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Government Of Assam Dibrugarh District

RNTCP (Revised TB Control Programme)

ABOUT RNTCP :

The national tuberculosis programme of India (NTP) was initiated in 1962 and was originally designed for domiciliary treatment, using self-administered standard drug regimen. In 1992, the Government of India with World Health Organization (WHO) and Swedish International Development Corporation Agency (SIDA) reviewed the tuberculosis (TB) situation and the performance of NTP which revealed that the NTP, though technically sound, suffered from managerial weakness, inadequate funding, over-reliance on X-ray for diagnosis, frequent interrupted supplies of drugs and low rate of treatment completion. In 1997, Revised TB Control Programme (RNTCP) was launched which formulated and adopted the internationally recommended Directly Observed Short Course (DOTS) strategy as the most systemic and cost-effective approach to revitalize the TB control programme in India.

The objectives of RNTPCP were to achieve at least 85% cure rate among the new smear-positive cases initiated on treatment and thereafter a case detection rate of at least 70% of such cases. The major addition of RNTCP was the establishment of a sub-district supervisory unit known as TB Unit, with RNTCP supervisor and decentralization of diagnostic and treatment services with treatment given under the support of DOT provider (DP).

The first technical and operational guidelines for RNTCP were developed during the initial years of implementation of the programme and were updated in 2005. The current document outlines the guidelines on TB care in line with RNTCP national strategic plan for TB control 2012–2017. Experts from National Institute, National and Intermediate Laboratories, Medical Colleges and Partners were involved in the process of preparing it. The documents covered strategies and guidelines for diagnosis and treatment for all forms of TB including pulmonary TB, extra-pulmonary TB, drug-resistant TB (DRTB), TB with comorbidity and paediatric TB. The programme management aspect covering patients support system, human resource management, partnership for TB control, advocacy, communications and social mobilization, infection control measures, planning and finance are also incorporated.

The goal of the national strategic plan is to achieve universal access of quality of TB diagnosis and treatment of all TB patients in the community. The objectives of the national strategic plan are:

  1. To achieve 90% notification rate for all cases
  2. To achieve 90% success rate for all new and 85% for re-treatment cases
  3. To significantly improve the successful outcome of treatment for DRTB cases
  4. To achieve decreased morbidity and mortality for HIV-associated TB cases
  5. To improve the outcome of TB care in the private sectors.

A government order issued by the Government of India in May 2012 mandates all health care providers to notify every TB case and/or treated to the local authorities. To support TB notification and strengthen TB surveillance in general, a case-based, web-based TB notification system NIKSHAY was established to provide platform for notification from both public and private sectors.
 

The major change in the organization structure of RNTCP is the formation of one TB Unit per block/1.5–2.5 lakh population in urban areas in contrast to previous RNTCP guidelines, where there was one TB Unit per 5 lakh population/1 per 2.5 lakh in tribal, hilly and difficult areas.

  Presumptive TB cases

 

 


As per the previous guidelines, a pulmonary TB suspect was defined as:

  • An individual having cough for 2 weeks or more
  • Contacts of smear-positive TB patients having cough for any duration
  • Suspected/confirmed extra-pulmonary TB having cough for any duration
  • HIV-positive patient having cough for any duration.


But according to the new guidelines –

Presumptive pulmonary TB refers to a person with any of the symptoms or signs suggestive of TB:

  • cough >2 weeks,
  • fever >2 weeks,
  • significant weight loss,
  • haemoptysis,
  • any abnormalities in chest radiography.

    In addition, contact of microbiologically confirmed TB patients, PL HIV, diabetics, malnourished, cancer patients, patients on immunosuppressive therapy or steroid should be regularly screened for signs and symptoms of TB.

    There is no change in the definition of presumptive extra-pulmonary TB cases.

    There are few additions in the definition of presumptive TB cases in paediatric patients, where loss of body weight is defined that loss of >5% body weight as compared to highest weight recorded in the last 3 months. The history of unexplained or no weight gain in the past 3 months and symptomatic child contact with any form of active TB in the last 2 years may be significant.

    There have been changes in the definition of presumptive DRTB cases as follows:
  • TB patients who have failed treatment with first-line anti-tubercular drugs (ATD)
  • Paediatric TB non-responder
  • TB patients who are contacts of DRTB
  • TB patients who are found positive on any follow-up sputum smear examination during treatment with first-line ATD
  • Previously treated TB cases
  • TB patients with HIV co-infection.



