Professional Documents
Culture Documents
What Is New in RNTCP 1st May 2019 PDF
What Is New in RNTCP 1st May 2019 PDF
5/2/2019 KGMU
Tuberculosis
• Known since vedic era in India as
– Kshaya Roga (Kshaya = decay)
– Raj yakshma
• Similar description by Hippocrates (Father of
Medicine) as Phthisis (decay)
• Discovery of causative organism on 24th
March 1882 by Robert Koch – Koch’s
disease.
• 24th March – World TB Day
5/2/2019 KGMU
Tuberculosis
• Prechemotherapeutic Era – before
1944.
• Basics of Treatment of TB
– Nursing care
– Good nutrition
– Fresh air
} described in
Ayurveda
Sanitaria treatment
5/2/2019 KGMU
Chemotherapy Era – Beginning in 1944
• Streptomycin 1944 (Wakesman)
PAS
Isoniazid 1950s
Thiacetazone 60s
Ethambutol 70s
Pyrazinamide
Rifampicin 80s
Bedaquiline 2012
Dalamanid
5/2/2019 KGMU
Resurgence of TB in late 80s
– mainly due to HIV
5/2/2019 KGMU
India is the Highest TB
Burden Country
HBC = High Burden
Country India
27%
Other countries
20%
Other 13 HBCs
16% China
12%
Phillipines
3% South Africa
Ethiopia 6%
3%
Nigeria Bangladesh Pakistan 5% Indonesia
3% 4% 5%
16,74,000 4,35,000
Deaths
(22/lakh) (33/lakh)
5/2/2019 KGMU
Definitions and classification of DR-TB
patients
Presumptive DR-TB: It refers to the
following patients in order of their risk:
• Correct diagnosis
• Correct categorization
• Compliance/adherence to treatment
5/2/2019 KGMU
Correct Diagnosis
• Molicular Diagnosis : CBNAAT
LPA
• Bacteriological Diagnosis :
Sputum smear for AFB, sputum for AFB culture
• Histo-Pathological Diagnosis:
FNAC/Biopsy
• Clinico-Radiological Diagnosis:
5/2/2019 KGMU
TB Molecular Diagnostics
NAAT
GeneXpert MTB/RIF
Automated NAAT
TB Molecular Diagnostics
DR-diagnostic
Choice
technology
CBNAAT/LPA First
Liquid culture isolation
Second
and LPA DST
Liquid culture isolation
Third
and liquid DST
Turnaround (Testing) time
LPA up to 72 hours.
CBNAAT - 2 hours.
CHEST RADIOGRAPHY
• High inter and intra reader variation
• No shadow is characteristic of TB
5/2/2019 KGMU
Diagnostic algorithm for pulmonary
tuberculosis
5/2/2019 KGMU
Investigation in EPTB
Site of extra-pulmonary tuberculosis Investigation
Node (excluding abdominal) FNAC, LN biopsy, AFB smear, culture and histology,
molecular tests
Intra-abdominal (excluding renal) FNAC, Biopsy, Excision and culture, Guided procedures,
molecular tests
Pleural Pleural aspirate, AFB smear,
total lymphocyte count and differential, biochemistry,
Culture, Biopsy and HPE, molecular tests
SL - FL-LPA*
LPA**
5/2/2019 KGMU
Correct Categorization
Tuberculosis
Cat. IV Cat. V
Cat. I
CAT III Removed in 2010
CAT II Removed in 2018
Daily Regimen introduced in 2016
5/2/2019 KGMU
Treatment Drug sensitive TB
Type of TB Intensive Continuation Total duration
cases Phase Phase
(IP) (CP)
5/2/2019
Note
• There is no need to extend IP
• CP in both new and previously treated
cases may be extended by 3-6 months
in certain form of TB like
CNS TB
Skeletal TB
Disseminated TB
5/2/2019 KGMU
Weight band for daily dose
regimen
• New (2016) guidelines by Govt. of India
Central TB Division provides number of
FDCs according to weight bands.
• 4 weight bands for Adults, 7 for children.
• This is to prevent further drug resistance
and assured bioavailability by increasing
drug compliance.
