Scaling-up HIV/AIDS Care and Treatment Including ART

Size: px

Start display at page:

Download "Scaling-up HIV/AIDS Care and Treatment Including ART"

Janel Owen
5 years ago
Views:

1 Scaling-up HIV/AIDS Care and Treatment Including ART Masami Fujita Medical Officer, HIV/AIDS, WHO/WPRO Phnom Penh, Cambodia December 2004

2 HIV-AIDS global overview millions people already infected 1% current world population 30 millions people already passed away Destroying families, communities, economies Driving poverty, illiteracy Collapsing health systems & social systems Threatening security Entire countries face economic & social collapse 2 WPRO

3 HIV burden in the world 3 WPRO

4 HIV/AIDS burden as of 2004 Adults and children living with HIV/AIDS Adults and children newly infected Adult and child deaths due to AIDS World Asia/Pacific 39.4 million 8.2 million 4.9 million 1.2 million 3.1 million 0.5 million 4 WPRO

5 Widening Gap of AIDS Treatment Yearly deaths as a proportion of 1995 values Introduction of HAART Highly active antiretroviral treatment AIDS deaths in Africa AIDS deaths in Western Europe Source: Adapted from WHO/UNAIDS Statistics, & HIV/AIDS Surveillance in Europe, End- year report 2001, No. 66, CESES 5 WPRO

6 Extensive efforts made ART in resource-limited settings feasible People living with HIV/AIDS play critical role Prices have been dropping Funding is increasing (WB, GFTAM, US, etc.) Country response building on small scale-initiatives 6 WPRO

7 The 3 by 5 Initiative WHO, UNAIDS and partners: Addressing a global public health emergency 400,000 people receive treatment today Treat 3 million by 2005 Measurable, fixed target towards the goal of universal access to ART Accelerating HIV prevention 7 WPRO

8 The 5 pillars of the 3 by 5 strategy Global leadership, strong partnership & advocacy Urgent sustained country support Simplified, standardized tools for delivering antiretroviral therapy Effective, reliable supply of medicines & diagnostics Learn by doing & rapidly identify & reapply new knowledge & successes 8 WPRO

9 Global guiding principles: Three ONEs hone agreed AIDS action framework that provides the basis for coordinating the work of all partners hone national AIDS coordinating authority with broad based multi-sectoral mandate hone agreed country level monitoring and evaluation system 9 WPRO

10 Natural Course of HIV Infection and Common Complications CD4+ cell Count Acute HIV infection syndrome Asymptomatic TB TB HZV OHL PPE OC CMV, MAC PCP CM Months CD4+ T cells Years After HIV Infection VL Relative level of Plasma HIV-RNA WPRO

11 Antriretroviral Treatment (ART) hcontrol of HIV replication hrestoration and/or preservation of immunologic function 8 stabilization or increase in CD4 cell count hreduction of HIV-related complications himprovement of quality of life h Increased survival 11 WPRO

12 Goals of Therapy Plasma HIV-RNA (copies/ml) 1,000, ,000 10,000 1, VL < Goal is Viral load undetectable viral load CD4 12 WPRO 370 M1 M2 M3 M6 M12 M18 M24 Months on triple therapy CD4 count (cells/mm 3 )

13 For successful ART hdo not initiate ARVs too soon: When the CD4 count is high or in patients with no symptoms 8If ARVs are started too soon, the patient will incur the risks of therapy (side effects, viral resistance) without the clinical benefits hdo not initiate ARVs too late: 8If ARVs are started too late, the patient will be at high risk for clinical complications of AIDS However, it is still possible to start ARV in patents with very advanced disease 13 WPRO

14 Manage OIs and other conditions before ART h Stabilize OIs and other acute infections before commencing ART, in principle h TB (next slide) h Treat esophageal candidiasis but commence ART as soon as can swallow pills h Anemia (Hb<8): Look for treatable cause (e.g. blood loss, malaria, MAC, etc.), use no-azt containing regimen h Pregnancy: Commence ART after the 1 st trimester, Avoid EFV for pregnant women or women with the potential h Conditions which may be improved/resolved with ART MAC, CMV, Chronic diarrhea, Skin conditions such as PPE, seborrheic dermatitis 14 WPRO

15 WHO Clinical Stage I Asymptomatic hno weight loss hno symptoms or only: Persistent generalized lymphadenopathy hprophylaxis: INH prophylaxis if eligible hart: Only if CD4< WPRO

16 WHO Clinical Stage II Mild disease h Weight loss 5-10% hsores or cracks around lips (angular cheilitis) h Itching rash (seborrhea or prurigo) hherpes zoster within last 5 years hrecurrent upper respiratory infections such as sinusitis or otitis h Recurrent mouth ulcers hprophylaxis: INH prophylaxis if eligible Cotrimoxazole prophylaxis hart: Only if CD4<200 or TLC <1200/mm3 16 WPRO

