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Good quality locally procured drugs can be as effective as internationally quality assured drugs in treating multi-drug resistant tuberculosis.

Qadeer E, Fatima R, Fielding K, Qazi F, Moore D, Khan MS - PLoS ONE (2015)

Bottom Line: Despite price reductions, internationally quality assured (IQA) drugs can be more expensive than locally procured drugs.There is little evidence to inform decision-makers about whether IQA drugs are more effective than local drugs.The primary outcome compared between cohorts was time to culture conversion.

View Article: PubMed Central - PubMed

Affiliation: National Tuberculosis Control Program Pakistan, Islamabad, Pakistan.

ABSTRACT

Background: Owing toGiven the high costs of drugs to treat multi-drug resistant tuberculosis (MDR-TB), the Green Light Committee (GLC) initiative enables TB programs to procure quality-assured drugs at reduced prices. Despite price reductions, internationally quality assured (IQA) drugs can be more expensive than locally procured drugs. There is little evidence to inform decision-makers about whether IQA drugs are more effective than local drugs. This is the first study to compare outcomes between MDR-TB patients treated using IQA, and locally procured drugs in the same hospitals during the same time period.

Methods/findings: A retrospective cohort study was conducted in three hospitals across Pakistan. Data on baseline characteristics and treatment outcomes during the first six months of treatment were extracted from hospital records of adult culture-positive pulmonary MDR-TB patients starting treatment between January 2011 and June 2012. Two cohorts were defined: patients receiving IQA drugs, and patients receiving locally procured non-IQA drugs. Data were analysed using Kaplan-Meier curves and Cox proportional hazards regression. The primary outcome compared between cohorts was time to culture conversion. Of 231 patients, 90 were in the IQA and 141 in the non-IQA cohorts. Baseline characteristics were similar except for higher frequency of quinolone resistance in the IQA cohort. Overall, 193 patients (84%) culture converted. Culture conversion was not faster in the IQA cohort; the median time was 81 and 68 days in the IQA and non-IQA cohorts, respectively. Unadjusted and adjusted hazard ratios for culture conversion in IQA verses non-IQA cohorts were 0.82 (95%-CI, 0.62-1.10) and 0.95 (95%-CI, 0.66-1.36) respectively.

Conclusions: Use of good quality, locally procured drugs can be effective in treating MDR-TB, may involve lower costs than using IQA drugs and could strengthen developing country drug quality assurance systems. This may be a suitable alternative in lieu of or whilst awaiting arrival of internationally procured medicines.

No MeSH data available.


Related in: MedlinePlus

Kaplan-Meier curve showing time to culture conversion by cohort (n = 231).
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pone.0126099.g001: Kaplan-Meier curve showing time to culture conversion by cohort (n = 231).

Mentions: One hundred and ninety-three patients (84%) culture converted within six months of treatment initiation. Median time to culture conversion was 81 days in the IQA cohort and 68 days in the non-IQA cohort (Table 2 and Fig 1). The unadjusted hazard ratio for culture conversion in the IQA verses non-IQA cohort was 0.82 (95% CI, 0.62–1.10; p = 0.19). After adjusting for potential confounding factors (age, gender, initial weight, previous first or second line drug use, sputum microscopy result at treatment initiation, resistance to first and second line drugs, number of drugs received to which the patient isolate was sensitive, period of treatment initiation, hospital at which patients received MDR-TB treatment and treatment initiation delay), the hazard ratio was 0.95 (95% CI, 0.66–1.36; p = 0.78).


Good quality locally procured drugs can be as effective as internationally quality assured drugs in treating multi-drug resistant tuberculosis.

Qadeer E, Fatima R, Fielding K, Qazi F, Moore D, Khan MS - PLoS ONE (2015)

Kaplan-Meier curve showing time to culture conversion by cohort (n = 231).
© Copyright Policy
Related In: Results  -  Collection

License
Show All Figures
getmorefigures.php?uid=PMC4414548&req=5

pone.0126099.g001: Kaplan-Meier curve showing time to culture conversion by cohort (n = 231).
Mentions: One hundred and ninety-three patients (84%) culture converted within six months of treatment initiation. Median time to culture conversion was 81 days in the IQA cohort and 68 days in the non-IQA cohort (Table 2 and Fig 1). The unadjusted hazard ratio for culture conversion in the IQA verses non-IQA cohort was 0.82 (95% CI, 0.62–1.10; p = 0.19). After adjusting for potential confounding factors (age, gender, initial weight, previous first or second line drug use, sputum microscopy result at treatment initiation, resistance to first and second line drugs, number of drugs received to which the patient isolate was sensitive, period of treatment initiation, hospital at which patients received MDR-TB treatment and treatment initiation delay), the hazard ratio was 0.95 (95% CI, 0.66–1.36; p = 0.78).

Bottom Line: Despite price reductions, internationally quality assured (IQA) drugs can be more expensive than locally procured drugs.There is little evidence to inform decision-makers about whether IQA drugs are more effective than local drugs.The primary outcome compared between cohorts was time to culture conversion.

View Article: PubMed Central - PubMed

Affiliation: National Tuberculosis Control Program Pakistan, Islamabad, Pakistan.

ABSTRACT

Background: Owing toGiven the high costs of drugs to treat multi-drug resistant tuberculosis (MDR-TB), the Green Light Committee (GLC) initiative enables TB programs to procure quality-assured drugs at reduced prices. Despite price reductions, internationally quality assured (IQA) drugs can be more expensive than locally procured drugs. There is little evidence to inform decision-makers about whether IQA drugs are more effective than local drugs. This is the first study to compare outcomes between MDR-TB patients treated using IQA, and locally procured drugs in the same hospitals during the same time period.

Methods/findings: A retrospective cohort study was conducted in three hospitals across Pakistan. Data on baseline characteristics and treatment outcomes during the first six months of treatment were extracted from hospital records of adult culture-positive pulmonary MDR-TB patients starting treatment between January 2011 and June 2012. Two cohorts were defined: patients receiving IQA drugs, and patients receiving locally procured non-IQA drugs. Data were analysed using Kaplan-Meier curves and Cox proportional hazards regression. The primary outcome compared between cohorts was time to culture conversion. Of 231 patients, 90 were in the IQA and 141 in the non-IQA cohorts. Baseline characteristics were similar except for higher frequency of quinolone resistance in the IQA cohort. Overall, 193 patients (84%) culture converted. Culture conversion was not faster in the IQA cohort; the median time was 81 and 68 days in the IQA and non-IQA cohorts, respectively. Unadjusted and adjusted hazard ratios for culture conversion in IQA verses non-IQA cohorts were 0.82 (95%-CI, 0.62-1.10) and 0.95 (95%-CI, 0.66-1.36) respectively.

Conclusions: Use of good quality, locally procured drugs can be effective in treating MDR-TB, may involve lower costs than using IQA drugs and could strengthen developing country drug quality assurance systems. This may be a suitable alternative in lieu of or whilst awaiting arrival of internationally procured medicines.

No MeSH data available.


Related in: MedlinePlus