Extension of the intensive phase reduces relapse but not failure in a regimen with rifampicin throughout

Kj, Aung; Declercq, Eugene; Ma, Ali; Naha, Sowjanya; Sc, Datta; Ma, Taleb; Ma, Hossain; Rigouts, Leen; Gumusboga, Aysel; A, Van Deun

doi:10.5588/ijtld.11.0216

Cited by 15 publications

(13 citation statements)

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“…There is some discussion about the value of sputum smear examination at 2 months in predicting fi nal treatment outcomes, 11,12 but recent evidence shows that extending the initial phase of treatment does not reduce failure. 13 Our fi ndings are in line with these observations. The strengths of this study were the large number of patients studied and the adherence to the conduct and reporting of the study according to the Strengthening the Reporting of Observational studies in Epidemiology (STROBE) guidelines.…”

Section: Public Health Action Failure To Smear Convert At 2 Months 29supporting

confidence: 82%

Characteristics and outcomes of tuberculosis patients who fail to smear convert at two months in Sri Lanka

Jayakody

Harries

Malhotra

et al. 2013

public health action

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men, with a 2-month initial phase consisting of four drugs (INH, RMP, pyrazinamide and ethambutol), followed by a 4-month continuation phase with RMP and INH. Patients submit sputum for smear examination at 2 and 5 months and at the end of the treatment period. Those who convert to negative at 2 months start the continuation phase of treatment, while those who are still smear-positive are supposed to have a sputum specimen sent for culture and drug susceptibility testing (DST), with a 1-month extension of the initial phase and an additional sputum specimen sent for smear examination and possible culture and DST at 3 months. 4 Drug-resistant TB may be identifi ed either through the DST results at 2 months or due to failure to convert at 5 or 6 months. Such patients are considered treatment failures, and are moved to a retreatment or second-line MDR-TB treatment regimen.In Sri Lanka, we were interested to know about sputum smear conversion rates at 2 months, whether recommendations from the NPTCCD are being followed, and whether following these recommendations has any effect on fi nal treatment outcomes. We therefore aimed to determine, in patients registered with new smearpositive PTB in fi ve selected districts in Sri Lanka: 1) the proportion alive, known to be on treatment and failing to smear convert at 2 months; 2) whether these patients submitted sputum specimens for culture and DST, had the initial phase of treatment extended and submitted an additional sputum sample at 3 months; and 3) whether the characteristics and treatment outcomes of such patients were different from those who did achieve conversion at 2 months. METHODS Study designThis was a cross-sectional descriptive study using routine programme records. Study settingThe Sri Lanka NPTCCD comprises a central unit and 24 district chest clinics that are run by medical doctors working as district TB control offi cers. All district chest clinics have laboratories that perform smear microscopy, and another 150 microscopy centres provide smear microscopy services throughout the country. All smear microscopy services undergo internal and external quality control. Patients with cough of more than 2 weeks are regarded as PTB suspects and are investigated using sputum smear microscopy and chest X-ray, according to national guidelines. Patients are diagnosed as smear-positive if at least two of three sputum Interna onal Union Against Tuberculosis and Lung DiseaseHealth solu ons for the poor Setting: Five districts in Sri Lanka. Objectives: To determine: 1) the proportion of sputum smear-positive pulmonary tuberculosis (PTB) cases who failed to smear convert at 2 months, 2) their management, and 3) whether baseline characteristics and final treatment outcomes were different from those who did smear convert. Design: Cross-sectional retrospective review of medical files, tuberculosis (TB) registers and TB treatment records of new smear-positive PTB patients registered from January to December 2010. Results: Of 925 patients, 840 were available to submit sputum at...

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Section: Public Health Action Failure To Smear Convert At 2 Months 29supporting

confidence: 82%

Characteristics and outcomes of tuberculosis patients who fail to smear convert at two months in Sri Lanka

Jayakody

Harries

Malhotra

et al. 2013

public health action

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“…A prospective study in Bangladesh compared patients who remained smear positive after finishing the intensive phase and then prolonged treatment for 1 month to those who did not prolong the intensive phase, and showed that prolonged treatment decreased the rate of relapse within 2 years from 3.3% to 1.4%. 14 However, that study was confined to patients who remained smear positive. In our study, the extended treatment was performed on patients who were smear negative and reported to be cured or to have completed treatment.…”

Section: Discussionmentioning

confidence: 99%

Prevalence of extended treatment in pulmonary tuberculosis patients receiving first-line therapy and its association with recurrent tuberculosis in Beijing, China

