CLINICAL GUIDELINES FOR THE MANAGEMENT OF HIV & AIDS IN .

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CLINICAL GUIDELINES FOR THEMANAGEMENT OF HIV & AIDS IN ADULTSAND ADOLOSCENTSNational Department of HealthSouth Africa 20101

Table of ContentsForeword. 4Abbreviations . 5Introduction . 71.Standardised National Eligibility Criteria for Starting ART Regimens for Adults and Adolescents . 82.Standardised National ART Regimens for Adults and Adolescents . 93.Standardized National Monitoring for Adults and Adolescents with HIV . 104.Standardised National ART and ARV Regimens for HIV Positive Pregnant Women and their Infants 115.Visit Scheduling for Adults with HIV . 126.Recommended ART Regimens for Treatment-Naive Adults and Adolescents. 146.1a)6.2First Line Therapy for Treatment-Naive Patients . 14Primary Treatment for ART-Naive Patients . 14Clinicial and Laboratory Monitoring of Patients on First Line Treatment . 16Routine Monitoring . 167.Adherence Support, Assessment and Monitoring . 177.1General Principles . 178.What to Expect in the First Four Months of Therapy . 199.When to Switch ART Regimens . 209.1Substituting Drugs in First Line Regimen . 209.2Treatment Failure . 209.3When to Switch from First Line to Second Line Therapy. 219.4Clinical and Laboratory Monitoring of Patients on Second Line Treatment. 219.5Management of Treatment Failure After Second Line Treatment . 219.6Management of Patients Previously Treated with Antiretroviral Therapy . 229.7Treatment Interruptions . 2210. Special Considerations . 2310.1TB Patients . 2310.2Hepatitis B Patients . 2410.3Patients with anaemia . 2411. Expectations Regarding Care . 2512. Diagnosis and Management of Adverse Events . 2612.1Principles of Managing Adverse Events . 2612.2Important Adverse Events . 2613. Patient Management . 2813.1Routine Patient Management. 28a)Patient weight . 282

b)TB Screening, INH Prevention and TB Diagnosis . 28c)INH Prophylaxis . 29d)Clinical HIV Stage . 29e)Opportunistic Infection Diagnosis and Management . 30f)CD4 and Viral Load monitoring . 30g)Cotrimoxazole Prophylaxis . 30h)STI Screen . 31i)Pap Smear . 31j)Immunizations. 31k)Family Planning . 31l)Mental Health Screen . 32m) Adherence Check . 32n)Prevent HIV Transmission and Reinfection . 32o)Provide Support. 32Annexure A: Creatinine Clearance Tables . 33Annexure B: Patient Adherence Record . 38Annexure C: Adverse Drug Reaction Reporting Form . 39Annexure D: WHO Clinical Staging . 41TablesTable 1: Eligibility Criteria . 8Table 2: National ART Regimens . 9Table 3: Standardized Monitoring (Pre-ART and on ART) . 10Table 4: Maternal Regimens . 11Table 5: Infant Regimens . 11Table 6: Visits Checklist . 13Table 7: Primary Regimen for ART-Naive Patients. 14Table 8: Containdications and Special Considerations . 14Table 9: Contraindications and Special Recommendations for Those Patients on Treatment . 16Table 10: Monitoring Tests . 16Table 11: Viral Load Monitoring and Recommended Responses . 20Table 12: Recommended Second Line Treatment for Patients Failing First Line Regimen . 21Table 13: Contraindications and Special Recommendations . 21Table 14: Rotutine Monitoring Tests for All HIV Positive Initiating/On Second Line Treatment . 21Table 15: Common Shared Side-Effects of TB and ART . 24Table 16: Important ART Adverse Reactions and Safety Monitoring . 263

ForewordIt is with pleasure that I present the new guidelines for the management of HIV-infected adolescentsand adults.Government has adopted a new outcome-based approach to accelerate attainment of the objectivesoutlined in the MTSF (Medium-Term Strategic Framework) 2009-2014; one of the objectives beingto improve the health profile of all South Africans. The 10 point plan of the Health Sector is aimedat creating a well functioning health system capable of producing improved health outcomes.Priority 7 of the 10 point plan alludes to accelerated implementation of the HIV/AIDS plan and thereduction of mortality due to TB and associated diseases.On the 1st December 2009, on World AIDS Day, the Honourable President Jacob Zuma announcedthe new key interventions to improve antiretroviral treatment (ART) access to special groups (allHIV-infected infants, and pregnant women and people with TB and HIV at CD4 less or equal to350/mm3), in order to decrease the disease burden, to address maternal and child mortality and toimprove life expectancy.This document serves as a new guidance to health practitioners with regard to the comprehensivemanagement of HIV infected adults and adolescents. The new ART regimens are described as wellas laboratory and clinical monitoring at diagnosis, at initiation of antiretroviral treatment and whilston treatment. It prioritizes integration of HIV with TB, maternal and child health (MCH), sexualand reproductive health (SRH), scaling up of TB preventive therapy (IPT), sexually transmittedinfections (STI) and access to contraceptives. Furthermore all HIV positive multi/extensive drugresistant TB (MDR/XDR-TB) patients will commence ART regardless of CD4 count.The many comments, additions and overall involvement from internal and external stakeholders iscommended and has contributed to the excellence of the guidelines. I would like to thank them allfor the development of these guidelines despite their busy schedules.DR. AARON MOTSOALEDIMINISTER OF HEALTHDATE:4

