Evaluation of a Directly Observed Therapy Short-Course Strategy for Treating Tuberculosis --- Orel Oblast, Russian Federation, 1999--2000

During the 1990s, the number of tuberculosis (TB) cases increased dramatically in the Russian Federation (1--3), and the rise paralleled concomitant increases in TB-associated mortality (2,3). In November 1998, the World Health Organization (WHO), the U.S. Agency for International Development, and CDC, in collaboration with the Central Tuberculosis Research Institute of the Russian Academy of Medical Sciences and the Russian Ministry of Health, identified three regions as demonstration sites for implementing a WHO control strategy program of directly observed treatment short-course (DOTS). The program was designed to provide comprehensive TB care to both civilian and prison populations within each region (oblast), and periodic cohort analyses of treatment outcomes were recommended to evaluate its progress. This report summarizes evaluations of treatment outcomes for patients enrolled during the first 6 months of the project in Orel oblast and indicates that treatment success rates among TB patients in Orel were high. These findings support the use of DOTS as a control strategy in the Russian Federation.

Orel (1999 population: 900,000) is located approximately 200 miles southwest of Moscow. In 1999, the TB rate for Orel was 72 per 100,000 population, and 3.7% of newly diagnosed, smear-positive patients had primary multidrug-resistant TB (MDR TB) (i.e., TB resistant to at least isoniazid and rifampin). Case finding for TB followed existing national directives, which include the passive detection of symptomatic cases, active case finding among household contacts, and regular screening of groups considered to be at risk (e.g., prisoners, teachers, and health-care workers). In the Russian Federation, TB is generally diagnosed by chest radiograph and clinical findings; however, in the oblasts where the demonstration projects have been implemented, smear microscopy and mycobacterial culture are used by clinicians to diagnose TB. In Orel, clinicians use the standard WHO-recommended short course chemotherapy regimen (isoniazid, rifampin, ethambutol, and pyrazidamine for 2 months followed by isoniazid and rifampin for 4 months) for patients not treated previously for TB.

Prospective data collection began in October 1999 on all Orel TB patients without a history of TB treatment. Sputum conversion and treatment outcomes for patients registered during October--December 1999 and January--March 2000 are presented in this report. Sputum conversion was defined as achieving three consecutive negative sputum smear and/or culture specimens from a previously positive patient. WHO/International Union Against Tuberculosis and Lung Disease definitions for six mutually exclusive treatment outcomes were used.* Prison patients and retreatment patients (i.e., patients who had previously been treated for TB) were enrolled beginning in January 2000 and were included in the analysis of second quarter outcomes.

A total of 349 patients were enrolled in the study: 128 during October--December 1999 and 221 during January--March 2000; 331 (95%) had pulmonary TB, and 265 (76%) were men. Mean age at diagnosis was 40 years (range: 15--89 years). Enrollment was higher in the second quarter, in part because of the inclusion of prisoners (n=39) and retreatment case-patients (n=six). Of the 310 civilian patients, 182 (52%) had positive smears or cultures for Mycobacterium tuberculosis before treatment, and 128 (41%) had negative bacteriologic findings; 146 (47%) reported having symptoms at TB diagnosis, and 164 (53%) were asymptomatic and were identified through routine screening. Culture confirmation of TB diagnosis was significantly higher in symptomatic patients than in those diagnosed through a screening procedure (77% versus 56%; p<0.001). In prisoners, routine biannual screening is mandatory. Fifteen (39%) prison case-patients had positive smears, and 20 (51%) were bacteriologically confirmed.

Of isolates from 179 culture-positive patients tested for susceptibility to five anti-TB drugs, 55 (31%) were resistant to streptomycin, 27 (15%) to isoniazid, 20 (11%) to kanamycin, five (3%) to rifampin, and five (3%) to ethambutol. Six (3%) patients had MDR TB, and all were civilians. MDR TB prevalence was 1% among patients with no history of previous TB treatment (five of 343) and 17% among retreatment cases (one of six).

Treatment success (i.e., patients with bacteriologically documented cure and those who completed treatment) was attained for 88% of new and 60% of retreatment TB patients. Among new, culture-positive pulmonary case-patients, 88% were either cured or completed treatment; this proportion declined to 81% for patients identified as smear-positive at diagnosis. Cure and completion rates among prisoners were high (97%), with no prison patients defaulting. Overall, case-fatality rates were high in Orel (5%), particularly among smear-positive patients (12%).

