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65ece73de84d4c0a8a3d24567c3d78a8 | Updated-RR-TB-Clinical-Guidelines-September-2023.pdf | Advancements in Rifampicin-Resistant Tuberculosis Treatment | The past five years have seen revolutionary changes in the diagnosis and management of rifampicin-resistant tuberculosis (RR-TB), including the use of new and repurposed drugs and novel therapeutic approaches. South Africa has been a global leader in introducing innovation to the field of RR-TB, and the work done in th... | The past five years have seen revolutionary changes in the diagnosis and management of rifampicin-resistant tuberculosis (RR-TB), including the use of new and repurposed drugs and novel therapeutic approaches [1] . South Africa has been a global leader in introducing innovation to the field of RR-TB and the work done i... | ACCEPT | train |
29058b2ee6fc47b9b19ec9a620ded1e9 | Updated-RR-TB-Clinical-Guidelines-September-2023.pdf | TB Resistance Testing Updates | The Line Probe Assay will be phased out, and the GeneXpert XDR (Xpert MTB/XDR) cartridge will be used to detect fluoroquinolone and isoniazid (INH) resistance. This test also detects resistance to ethionamide and second-line injectables (amikacin, kanamycin, and capreomycin) in a single assay. Phenotypic testing for li... | The Line Probe assay will be phased out and the GeneXpert XDR (Xpert MTB/XDR) cartridge will be used to detect fluoroquinolone and INH resistance. This test also detects resistance to ethionamide and the second line injectables (amikacin, kanamycin and capreomycin) in a single test. Phenotypic testing for linezolid and... | ACCEPT | train |
d6cea796ddf244349dd3fc1f2696e056 | Updated-RR-TB-Clinical-Guidelines-September-2023.pdf | Treatment Guidelines for RR-TB | All persons with RR-TB will either be treated with a short, all-oral, 6-month regimen or with a long, individualized regimen. The previously recommended 9-11 month regimen is no longer included in these guidelines. Recommendations for the treatment of RR-TB in children under 15 years of age have been updated. | All persons with RR-TB will either be treated with a short, all-oral, 6month regimen or with a long-individualized regimen. The previously recommended 9-11-month regimen is no longer included in these guidelines. Recommendations for treatment of RR-TB in children < 15 years of age have been updated. | ACCEPT | train |
a4abeab582194c7fba1acbec1ca1cb1f | Updated-RR-TB-Clinical-Guidelines-September-2023.pdf | Long-Individuated Regimen for Drug-Resistant Tuberculosis | This is to be offered to persons with documented resistance to pretomanid, BDQ, and/or LZD. Prior exposure to pretomanid, linezolid, and bedaquiline for more than a month is not an indication for a long-individualized regimen. Extended DST will be conducted upon request by clinicians only to support the individualized ... | This is to be offered to persons with documented resistance to pretomanid and/or BDQ and/or LZD. Prior exposure to pretomanid, linezolid and bedaquiline for more than a month is not an indication for a long-individualized regimen. Extended DST will be done on request by clinicians only to support individualized long re... | ACCEPT | train |
e88152b4c94a4aeb8813c9830f787f41 | Updated-RR-TB-Clinical-Guidelines-September-2023.pdf | TB Diagnosis and Classification Definitions | Microbiologically confirmed: when a biological specimen is positive by smear microscopy, culture, or a rapid diagnostic test for Mycobacterium tuberculosis (M. tuberculosis) as recommended by the World Health Organization (WHO). This is also referred to as bacteriologically confirmed. Clinically diagnosed: when a perso... | Microbiologically confirmed: when a biological specimen is positive by smear microscopy, culture, or a rapid diagnostic test for Mycobacterium tuberculosis (M. tuberculosis) recommended by the World Health Organization (WHO). This is also referred to as bacteriologically confirmed. Clinically diagnosed: when a person w... | ACCEPT | train |
0cfc0a2fb8a14bc381caf0b401557d94 | Updated-RR-TB-Clinical-Guidelines-September-2023.pdf | Drug-Resistant Tuberculosis | Bacilli that are resistant to one or more anti-TB drugs. Case definitions and outcome definitions have recently been revised. | bacilli that are resistant to one or more anti-TB drugs. Case definitions [6, 8, 9] and outcome definitions have recently been revised [9] . | ACCEPT | train |
c6ec80dd57c54af8ba4eabfb0fab494d | Updated-RR-TB-Clinical-Guidelines-September-2023.pdf | Types of Drug-Resistant Tuberculosis | - Mono-resistant TB: resistance to only one anti-TB drug, without resistance to other drugs.
