Who hiv guidelines ppt - My presentation

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Who hiv guidelines ppt - My presentation

  1. 1. CONSOLIDATED GUIDELINES ON THE USE OF ANTIRETROVIRAL DRUGS FOR TREATING AND PREVENTING HIV INFECTION SUMMARY OF KEY FEATURES AND RECOMMENDATIONS JUNE 2013
  2. 2. Overview • The 2013 consolidated guidelines compile new , existing recommendations and other guidance across the continuum of HIV care. • Includes guidance on HIV diagnosis, general HIV care and the strategic use of ARV drugs. • Developed in accordance with procedures outlined by the WHO Guidelines Review Committee and are based on the GRADE (Grading of Recommendations, Assessment, Development and Evaluation) system.
  3. 3. KEY FEATURES OF THE 2013 CONSOLIDATED GUIDELINES • New and easy-to-use HIV testing technologies • Simpler, safer, once-daily, single-pill treatments • Programs for preventing mother-to-child transmission of HIV (PMTCT) - earlier and simpler treatments • ART to prevent the sexual transmission of HIV. • Trend towards starting treatment.
  4. 4. HIV Testing & counselling Topic Old Guidelines New Guidelines HIV Testing Providerinitiated testing and counselling Community-based HIV testing and counselling with linkage to prevention, care and treatment services is recommended, in addition to old guidelines. Couples Voluntary HIV testing and counselling
  5. 5. Who to test Pregnant women and male partners When to test At first antenatal care visit Re-test in third trimester or peripartum Offer partner testing At 4–6 weeks for all whose mothers are HIV Positive Infants and children or status uncertain; <18 months old Final status after 18 months and/or when breastfeeding ends Children Establish HIV status for all health contacts Tell their HIV status & parents or caregiver’s status Adolescents Integrate into all health care encounters. Annually if sexually active; with new sexual partners
  6. 6. HIV prevention based on ARV drugs Oral pre-exposure prophylaxis Serodiscordant couples daily oral PrEP (either TDF or TDF + FTC) Men and transgender women daily oral PrEP (Specifically TDF + FTC) ART for prevention among serodiscordant couples PLHIV in serodiscordant couples who start ART for their own health, ART is also recommended to reduce HIV transmission to the uninfected partner. HIV-positive partners with a CD4 count ≥350 cells/mm3.
  7. 7. Post-exposure prophylaxis for occupational and non-occupational exposure to HIV Post-exposure prophylaxis for women within 72 hours of a sexual assault •Recommended duration of PoEP is 28 days, •First dose as soon as possible within 72 hours •The choice based on first-line ART regimen.
  8. 8. NEW CLINICAL RECOMMENDATIONS • A new, preferred first-line ART regimen harmonized to all different eligible groups. • Accelerate the phasing out of stavudine (d4T). • HIV testing of adolescents to diagnose people with HIV earlier and link them to care and treatment.
  9. 9. GUIDELINES TO START ART • Start ART in all individuals with a CD4 < 500 • Priority to severe or advanced HIV disease and CD4 < 350 . • ART at any CD4 count in PLHIV  Active TB disease ,  HBV co-infection with severe chronic liver disease,  HIV-positive partners in sero-discordant couples,  Pregnant and breastfeeding women and  Children younger than five years of age
  10. 10. When to start ART in people living with HIV Adults and Initiate ART if CD4 cell count ≤500 cells/mm3 NEW adolescents • As a priority, NEW (≥10 years)  Severe/advanced HIV (WHO clinical stage 3 or 4) or  CD4 count ≤350 cells/mm3 Regardless of WHO clinical stage and CD4 • Active TB disease NEW • HBV coinfection with severe chronic liver disease NEW • Pregnant and breastfeeding women with HIV • HIV-positive individual in a serodiscordant partnership (to reduce HIV transmission risk) Infants <1 year old In all , Regardless of WHO clinical stage and CD4 cell count.
