Elsevier

The Lancet

Volume 359, Issue 9322, 8 June 2002, Pages 1980-1989
The Lancet

Articles
Feasibility and cost-effectiveness of standardised second-line drug treatment for chronic tuberculosis patients: a national cohort study in Peru

https://doi.org/10.1016/S0140-6736(02)08830-XGet rights and content

Summary

Background

There are no data on the feasibility and cost-effectiveness of using second-line drugs to treat patients with chronic tuberculosis, many of whom are infected with multidrug resistant (MDR) strains of Mycobacterium tuberculosis, in low or middle-income countries.

Methods

A national programme to treat chronic tuberculosis patients with a directly observed standardised 18-month daily regimen, consisting of kanamycin (3 months only), ciprofloxacin, ethionamide, pyrazinamide, and ethambutol, was established in Peru in 1997. Compliance and treatment outcomes were analysed for the cohort started on treatment between October, 1997, and March, 1999. Total and average costs were assessed. Cost-effectiveness was estimated as the cost per DALY gained.

Findings

466 patients were enrolled; 344 were tested for drug susceptibility and 298 (87%) had MDR tuberculosis. 225 patients (48%) were cured, 57 (12%) died, 131 (28%) did not respond to treatment, and 53 (11%) defaulted. Of the 413 (89%) patients who complied with treatment, 225 (55%) were cured. Among MDR patients, resistance to five or more drugs was significantly associated with an unfavourable outcome (death, non-response to treatment, or default; odds ratio 3·37, 95% CI 1·32–8·60; p=0·01). The programme cost US$0·6 million per year, 8% of the National Tuberculosis Programme budget, and US$2381 per patient for those who completed treatment. The mean cost per DALY gained was $211 ($165 at drug prices projected for 2002).

Interpretation

Treating chronic tuberculosis patients with high levels of MDR with second-line drugs can be feasible and cost-effective in middle-income countries, provided a strong tuberculosis control programme is in place.

Published online May 14, 2002. http://image.thelancet.com/extras/01art7269web.pdf

Introduction

Multidrug-resistant (MDR) tuberculosis-ie, resistance to at least rifampicin and isoniazid-is a threat to tuberculosis control efforts in some countries.1, 2 Patients with MDR tuberculosis often do not respond to short-course chemotherapy with first-line drugs.3 Thus, treatment with second-line drugs may be needed to cure these individuals and to curtail transmission of such strains of Mycobacterium tuberculosis. However, data from low-income or middle-income countries on the management of MDR tuberculosis with second-line drugs under programme conditions are not available. As a result, international public-health institutions, including the WHO, do not have definitive policy recommendations in place; guidelines exist only for specialised centres where resources that permit treatment are available.4 Treatment of MDR tuberculosis is, however, available in more-developed countries.5, 6

After results of a survey of drug-resistant tuberculosis showed an MDR prevalence of 16% among previously treated individuals,1 Peru's National Tuberculosis Programme introduced a standardised treatment regimen, including second-line drugs, for patients who had failed to respond to standard treatment with first-line drugs. Our aim was to assess the feasibility, effectiveness, affordability, and cost-effectiveness of implementing such treatment services.

Section snippets

Setting

Peru is a middle-income country that had a per capita Gross National Income of US$2390 in 1999.7 The DOTS strategy was introduced in 1991 and is now implemented in all health facilities.8, 9 WHO targets for tuberculosis control (70% case detection and 85% cure rate among new smear-positive pulmonary cases) have been achieved and sustained, as a result of which the incidence rate is declining at an estimated 6% per year.9

Before 1997, the treatment policy in Peru was limited to short-course

Baseline characteristics and monitoring of participants

During enrolment, the committee assessed 755 requests to treat tuberculosis cases with second-line drugs; 477 (63%) were accepted. 21 of 34 health departments in Peru enrolled patients. 11 (2%) of the enrolled patients were excluded from our analysis; reasons included use of a non-standardised treatment regimen, and unfinished treatment. Table 2 shows demographic characteristics according to entry criteria. Susceptibility test results were available for 344 (74%) patients. 335 (97%) individuals

Discussion

These data from Peru provide evidence with respect to the feasibility and cost-effectiveness of providing standardised second-line drug treatment for chronic tuberculosis patients among whom MDR prevalence is high, under programme conditions and on a national basis, in a middle-income country. They show that Peru's National Tuberculosis Programme was able to achieve a compliance rate of nearly 90%, a cure rate of almost 50% among all patients enrolled, and a cure rate of 63% among those who

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