- Poly-drug resistant TB: resistance to more than one anti-TB drug, excluding both isoniazid and rifampicin.
- Multidrug-resistant TB (MDR-TB): resistance to isoniazid and rifampicin, with or without resistance to other ant... | • Mono-resistant TB: resistance to only one anti-TB drug, without resistance to other drugs. • Poly-drug resistant TB: resistance to more than one anti-TB drug, other than both isoniazid and rifampicin. • Multidrug-resistant TB (MDR-TB): resistance to isoniazid and rifampicin with or without resistance to other anti-TB... | ACCEPT | train |
73b69e7230f748e4854544c7de8a59d2 | Updated-RR-TB-Clinical-Guidelines-September-2023.pdf | Decentralized Management of RR-TB Care | Most of the RR-TB care and services should be provided in the outpatient setting according to the national decentralization plan, which aligns with our policy framework on decentralized and deinstitutionalized management of multidrug-resistant tuberculosis. Children do not need to be treated at central sites and can be... | Most of the RR-TB care and services should be provided in the outpatient setting according to the National decentralization plan which aligned with our policy framework on decentralized and deinstitutionalized management of multidrug-resistant tuberculosis [10] . Children do not need to be treated by central sites and ... | ACCEPT | train |
01f3cfdbd99d4972a14125c466454974 | Updated-RR-TB-Clinical-Guidelines-September-2023.pdf | Management of Rifampicin-Resistant Tuberculosis in Pregnant Women | Note that pregnant women with RR-TB can be initiated on treatment by providers without NCAC approval; however, these cases should still be presented to the NCAC for formal monitoring at a national level.
Overall Flow Diagram for people ≥ 15 years of age:
- Xpert, TB-NAAT, or culture reported as rifampicin resistant
... | -note that pregnant women with RR-TB can be initiated on treatment by providers without NCAC approval but these cases should still be presented to the NCAC so that this cohort can be more formally monitored on a national level[11] 1.7. Overall Flow Diagram for people ≥ 15 years of age Xpert , TB-NAAT or culture reporte... | ACCEPT | train |
7b2239a020874756acff7026972d170d | Updated-RR-TB-Clinical-Guidelines-September-2023.pdf | Rifampicin Resistance and Isoniazid Susceptibility in TB Treatment | In-lab reflex is done when rifampicin is resistant and isoniazid is susceptible. Confirm susceptibility to isoniazid if INH will be added to the treatment regimen. | In-lab reflex done when rifampicin resistant and isoniazid susceptible. Confirm susceptibility to isoniazid if INH will be added to the treatment regimen. | ACCEPT | train |
57330dced92947199e2ac46cc42e24bb | Updated-RR-TB-Clinical-Guidelines-September-2023.pdf | Individualized Extended Phenotypic DST (done by the National Institute of Communicable Diseases) | Requested when RR-TB regimen is failing, resistant to BDQ or LZD, or there is previous exposure to second-line drugs. Susceptibility to multiple TB drugs is used to construct a rescue regimen. *TAT: Turnaround time. | Requested when RR-TB regimen failing, resistant to BDQ or LZD or previous exposure to second-line drugs Susceptibility to multiple TB drugs, used to construct a rescue regimen *TAT, Turn around time | ACCEPT | train |
633f929428494e829efaff9be117cddc | Updated-RR-TB-Clinical-Guidelines-September-2023.pdf | Short Regimen Treatment for Rifampicin-Resistant Tuberculosis | Patients started on the short regimen based on genotypic (e.g., GeneXpert) rifampicin resistance results:
- **INH, ETH, SLID, and FLQ**:
- **Action for INH resistant** (any combination of inhA and/or katG mutation or katG): Continue short RR-TB regimen (BPaL-L), modify according to other genotypic and phenotypic s... | Patients started on the short regimen based on genotypic (e.g. GeneXpert) rifampicin resistance Genotypic Results INH, ETH, SLID and FLQ and phenotypic BDQ, LZD and Pa Action INH resistant (any combination of inhA and/or katG mutation) or katG Continue short RR-TB regimen (BPaL-L), modify according to other genotypic a... | ACCEPT | train |