17 WHO Clinical Stage III Moderate disease h Weight loss >10% h Oral thrush (or hairy leukoplakia) h More than 1 month: - Diarrhoea - Vaginal candidiasis -Unexplained fever h Pulmonary TB with last year h Prophylaxis: - INH prophylaxis if eligible and able to exclude TB - Cotrimoxazole prophylaxis - Other prophylaxis on treatment plan h ART: - If CD4 not available, treat in all stage 3 - If CD4 available, take into consideration CD4<350 when deciding to treat 17 WPRO

18 WHO Clinical Stage IV Severe disease (AIDS) h HIV wasting syndrome (WL >10% plus either unexplained chronic diarrhea or chronic weakness and unexplained prolonged fever) h Oesophageal thrush, PCP, Extra-pulmonary TB, CMV retinitis, Cryptococcal meningitis, Toxoplasmosis of the brain, HIV encephalopathy, Lymphoma, Invasive cervical cancer, Kaposi sarcoma,, More than 1 month of Herpes simplex ulcerations (>1 month), etc. h Prophylaxis: - INH prophylaxis if eligible and able to exclude TB - Cotrimoxazole prophylaxis - Other prophylaxis on treatment plan h ART: - All in stage 4 are medically eligible (most OI need to be stabilized before ART) 18 WPRO

19 % patients with viral suppression <400 copies/ml Adherence Matters % 70-80% 80-90% 90-95% <95% Percent adherence to therapy From Peterson et al, 6th Conf ROI 1999 abstr #92 19 WPRO

20 Probability of virologic failure In case, drug taking is like this for many months. SUN MON TUE WED THU FRI SAT 50 % 75 % 36 % 20 WPRO

21 Key Elements of Comprehensive HIV/AIDS Care and Treatment HIV Testing & Counseling Pre-test education/counselling HIV testing Post-test counselling Clinical care Management of OIs including TB ART incl. Adherence support Palliative care incl. Symptom & pain Mobilization & coordination of key players incl. PHA Public health and clinical services (incl. TB, ANC/MCH, STI), PHA, CBO, Local authority, FBO and NGO Referral across and within levels for organizing entry points to and continuity of care Promotion of PHA group development and peer support Participation of PHA in planning, implementation and evaluation HIV Prevention Safer sex and condom promotion Harm reduction Universal precautions and PEP PMTCT Psychological & socioeconomic support HIV counselling and spiritual support End of life care Social welfare and legal support Nutritional and daily living support Stigma & discrimination reduction Prolonged quality of life through optimal ART adherence Accelerated HIV prevention 21 WPRO

22 Identifying level of focus for rapid expansion hin Africa where HIV prevalence is very high, decentralized service delivery at PHC/community level is being developed hin selected countries in Asia with HIV prevalence of 0.1-3%, what level of service delivery should be the focus? 22 WPRO

23 Provincial/Tertiary - Management of complicated cases - Specialized services & support Referral up & down District/Intermediate - Comprehensive services including ART & coordination - PHA group formation & peer support Health Centre & Home-Community - ART adherence support -Basic care 23 WPRO

24 District or intermediate level of service delivery as the focus hwith capacity to provide HIV/AIDS clinical management of common OIs & basic ART hhas sufficient numbers of PHAs to form groups his not too far for PHAs to access care (e.g. transportation) hnot too close to home and community where stigma and discrimination is still a barrier 24 WPRO

25 HIV Tests OI Drugs - Prophylaxis - Treatment ARV Drugs Lab for OI diagnosis & ART monitoring Service packages Provincial/tertiary level District/intermediate level Health centre/home-community level 25 WPRO

26 ARV Guidelines WHO December 2003 hfirst line regimen: (d4t or ZDV) + 3TC + (NVP or EFZ) d4t/3tc/nvp AZT/3TC/NVP d4t3tc/efv AZT/3TC/EFV hfixed dose combination (FDC) Never use AZT & d4t together: Antagonistic 26 WPRO

27 Selection of first line regimen hd4t: No lab requirement, 30mg (<60kg), 40mg (>60kg) ZDV: Require hemoglobin check hnvp: Dose escalation first 2 weeks Not for Refampicin containing TB regimen EFV: Not for pregnant women 27 WPRO

28 % of patients progressing Why NOT to use dual and monotherapy 30 Progression to AIDS/Death No therapy Mono-therapy 15 Dual-therapy 10 5 Triple therapy Months JAMA 1998 & CMAJ WPRO

29 4S hstart h (AZT-d4T, NVP-EFV if toxicity) hswitch (to 2 nd line if failure) Symptom based - Occurrence of Stage III, IV conditions (Should not switch in case of IRS) CD4 based - Return of CD4 cell to pre-therapy baseline or below - >50% fall from on therapy CD4 peak level (No other infection to explain transient CD4 decrease) hstop 29 WPRO

30 Substituting and Switching 1st Line ART Regimen d4t to ZDV If neuropathy or pancreatitis and severe anemia If neuropathy or pancreatitis d4t to ddi (or ABC) Substitu te TDF to ABC If renal failure LPV/r to SQV/r 1 st Line d4t+3tc+nvp 2 nd Line Therapeutic Failure TDF+ddI+LPV/r TB/HIV ddi to ABC If clinical hepatitis If severe rash If severe dislipidemia If severe GI intolerance NVP to EFV NVP to EFV LPV/r to NFV (or ATV/r) Switch 30 WPRO