Diagnostic algorithm of pulmonary TB has been completely changed from the previous guidelines
All presumptive TB will undergo sputum smear examination (spot–early morning or spot–spot). If the first sputum is positive and not at risk for DRTB, it is categorized as microbiologically confirmed TB

  • Smear-positive and presumptive multi-drug resistance TB (MDR TB): A Cartridge-Based Nucleic Acid Amplification Test (CBNAAT) will be performed to rule out Rifampicin resistance and categorized as microbiologically confirmed drug-sensitive TB or RIF-resistant TB
  • If the first smear is negative and chest X-ray (CXR) is suggestive of TB, 2nd sample will be subjected to smear and CBNAAT simultaneously
  • On the basis of the CBNAAT result, patients will be categorized as microbiologically confirmed drug-sensitive TB or RIF-resistant TB
  • A RIF indeterminate result will get an additional CBNAAT to get a valid result and in case of indeterminate on second occasion, the specimen will be sent to the Intermediate Reference Laboratory (IRL) or Culture and Drug Sensitivity Test (C and DST) centre for Line Probe Assay (LPA) or Liquid Culture and Drug Sensitivity Test (LC and DST)
  • Whenever facilities are available, effort should be made to obtain DST results of all drugs
  • If both the sputum smear and CXR are negative, the patient should be referred to a pulmonologist
  • All key population (PLHIV, children, EPTB, etc.) will preferentially get a CBNAAT
  • All diagnostic health care facilities should have TB lab that are quality assured by competent authority.

    Diagnostic algorithm of extra-pulmonary TB has been completely changed:

    Diagnostic algorithm of paediatric TB has also been completely changed from the previous guidelines:

    Case definition: There are significant changes in the definition of cases as per New Guidelines:
  1. Microbiologically confirmed TB case refers to a presumptive TB patient with biological specimen positive for acid-fast bacilli, or positive for mycobacterium TB on culture, or positive for TB through Quality Assured Rapid Diagnostic molecular test.
  2. Clinically diagnosed TB case refers to a presumptive TB patient who is not microbiologically confirmed, but has been diagnosed with active TB by a clinician on the basis of X-ray abnormalities, histopathology or clinical signs with a decision to treat the patient with a full course of anti-TB treatment.
     

 

Microbiologically confirmed or clinically diagnosed cases of TB are classified according to:

  1. Anatomical site of disease
  2. History of previous TB
  3. Drug resistance.


There are significant changes in the definition while the classification is done on the basis of history of the previous treatment.

  1. New case – A TB patient who has never had treatment for TB or has taken ATD for <1 month. (No change in new guidelines.)
  2. Previously treated patients have received one month or more ATD in the past. This may be:
    1. Recurrent TB case – A TB patient previously declared as successfully treated (cured/treatment completed) and who is subsequently found to be microbiologically confirmed TB case is a recurrent TB case. (Previously called relapse.)
    2. Treatment after failure – Patients are those who have previously been treated for TB and whose treatment failed at the end of their most recent course of treatment.

      Previously, it was called failure where a TB patient is sputum-positive at 5 months or more after initiation of treatment.
  1. Treatment after loss to follow-up – A TB patient previously treated for TB for one month or more and who was declared lost to follow-up in their most recent course of treatment and subsequently found microbiologically confirmed TB cases.

    Previously called treatment after default – a patient who has received treatment for TB for a month or more from any source and return for treatment after having defaulted, that is, not taking ATD consecutively for 2 months or more and found to have smear-positive.

    There are significant additions in the definition while classification was done on the basis of drug resistance.
  1. Mono resistance (MR) – A TB patient whose biological specimen is resistant to one first-line anti-TB drug only.
  2. Poly resistance (PDR) – A TB patient whose biological specimen is resistant to more than one first-line anti-TB drug, other than both INH and Rifampicin.
  3. Multi-drug resistance (MDR) – A TB patient whose biological specimen is resistant to both INH and Rifampicin with or without resistance other first-line ATD, based on results from a Quality Assured Laboratory. (No changes.)
  4. Rifampicin resistance (RR) – Resistance to Rifampicin detected by phenotypic or genotypic methods with or without resistant to other ATD excluding INH. Patient with RR should be managed as if they are in MDR TB case.
  5. Extensive drug resistance (XDR) – MDR TB case whose biological specimen was resistant to a Fluroquinolone (FQ) and a second-line injectable ATD from a Quality Assured Laboratory. (No changes.)