472b56ecb42e49159b394f01d43b64fb | Updated-RR-TB-Clinical-Guidelines-September-2023.pdf | Discordant results between phenotypic and genotypic tests | Clinician to phone the laboratory to discuss discordant results. In general, treatment should be based on the "most resistant" scenario; consult with PCAC or NCAC. | Clinician to phone the laboratory to discuss discordant results. In general, treatment should be based on the "most resistant" scenario; consult with PCAC or NCAC. | ACCEPT | train |
3fcbb3f6ee5d43eab83fd92bd29fbaad | Updated-RR-TB-Clinical-Guidelines-September-2023.pdf | Key points to consider in RR-TB diagnosis in children | • The diagnosis of TB disease in children is often made based on patient history, clinical and radiological findings, with consideration of RR-TB disease risk factors, such as recent RR-TB exposure or failure of first-line TB treatment with good adherence. Children with clinically diagnosed TB may also have Xpert MTB/R... | • The diagnosis of TB disease in children is often made on patient history, clinical and radiological grounds with consideration of RR-TB disease based on risk factors for RR-TB, such as recent RR-TB exposure or failure of first-line TB treatment with good adherence. However, children with clinically diagnosed TB may a... | ACCEPT | train |
eff5ebcfb18e4f7bb0ee37e975c59979 | Updated-RR-TB-Clinical-Guidelines-September-2023.pdf | Treatment of RR-TB in Children | The recommendations for the treatment of RR-TB in children under 15 years of age follow the approach outlined in the Sentinel Guide for the Management of MDR-TB in Children, considering available programmatic pediatric data, extrapolated efficacy data from adult clinical trials, expert pediatric opinion, and the latest... | following recommendations for treatment of RR-TB in children under 15 years of age follows the approach outlined in the Sentinel Guide for Management of MDR-TB in Children [15] , considering available programmatic paediatric data, extrapolated efficacy data from adult clinical trials, expert paediatric opinion and the ... | ACCEPT | train |
e0c9b295c0624dbea59bd245f9e34beb | Updated-RR-TB-Clinical-Guidelines-September-2023.pdf | Pediatric Regimen Design for RR-TB | The general approach to pediatric RR-TB regimen design is the same for children of all ages (0-14 years). The following principles of treatment are recommended:
- In designing treatment regimens for children, the following factors must be considered:
- RR-TB regimen composition is based on the current WHO drug group... | The general approach to paediatric RR-TB regimen design is the same for children of all ages (0-14 years). The following principles of treatment are recommended: • In designing treatment regimens for children, the following factors must be considered: o RR-TB regimen composition is based on the current WHO drug groupin... | ACCEPT | train |
8176075980224eaf9f631f350565f9c9 | Updated-RR-TB-Clinical-Guidelines-September-2023.pdf | Principles of RR-TB treatment in children under 15 years of age | The past five years have seen revolutionary changes in the diagnosis and management of rifampicin-resistant tuberculosis (RR-TB), including the use of new and repurposed drugs and novel therapeutic approaches. South Africa has been a global leader in introducing innovation to the field of RR-TB, and the work done in th... | The past five years have seen revolutionary changes in the diagnosis and management of rifampicin-resistant tuberculosis (RR-TB), including the use of new and repurposed drugs and novel therapeutic approaches [1] . South Africa has been a global leader in introducing innovation to the field of RR-TB and the work done i... | ACCEPT | train |