  11. 11. Children 1–5 yrs old NEW ART in all regardless of WHO clinical stage and CD4 • As a priority,  All HIV-infected children 1–2 yrs old or  WHO clinical stage 3 or 4 or  CD4 count ≤750 or <25%, whichever is lower Any child < 18 months with presumptive clinical diagnosis of HIV infection. Children CD4 ≤500 cells/mm3 ≥5 yrs to <10 • As a priority, yrs old  All WHO clinical stage 3 or 4 or  CD4 count ≤350 NEW Initiate ART regardless of CD4 cell count • WHO clinical stage 3 or 4 • Active TB disease
  12. 12. Populations for which no specific new recommendation is made • Individuals with HIV > 50 years of age . • Individuals with HIV-2 • Individuals coinfected with HIV and HCV
  13. 13. Why to Initiate early ART ? • Reduces risk of progression to AIDS and/or death, TB, non-AIDS-defining illness & increased the likelihood of immune recovery. • Reduces sexual transmission in HIV-serodiscordant couples, • More convenient and less toxic regimens widely available, • Costs and epidemiological benefits • The increased cost of earlier ART would be partly offset by subsequent reduced costs (such as decreased hospitalization and increased productivity) and preventing new HIV infections.
  14. 14. HIV and HBV coinfection with evidence of severe chronic liver disease • HIV coinfection affects natural history of HBV infection. o o o o o higher rates of chronicity; less spontaneous HBV clearance; accelerated liver fibrosis progression increased risk of cirrhosis and hepatocellular carcinoma; higher liver-related mortality and decreased ARV response • Liver disease a leading cause of death in people coinfected with HIV and HBV
  15. 15. • 2010 guidelines- ART for all HIV + HBV with chronic active hepatitis, regardless of CD4 or WHO clinical stage. • 2013 guidelines - ART to all HIV + HBV regardless of CD4 count in people with evidence of severe chronic liver disease.
  16. 16. ARV drugs for pregnant and breastfeeding women. • The 2010 WHO PMTCT guidelines recommended – lifelong ART for women eligible for treatment (based on CD4 ≤350 or presence of WHO clinical stage 3 or 4 disease) – ARV prophylaxis for PMTCT for those not eligible for treatment. • If not eligible for treatment, • “Option A” - AZT for the mother during pregnancy, single-dose NVP + AZT and 3TC for mother at delivery &continued for a week postpartum; • “Option B”- triple ARV drugs for the mother during pregnancy & throughout breastfeeding.
  17. 17. National PMTCT program option Use lifelong ART for all pregnant and breastfeeding women (“Option B+”) Use lifelong ART only for pregnant and breastfeeding women eligible for treatment (“Option B”) Pregnant and breastfeeding women with HIV HIV-exposed infant Regardless of WHO clinical stage or CD4 Breastfeeding Initiate ART and maintain after delivery & cessation of breastfeeding 6 weeks of infant prophylaxis with once-daily NVP Eligible for treatment Not eligible for treatment Initiate ART and maintain after delivery and cessation of breastfeeding Initiate ART and stop after delivery and cessation of Breastfeeding Replacement feeding 4–6 weeks of infant prophylaxis with once-daily NVP (or twice-daily AZT)
  18. 18. • Option A and B regimens have similar efficacy . • Option A is impediment to scaling up PMTCT in many countries. • Different treatment and prophylaxis regimens • CD4 measurement to determine eligibility and type of regimen; • changing antepartum-intrapartum postpartum regimens; • The need for an additional postpartum ARV “tail” in mothers; and • Extended NVP prophylaxis in infants.
  19. 19. New guidelines NEW • To accelerate the rapid global scaling up, ensure equitable access , recommendations need to be further simplified, standardized & harmonized. • 2013 guidelines recommend ART (one simplified triple regimen) for all PLHIV women during the period of risk of mother-to-child HIV transmission and continuing lifelong ART either for all women.
  20. 20. Benefits • Ease of implementation & Harmonized regimens. • Increased coverage of ART & acceptability. • Vertical transmission benefit • Maternal health benefit • avoid stopping and starting drugs with repeat pregnancies, • Early protection against MTCT in future pregnancies, • Reduce the risk of HIV transmission to HIV-serodiscordant partner.
  21. 21. ARVs & Duration of breastfeeding National or sub national health authorities should decide whether support breastfeed & receive ARV or avoid all. When breastfeeding and ARV interventions is supported... Exclusive breastfeeding for the first 6 months, Introducing appropriate complementary foods thereafter, and continue breastfeeding for the first 12 months of life. Breastfeeding should then only stop once a nutritionally adequate and safe diet without breast-milk can be provided
  22. 22. HIV in children • In young children high risk of poor outcomes from HIV . • 52% die before 2 yrs age if no intervention • Most children who are eligible for ART are still not being treated, • ART coverage among children lags significantly behind that among adults (28% versus 57%) • Unique challenges because of their dependence on a caregiver.
