMPLIFIED GUIDELINES FOR ARV TREATMENT (HIV-1 INFECTION) If serious frailty If extreme CNS manifestations or pregnancy Substitute ZDV to d4T 1 st Line Regimen ZDV/3TC + EFV Substitute EFV to NVP If hepatitis or serious rash If extreme iron deficiency and neuropathy or pancreatitis Therapeutic Failure Substitute EFV to NFV Substitute ZDV to ddI (or ABC) If serious dislipidemia 2 nd Line Regimen TDF + ddI + LPV/r If renal disappointment Substitute LPV/r to NFV (or ATV/r) Substitute TDF to ABC TB/HIV If serious GI narrow mindedness Substitute LPV/r to SQV/r DISTRICT/REGIONAL LEVEL LOCAL LEVEL key Substitute ddI to ABC

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HIV-tainted pregnant ladies without signs for ARV treatment Alternative regimens (not in any request of inclination) key

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HIV-contaminated pregnant ladies with signs for ARV treatment Women Follow the treatment rules with respect to non-pregnant grown-ups aside from that EFV ought not be given in the primary trimester First-line regimens: ZDV + 3TC + NVP or d4T + 3TC + NVP Consider deferring starting ARV treatment until after the principal trimester, in spite of the fact that for extremely sick ladies the advantages of starting treatment early obviously exceed the potential dangers Infants ZDV for one week or single-dosage NVP or single-measurement NVP in addition to ZDV for one week key .:ts

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