c265e6e847864571bd9a7eb6ba4c2aa0 | Updated-RR-TB-Clinical-Guidelines-September-2023.pdf | Pediatric Management of RR-TB and BPaL-L Regimen | Clinicians with limited experience in managing pediatric RR-TB are advised to discuss cases with more experienced clinicians. All cases of RR-TB with confirmed or presumed resistance to BDQ, LZD, or CFZ should be referred to a pediatric DR-TB expert or pediatric infectious diseases expert, or to the PCAC/NCAC for guid... | Table 3 .4.1 below provides some examples of individualized regimens that would be appropriate in various situations based on drug susceptibility test pattern and site / severity of disease. Clinicians with limited experience in the management of paediatric RR-TB are advised to discuss cases with more experienced clini... | ACCEPT | train |
45301d7d881c47f4bf34e7a55a0083c9 | Updated-RR-TB-Clinical-Guidelines-September-2023.pdf | Individualized Regimen for TB Risk Factors | No to all these risk factors. Yes to any of these risk factors. Start a longer individualized regimen while awaiting DST and blood test results. Start BPaL-L regimen while awaiting DST and blood test results. | No to all these risk factors Yes, to any of these risk factors Start a longer individualized regimen while awaiting DST and blood test results Start BPaL-L regimen while awaiting DST and blood test results | ACCEPT | train |
84ec2a4fcebf4fb3928940f1ab355bd0 | Updated-RR-TB-Clinical-Guidelines-September-2023.pdf | Short RR-TB Regimens | The short RR-TB regimen in this chapter refers to the 6-month BPaL-L and BPaL regimens. It does not refer to the 9-month regimen currently used per the 2019 Clinical Reference Guide. | The short RR-TB regimen in this chapter refers to the 6-month BPaL-L and BPaL regimens [18] . It does not refer to the 9-month regimen currently used per the 2019 Clinical Reference Guide. | ACCEPT | train |
c43525599ba74a6b8aa77f5fed032983 | Updated-RR-TB-Clinical-Guidelines-September-2023.pdf | Resistance Patterns in Tuberculosis | Resistance Patterns:
- Individuals with RR-TB: resistance based on initial genotypic results while awaiting further susceptibility results.
- Documented resistance to bedaquiline or linezolid.
- RR-TB with additional resistance to pretomanid or delamanid.
- XDR-TB: resistance to fluoroquinolones and resistance ... | Resistance patterns • Individuals with: RR-TB: resistance, based on initial genotypic result, while awaiting further susceptibility results • Documented resistance to Bedaquiline or Linezolid. • RR-TB with additional resistance to pretomanid or delamanid • XDR-TB (resistance to the fluroquinolones and/ resistance to be... | ACCEPT | train |
3d2cc6bf39ae4642b9d3ae28d3ced16e | Updated-RR-TB-Clinical-Guidelines-September-2023.pdf | Pediatric RR-TB Treatment and Disease Classification | In cases of slow or inadequate clinical, radiological, and/or microbiological treatment response, there is no specified intensive or continuation phase for pediatric RR-TB regimens. Most drugs should be continued throughout treatment, if possible, unless limited by toxicity or intolerance. Bedaquiline and delamanid are... | in cases of slow or inadequate clinical, radiological and/or microbiological treatment response. There is no specified intensive or continuation phase for paediatric RR-TB regimens and most drugs should be continued throughout treatment, if possible, unless limited by toxicity or intolerance. Bedaquiline and delamanid ... | ACCEPT | train |
b268db8c53a34ee2b027a56769fa5024 | Updated-RR-TB-Clinical-Guidelines-September-2023.pdf | Patient Safety Considerations for Pretomanid | - Children under the age of 15 years (since pretomanid safety is not yet confirmed in this population).
- Pregnant women (since pretomanid safety is not yet confirmed in this population).