  23. 23. The 2013 WHO guidelines… • Simplify and expand treatment in children. • Eliminates the need for CD4 in <5 yrs for treatment & avoids delaying ART in settings without access to CD4 testing. • Targeting these children for HIV care may facilitate treatment of other preventable causes of under-five mortality. • Increase the CD4 count threshold for ART initiation to ≤500 in children > 5 Yrs, aligning with the new threshold in adults. • ? Risk of resistance if treatment is initiated early in young children when adherence is poor/ suboptimal drug supplies.
  24. 24. Ideal first-line ART ? • • • • Simplified, less toxic more convenient regimens fixed-dose combinations.
  25. 25. What ART to start ? Once-daily regimens comprising a non- thymidine NRTI backbone (TDF + FTC or TDF + 3TC) and one NNRTI (EFV) as the preferred choices in adults, adolescents and children >3 yrs. First-line ART First-line ART = two (NRTIs) + (NNRTI). regimens for adults • TDF + 3TC (or FTC) + EFV (fixed-dose combination) NEW If TDF + 3TC (or FTC) + EFV is contraindicated/not available, options are… • AZT + 3TC + EFV • AZT + 3TC + NVP • TDF + 3TC (or FTC) + NVP Countries should discontinue d4T use in first-line regimens because of its well-recognized metabolic toxicities.
  26. 26. • For pregnant and breastfeeding women… • The 2010 guidelines - choice of 4 different ART regimens : AZT + 3TC or TDF + 3TC (or FTC) plus either NVP or EFV. • Because of risk of toxicity of NVP among pregnant women, for PMTCT, – Preferred NNRTI regimens were AZT + 3TC + EFV or TDF + 3TC (or FTC) + EFV – Alternative regimens were AZT + 3TC + LPV/r (or ABC) • Although TDF & EFV were recommended, there were limited safety data on their use during pregnancy and breastfeeding.
  27. 27. First-line ART for pregnant and breastfeeding women TDF + 3TC (or FTC) + EFV as first-line ART including pregnant women in the first trimester and women of childbearing age as well as breastfeeding women with HIV. The recommendation applies both to lifelong treatment and to ART initiated for PMTCT and then stopped
  28. 28. First-line ART Adults (including pregnant and breastfeeding women and adults with TB and HBV coinfection) Preferred first-line regimens NEW Alternative first-line Regimens AZT + 3TC + EFV AZT + 3TC + NVP TDF + 3TC (or FTC) + NVP TDF + 3TC (or FTC) + EFV Adolescents (10 to 19 years) ≥35 kg AZT + 3TC + EFV AZT + 3TC + NVP TDF + 3TC (or FTC) + NVP ABC + 3TC + EFV (or NVP) Children 3 - 10 years and adolescents <35 kg ABC + 3TC + EFV ABC + 3TC + NVP AZT + 3TC + EFV AZT + 3TC + NVP TDF + 3TC (or FTC) + EFV TDF + 3TC (or FTC) + NVP Children <3 years ABC or AZT + 3TC + LPV/r ABC + 3TC + NVP AZT + 3TC + NVP New guidelines promote further simplification of ART delivery by reducing the number of preferred first-line regimens.
  29. 29. • People receiving NVP discontinue because of adverse events • With EFV no increased risk of birth defects compared with other ARV drugs during the first trimester of pregnancy • TDF/FTC or TDF/3TC are the preferred NRTI backbone for HIV + HBV HIV with TB and pregnant women. • EFV is the preferred NNRTI for HIV & TB (pharmacological compatibility with TB drugs) HIV +HBV coinfection (less risk of hepatic toxicity) and Pregnant women, including first trimester.
  30. 30. Stopping NNRTI-based ART (use of a “tail”) • Because of longer ½ -life of EFV (and NVP), suddenly stopping NNRTI-based regimen risks developing NNRTI resistance. • For women who stop EFV-based ART due to toxicity or other conditions, more data are needed to determine whether an NRTI “tail” coverage is needed to reduce this risk. • Guidelines suggests that, if the NRTI backbone included TDF, such a tail may not be needed, • But if the NRTI backbone included AZT, a two-week tail is advisable (EFV has a longer half-life than NVP)
  31. 31. TDF toxicity • TDF has a low rate of renal toxicity in the short to medium term, especially with pre-existing, or risk factors for, renal disease. • Reduction in renal function reflected by decrease in the eGFR. • Reduction in bone mineral density • High-risk populations, like hypertension , diabetes or those using boosted PIs. • Usually tubular, hence glomerular function tests do not provide a direct measure, and no other simple test can detect renal tubular toxicity. • Overall improvement in renal function resulting from ART can offset the risk of TDF toxicity in people not having secondary renal disease.
