An overview of Programmatic Management of Drug Resistance Tuberculosis (PMDT) in India

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1 PMDT in India An verview f Prgrammatic Management f Drug Resistance Tuberculsis (PMDT) in India Sanjay Singh 1, Sanat Kumar Tripathy 2, Prahlad Kumar 3 Intrductin: Tuberculsis (TB) is a majr public health cncern in India, accunting abut nefurth f the wrld's annual incidence f TB cases. Each year, abut 2.8 millin peple develp TB in India and an estimated 4.8 lakh peple die frm the disease. As per the Glbal TB Reprt 2016, abut 1.3 lakh multi-drug resistant TB patients emerge annually in India. The Revised Natinal TB Cntrl Prgramme (RNTCP) till date has treated ver 19 millin patients and thus saved an additinal three millin lives. The cure rates under RNTCP have cnsistently been abve 85%. TB Millennium Develpment Gals f 50 per cent reductin in the prevalence f TB and reducing TB death by 50 per cent have been achieved. India is nw stepped int Natinal Strategic Plan and is a signatry t The End TB Strategy that calls fr a wrld free f tuberculsis, with measurable aims f a 50% and 75% reductin in incidence and related deaths, respectively, by 2025, and crrespnding reductins f 90% and 95% by Sustainable Develpment Gals (SDGs) which came int effect frm 1 st January 2016 require that all three dimensins f sustainable develpment i.e. ecnmic, scial and envirnmental, are addressed in an integrated manner t ensure that n ne is left behind. As a step twards achieving the SDGs and End TB Strategy, the RNTCP is adpting newer strategies and tls t ensure universal access t quality TB care. Hwever, despite a cmprehensive natinal TB cntrl prgram-guiding states fr implementatin f TB diagnsis and treatment there is still a lng way t g. The decline in TB incidence has been slw, mrtality remains unacceptably high and the emergence f drug-resistant TB has becme a majr challenge. The reasns why drug resistance cntinues t emerge and spread are mismanagement f TB treatment and persn-t-persn transmissin. Mst peple with TB can be cured by a strictly fllwed, 6-mnth treatment prvided t patients with supprt and supervisin. Inapprpriate r incrrect use f antimicrbial drugs, r use f ineffective frmulatins f drugs (such as use f single drugs, inapprpriate dsage, pr quality medicines r bad strage cnditins), and premature treatment interruptin can cause drug resistance, which can then be transmitted, especially in crwded settings like urs. 1, 2& 3 Natinal Tuberculsis Institute, Bangalre, N. 8, Bellary Rad, Karnataka , India Address fr crrespndence: Dr.Prahlad Kumar, Directr, Natinal Tuberculsis Institute, N. 8, Bellary Rad, Bangalre, Karnataka 56003, Phne n /93, nti@ntiindia.rg.in 2

2 The tw mst ptent anti TB drugs f strains resistant viz. isniazid (H) and rifampicin (R) (multidrug resistant-tuberculsis, MDR-TB). The respnse f patients with MDR-TB t treatment is pr and the mrtality rate is usually high. Since these patients need t be treated with expensive and txic secnd line drugs, and may require hspitalizatin t manage their txic reactins and ther cmplicatins, they require a sizeable prprtin f health care resurces. Further, an alarming increase in infectin due t the human immundeficiency virus (HIV) has accelerated this situatin. There is a cncern in India regarding the increase in HIV-assciated TB and the emergence f MDR-TB in bth magnitude and severity f TB epidemic. Classificatin f TB based n drug resistance: Mn-resistance (MR): A TB patient, whse bilgical specimen is resistant t ne first-line anti-tb drug nly. Ply-Drug Resistance (PDR): A TB patient, whse bilgical specimen is resistant t mre than ne first-line anti-tb drug, ther than bth INH and Rifampicin. Multi Drug Resistance (MDR): A TB patient, whse bilgical specimen is resistant t bth isniazid and Rifampicin with r withut resistance t ther first line drugs, based n the results frm a quality assured labratry. Rifampicin Resistance (RR): resistance t Rifampicin detected using phentypic r gentypic methds, with r withut resistance t ther anti-tb drugs excluding INH. Patients, wh have any Rifampicin resistance, shuld als be managed as if they are an MDR TB case. Extensive Drug Resistance (XDR): A MDR TB case whse bilgical specimen is additinally resistant t a flurquinlne (flxacin, levflxacin, r mxiflxacin) and a secnd-line injectable anti TB drug (kanamycin, amikacin, r capremycin) frm a quality assured labratry. Prgrammatic Management f Drug-resistant Tuberculsis: PMDT, earlier referred t as DOTS-Plus, is prvided as a specialized service under the expanded framewrk f the DOTS package fr management f MDR-TB. The implementatin f DOTS is t be accrded higher pririty ver PMDT with the view that effective implementatin f DOTS wuld reduce the emergence f drug-resistant TB cases. India began services fr diagnstic and treatment fr MDR-TB in the year 2007 and achieved cmplete cverage in the year Till 2016, 1,39,369 persns with MDR-TB/RR TB were diagnsed and 91% f these patients were put n treatment under PMDT f RNTCP. The diagnstic tls, diagnstic algrithms and treatment practices under PMDT are briefed as under: 3