Patients with extensive disease can have their regimen extended to 9 months at the discretion of the clinician. | • Children under the age of 15 years (since pretomanid safety is not yet confirmed in this population) • Pregnant women (since pretomanid safety is not yet confirmed in this population) Patients with extensive disease can have their regimen extended to 9 months at the discretion of the clinician. | ACCEPT | train |
92ffb83b00af493cb81a6943943423d6 | Updated-RR-TB-Clinical-Guidelines-September-2023.pdf | Switching from BPaL-L to Long Individualized Regimen | It is important to recognize when a person needs to switch from the short RR-TB regimen to a longer regimen. Input should be sought from the PCAC or NCAC where needed. A switch to a long individual regimen should be strongly considered in the following situations:
- Resistance to bedaquiline, pretomanid, clofazimine, ... | It is important to recognize when a person needs to switch from the short RR-TB regimen to a longer regimen. Input should be sought from the PCAC or NCAC where needed. A switch to a long individual regimen should be strongly considered in these situations: • Resistance to Bedaquiline, pretomanid, clofazimine, delamanid... | ACCEPT | train |
8b6bd3fcab0245db9640303b3aa8e4a6 | Updated-RR-TB-Clinical-Guidelines-September-2023.pdf | Treatment Regimens for Drug-Resistant Tuberculosis | **Group A:** Include all three medicines, where possible: Levofloxacin or Moxifloxacin (include for CNS disease; omit in fluoroquinolone-resistant RR-TB). Bedaquiline (include if no resistance). Linezolid (include for all, including CNS disease, unless contraindication or resistance). In patients with Hb < 8 g/dL, neut... | Group A: Include all three medicines, where possible Levofloxacin or Moxifloxacin Include for CNS disease. Omit in fluoroquinolone-resistant RR-TB. Bedaquiline Include if no resistance. Linezolid Include for all including CNS disease, unless contraindication or resistance. In patients with Hb ˂8 g/dL, neutrophils ˂0.75... | ACCEPT | train |
9f83b247ba0d44118b0e04e4ebc60166 | Updated-RR-TB-Clinical-Guidelines-September-2023.pdf | Rescue Regimen for RR-TB with Drug Resistance | Clients with RR-TB and suspected or confirmed resistance to linezolid, clofazimine, bedaquiline, and pretomanid/delamanid need to be given a rescue regimen. All persons requiring treatment with a rescue regimen should have a specimen or sample sent for EDST. While awaiting the results of that DST, an empiric rescue tre... | Clients with RR-TB and suspected or confirmed resistance to linezolid, clofazimine, bedaquiline and pretomanid/delamanid need to be given a rescue regimen. All persons requiring treatment with a rescue regimen should have a specimen or sample sent for EDST. While awaiting the results of that DST, an empiric rescue trea... | ACCEPT | train |
5f9424b4bce54f8abade10dfa96ebb8a | Updated-RR-TB-Clinical-Guidelines-September-2023.pdf | Meropenem (given with amoxicillinclavulanate) | • Meropenem: 1000 mg every 12 hours; for creatinine clearance <10 ml/min, dose 1000 mg once daily.
• Ertapenem: 500 mg once daily.
• Amoxicillin-clavulanate: 250 mg/125 mg given 30 minutes prior to Imipenem. | • Meropenem: 1000 mg every 12 hours; for creatinine clearance ˂10 ml/min dose 1000 mg once daily. • Amoxicillin-clavulanate: 250 mg / 125 mg given 30 minutes prior to Imipenem Ertapenem (given with amoxicillinclavulanate) • Ertapenem: 500 mg once daily • Amoxicillin-clavulanate: 250 mg / 125 mg given 30 minutes prior t... | ACCEPT | train |
90b8feab93e94b58845d622536810e41 | Updated-RR-TB-Clinical-Guidelines-September-2023.pdf | Para-Aminosalicylic Acid and Amikacin Dosing | Para-aminosalicylic acid: 4 g/dose, twice daily. Maximum dose: Amikacin. Stop amikacin, or if considered essential to treatment, administer only with therapeutic drug monitoring. | Para-aminosalicylic acid 4 g/dose, twice daily maximum dose Amikacin Stop amikacin, or if considered essential to treatment administer only with therapeutic drug monitoring | ACCEPT | train |
78d510c113e94a3badbe1bc09174e0de | Updated-RR-TB-Clinical-Guidelines-September-2023.pdf | Management of RR-TB in Pregnant and Breastfeeding Women | • All non-pregnant women of childbearing potential should be appropriately counseled throughout RR-TB treatment and offered family planning as part of routine RR-TB care.
• Healthcare providers can initiate RR-TB treatment for pregnant patients without NCAC approval. A pregnancy registry will be developed to formally... | • All non-pregnant women of childbearing potential should be appropriately counselled throughout RR-TB treatment and offered family planning as part of routine RR-TB care. • Healthcare providers can initiate RR-TB treatment for pregnant patients without NCAC approval. A pregnancy registry will be developed so that this... | ACCEPT | train |
161208dfb3974eabb9f84a7bb9a67845 | Updated-RR-TB-Clinical-Guidelines-September-2023.pdf | DR-TB Treatment in HIV Co-Infection | - Both short and longer DR-TB regimens may be offered to people with HIV, and HIV status alone does not necessitate changes in the DR-TB regimen composition.