  32. 32. EFV USE Concerns • Birth defects, including anencephaly, microphthalmia and cleft palate among primates with EFV exposure in utero. • The United States Food and Drug Administration & European Medicines Agency advise against using EFV unless the benefits outweigh the risks. • But, the British HIV Association recently allowed EFV in the 1st trimester . • Risk of neural tube defects (NTDs) is limited to the first 5-6 weeks of pregnancy, and pregnancy is rarely recognized this early, • NTDs are relatively rare & available data sufficiently rule out a risk • Guidelines Development Group felt confident that this low risk should be balanced against the programmatic advantages & clinical benefit of EFV .
  33. 33. HIV-2 infection • HIV-2 is naturally resistant to NNRTIs • Treatment-naive people coinfected with HIV-1 and HIV-2 should be treated with three NRTIs TDF + 3TC / FTC + AZT or AZT + 3TC + ABC or a ritonavir-boosted PI plus two NRTIs. • In PI-based regimen, the preferred option is LPV/r • SQV/r and DRV/r are alternative boosted-PI options, but they are not available as heat-stable fixed-dose combinations.
  34. 34. Simplified Infant Prophylaxis doses Drug Infant age Daily dosing Birth to 6 weeks • Birthweight 2000−2499 g • Birthweight ≥2500 g NVP 10 mg once daily 15 mg once daily > 6 weeks to 6 months 20 mg once daily > 6 months to 9 months > 9 months until breastfeeding ends AZT Birth to 6 weeks • Birthweight 2000−2499 g • Birthweight ≥2500 g 30 mg once daily 40 mg once daily 10 mg twice daily 15 mg twice daily If toxicity from NVP requires discontinuation or if NVP is not available, infant 3TC can be substituted.
  35. 35. Monitoring ART response and diagnosis of treatment failure • Before 2010, clinical outcomes and CD4 count were used for monitoring the response to ARV drugs. • However, viral load is a more sensitive and early indicator of treatment failure & gold standard for monitoring response to ARV. • In 2010 WHO recommended phasing in viral load testing to monitor response to ART and viral load threshold > 5000 copies/ml in an adherent person with no other reasons for an elevated viral load (such as drug interactions, poor absorption and inter current illness) • 2013 guidelines strongly recommend viral load as monitoring tool. • Also reduced viral load threshold for treatment failure from 5000 to 1000 copies/ml.
  36. 36. • Treatment failure is defined by a persistently detectable viral load exceeding 1000 copies/ml (i.e. two consecutive viral load measurements within a 3 month interval, with adherence support between measurements) after at least 6 months of ARV. • Viral load testing is usually performed in plasma; tests using whole blood as a sample type, are unreliable at this lower threshold • Viral load testing is done after initiating ART (at 6 months) and then every 12 months . • When not available, CD4 and clinical monitoring is used .
  37. 37. WHO definitions of clinical, immunological and virological failure Failure Definition Adults and adolescents New or recurrent clinical event indicating severe immunodeficiency (WHO clinical stage 4 condition) after 6 months of effective treatment -------------------------------------------------Clinical Children failure New or recurrent clinical event indicating advanced or severe immunodeficiency (WHO clinical stage 3 and 4 clinical condition with exception of TB) after 6 months of effective treatment Comments differentiate from IRIS For adults, certain WHO clinical stage 3 conditions (PTB and severe bacterial infections) also indicate treatment failure
  38. 38. Immunological failure Adults and adolescents CD4 count falls to baseline (or below) or Persistent CD4 <100 -----------------------------------------Children < 5 years Persistent CD4 <200 or <10% >5 years Persistent CD4 <100 Without concomitant or recent infection to cause a transient fall in CD4 Virological failure Plasma viral load >1000 based on two consecutive viral load measurements after 3 months, with adherence support Must be on ART for at least 6 months before declaring failure
  39. 39. Test viral load Viral load >1000 copies/ml Evaluate for adherence concerns Repeat viral load testing after 3–6 months Viral load ≤1000 Maintain first-line therapy Viral load >1000 Switch to second-line therapy
  40. 40. Lab monitoring before starting ART Phase of HIV management HIV diagnosis Recommended HIV serology, CD4 TB screening Desirable (if feasible) HBV (HBsAg) serology HCV serology Cryptococcus antigen if CD4 ≤100 Screening for STIs Assessment for major noncommunicable chronic diseases and comorbidities F/U before ART CD4 cell count (every 6–12 mths) ART initiation CD4 cell count Hemoglobin for AZT Pregnancy test Blood pressure Urine dipsticks for glycosuria and (eGFR) and serum creatinine for TDF ALT for NVP