FCPTddId4TDOTEEFVELISA dineAbacavirAcquired immune deficiency syndromeAlanine TransaminasesAntiretroviral therapyAntiretroviralZidovudineBacille Calmette Guerin (TB vaccine)Twice-dailyBody mass indexCD4 cell or T4 ‘helper’ lymphocyteCreatinineCerebrospinal fluidCotrimoxazole preventive therapyDidanosineStavudineDirectly observed treatmentEthambutolEfavirenzEnzyme-linked immunosorbent assay (A type of HIV antibody laboratory test)Extrapulmonary tuberculosisFull blood countEmtracitabineGlomerular filtration rateGastrointestinal tractHaemoglobinHepatitis B coreHIV counselling and testingHigh density lipoproteinsHepatitis B surface antigenHuman immunodeficiency virusIsoniazidIsoniazid preventive therapyImmune reconstitution inflammatory syndromeLactose dehydrogenaseLiver function testsLoss of weightLopinavir/RitonavirMedicines Control CouncilMaternal and child healthMicroscopy, culture and sensitivityMulti-drug resistant tuberculosisNon-nucleoside reverse transcriptase inhibitorNucleoside reverse transcriptase inhibitorNevirapine5

OdOHLOIP24PAP ITMP-SMXTBTBMTDFTIDVASVLWBCWHOXDR-TBZZAPOnce dailyOral hairy leukoplakiaOpportunistic infectionHIV antigen testPapanicolaou testPolymerase chain reaction (a laboratory HIV detection test)Post-exposure prophylaxisPrimary health careProtease inhibitorPrevention of mother to child transmissionPurified protein derivativePulmonary tuberculosisPerson living with HIV/AIDS6 hourlyRifampicinRed blood countStreptomycinSouth African National AIDS CouncilSexual and reproductive healthSexually transmitted infectionsTrimethoprim/sulphamethoxazole – also known as cotrimoxazoleTuberculosisTuberculous meningitisTenofovir8 hourly – 3 times a dayVisual analog scaleViral load (HIV)White blood countWorld Health OrganizationExtensively drug resistant TuberculosisPyrazinamideZoster-associated pain6

IntroductionThese guidelines complement existing HIV/AIDS and TB management guidelines, and are theresult of extensive consultation through the SANAC Treatment Technical Task Team. Theguidelines aim to achieve the following:Goals of the Programme Achieve the best health outcomes in the most cost-efficient manner;Implement nurse-initiated treatment;Decentralise service delivery to primary health care (PHC) facilities;Integrate services for HIV, TB, maternal and child health (including prevention of mother tochild transmission), sexual and reproductive health, and wellness;Diagnose HIV earlier;Prevent HIV disease progression;Avert AIDS-related deaths;Retain patients on lifelong therapy;Prevent new infections among children, adolescents, and adults; andMitigate the impact of HIV/AIDS.Objectives To contribute to strengthening of the public and private health sectors’ capacity to deliverhigh quality integrated health and wellness services;To ensure timely initiation of antiretroviral drugs (ARVs) for treatment and preventionaccording to the Presidential mandates;To minimize unnecessary drug toxicities.Specific Objectives To prioritise ARVs for:o Patients with CD4 counts 200cells/mm3 or with severe HIV disease irrespective ofCD4o Patients co-infected with TB/HIVo Pregnant womenTo ensure access to ART within 2 weeks in pregnant women, those with low CD4 counts,very ill patients, and those with MDR-TB or extensively drug resistant TB (XDR-TB);To standardise first and second line therapy for children, adolescents, and adults in thepublic and private sector;To reduce the use of Stavudine;To expand the use of fixed-dose and co-packaged formulations;To enable nurses to initiate ARVs for treatment and prevention;To enable PHC facilities to initiate, manage, monitor and refer patients.7