3 Diagnsis tls: All effrts shuld be undertaken fr micrbilgically cnfirming the diagnsis in presumptive TB patients. Under RNTCP, the acceptable methds fr micrbilgical diagnsis f TB are: Sputum Smear Micrscpy(fr AFB): Zeihl -Neelsn Staining Flurescent Staining Culture& DST: Liquid culture Slid(Lwenstein Jensen) media Autmated Liquid Culture System e.g. BACTEC MGIT 960, BacTAlert, Versatrek etc. Rapid Mlecular diagnstic testing: Line Prbe Assay fr M.TB cmplex and detectin f Rif and INH resistance Nucleic Acid Amplificatin testing ( NAAT) Xpert MTB/RIF testing using GeneXpert System (CBNAAT) 4

4 Diagnstic algrithms: 5

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7 Treatment regimens: Treatment regimen fr MDR/RR-TB cases withut additinal resistance These patients are t be treated with standard treatment regimen fr MDR-TB that cntains 6 t 9 mnths f IP with Kanamycin, Levflxacin, Ethambutl, Pyrazinamide, Ethinamide and Cyclserine and 18 mnths f CP with Levflxacin, Ethambutl, Ethinamide and Cyclserine. Type f TB Case Treatment regimen in IP Treatment regimen CP Rifampicin resistant + Isniazid sensitive r unknwn MDR TB (6-9) Km Lfx Et Cs Z E H (18) Lfx Et Cs E H (6-9) Km Lfx Et Cs Z E (Mdify treatment based n the level f INH resistance as per the ftnte) (18) Lfx Et Cs E All MDR TB islates wuld be subjected t LC DST at baseline fr Kanamycin and Levflxacin. The results wuld be received after 6-8 weeks. Apprpriate medicatins f the treatment regimens can be dne in the presence f additinal resistance. Treatment regimen fr XDR TB XDR TB cases will be treated with the STR fr XDR TB cmprising f Injectin Capremycin, Mxiflxacin, Linezlid, PAS, Clfazimine High Dse INH & C- Amxyclav. The duratin f IP will be fr 6-12 mnths. Only the injectables will be stpped in CP and the remaining medicines will cntinue fr anther 18 mnths in CP. All DR TB treatment regimens are t be given n daily basis under supervisin. Type f TB Case XDR Treatment regimen in IP (6-12) Cm, PAS, Mfx, High dse-h, Cfz, Lzd, Amx/Clv Treatment regimen CP (18) PAS, Mfx, High dse- H, Cfz, Lzd, Amx/Clv Whenever DST pattern f extended panel f drugs wuld be available t guide the treatment like at six sites where Bedaquiline is intrduced initially. The management prtcl will fllw essentially ptimized regimen in case patients are diagnsed with drug resistance ther than r in additin t MDR and XDR. 8

