MEDICAL MANAGEMENT :

Pulmonary TB is treated primarily with chemotherapeutic agents (antituberculosis agents) for

6 to 12 months. A prolonged treatment duration is necessary to ensure eradication of the
organisms and to prevent relapse. A worldwide concern and challenge in TB therapy is the
continuing (since the 1950s) and increasing resistance of M. tuberculosis to TB medications.
Several types of drug resistance must be considered when planning effective therapy :

• Primary drug resistance: resistance to one of the first-line antituberculosis agents in a

person who has not had previous treatment
• Secondary or acquired drug resistance: resistance to one or more antituberculosis
agents in a patient undergoing therapy
• Multidrug resistance: resistance to two agents, isoniazid (INH) and rifampin. The
populations at highest risk for multidrug resistance are those who are HIV-positive,
institutionalized, or homeless.

The increasing prevalence of drug resistance points out the need to begin TB treatment with four or
more medications, to ensure completion of therapy, and to develop and evaluate new anti-TB
medications.

PHARMACOLOGIC THERAPY:

In current TB therapy, five first-line medications are used : INH, rifampin, pyrazinamide, and
either streptomycin or ethambutol.

Combination medications, such as INH and rifampin (Rifamate) or INH, pyrazinamide and
rifampin and medications administered twice a week (eg, rifapentine) are available to help
improve patient adherence. Capreomycin, ethionamide, paraaminosalicylate sodium, and
cycloserine are second-line medications. Additional potentially effective medications include
other aminoglycosides, quinolones, rifabutin, clofazimine, and combinations of medications.

Recommended treatment guidelines for newly diagnosed cases of pulmonary TB (CDC,

2000) consist of a multiple-medication regimen of INH, rifampin, pyrazinamide, and either
streptomycin or ethambutol. This initial intensive-treatment regimen is usually administered
daily for 8 weeks. If cultures demonstrate that the organism is sensitive to the medications
before the 8 weeks of therapy have been completed, either ethambutol or streptomycin can be
discontinued. After 8 weeks of this medication regimen, pyrazinamide can be discontinued
and INH and rifampin are administered for an additional 4 months. The medication regimen,
however, may continue for 12 months. A person is considered noninfectious after 2 to 3
weeks of continuous medication therapy. Vitamin B (pyridoxine) is usually administered with
INH to prevent INH-associated peripheral neuropathy. INH also may be used as a
prophylactic (preventive) measure for those at risk for significant disease, including:

• Household family members of patients with active disease

• HIV-infected patients with a PPD test reaction of 5 mm of induration or more

• Patients with fibrotic lesions detected on a chest x-ray, suggestive of old TB, and a PPD
reaction of 5 mm of induration or more

• Patients whose current PPD test results show a change from former test results, suggesting
recent exposure to TB and possible infection (also called skin test converters)

• Drug (intravenous or injectable) users with PPD test results of 10 mm of induration or more

• Patients with high-risk comorbid conditions with a PPD result of 10 mm of induration or

more.

Other candidates for preventive INH therapy are those age 35 years or younger with PPD test
results of 10 mm of induration or more and one of the following criteria:

• Foreign-born individuals from countries with a high prevalence of TB

• High-risk, medically underserved populations

• Institutionalized patients.

Prophylactic INH treatment involves taking daily doses for 6 to 12 months. Liver enzyme, blood urea
nitrogen, and creatinine levels are monitored monthly. Sputum culture results are monitored for acid-
fast bacillus to evaluate the effectiveness of treatment and the patient’s compliance with therapy. In
1998, the federal Advisory Council for the Elimination of Tuberculosis published recommendations
for the development of TB vaccines. The recommendations include a focus on a “postinfection
vaccine” to prevent people infected with TB from developing active disease (CDC, 1998). To date,
this vaccine has not become clinically available. In 2000, recommendations were released regarding
the treatment of latent TB infection (American Thoracic Society and CDC, 2000). Isoniazid (INH) for
6 to 12 months has been the mainstay of treatment for latent TB infection. However, this long
duration of treatment has been limited due to poor adherence and concerns of toxicity. The American
Thoracic Society and CDC released newer guidelines in the 2000 document, which focused on
treating a latent infection over a shorter period of time. The CDC released case reports of liver injury
associated with the 2-month rifampin-pyrazinamide (RIF-PZA) dosing regimen in August 2001
(MMWR, 2001). This prompted a review and changes to the 2000 guidelines. In summary, a 2-month
RIF-PZA treatment regimen for latent TB infection should be used with caution, especially in patients
who are concurrently taking medications for liver disease or those with a history of alcoholism. For
patients not infected with HIV, 9 months of daily INH remains the preferred treatment, and 4 months
of daily RIF is an acceptable alternative. No more than a 2-week supply of RIF-PZA should be
dispensed at any one time to facilitate periodic clinical assessments. Lastly, serum aminotransferase
and bilirubin should be measured at baseline and at 2, 4, and 6 weeks of treatment in patients taking
RIF-PZA (MMWR, 2001).
 NTEP (RNTCP) DISTRICT ROP 2020-2021

( NATIONAL TUBERCULOSIS ELIMINATION PROGRAMME (NTEP) Earlier (RNTCP)

Programme Implementation Guideline for 2020-21)