5/2/2019 KGMU
Weight bands for Adults
5/2/2019 KGMU
Weight bands for children
5/2/2019 KGMU
Follow up evaluation in drug
sensitive patients
Type of case Follow up Extension of Action on Long term
treatment follow up follow up
5/2/2019 KGMU
Treatment Drug
resistant TB
5/2/2019 KGMU
Pre-treatment evaluation
# HBsAg at baseline
Pre-treatment evaluation
Classes of Anti TB Drugs recommended for treatment of DR-TB
New Grouping of Drugs
A. Fluoroquinolones Levofloxacin Lfx
Moxifloxacin Mfx
Gatifloxacin Gfx
B. Second-line injectable Amikacin Am
agents Capreomycin Cm
Kanamycin Km
(Streptomycin) (S)
C. Other second-line Ethionamide / Prothionamide Eto/Pto
agents Cycloserine / Terizidone Cs/Trd
Linezolid Lzd
Clofazimine Cfz
D. Add-on agents (not part D1 Pyrazinamide Z
of the core MDR-TB Ethambutol E
regimen) High-dose isoniazid Hh
D2 Bedaquiline Bdq
Delamanid Dlm
D3 p-aminosalicylic acid PAS
Imipenem-cilastatin Ipm/Cls
Meropenem Mpm
Amoxicillin-clavulanate Amx-Clv
(Thioacetazone) (T)
Treatment Drug resistant TB
Type of TB Intensive Continuation Total duration
cases Phase Phase
(IP) (CP)
Regimen for (6-9) Lfx (18) Lfx Eto Cs E 24-27months
MDR/RR-TB Km
Eto Cs Z E
5/2/2019
Treatment Drug resistant TB
Type of TB Intensive Continuation Total duration
cases Phase Phase
(IP) (CP)
XDR-TB (6-12) (18) Mfx(high 24-30 months
Mfx(high dose)Cm dose) Eto Cs Lzd
Eto Cs Z Lzd Cfz E Cfz E
5/2/2019
Features of Shorter MDR-TB Regimen
5/2/2019 KGMU
Clinical monitoring
• After initiation of Rx from the DR-TB Centre,
MO District/Nodal-DR TB center
– at monthly intervals during the IP, and
– at 3-monthly intervals during the CP until the end
of treatment
• Assess clinical, microbiologic, and radiologic
response to treatment
• Measure weight
• Assess possible adverse drug reactions
(ADR)
• Encourage the patient to continue treatment
• Verify treatment card
Correct Prescription
Pre-requisites
• Weight of patient
• Financial condition of patient
• Health education regarding disease, infectiousness,
toxicity of drugs and social behaviour
• Motivation for regular and complete treatment
• Prescription according to category
5/2/2019 KGMU
Compliance / Adherence to Treatment
• Key issue in the success of treatment
• Require involvement of
– Doctor / Health worker
– Patient
– Peer / Family
– Society
– Government / NGO
– Media
– Pharma Industry
5/2/2019 KGMU
NEWER DRUGS FOR MDR-TB
• FDA APPROVED:
– BEDAQUILINE
– DELAMANID
KGMU
• Approved by the US FDA in 2012 for the
treatment of MDR-TB in adults with limited
options.
• In March 2016, RNTCP introduced BDQ
through CAP at six DR-TB centres
• Expansion of access to BDQ has been
initiated in all states in early 2017.
5/2/2019 KGMU
Inclusion criteria
The dosage of BDQ would apply to all weight bands while the dosage of other
drugs in the OBR would be as per the weight bands in accordance to the RNTCP
PMDT guidelines.
Bedaquiline: Administration
Delamanid(DLM)
• Bactericidal with Half-life of 36 hours.
• First approved drug in the class of nitro-dihydro-imidazo-
oxazoles for the treatment of MDR-TB.
• Developed by Otsuka Pharmaceutical Ltd,Japan.
• Dlm achieved culture conversion on average six to 13 days
earlier than the conventional regimen.
• Dlm may have a protective role in preventing the
emergence of additional drug resistance.
5/2/2019 KGMU
Contd…
• First approved by the European Medicines Agency (EMA)
in November 2014.
• On 14 June 2017 Ministry of Health and Family Welfare in
its 34th meeting has approved the use of Dlm under
RNTCP PMDT through conditional access.