  41. 41. Lab monitoring during ART Phase of HIV management Recommended Desirable (if feasible) Receiving ART CD4 (every 6 months) HIV viral load (at 6months after initiating ART and every 12 months ) Urine dipstick for glycosuria and Serum creatinine for TDF Treatment failure CD4 HIV viral load HBV (HBsAg) serology (before switching ART regimen if not done or negative at baseline)
  42. 42. Preferred second-line ART regimens for adults and adolescents Target population Adults and adolescents (≥10 years) Pregnant women Preferred second-line regimen If d4T or AZT was used in firstTDF + 3TC (or FTC) + ATV/r or LPV/r line ART If TDF was used in first line ART AZT + 3TC + ATV/r or LPV/r Same regimens recommended for adults and adolescents If rifabutin is available HIV and TB Coinfection NEW HIV +HBV coinfection Standard PI-containing regimens If rifabutin is not available Same NRTI plus double-dose LPV/r (ie, LPV/r 800 mg/200 mg ) or standard LPV dose with an adjusted dose of RTV (i.e, LPV/r 400 mg/400 mg ) AZT + TDF + 3TC (or FTC) + (ATV/r or LPV/r)
  43. 43. Third-line ART All populations National programmers should develop policies for third-line ART New drugs with minimal risk of cross-resistance to previous regimens, like integrase inhibitors & 2nd-generation NNRTIs & PIs Failing second-line regimen with no new ARV options should continue with a tolerated regimen Special considerations for children Strategies that balance the benefits and risks for children need to be explored when second-line treatment fails. For older children & adolescents having more therapeutic options available , novel drugs such as ETV, DRV and RAL may be possible. Second-line regimen that is failing with no new ARV drug options should continue with a tolerated regimen. If ART is stopped, opportunistic infections still need to be prevented, symptoms relieved and pain managed.
  44. 44. Timing of ART with TB • ART should be started in all TB patients, including drug-resistant TB, irrespective of the CD4 count • AKT should be initiated first, followed by ART as soon as possible within the first 8 weeks of treatment. • HIV-positive TB patients with profound immunosuppression (CD4 <50) should receive ART immediately within the first 2 weeks of AKT . • ART should be started in any child with active TB disease as soon as possible and within 8 weeks After the initiation of AKT irrespective of the CD4 and clinical stage. • Preferred NNRTI is EFV in patients starting ART while on AKT .
  45. 45. Timing of ART with Cryptococcal meningitis • Immediate ART not recommended in cryptococcal meningitis due to the high risk of IRIS with CNS disease, which may be life-threatening . • Among PLHIV with a recent cryptococcal meningitis, – ART initiation should be deferred until there is evidence of a sustained clinical response to antifungal therapy and – after two to four weeks of induction and consolidation treatment with amphotericin containing regimens combined with flucytosine or fluconazole; or
  46. 46. NEW OPERATIONAL GUIDANCE AND RECOMMENDATIONS This guidance focuses on: • Strategies to improve retention in HIV care and adherence to ART. • Task-shifting to address human resource gaps. • Decentralizing delivery of ART and… • Integrating ART services within maternal and child health clinics, tuberculosis (TB) clinics and drug dependence treatment services.
  47. 47. WHAT IS THE EXPECTED IMPACT OF THE GUIDELINES • Globally, 26 million PLHIV in low- and middle-income countries will be eligible for ARV drugs compared with the previous 17 million people as per 2010 guidelines. • Full implementation of the guidelines could avert as many as 3 million AIDS-related deaths and 3.5 million new HIV infections between 2013 and 2025 over and above those averted by implementing the 2010 WHO treatment guidelines. • 10% increase in the total annual investment .
  48. 48. Ongoing Trials • The Strategic Timing of Antiretroviral Therapy (START) trial in ARV-naive adults aged 18 years and older is comparing immediate ART in those with CD4> 500 to ART deferred until the CD4 count falls below 350 or an AIDS event develops. • The TEMPRANO trial (Early Antiretroviral Treatment and/or Early Isoniazid Prophylaxis against Tuberculosis in HIV-infected Adults – ANRS 12136) is comparing the benefits and risks of initiating ART according to the 2010 WHO guidelines (CD4 ≤350 ) to the benefits and risks of initiating ART immediately among adults with CD4 counts >350.

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