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This article discusses the options available for TB control programs to prevent recurrent TB in high HIV-prevalent areas, including the use of RH in the continuation phase, extending the duration of CP in HIV+ patients, post-treatment isoniazid, and treating HIV+ TB patients with HAART.
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Preventing recurrent TB in high HIV-prevalent areas What are the options for TB Control Programmes?
DEFINITION OF RECURRENT TB • TB which re-occurs after a patient has been previously diagnosed with TB and completed a full course of treatment • Bacteriologically confirmed or based on clinical criteria • Due to reactivation or reinfection
EXTENT OF RECURENT TB:RESULTS OF STUDIES (1) Systematic review assessing the influence of HIV and rifampicin therapy • 47 studies world wide • 17 studies from sub-Saharan Africa (Korenromp, Scano, Williams, Dye, Nunn. Clin Inf Dis)
EXTENT OF RECURENT TB:RESULTS OF STUDIES (2) Recurrent TB (rate/pa) HIV-negative 1.9% HIV-positive 4.5% 7 months or > Rifampicin 1.4% 5-6 months Rifampicin 2.0% 2-3 months Rifampicin 4.0% [level of background TB is important]
EXTENT OF RECURRENT TB: REPORTS FROM NTPs AND WHOProblems • NTP annual notifications to WHO include “Relapse”, “Failure” and “Rx after DF” • WHO does not include “Failure” or “Rx after DF” in Global TB Reports • NTPs do not notify WHO about recurrent smear-negative TB or EPTB
Case History: MalawiHigh HIV-prevalence countryIn 2000, 77% of TB patients HIV+ve 1990 - 1999 • 2- 4% all cases were relapse sm+ve PTB • Almost no cases of recurrent sm-ve PTB / EPTB Operational research 1999 • 12% sm-PTB /EPTB registered as “new” cases had been previously treated for TB
From 1999, Malawi improved its registration of patients in terms of new and previously treated cases, especially with smear-ve PTB and EPTB
Malawi Case Notifications Year Total TB New Recurrent 1998 22674 22069 605 (3%) 1999 24396 23728 668 (3%) 2000 24846 22789 2057 (8%) 2001 27672 25217 2455 (9%) 2002 26532 23724 2808 (11%) recurrent TB = relapse, failures, treatment after default plus recurrent sm-ve PTB and EPTB
Why the need to reduce recurrent TB? Recurrent TB cases:- • consume resources • have a more difficult regimen • increase TB transmission in the community • cause additional morbidity and mortality • erode faith in NTP amongst patients, staff, and community
Options to reduce risk of recurrence • Use RH in continuation phase (CP) • Extend duration of CP in HIV+ patients • Give post-treatment isoniazid to HIV+ve patients who complete anti-TB treatment • Treat HIV+ve TB patients with HAART
For each option: • Evidence of effectiveness • Current practice • Operational considerations [consider especially for sub-Saharan Africa]
RH in Continuation Phase (CP)evidence of effectiveness • Systematic review by Korenromp, Scano et al (Clin Inf Dis) • IUATLD Clinical Trial A, RH throughout has lower recurrence than EH in CP [done mainly in HIV-negative patients]
RH in the CP:current practice in Africa • All programmes use RH in IP • Many programmes use EH in CP (6mo)
Option:Replace EH with RH in CP for all patients The dangers: • RH needs distribution to all Rx outlets • RH must be given by DOT • Possible irrational use of RH • If H resistance high, then R as “monotherapy” • Risk of creating MDR-TB • May increase difficulties with use of HAART
Extend duration of CP:evidence of effectiveness In HIV+ve patients: • 2RHZE/4RH, then 6RH recurrent TB = 1.9% • 2RHZE/4RH, then placebo recurrent TB = 9.0% (Perriens et al, NEJM 1995)
Extend duration of CP:current practice in Africa Not used by any TB programme in Africa
Option:Extend duration of CP for HIV+ve patients • Need knowledge of HIV-status and therefore need links with VCT • Evidence only for RH (although may work for EH) • Different lengths of Rx for HIV+ve and HIV-ve patients, and may cause confusion • Long use of RH may delay start of HAART
Provide IPT to HIV+ve patients who complete treatment:evidence of effectiveness Study in Haiti HIV+ve patients: • 2RHZ/4RH, then 12H recurrent TB = 1.4% • 2RHZ/4RH, then placebo recurrent TB = 7.8% (Fitzgerald et al, Lancet 2000)
Post-treatment isoniazid:current practice in Africa Not used by any TB programme in Africa
Option:IPT to HIV+ve patients who complete Rx • Need knowledge of HIV-status and therefore need links with VCT • Adherence may be better than with 1o IPT • What is the optimal length of 2o IPT ? • Who administers and monitors 2o IPT ? • Will HAART obviate the need for 2o IPT?
Treat HIV+ TB patients with HAART:evidence of effectiveness • In West, HAART reduces risk of TB in HIV-positive persons • In South Africa HAART reduces risk of TB in HIV-positive persons (2.4% vs 9.7% pa) [Risk reduction most in the immunocompromised] • No studies showing effect for recurrent TB
HAART to HIV+ve TB patients:current practice in Africa Not used by any TB programme in Africa
Option:HAART to HIV+ve patients with TB • Need knowledge of HIV-status and therefore need links with VCT • Need significant increased funding • Need a structure for safe and secure supply and delivery of HAART
WAYS FORWARD • Country TB programmes to determine true burden of recurrent TB • If burden is high, then determine which of the four options is most cost-effective, feasible and least dangerous to do - • Clinical studies / operational research / philosophy of “learn as we do”