31 Substituting and Switching 1st Line ART Regimen If severe anemia or persistent GI intolerance ZDV to d4t If severe anemia and neuropathy or pancreatitis ZDV to ddi (or ABC) If renal failure TDF to ABC LPV/r to SQV/r 1 st Line ZDV+3TC+NVP 2 nd Line Therapeutic Failure TDF+ddI+LPV/r TB/HIV If clinical hepatitis If severe rash If severe dislipidemia If severe GI intolerance NVP to EFV NVP to EFV LPV/r to NFV (or ATV/r) DISTRICT/REGIONAL LEVEL ddi to ABC Switch LOCAL LEVEL 31 WPRO

32 Substituting and Switching 1st Line ART Regimen Substitu te d4t to ZDV If neuropathy or pancreatitis and severe anemia d4t to ddi (or ABC) Substitu te TDF to ABC If neuropathy or pancreatitis If renal failure LPV/r to SQV/r 1 st Line d4t+3tc+efv Therapeutic Failure 2 nd Line TDF+ddI+LPV/r TB/HIV ddi to ABC If severe CNS symptoms or preganacy If severe dislipidemia If severe GI intolerance EFV to NVP If hepatitis or severe rash EFV to NFV LPV/r to NFV (or ATV/r) Switch 32 WPRO

33 Substituting and Switching 1st Line ART Regimen If severe anemia or persistent GI intolerance ZDV to d4t If severe anemia and neuropathy or pancreatitis ZDV to ddi (or ABC) TDF to ABC If renal failure TB/HIV LPV/r to SQV/r 1 st Line ZDV+3TC+EFV 2 nd Line Therapeutic Failure TDF+ddI+LPV/r ddi to ABC If severe CNS symptoms or pregnancy If severe dislipidemia If severe GI intolerance EFV to NVP If hepatitis or severe rash EFV to NFV LPV/r to NFV (or ATV/r) Switch33 WPRO

34 Main symptoms Neurological Respirotory Cryptococcossis Managing OIs & other conditions at district hospital Disease Prophylaxis Diagnosis Treatment TB P: INH Smear, CXR NTP regimen Bacterial pneumonia P:Cotri. CXR, Smear Antibiotics PCP P&S:Cotri. Clinical, CXR Cotri. Toxoplasmosis TB meningitis Bacterial meningitis S:Fluconazole P:Cotri. S:Pyrimethamine +sulfadiazine Spinal tap, Indian Ink Clinical P: INH Clinical, Spinal tap Clinical, Spinal tap Diarrhea P: Cotri. (Empirical treatment) Amphotericin B, flucytosine, fluconazole, or referral (*) Pyrimethamin+sulfadiazone, or referral (*) NTP regimen Antibiotics Rehydration fluids, loperamide, antibiotics, metronidazole, cotrimoxazole, mebendazole, (ART) 34 WPRO

35 Managing OIs & other conditions at district hospital Main symptoms Skin & mucosal Disease Prophylaxis Diagnosis Treatment Candidiasis Clinical Topical (gentian violet, nystatin or clotrimazole lozenges), fluconazole or ketoconazole Lymphadenop athy Peniciliosis S: Itraconazole Clinical, Smear Amphotericin B, itraconazole, Herpes Simplex Clinical Topical, acyclovir if available Herpes Zoster Clinical Topical, acyclovir if available PPE, Seb.der. Clinical Steroid (ART effective) Fever Septicemia (Empirical treatment) TB P: INH Clinical, Aspitation Antibiotics NTP regimen 35 WPRO

36 An example of laboratory requirement for OI management and ART at district hospital h HIV testing h Complete blood count (CBC) and differential h Pregnancy test hsputum smear for TB hgram and Wright stains h Malaria smears hurinalysis h Chest X-Ray <Preferable> h Alanine Aminotransferase (ALT) hcd4 count hfundoscopy, Spinal tap and Indian Ink stain 36 WPRO

37 A framework for country action on HIV/AIDS Care and Treatment 1. Political commitment, coordination and management: 3 Ones 2. Uninterrupted supply of affordable HIV medicines and diagnostics 3. Scaling up ART integrated into Continuum of Care 4. Equitable access to care including ARV 5. Responding to diverse and changing situation: M&E 6. Accelerating HIV prevention 37 WPRO

38 Uninterrupted supply of affordable HIV medicines and diagnostics hhow can it be integrated into existing drug procurement and supply system? hwhat need to be done differently for HIV medicines and diagnostics? 38 WPRO

World Bank Training Program on HIV/AIDS Drugs

World Bank Training Program on HIV/AIDS Drugs Training Module 3 Selection and Quantification based on the World Bank document Battling HIV/AIDS: A Decision Maker s Guide to the Procurement of Medicines