    According to the previous guidelines, drug regimen for drug-sensitive TB was as follows:
  • Standard intermittent regimen with 2 categories of treatment
  • Treatment under direct observation of DP
  • Category decided by MO (category I/II)
  • Drugs to be taken three times a week under direct observation of the DP
  • Intensive phase (IP) for 2–3 months – all doses given under supervision
  • Continuation phase (CP) for 4–5 months – first dose of the week given under supervision.

    But there are significant changes in the drug regimen in the new guidelines:
  • Principle of treatment of TB has been shifted towards daily regimen with administration of daily fixed dose combination of first-line ATD as per appropriate weight bands.

    For new TB cases
  • Treatment in IP will consist of 8 weeks of INH, Rifampicin, Pyrazinamide and Ethambutol in daily dosages as per four weight bands categories
  • There will be no need for extension of IP
  • Only Pyrazinamide will be stopped in CP while the other three drugs will be continued for another 16 weeks as daily dosages.

    For previously treated cases:
  • IP will be of 12 weeks, where injection Streptomycin will be stopped after 8 weeks and the remaining four drugs in daily dosages as per weight band for another 4 weeks
  • No need of extension of IP
  • At the start of CP, Pyrazinamide will be stopped while rest of the drugs will be continued for another 20 weeks as daily dosages.

Management of extra-pulmonary TB (new guidelines) – There is only one change as follows:

  • The CP in both new and previously treated cases may be extended 3–6 months in certain TB such as CNS, skeletal, disseminated TB, and so on based on clinical decision of the treating physicians
  • Extension beyond 3 months will only be on recommendation of experts of concerned field.(In the previous guidelines, extension of ATD in case of CNS and skeletal TB was maximum 3 months).


According to the new guidelines, ATD are to be given in fixed dose combination as daily doses; drug doses for adult TB is as follows:

Drug Dosage for Adult TB

In patients above 50 years of age, maximum dose of Streptomycin should be 0.75 g.

Drug Dosage for Pediatric TB

Follow-up of treatment: There are some changes in the new guidelines:

Clinical follow-up – (new addition)

Should be at least monthly – the patient may visit the clinical facility, or the medical officer may conduct the review when she/he visits the house of the patient to observe improvement of chest symptoms, weight gain, control the co-morbid conditions such as HIV and diabetes and to monitor any adverse reaction to ATD.

Follow-up laboratory investigation

For PTB cases – sputum smear examination at the end of IP and at the end of treatment. (In the previous guidelines, follow-up sputum smear to be done at 2, 4 and 6 months for new cases and 3, 5 and 8 months in previously treated cases.)

  • In case of clinical deterioration, the Medical Office may consider repeat sputum smear even during CP. (New addition.)
  • At the completion of treatment, sputum smear and culture should be done for every patient
  • CXR – to be offered whenever required and available.


Long-term follow-up

After completion of treatment, the patient should be followed up at the end of 6, 12, 18 and 24 months. Any clinical symptoms and/or cough, sputum microscopy and/or culture should be considered. (New addition) However, there was no provision of long-term follow-up in the previous guidelines.
 

Difference of RNTCP regimen between new and previous guidelines
Treatment outcomes

Cured

A microbiologically confirmed TB at the beginning of the treatment who was smear- or culture-negative at the end of complete treatment. (Changed).

Treatment success

TB patients either cured or treatment completed are accounted in the treatment success. (New addition).

Failure

A TB patient whose biological specimen is positive by smear or culture at the end of the treatment. (Changed).

Failure to respond

For paediatric TB patients. (New addition).

Lost to follow-up

A TB patient whose treatment was interrupted for one consecutive month or more. (New addition).

Not evaluated

A TB patient for whom no treatment outcome is assigned. (Former transfer out).

Treatment regimen changed

Previously, it was called as switched over to MDR treatment.

 

Report on TB case holding under RNTCP for the month of June’2018

Indicator

Target

Achieved in June’2018

 

Total Private notification received from Nursing homes/Laboratories.

 

22

 

Total TB case detected

 

202

 

New sputum pos. case(NSP)

 

70

 

New Extra-pulmonary case(NEP)

 

65

 

New sputum neg. case(NSN)

 

38

 

Previously treated pos. case(Pt+ve)

 

16

 

Previously treated neg. case(Pt-ve)

 

13

 

MDR TB detected

 

4

 

XDR TB detected

 

0

 

Success rate

>85 %

91 %

 

Default rate

<4 %

3 %

 

Death rate

<5 %

2 %

 

Failure Rate

<4 %

2 %

 

Case Detection rate

>70 %

75 %

 

IEC activities

June’2018

Community awareness meeting at Rajgarh TE on 18th June’2018

1 (one )no.