- To improve the chances of RR-TB treatment success, all individuals co-infected with RR-TB and HIV should receive antiretroviral therapy (ART) to suppress their... | • The short and longer DR-TB regimens may both be offered to people with HIV, and HIV status alone does not mandate any changes in the DR-TB regimen composition. • To improve the chances of RR-TB treatment success, all people co-infected with RR-TB and HIV should receive antiretroviral therapy (ART) to suppress their v... | ACCEPT | train |
515ffb26bf3c4bb686993b5404c77617 | Updated-RR-TB-Clinical-Guidelines-September-2023.pdf | Integrated Management of RR-TB and HIV | - Treating RR-TB and HIV simultaneously can:
- Negatively affect serum drug levels due to drug-drug interactions.
- Negatively affect adherence due to increased pill burden.
- Potentiate side effects due to overlapping toxicities, e.g., hepatic toxicity.
- Selected ART regimens should therefore be optimi... | • Treating RR-TB and HIV simultaneously can: o Negatively affect serum drug levels due to drug-drug interactions o Negatively affect adherence, due to increased pill burden o Potentiate side effects due to overlapping toxicities, e.g., hepatic toxicity • Selected ART regimens should therefore be optimized to avoid drug... | ACCEPT | train |
d4c663792ff24d9499e85e3279562a81 | Updated-RR-TB-Clinical-Guidelines-September-2023.pdf | Antiretroviral Therapy in HIV-infected persons with RR-TB | Initiating (or re-initiating) ART after starting RR-TB treatment:
For ART-naïve clients and clients re-initiating ART after a previous interruption, TLD should be initiated within 2 to 8 weeks after starting RR-TB therapy. In patients with CD4 < 50 cells/mm³, ART should be started within 2 weeks. In patients with RR-... | Initiating (or re-initiating) ART after starting RR-TB treatment • For ART naïve clients and clients re-initiating ART after previously interrupting ART, TLD should be initiated within 2 to 8 weeks after starting RR-TB therapy. In patients with CD4 ˂50 cells/mm3 ART should be started within 2 weeks. In patients with RR... | ACCEPT | train |
002aedc22abb48d4844a02728f6a19a0 | Updated-RR-TB-Clinical-Guidelines-September-2023.pdf | ART Management in RR-TB Patients | • Clients who are already on ART when RR-TB is diagnosed should have a CD4 count and viral load (VL) test at the time of RR-TB treatment initiation. Any VL > 50 c/mL should receive a thorough 'ABCDE' assessment, have interventions implemented, and have a repeat VL in 3 months (see the VL monitoring and management algor... | • Clients who are already on ART when RR-TB is diagnosed should have a CD4 count and viral load test at the time of RR-TB treatment initiation. Any VL > 50 c/mL should receive a thorough 'ABCDE' assessment, have interventions implemented, and have a repeat VL in 3 months' time (see The VL monitoring and management algo... | ACCEPT | train |
e96dfe26831c4c25a508f40406f85c0e | Updated-RR-TB-Clinical-Guidelines-September-2023.pdf | Outdated Antiretroviral Agents and Recommendations | **Text:**
9.4. Earlier antiretroviral agents that are no longer recommended in standard care:
- Although protease inhibitors (PIs) increase bedaquiline exposure via enzyme inhibition, this does not appear to increase toxicity. PI-based regimens are compatible with rifampicin-resistant tuberculosis (RR-TB) treatment. ... | https://knowledgehub.health.gov.za/elibrary/2023-art-clinical-guidelines-management-hiv-adults-pregnancy- and-breastfeeding-adolescents 9.4. Earlier antiretroviral agents that are no longer recommended in standard care • Although PIs increase bedaquiline exposure via enzyme inhibition, this does not appear to increase ... | ACCEPT | train |
d3760d02c41146dca28c9ae69259e0b6 | Updated-RR-TB-Clinical-Guidelines-September-2023.pdf | Tenofovir Contraindications | Tenofovir is contraindicated in patients with impaired renal function, which can be assessed by checking eGFR/creatinine, as detailed in the table below. Tenofovir should not be used in patients under 10 years of age or weighing less than 30 kg. | Tenofovir is contra-indicated in patients with impaired renal function, which can be assessed by checking eGFR/creatinine, as detailed in the table below. Tenofovir should not be used for any patients ˂10 years of age or weighing ˂30 kg. | ACCEPT | train |
c522fdafd96e4c3c9b083d2fead1f8bc | Updated-RR-TB-Clinical-Guidelines-September-2023.pdf | Monitoring Schedule for a patient on a BPaL-L/BPaL 6 month regimen | An example of the schedule for baseline, routine, and post-treatment monitoring examinations for the BPaL-L/BPaL regimen is as follows:
**Abbreviations:**
- ALT: alanine aminotransferase
- AST: aspartate aminotransferase
- BMI: body mass index
- BPaL: bedaquiline, pretomanid, and linezolid
- BPaL-L: bedaquiline, preto... | An example of the schedule of baseline, routine, and post-treatment monitoring examinations for the BPaL-L/BPaL regimen. ALT: alanine aminotransferase; AST: aspartate aminotransferase; BMI: body mass index; BPaL: bedaquiline, pretomanid and linezolid; BPaL-L: Examination Baseline 2 Weeks Monthly End of Treatment 6 & 12... | ACCEPT | train |
3ec60044d5da47e983e1bb68a7cef0be | Updated-RR-TB-Clinical-Guidelines-September-2023.pdf | Principles for monitoring and management of adverse events | - All persons with RR-TB need baseline assessments and monthly monitoring during treatment. This includes assessment for substance use and mental health.