8 Treatment regimen fr Mn/Ply DR TB Mn Drug Resistant TB- The treatment regimen is cnsisting f Injectable SLD + FQ + Rifampicin + tw ut f the first line drugs (frm H,E & Z) t which the patient is sensitive t make a ttal f 5 effective drugs regimen given daily. In case f reprted baseline additinal resistance t ther FLDs, the regimen is Inj SLD + FQ + Rifampicin + any FLD t which patient is sensitive + ne f the remaining Grup 4 drugs (Ethinamide, Cyclserine, and PAS). In additin High Dse INH is added t the regimen if LPA shws inha mutatin r culture reprts shw lw level INH resistance The ttal duratin f treatment will be 9 t 12 mnths. The Intensive Phase (IP) is fr 3 mnths with scpe fr extensin t a maximum f 6 mnths. The Cntinuatin phase (CP) is fr a fixed duratin f 6 mnths. The patient is initiated n treatment at DR-TB Centre, and then sent back fr ambulatry treatment t the DTO fr cntinuatin f treatment regimen and regular fllw-up. Type f TB Case Treatment regimen in IP Treatment regimen CP Rifampicin Sensitive, INH Resistant TB & DST f SEZ nt knwn (3-6) Km, Lfx R E Z (Mdify treatment based n baseline DST reprt t E, Z, KM, CM, Lfx, Mfx) (6) Lfx R E Z Intrductin f newer anti-tb drug - Bedaquiline After 40 years, the new drug Bedaquiline has been intrduced at six sites in 5 states in the cuntry in March, The drug is currently being used under RNTCP fr MDR/RR-TB patients with resistance t flurquinlne and r secnd line injectable, mixed pattern f drug resistance. The Bedaquiline is used alng with ptimum backgrund regimen designed based n drug susceptibility testing. Being a new drug, a natinal level cmmittee is mnitring its safety as per the glbal guidelines n use f Bedaquiline. Delamanid Delamanid belng t the nitrimidazle class f antibitics, they inhibit the synthesis f myclic acids, which are cmpnents f the cell envelpe f M. tuberculsis. RNTCP is in the prcess f including this drug under PMDT services f RNTCP. 9

9 Strategies fr Drug Resistance TB Cntrl: DST guided Treatment fr all type f TB Preventin f DR TB Strengthening Prcurement, SCM f SLD Drug Resistance Surveillance (DRS) Strategies fr DR TB Cntrl Nutritinal Assessment and supplementatin Regimen cntaining Newer Drugs/shrter regimen Imprving adherence thrugh cunselling supprt Cnclusins: There are many challenges fr TB cntrl in India. Prmpt, accurate diagnsis and effective treatment f TB are nt nly essential fr gd patient care, but they are als the key elements in the public health respnse t tuberculsis and the crnerstne f any initiative fr tuberculsis cntrl. The private sectr hlds a factual predminance f health care service delivery in India. There is very little infrmatin abut the TB patient frm the private sectr available t the prgramme and little is knwn abut their quality f treatment, including treatment utcmes. The visin f India's natinal TB cntrl prgramme is that the peple suffering frm TB receive the highest standards f care and supprt frm healthcare prviders f their chice. The prgramme has nw adpted WHO s The End TB Strategy under Natinal Strategic Plan twards Ending TB in India by adpting the fllwing pillars: 1. Integrated, patient centred care and preventin. Precisin in TB diagnsis and treatment Precisin in TB preventive therapy TB digital health applicatin fr mnitring and evaluatin 10

10 ICT t supprt patients 2. Bld plicies and supprtive system 3. Intensified research and innvatin References: 1. Wrld Health Organisatin, The Glbal TB Reprt Central TB Divisin, DGHS: TB India 2017 Revised Natinal TB Cntrl Prgramme, Annual status reprt. 3. P. Kumar: Revised Natinal Tuberculsis Cntrl Prgram in India; Chapter 14; Wrld ClinPulmCrit Care Med Revised Natinal Tuberculsis Cntrl Prgramme: Technical and peratinal guidelines fr tuberculsis cntrl in India, WHO: Standards f TB Cntrl in India,

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