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Progress Towards 3 x 5Uganda 2003-2005
Geoffrey Taylor
Division of Infectious Diseases
University of Alberta
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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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Meta-analysis of ARV programs in RLSL. Ivers, D Kendrick, K DoucetteCID 41:217
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3 x 5
Uses a public health service approach
Simplified initial and alternate regimens
Limited laboratory requirements
Strengthening of personnel infrastructure
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Move to use of ARV’s earlier in disease continuum
Easier to implement , less monitoring , less toxicity
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Source:WHO
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Equivalent to a vaccine with 80% protective efficacy
Abstain Be faithful Use Condoms
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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
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Rakai : incidence and mortality 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
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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
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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%)
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Nevirapine Resistance Genotyping Results NVP resistant mutations were detected in
19% 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
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THE REPUBLIC OF UGANDA
National Antiretroviral Treatment and Care Guidelines for Adults and Children
Adaptation by Dr. Hans Spiegel/CNMC/AAACP
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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
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UgandaHIV and ARV situation 2005
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
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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
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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
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Academic Alliance for AIDS Care and Prevention in Africa
Transferred to Makerere Feb 2005
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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)
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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
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CASE PRESENTATION
HAART CLINIC
NYAKIBALE HOSPITAL
RUKUNGIRI
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Presentation ( 2002 )
36 yr old widow History:h/o Cough x 3/12 Fever x 2/12
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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.
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Lab findings
CD4 2 cells / mm3 C x R: Cavitations
Fibrosis of lung tissue With bilateral
reticular opacities
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Treatment - started on
Anti TB drugs2 months RHEZ 6 months EH
Septrin tabs ARVSCombivir Efavirenz
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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)
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Weight gained to 53 kg But occasionally she could run out of
ARVS and Septrin due to financial constraints and transport problems
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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)
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CD4-175 cells/ mm3 Retreated Tb Enrolled in free ARV program
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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
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CASE PRESEENTATIONworkers’ treatment centre II
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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.
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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
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Follow up cont.
Clinical
Wt
No new OIs Immunological
70 68 65 63 70 75 74 77 80 80 82
Date Feb 04 Aug 04 Feb 05
CD4 Count 64 168 143
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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
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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)
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HISTORY
Mr N B, 7yr old Karamojong from Kotido. Admitted on October 4th 2004
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PRESENTING COMPLAINT
Chest Pain Cough Fever Wt loss
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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.
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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
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Diagnosis
Right Sided Pleural Effusion R/O Pulmonary Tuberculosis Underlying HIV/AIDS
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Management Plan
Chest X-rayConfirmed the presence of effusion SputumAAFB +++ Hb 6.2g/dl HIV (+)
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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
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ISSUES
1. How reliable is Wt and Hb. monitoring in a resource limited environment.
2. Should HIV patients in contact with TB patients be given TB prophylaxis ( not national policy)
3. If nevirapine is to used in the face of TB treatment, under what circumstances and how?
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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
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3 x 5 – Uganda ,2005A mixed picture 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