Preface: -

National TB Elimination Programme (NTEP) was started as a pilot project in Dibrugarh

district of Assam in the year 1998. Through phase wise expansion, the complete coverage of
the state was achieved in the year 2004. The programme has been able to roll out PMDT
(Programmatic Management of Drug Resistant TB) services for the MDR-TB patients from
the year 2012. The basic objective of NTEP is to provide free and quality services to all TB
patients throughout the State. Since the inception of the programme it has emphasised to
reach the unreached by decentralizing DOTS (Directly Observed Treatment Short-course)
services. At present 27 functional District TB Centers, 150 Tuberculosis Units (TU) and 350
numbers of Designated Microscopy Centers (DMC) are functional to provide quality services
to control TB in the state. In addition to these DMCs, state has also initiated process of
further decentralizing TB testing in non-DMC PHIs by training the existing LTs in these
facilities. Apart from these, all NUHM facilities have also initiated TB testing in their
laboratories. NAAT diagnostic facility to identify MDR-TB patients is available in all
Districts of the state. The state has the network of more than 7000 DOTS Centers for
providing DOTS (Directly Observed Treatment Short course) to the TB patients at their door
steps free of cost. The state also has a well-equipped Intermediate Reference Laboratory
(IRL) at Gauhati Medical College, to provide both diagnostic services for Multi – Drug
Resistant TB (MDR) by Solid, Liquid and Molecular technology (LPA &NAAT) to the entire
state of Assam. This is the only IRL in the entire North East region which is NABL certified
and is supporting all 7 NE states. Assam achieved the distinction of launching the new drug,
Bedaquiline on 6th June’2016 for the first time in entire Asia which is now being provided
free of cost to eligible MDR-TB patients. 99 DOTS and IPT have been rolled out in all the
ART centres of Assam. Daily regimen for all TB patients has been rolled out in the state
since October’17. The state has also rolled out shorter regimen for treatment of MDR-TB
patients and regimen for treatment of Isoniazid mono/poly resistant patients. State has also
implemented Delamanid containing regimen as per GoI guidelines.
Key Challenges and activities in NTEP in 2020-21

Case Notification:

Achievement of TB Case notification has been above 95% of the target in public sector but
only around 15% in the private sector. Following strategies have been planned to address the
issue:

1. Active TB Case Finding activities throughout the state at least once in a quarter. Activities
to be implemented as per TB Free Roadmap.

2. Mapping of all private health care providers including private health care providers, clinics
and hospitals and laboratories and registration in NIKSHAY.

3. Incentive for first informer @₹ 500/- per case notified to be implemented which has been
implemented but needs further strengthening.

4. CME / Sensitization for private care providers on recent advances of NTEP by involving
IMA and JEET Project.

5. PPSA to be implemented in 8 districts in addition to the existing 2 districts and has been
approved in the PIP 2020-21.

6. Wide publicity of the facilities available under NTEP including all benefits to various
beneficiaries.

7. Involving TB champions for community engagement in NTEP

8. Enhancing activities towards the “TB Harega Desh Jeetega” campaign.

9. Involvement of all stakeholders (inter-sectoral and inter-ministerial collaboration).

Treatment

1. Rapid uptake of the treatment regimens especially the injection free regimen containing
newer drugs for drug resistant TB patients

2. Complete coverage of the INH chemoprophylaxis for children < 6 years and PLHIV as per
existing guidelines and LTBI management for eligible beneficiaries as per GoI guidelines for
adolescent (5 – 18 years) as approved in the PIP 2020-21 in the selected districts.
MAIN OBJECTIVES:

 Pursue high-quality DOTS expansion and enhancement

 Address TB/HIV, MDR-TB, and the needs of poor and vulnerable populations
 Engage all care providers
 Empower people with TB, and communities through partnership.
 Enable and promote research.

KEY STRATEGY:

1. Early diagnosis of TB with latest diagnostic tools

2. Find, Treat all people with TB with standard complete regimen

3. Implementation of strategies and activities laid down in the TB Free Raodmap

4. Screen contacts and high-risk groups

5. Rational deployment of all NAAT machines and ensuring Universal drug susceptibility
testing and LPA

6. Notify all TB cases- public and private

7. Provide patient support- link with nutrition/promote adherence, manage adverse drug
reactions and manage co-morbidities- Diabetes, HIV by implementing Public Health Action
(PHA) for all TB patients.

NIKSHAYPOSHAN YOJANA (NPY):

Financial incentive of Rs.500/- per month for all TB patients (Public & Private) as nutritional
support till end of treatment to be provided into their bank account. o Incentive of Rs 750/-
per patient is provided for all TB patients in the notified trial districts (Baksa, Chirang, Dima
Hasao, Kokrajhar, KarbiAnglong and Udalguri) under Tribal Action Plan.
o Incentive of Rs 1000/- to community DOT Providers for providing treatment support to
drug sensitive patient. o Incentive of Rs 5000/- to community DOT Providers for providing
treatment support to drug resistant TB patient

o Incentive to community DOT Providers for providing injection @Rs 25/- per prick o
Incentives of Rs. 500/-for PP for TB Notification and Public Health Action

o Incentive of Rs. 500/-for Chemist for TB Notification

o Incentive for community volunteers undertaking ACF (Rs. 500/- per Notified Case
distributed equally among all ACF Volunteers). o Pre-treatment investigations for Drug
Resistant TB patients (Reimbursed as per actual).