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Progress Towards 3 x 5 Uganda 2003-2005

Progress Towards 3 x 5 Uganda 2003-2005. Geoffrey Taylor Division of Infectious Diseases University of Alberta. DART : triple NRTI ( AZT/3TC/TDF) randomized to lab vs clinical monitoring and to continuous vs interupted therapy 54% <50 copies @ 24 wks.

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Progress Towards 3 x 5 Uganda 2003-2005

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  1. Progress Towards 3 x 5Uganda 2003-2005 Geoffrey Taylor Division of Infectious Diseases University of Alberta

  2. DART : triple NRTI ( AZT/3TC/TDF) randomized to lab vs clinical monitoring and to continuous vs interupted therapy 54% <50 copies @ 24 wks

  3. Meta-analysis of ARV programs in RLSL. Ivers, D Kendrick, K DoucetteCID 41:217

  4. 3 x 5 • Uses a public health service approach • Simplified initial and alternate regimens • Limited laboratory requirements • Strengthening of personnel infrastructure

  5. Move to use of ARV’s earlier in disease continuum • Easier to implement , less monitoring , less toxicity

  6. Source:WHO

  7. Equivalent to a vaccine with 80% protective efficacy • Abstain • Be faithful • Use Condoms

  8. Update on Epidemiology of HIV in the Rakai CohortDr F Wabwire-Mangen4th National HIV Conference Kampala , March 2005 • Open cohort study of HIV epidemiology in Rakai district • Initiated in 1986

  9. Incidence of new infections unchanged in men/women ages 15-49 between 1994 -2003 (1.2-1.5/100py) 2002-2003:125 incident cases Mortality HIV(-) 1/100py HIV (+) 11.8 -14.0/py 2002- 2003 : 200 deaths 81% of decline in prevalence from 1994 to 2003 can be accounted for by mortality Rakai : incidence and mortality

  10. What will be the effect of ARV’s on prevalence? • ARV’s may increase survival in HIV (+) populations ie increase duration of disease • ARV’s may reduce infectivity • Will availability of ARV’s broadly alter risk behaviours? • Wide spread availability of ARV’s may increase prevalence , even if incidence is unchanged

  11. Antiretroviral therapy for PMTCT( Preventing mother to child transmission) • Nevirapine (42% reduction in transmission) • Maternal single dose NVP at onset of labor • Infant single dose NVP syrup within 1 week • HAART : as used in developed countries ( 3 drugs from second trimester): >95% reduction in transmission ( to ~1-2%)

  12. Nevirapine Resistance Genotyping Results • NVP resistant mutations were detected in19% of the mothers and 44% of the babies by 6 weeks • Majority of the mothers had K103N mutants while most of the babies had Y181C mutants • In both mothers and infants the resistance faded by 12-18 months

  13. THE REPUBLIC OF UGANDANational Antiretroviral Treatment and Care Guidelines for Adults and Children Adaptation byDr. Hans Spiegel/CNMC/AAACP

  14. Free ARV Sources - Uganda • MOH • Global Fund • World Bank • Generics : NRTI’s, NNRTI’s ( nevirapine) • Limited lab capability ( CD4) • PEPfAR ( President’s Emergency Program for AIDS Relief) • FDA approved ( Brand name) : NRTI’s, NNRTI’s, PI’s • Greater lab support ( CD4, some viral load , no resistance testing) • Research Trials • DART ~ 2000 Currently ( March 2005), more drug available in stock than requested by clinics

  15. UgandaHIV and ARV situation2005 • 1,000,000 HIV (+) • 110,000 immediately need ARV’s (WHO estimate 2003) • 3 x 5 target 55,000 • June 2005 (WHO) • 114 clinics prescribing ARV’s ( 2 districts without) • 63,896 on ARV’s ; 10,600 free from Ministry • Major clinics • JCRC – private ; 12,500 on ARV’s . • IDC – Academic Alliance – adult/peds. • Mildmay (charitable – pediatric). • Mbuya Outreach ( faith based). • Employer clinics eg Bell Breweries, Bank of Uganada, Coca-Cola

  16. Clinical Management of ARV’s – Uganda (urban) • Limited laboratory monitoring • Slow to detect failure • Intensive formal counselling • Very intensive clinical monitoring – eg Q2 week – 1 month clinic visits

  17. Clinical Management of ARV’s – Uganda (urban) • Clinical staging for the most part but increasing use of CD4. • Usually start ARV’s only with very advanced disease – more comorbidities , more drug adverse effects • First line regimens use NNRTI’s ( nevirapine, efavirenz) and 3TC • Low genetic barrier to resistance • Resistance testing not used clinically (some country level surveillance) • D4T first line NRTI • Sensory neuropathy very common • Lipoatrophy

  18. Academic Alliance for AIDS Care and Prevention in Africa Transferred to Makerere Feb 2005

  19. AIDS Training Program • AIDS training program for physicians (1 month) • ID resident training in Utah • Short course (1 week) • Nurses and para-medical staff ( 250 to date)

  20. AIDS Training Program for Physicians • 25 students/ 1 month Session /6 sessions/year • Highly competitive • Clinical/ Didactic; emphasis on ARV use • 350 students trained to August 2005 from 10 sub-Saharan countries • Post training , return to local clinics where regarded as local ‘HIV expert’ or take positions as clinical officers in large clinical/research programs

  21. CASE PRESENTATION HAART CLINIC NYAKIBALE HOSPITAL RUKUNGIRI

  22. Presentation ( 2002 ) • 36 yr old widow • History:h/o Cough x 3/12 Fever x 2/12

  23. Social and occupational History • A peasant, • being support by her brother ( in Kampala) for financial & medical support sometimes food. • Too weak to cater for needs for her young children. Small piece of land to cultivate.

  24. Lab findings • CD4 2 cells / mm3 • C x R: Cavitations Fibrosis of lung tissue With bilateral reticular opacities

  25. Treatment - started on • Anti TB drugs 2 months RHEZ 6 months EH • Septrin tabs • ARVS Combivir Efavirenz

  26. Patient was discharged after 2 weeks of D.O.T on TB drugs, Septrin prophylaxis, pyridoxin tabs, iron and ARVS • weight gain - 48 kg • HB - 10 g/dl • Appetite - improved • Sputum - no AAFBS seen • Changed ARVS to - Stavudine - Lamivudine • Nevirapine • ( less expensive , compatible with continuation phase of Tb Rx)

  27. Weight gained to 53 kg • But occasionally she could run out of ARVS and Septrin due to financial constraints and transport problems

  28. On 20/1/04 • She had missed 3/12 of drugs and presented with cough 3/12 fever on & off, weight loss poor appetite for feeds. • Relevant findings: Wasted, weight 41 kg(from 53 kg) Sputum analysis AAFBS + 2 (3 samples)

  29. CD4-175 cells/ mm3 • Retreated Tb • Enrolled in free ARV program

  30. Comment by G Taylor • CD4 available in remote location • Skilled use of Tb Rx and ARV’s • Tb relapse despite following national protocol • Logistical and financial problems of ARV’s in remote clinics prior to national program • Intermittent ARV’s - may be resistant to NNRTI’s and/or 3TC

  31. CASE PRESEENTATION workers’ treatment centre II

  32. History Feb. 2004 • MF, 38 yo male, lives about 2km from the clinic, known HIV +ve • Came in with h/o cough x 1 mon. had started anti- TB drugs and Septrin prophylaxis in Jinja hospital 3 wks prior to this visit and reported improvement.h/o marked wt loss, had no other complaints. • FSH:Married,spouse reportedly HIV –ve ; 3 children not yet had HIV test. Had disclosed status to the spouse.

  33. Follow up- visit 2 (mar 2004) • CD4- 64 • CBC ( WBC-2.3 HB- 11.3 PLT – 213 ) • More Labs- RFTs,LFTs • Treatment prep- individual counseling • Started on D4T,3TC,EFV

  34. Follow up cont. • Clinical Wt No new OIs • Immunological

  35. Follow up cont. • Adherence Anti-TB drugs- defaulted and Rx was restarted Septrin- Good ARVs- non- adherence( mar-oct 04) good (oct- march 05) Nov: switched from D4T,3TC,EFV to TDF,3TC,EFV

  36. Comment by G Taylor • Major role of private sector occupational health clinics • Concerns about adherence ( as in Canada) and management after failed 1st line regimens ( ie PI based regimens)

  37. HISTORY • Mr N B, 7yr old Karamojong from Kotido. • Admitted on October 4th 2004

  38. PRESENTING COMPLAINT • Chest Pain • Cough • Fever • Wt loss

  39. Review Of Systems FSH: He is an orphan, 3rd born of 5 siblings, 4th and 5th are dead. 1st and 2nd are okay and HIV-ve. Mother is peasant who is on TB treatment for the past 5 mths and ARV for 3mths and 3 other widows are okay.

  40. Cont…. • P/E : A school going boy ,grossly wasted ,listless and he is moderately pale, febrile T- 38.20 C and has oral thrush • R/S: He is in respiratory distress, RR=46pm, stony dull percussion right infraaxillar and absent breath sounds

  41. Diagnosis • Right Sided Pleural Effusion • R/O Pulmonary Tuberculosis • Underlying HIV/AIDS

  42. Management Plan • Chest X-ray Confirmed the presence of effusion • Sputum AAFB +++ • Hb 6.2g/dl • HIV (+)

  43. Follow Up – 1 Month • Appetite is improving and still has low grade fever • Wt. 15.4 Kg • Hb 7.2g/dl • Started 3Tc, d4t and efavirenz • Gave supplement foods from paediatric nutritional ward

  44. ISSUES • How reliable is Wt and Hb. monitoring in a resource limited environment. • Should HIV patients in contact with TB patients be given TB prophylaxis ( not national policy) • If nevirapine is to used in the face of TB treatment, under what circumstances and how?

  45. Comment : G Taylor • Repetitive theme of Tb / Advanced HIV • Poorer outcomes when HIV treated at advanced stage • Complex drug interactions • Suboptimal national Tb protocol • Re-infection

  46. Will exceed 3 x 5 target ARV’s now readily available in country; many clinicians have some experience Improved CD4 availability Problems of personnel infrastructure outside main centers Intensive clinical follow up will be difficult to sustain Difficult to initiate ARV’s in very advanced patients Problems with NNRTI based regimens Resistance Difficult to use with Tb drugs Hepatotoxicity 3 x 5 – Uganda ,2005A mixed picture

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