• Seven states (Punjab, Chandigarh, Rajasthan, Karnataka,
Odisha,Kerala,Lakshadweep) have been identified as initial
sites for the introduction of DLM under the RNTCP PMDT
through conditional access
5/2/2019 KGMU
Criteria for patients to receive
Delamanid
Inclusion Criteria: All Adults ≥18 yrs, including people
living with HIV (PLHIV) with;
5/2/2019 KGMU
Contd…
Special caution: HIV+ (in consultation with ART centres), 65yrs+,
patients with diabetes, hepatic or severe renal impairment, those with
serum albumin <2.8 g/dL or those who use alcohol or substances.
Exclusion Criteria:
Children under 6 years.
Pregnant & breastfeeding women.
Patients with repeated demonstration of a QT interval >500 ms,
history of torsades de pointes or cardiac ventricular arrhythmias
Hypersensitivity to the active substance or to any of the excipients
5/2/2019 KGMU
Doses Of Delamanid
• Week 0–24: Delamanid 100 mg (two tablets of 50 mg)
orally twice a day + OBR.
• Week 25 (start of month 7) to end of treatment:
Continue other second-line anti-TB drugs only as per
RNTCP recommendations.
5/2/2019 KGMU
NATIONAL STRATEGIC PLAN FOR TUBERCULOSIS
ELIMINATION
2017–2025
5/2/2019 KGMU
TB notification
Govt. of India declared Tuberculosis a
notifiable disease on 7th May 2012
5/2/2019 KGMU
Contd..
• As per MCI code of Ethics – Rules & regulations 2002,
Chapter 7, Point 7.7, a registered medical practitioner giving
incorrect information on his name and authority about
Notification is liable for deregistration
5/2/2019 KGMU
5/2/2019 KGMU
5/2/2019 KGMU
5/2/2019 KGMU
5/2/2019 KGMU
Nikshay Poshan Yojana
• Launched by Govt. of India in march 2018
5/2/2019 KGMU
5/2/2019 KGMU
99DOTS
5/2/2019 KGMU
Contd…
• 99DOTS is a low-cost approach for monitoring and
improving TB medication adherence.
• Using 99DOTS, each anti-TB blister pack is wrapped in a
custom envelope, which includes hidden phone numbers
that are visible only when doses are dispensed.
• After taking daily medication, patients make a free call to
the hidden phone number, yielding high confidence that
the dose was “in-hand” and has been taken.
5/2/2019 KGMU
Contd…
5/2/2019 KGMU
Key Benefits of 99DOTS
• Instead of traveling to a center for every dose,
patients can provide evidence of dosing from
their home.
• It improves the efficiency of care providers.
• Instead of mandating that all patients receive
frequent counseling, adherent patients can
proceed with less supervision, while limited
program resources are focused on cases that
need the most attention
5/2/2019 KGMU
Recent changes in TB
Management
• Category 3 of RNTCP abolished 2010
• Introduction of CBNAAT/Gene expert for TB diagnosis 2010
• Ban on serological test for TB diagnosis 2012
• TB declared as a Notifiable disease 2012
• Category 2 abolished 18/12/2018
• Withdrawal of Kanamycin from H mono/poly DR TB
Regimen 24/12/2018
• Non declaration of TB made punishable 2018
• Daily regimen introduction 2016
5/2/2019 KGMU
Contd…
• Newer definition and diagnostic algorhythm for TB
(pulmonary,extrapulmonary, pediatric TB, TB-HIV) 2016
• Nutritional support for TB patients (500/month) 2018
• Incentive for private doctors 1000 per patient at completion
of treatment
• Introduction of Bedaquiline for DR-TB patients 2016
• Introduction of Dalamanid for DR-TB patient 2018
• And above all historical and landmark decision of our PM
modified END TB BY 2025 ON 13TH MARCH 2018
5/2/2019 KGMU
Delhi End TB Summit 13 March
2018, To END TB By 2025
5/2/2019 KGMU
TB Free Lucknow campaign
5/2/2019 KGMU
Conclusion
• Tuberculosis is a major health problem in our country and
globally too
5/2/2019 KGMU
Conclusion
• Drug resistance is a bacteriological diagnosis.
5/2/2019 KGMU
THANK YOU