- Persons on either regimen need monthly samples sent for smear and culture for therapeutic decision-making.
- Increased attention needs to be given to monitoring f... | • All persons with RR-TB need baseline assessments and monthly monitoring during treatment. This includes assessment for substance use and mental health. • Persons on either regimen need monthly samples sent for smear and culture for therapeutic decision-making. • Increased attention needs to be given to monitoring for... | ACCEPT | train |
4abee1b7cf6048158f97f2ac5b735626 | Updated-RR-TB-Clinical-Guidelines-September-2023.pdf | Safety Monitoring Haematological | Anaemia in TB patients is common and is often due to TB itself, resulting in normocytic normochromic anemia. Treating TB typically resolves the anaemia. Other contributing factors may include nutritional deficiencies, blood loss from hemoptysis or other sources, and HIV co-infection. TB patients are vulnerable to drops... | Anaemia in TB patients is common. It is often due to TB itself, a normocytic normochromic anemia. Treating the TB treats the anaemia. There may be other contributing factors including nutritional deficiencies, blood loss from hemoptysis or other sources and HIV co-infection. TB patients are vulnerable to drops in Hb an... | ACCEPT | train |
653485bf4ee44deb9ae34208f3b033d0 | Updated-RR-TB-Clinical-Guidelines-September-2023.pdf | Management of Peripheral Neuropathy in TB Treatment | This adverse event tends to occur later in treatment, with a peak time of onset around 16 weeks. The patients' experience of it is subjective. Grade 3 peripheral neuropathy, according to the DAIDS tables, is characterized by severe symptoms. This grade is applied if there is an inability to perform usual social and fun... | This adverse event tends to occur later in treatment, with a peak time of onset around 16 weeks [23] . The patients' experience of it is subjective. Grade 3 peripheral neuropathy by the DAIDS tables is one that causes severe symptoms. This grade is applied if there is an inability to perform usual social and functional... | ACCEPT | train |
766a38c30c2f4f11b57504db30722890 | Updated-RR-TB-Clinical-Guidelines-September-2023.pdf | RR-TB Treatment Follow-Up Checklist | This checklist should be completed at each follow-up visit for anyone receiving RR-TB treatment, regardless of the regimen. Any "yes" answers should be followed up for more details. Ask the patient: "Since your last visit, have you experienced any of the following symptoms?"
ADVERSE EVENTS SYMPTOMS GRADING/DETAILS
1... | This checklist should be completed at each follow up visit for anyone receiving RR-TB treatment, regardless of the regimen. Any "yes" answers should be followed up for more details. Ask the patient: "Since your last visit, have you experienced any of the following symptoms?" ADVERSE EVENTS SYMPTOMS GRADING/DETAILS 1. H... | ACCEPT | train |
0da7b3ea737143c8a90a2aaa4efd3fe3 | Updated-RR-TB-Clinical-Guidelines-September-2023.pdf | Active Drug Safety Monitoring in RR-TB Treatment | Active drug safety monitoring (aDSM) consists of the following three core activities: 1. Patients targeted for aDSM should receive active and systematic clinical and laboratory assessments during RR-TB treatment to detect drug toxicity and adverse events. | