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ART – Current Guidelines and future options

ART – Current Guidelines and future options. Dr. A.K. Gupta Additional Project Director, Delhi State AIDS Control Society, Govt .of Delhi. Disease Burden of HIV/AIDS- India. Estimated number of People Living with HIV/AIDS: 2.27 million (1.8—2.9 million) in 2008

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ART – Current Guidelines and future options

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  1. ART – Current Guidelines and future options Dr. A.K. GuptaAdditional Project Director, Delhi State AIDS Control Society, Govt .of Delhi

  2. Disease Burden of HIV/AIDS- India Estimated number of People Living with HIV/AIDS: 2.27 million (1.8—2.9 million) in 2008 Six high prevalence states contribute more than 60% of PLHA Women constitute 39% and Children 3.8% Estimated Adult HIV prevalence : 0.29%

  3. Prevalence of HIV and Estimated Infected Population There is evidence that current strategies have stabilized the epidemic in the country

  4. HIV Prevalence: India, 2007 A total of 3,58,797 samples were tested during HIV Sentinel Surveillance 2007 Note: ANC Prevalence is the standardized for population.

  5. Routes of Transmission of HIV Analysis of information from around 300,000 persons tested HIV positive at various counseling and testing centers in 2009-10,

  6. Management of an HIV infected person Aims of Management: Reduce sufferings because of HIV infection. Treat/prevent Opportunistic Infections. Protect patient from acquiring further infection. Prolongation of life, improve quality of life. Prevent transmission of HIV from patient to others.

  7. BasicApproaches for Management of Patients of HIV/AIDS • Supportive therapy • Preventive Strategies: Prophylaxis for different O.Is depending on CD4 count. • Therapeutic Strategies: 1. Treatment of O.Is. 2. ARV Therapy.

  8. Antiretroviral Therapy (ART) Combine different classes of antiretrovirals: To achieve maximal and most durable suppression of viral replication To prevent emergence of drug resistant mutants To improve survival & quality of life Before ART After ART

  9. Goals of ART (1) Clinical goal To prolong life & improve quality of life 2. Virological goal Greatest possible reduction in viral load for as long as possible to halt disease progression and to prevent or delay resistance 3. Immunological goal Immune reconstitution that is both quantitative (CD4 within normal range) and qualitative (pathogen specific immune response)

  10. 4. Therapeutic goal Rational sequencing of drugs to achieve previous 3 goals while: Maintaining therapeutic options Minimizing drug toxicities & side effects Maximizing adherence 5. Epidemiological goal Reduce HIV transmission Goals of ART (2)

  11. Eradication of HIV? Not yet… And …. …in spite of plasma RNA below detection, there is evidence of genetic evolution in reservoirs.

  12. Issues concerning ART • When to start treatment ? • Which and how many agents to use ? Choice of optimal regimen ? • How to monitor the therapy ? • How long to give therapy ? • When to change therapy and to what ? • Drug interactions involving antiretroviral therapy.

  13. WHEN TO START?

  14. Initiation of ART in Adults and Adolescents National Guideline Revised National Guideline (April 2009) Total lymphocyte count is no longer to be usedfor initiation or monitoring of ART

  15. WHAT TO START WITH?

  16. Classes of Antiretroviral Drugs Four Broad Groups

  17. ANTIRETROVIRAL DRUGSAvailable in India

  18. Guidelines for Antiretroviral Therapy No MONOTHERAPY or DUAL THERAPY HAART: Highly Active Antiretroviral Therapy Human Immunodeficiency virus (HIV) infection is currently treated with combination therapy using at least three drugs from NRTI & NNRTI/PIs over an indefinite period. Possible combinations 1. 2 NRTI's + 1 NNRTI 2. 2 NRTI's + 1 PI 3. 2 NRTI's + 1 More NRTI

  19. HAART and Viral Load baseline 0 AZT + 3TC -1 Change in Viral Load (log scale) -2 AZT/3TC/Indinavir -3 12 24 36 48 NEJM 1997:337:734 Time (weeks)

  20. HAART and CD4 Count AZT/3TC/Indinavir 200 Rise in CD4 Count 100 AZT + 3TC 0 baseline -100 12 24 36 48 Time (weeks) NEJM 1997:337:734

  21. Approach to patient with HIV infection Step 1- Clinical History Step 1: Clinical History • HIV specific symptoms: Present & past • Past history: Jaundice, TB, coronary artery disease, dyslipidaemia & others • Personal history: Smoking, alcohol & drugs • Family history: Diabetes, hypertension, etc. • Sensitive & sexual history: Genital ulcers, other STIs, substance use, multiple sex partners, etc. • Treatment history: ARVs, contraceptives in women, herbal drugs, etc.

  22. Step 2: Physical Examination • Weight, height & BMI • Oral cavity, lymph nodes, skin, eyes • Genital examination • Vital signs • Systemic examination: all systems • Ophthalmic fundus examination • Quality of life assessment

  23. Laboratory Investigations For All patients; • Complete blood count. • Urine Analysis. • Blood Chemistry: • Transaminases, Blood Urea, Serum creatinine, Blood Sugar Serology: • Sero diagnosis for HIV • VDRL, Toxoplasma IgG, Hepatitis B & C serologies. • Chest X-Ray PA veiw.. • Montoux test. • PAP smear in women • CD4/CD8 cell count • Viral load??--not essential

  24. Laboratory Investigations… If indicated: • Pregnancy test. • Sputum Examination: • AFB • Gram Stain • PC • Stool Examinationfor parasites Including modified ZN stain • USG admomen: • Organomegaly • Abscessess in Liver & Spleen. • Ascites, neoplasms • L Nodes at • Porta hepatis. • Retroperitoneal

  25. Laboratory Investigations… If indicated: • Lymph node Biopsy: • CSF Examination: • Cytology. • Biochemistry. • India ink staining • CT/MRI Brain. • Blood Culture. • S.Amylase/S. lactic acid/S lipid profile. Decision to be taken on individual basis

  26. National ART regimen Zidovudine / Lamivudine / Nevirapine Or Stavudine / Lamivudine / Nevirapine ( Efavirenz in place of Nevarapine if coinfected with TB or side effects with NVP, Tenofovir under consideration for special situations only)

  27. First line FDCs Stavudine (30 mg) + Lamivudine (50mg) Zidovudine (300mg) + Lamivudine (150mg) Stavudine (30mg) + Lamivudine (150mg) + Nevirapine (200 mg) Zidovudine (300mg) + Lamivudine (150mg) + Nevirapine (200 mg) Efavirenz (600mg).

  28. HOW TO MONITOR THE PATIENTS?

  29. Monitoring the Therapy As clinically indicated *A 2 week follow up after initiation is strongly recommended wherever possible

  30. Important side effects • Zidovudine: Haematologic toxicities , Granulocytopenia, anemia, myopathy, pigmentation. • Lamivudine: Minimal toxicities, lactic acidosis and steatosis. • Stavudine: Lactic acidosis, peripheral neuropathy, pancreatitis. • Nevirapine: Severe, life-threatening hepatotoxicity, hepatic failure, severe life-threatening skin reactions, Stevens-Johnson syndrome, toxic epidermal necrolysis etc. ` A 14 day lead in dose needed. • Efavirenz:Neuro psychiatric side effects, contra indicated in pregnancy. • Protease Inhibitors: Metabolic complications - Lipid abnormalities, body fat redistribution, hyperglycaemia.

  31. SUCCESSFUL HIV THERAPY REQUIRES RIGOROUS ADHERENCE • >95% adherence necessary to achieve viral load <400 copies/mL in 81% of HIV patients • A 10% reduction in adherence was associated with a doubling of HIV RNA level • 80% adherence may be sufficient to achieve therapeutic goals in other chronic disease states (e.g., hypertension)

  32. Initiating ART: Patient Education • It is not curative, but prolongs life • Treatment is lifelong, expensive • High level of adherence is critical (>95%) • Short and long term adverse events • Drug interactions • Safer sex still essential • Do not share drugs with friends , family members Start ART when patient is ready

  33. ART in HIV and TB • Revised Guidelines for initiation of ART • In Adults and adolescents (April 2009) • Special Attention to be paid for monitoring Hepato toxicity

  34. WHEN TO CHANGE THE TREATMENT?

  35. Changing Therapy • Due to adverse drug effects. • Due to inconvenient regimens. • Due to treatment failure. • Due to occurrence of tuberculosis/ pregnancy.

  36. Definitions of ART failure

  37. NACO survey shows that treatment failure to first line is nearly 2.8% Issues with second line drugs Ten time costlier than the first line drugs; More toxic to patient than the first line drugs Training of health care providers required Institutional strengthening, particularly laboratories for viral load and drug resistance testing. Regulatory mechanisms to be developed All these mechanisms have to be in place before second line therapy can be rolled out as third line drugs are not available. Second Line ARV Drugs

  38. Second line ART drugs in National Programme TDF-Tenofovir; 3TC-Lamivudine;LPV-Lopinavir;r-Ritonavir;AZT-Zidovudine

  39. Before labeling failure….. ensure • Patient had a reasonable trial of first line ART for at least 6 months • Assess adherence and support patient to improve this (reinforce) • Screen and treat intercurrent OIs • Provide Cotrimoxazole as per guidelines if necessary • Exclude IRIS • If TB is present: assess if this is reinfection or IRIS or a new infection. If the response to TB therapy is good, then the decision to switch therapy can be postponed and the patient re-evaluated again. • CD4 count

  40. Important Practice Points What should not be done: • Do not start ART in a patient who is not fully motivated/or counselled about drugs, their side effects and economic factor or in whom adherence is doubtful. • No monotherapy at all. • Do not start ART without availability of minimal laboratory monitoring. • Do not provide ART without capacity to meet patient’s needs on nutrition and other supportive therapies.

  41. Cumulative Outcome of PLHAs on ART

  42. Cost of ART Services ARV Drugs • First line ART- Rs 5000/patient/yr • Alt First line ART- Rs- 11500/ patient/ yr • Second line ART- Rs- 29000/ patient/ yr Laboratory Services: • CD4 Count: Rs. 175-225 per test • DNA-PCR for young children: Rs. 1000-1200

  43. Second Line ART • The rollout of second line ART began form Jan.2008 at 2 sites –GHTM, Tambaram, Chennai and JJ Hospital, Mumbai on a pilot basis. • Expanded to 10 centers of excellence from Jan 2009. • Presently, 2500 patients are receiving second line drugs at these 10 centers.

  44. National ART Guidelines • FOLLOW NACO GUIDELINES AVAILABLE ON NACO WEBSITE—www.nacoonline.org • Even the Supreme Court of India has mandated that these guidelines need to be followed by all doctors –both in public and private sector

  45. PPP Model ART Centres : Concept As a part of Govt. commitment to involve private sector into the national program, ART services through PPP model are encouraged in • NGO/ Trust Hospitals • PSUs • Corporate Sector It includes—ART centers, Community Care Centres, STI clinics etc

  46. Thank You

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