1.Standardised National Eligibility Criteria for Starting ART Regimens forAdults and AdolescentsTable 1: Eligibility CriteriaEligible to Start ARTCD4 count 200cells/mm3 irrespective of clinical stageORCD4 count 350cells/mm3o In patients with TB/HIVo Pregnant womenORWHO stage IV irrespective of CD4 countORMDR/XDR-TB irrespective of CD4Require Fast-Track* (i.e. ART initiation within 2 weeks of beingeligible)Pregnant women eligible for lifelong ARTORPatients with very low CD4 ( 100 200cells/mm3)ORStage 4, CD4 count not yet availableORMDR/XDR-TBNot Yet Eligible for ART Transfer to a wellness programme for regular follow up and repeatclinical assessment/CD4 testing 6-monthly. Advice on how to avoid HIV transmission to sexual partners andchildren Initiate INH prophylaxis if asymptomatic for TB Contraceptive advice and Pap smear* All other patients should receive ART within 2 months of clinical staging event or qualifying CD4 count8

2.Standardised National ART Regimens for Adults and AdolescentsTable 2: National ART Regimens1st LineAll new patients needingtreatmentTDF 3TC/FTC EFV/NVPCurrently on d4T-basedregimen with no sideeffectsd4T 3TC EFV/NVPContraindication toTDF: renal diseaseAZT 3TC EFV/NVPFailing on a d4T orAZT-based 1st lineregimenFailing on a TDF-based1st line regimenFailing any 2nd lineregimen2nd LineTDF 3TC/FTC LPV/rFor TB co-infection EFV is preferred.For pregnant women or women of childbearing age, not on reliable contraception,NVP is preferred.Remain on d4T if well tolerated. Earlyswitch with any toxicity. Substitute TDF ifat high risk of toxicity (high BMI, older,female, TB treatment)Virological failure must be followed byintensive adherence management, asresuppression is often possible. If repeatVL remains 1000 in 3 months despiteadherence intervention, switch.AZT 3TC LPV/rVirological failure must be followed byintensive adherence management, asresuppression is often possible. If repeatVL remains 1000 in 3 months despiteadherence intervention, switch.Salvage TherapySpecialist referralVirological failure on protease inhibitors isalmost always due to non-adherence.Intensively exploring and addressingissues relating to causes of non-adherencewill most often lead to resuppression. IfVL remains high, refer where possible, butmaintain on failing regimen.9

3.Standardized National Monitoring for Adults and Adolescents with HIVTable 3: Standardized Monitoring (Pre-ART and on ART)At Initial Diagnosis of HIVCheck HIV resultClinical staging if HIV positiveAsk if pregnant or planning to conceiveScreen for TB symptomsCD4 countHb or FBC if availableAt Routine Follow-Up VisitsCheck that CD4 has been done in thelast 6 monthsWHO clinical stagingScreen for TB symptomsIf Eligible for ARTSerum creatinine and clearance ifstarting on a TDF-based regimenALT if starting on a NVP-based regimenPurposeEnsure that the national testing algorithm has been followedTo assess eligibility for ART;To assess eligibility for fast-trackingTo identify women who need ART or ARV for PMTCT(see section 6)To identify TB/HIV co-infectedTo identify eligibility for ART or ARVs if pregnantTo detect anaemiaPurposeTo see if they have become eligible for ARTTo see if they have become eligible for ARTTo identify TB/HIV co-infectionPurposeRefer urgently if estimated creatinine clearance is less than50; if referral not available, start AZT/3TC/EFV (or NVP),but dose adjust AZT and 3TCIf ALT raised 100, avoid NVP if possible; if noalternative, closley monitor the patientOnly patients who have a calculated creatinine clearance greater than 50 should receive Tenofovir.While the serum creatinine gives an indication of renal function patients can have siginificantlyreduced reduced renal function with a serum creatinine in the high normal range. This is particularlythe case in older people and those with low body weight where the serum creatinine is a poorindication of renal function.It is essential to calculate the creatinine clearance in all patients with:Age 50 yearsWeight 50kgSerum creatinine 100In all other patients where serum creatinine is 100 the calculated creatinine is likely to be 50and they can safely start Tenofovir.Creatinine may be elevated in acute illness, and repeat measurement when the patient is recoveredmay give a better reflection of clearance.See Annexure A for the creatinine clearance

These guidelines complement existing HIV/AIDS and TB management guidelines, and are the result of extensive consultation through the SANAC Treatment Technical Task Team. The guidelines aim to achieve the following: Goals of the Programme Achieve the best health outcomes in the most cost-efficient manner;

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