Xia

Goel

Harries

et al. 2014

Transactions of the Royal Society of Tropical Medicine and Hygi

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BackgroundIn China, it is known that extended treatment is given to patients with pulmonary TB after they have successfully completed 6 months of first-line treatment. This practice is not officially reported to the National Tuberculosis Control Programme, so there are no data on its prevalence, its possible benefits in terms of preventing recurrent disease or the costs. This study aimed to provide information, from a single TB dispensary in Beijing, China, on the prevalence of extended anti-TB treatment and its relationship with recurrent TB.MethodsRetrospective cohort study using the electronic national TB information system and dispensary medical records.ResultsOf 935 patients with pulmonary TB who completed 6–7 months of first-line drug treatment, 399 (43%) were given extended treatment. This was more common in patients with smear-positive disease, and those with lung cavities and more extensive radiographic lobar involvement at the time of diagnosis. Over 3–4 years' follow-up, recurrent disease was not significantly different in patients who received extended treatment (2.8%, 11/399) as compared to those who received the standard 6-month treatment (3.7%, 20/534). The median length of extended treatment was 89 days at a median cost of US$111 for drugs and US$32 for laboratory examinations.ConclusionsThis study shows that extended treatment is common in one TB dispensary in Beijing. Further studies are needed to determine the countrywide prevalence of this practice and ascertain more conclusively the apparent lack of benefit.

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“…Since the mid-1990s, strains from Bangladesh, or sputa transported in cetylpyridinium chloride (CPC) from Kinshasa (Democratic Republic of Congo), were tested by DST on solid medium at the Antwerp SRL for drug resistance surveillance through systematic sampling of smear-defined recurrences (failure and relapse/reinfection) after primary treatment (category 1) (12). For a number of years, a portion of the sputum samples were sent as ethanol-preserved samples for rpoB sequencing, in the context of retrospective studies on acquired rifampin resistance (13). These systematic sample data were used to determine the mutation prevalence rates reported here.…”

Section: Methodsmentioning

confidence: 99%

Rifampin Drug Resistance Tests for Tuberculosis: Challenging the Gold Standard

et al. 2013

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; Coordination Provinciale Lèpre/Tuberculose, Kinshasa, Democratic Republic of Congo dThe rapid diagnosis of rifampin resistance is hampered by a reported insufficient specificity of molecular techniques for detection of rpoB mutations. Our objective for this study was to document the prevalence and prognostic value of rpoB mutations with unclear phenotypic resistance. The study design entailed sequencing directly from sputum of first failure or relapse patients without phenotypic selection and comparison of the standard retreatment regimen outcome, according to the mutation present. We found that among all rpoB mutations, the best-documented "disputed" rifampin resistance mutations (511Pro, 516Tyr, 526Asn, 526Leu, 533Pro, and 572Phe) made up 13.1% and 10.6% of all mutations in strains from Bangladesh and Kinshasa, respectively. Except for the 511Pro and 526Asn mutations, most of these strains with disputed mutations tested rifampin resistant in routine Löwenstein-Jensen medium proportion method drug susceptibility testing (DST; 78.7%), but significantly less than those with common, undisputed mutations (96.3%). With 63% of patients experiencing failure or relapse in both groups, there was no difference in outcome of first-line retreatment between patients carrying a strain with disputed versus common mutations. We conclude that rifampin resistance that is difficult to detect by the gold standard, phenotypic DST, is clinically and epidemiologically highly relevant. Sensitivity rather than specificity is imperfect with any rifampin DST method. Even at a low prevalence of rifampin resistance, a rifampin-resistant result issued by a competent laboratory may not warrant confirmation, although the absence of a necessity for confirmation needs to be confirmed for molecular results among new cases. However, a result of rifampin susceptibility should be questioned when suspicion is very high, and further DST using a different system (i.e., genotypic after phenotypic testing) would be fully justified.

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Extension of the intensive phase reduces relapse but not failure in a regimen with rifampicin throughout

Abstract: Extension of P1 is very inefficient with this 6-month regimen. Operational research should define appropriate algorithms allowing an earlier switch to the next higher regimen for those in need, using follow-up smears for screening.

Cited by 15 publications

References 0 publications

Characteristics and outcomes of tuberculosis patients who fail to smear convert at two months in Sri Lanka

Characteristics and outcomes of tuberculosis patients who fail to smear convert at two months in Sri Lanka

Prevalence of extended treatment in pulmonary tuberculosis patients receiving first-line therapy and its association with recurrent tuberculosis in Beijing, China

Rifampin Drug Resistance Tests for Tuberculosis: Challenging the Gold Standard

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