Reported by: B Kazeonny, T Khorosheva, T Aptekar, Orel Oblast TB Dispensary, Orel; L Rybka, Central TB Research Institute of the Russian Academy of Medical Sciences; H Kluge, W Jakubowiak, D Pashkevich, World Health Organization, Moscow, Russia. International Activity, Div of TB Elimination, National Center for HIV, STD, and TB Prevention; and an EIS Officer, CDC.

Editorial Note:

The findings in this report indicate that treatment success rates among TB patients in Orel were high. Although rates for smear-positive patients during the first 6 months of the project were slightly lower than the WHO global target of 85%, these findings are consistent with expected success rates for a newly implemented DOTS project. The higher treatment success rates among Orel patients in whom asymptomatic TB was diagnosed using chest radiograph (without bacteriologic confirmation) compared with those with bacteriologic confirmation may reflect either early diagnosis of disease or incorrect diagnosis. The higher proportion of cases among prisoners identified through asymptomatic radiographic screening in Orel and the lack of defaulters in this group may account for their better outcomes compared with civilians.

The treatment success rates reported here were higher than those reported in the other project areas of the Russian Federation that implemented the DOTS strategy (5--7). Reasons for the higher treatment success rates in Orel may include earlier clinical presentation of patients and efforts by local staff to ensure that patients remained on treatment. Another factor may be the lower rates of MDR TB; studies in other areas of the Russian Federation have documented rates of 5%--22% in new TB patients (5--7). The higher proportion of deaths among Orel TB patients may indicate delays in treatment of TB disease, raising concern about sustained community transmission from unidentified infectious cases, the potential lack of education about TB symptoms in the general population, and the possibility of delayed recognition by physicians.

The public health system in the Russian Federation is struggling to control the newly re-emergent TB epidemic. Although the DOTS strategy is an inexpensive and effective method of TB control in other high-burden countries (1), the adoption of DOTS in the Russian Federation has begun only recently. Because aspects of the strategy depart from long-standing Russian TB control traditions, convincing TB physicians to adopt DOTS has been difficult. The findings in this report suggest that the successful implementation of DOTS in the Russian Federation is possible despite these historic differences in TB control, and that treatment success rates above the WHO global target of 85% can be achieved.

References

1. Shilova MV. Tuberculosis in Russia in 1999. Moscow, Russia: Ministry of Health of Russia, Sechenov Moscow Medical Academy, Scientific-Research Institute of Phthysiopulmonology, 2000.
2. Shilova MV. Tuberculosis in Russia in 1998. Moscow, Russia: Ministry of Health of Russia, Sechenov Moscow Medical Academy, Scientific-Research Institute of Phthysiopulmonology, 1999.
3. Perelman MI. Tuberculosis in Russia. Int J Tuberc Lung Dis 2000;4:1097--103.
4. World Health Organization. Treatment of tuberculosis: guidelines for national programmes. Geneva, Switzerland: WHO Global Tuberculosis Program, 1997.
5. Kimmerling ME, Kluge H, Vezhina N, et al. Inadequacy of the current WHO re-treatment in a central Siberian prison: treatment failure and MDR TB. Int J Tuberc Lung Dis 1999;3:451--3.
6. Espinal MA, Sang JK, Suarez PG, et al. Standard short-course chemotherapy for drug-resistant tuberculosis: treatment outcomes in 6 countries. JAMA 2000;283:2537--45.
7. CDC. Primary multidrug-resistant tuberculosis---Ivanovo Oblast, Russia, 1999. MMWR 1999;48:661--3.

* WHO treatment outcomes include bacteriologic cure: patients with a positive smear or culture before treatment and negative bacteriologic results at the end of therapy; treatment completion: patients who complete treatment without bacteriologic proof of cure or failure; treatment failure: patients who fail to achieve bacteriologic conversion within 5 months after the start of treatment, who become smear- or culture-positive again during treatment after a previous conversion, or who are identified with multidrug- resistant TB (i.e., resistant to isoniazid and rifampin with pretreatment positive culture); death: patients who die of any cause during the course of treatment; default: patients who interrupt treatment for >2 months after completing at least one month of therapy or patients whose drug intake is <80% of the prescribed doses at any given month during treatment; transferred out: patients who are transferred to another reporting unit before completion of therapy (4).

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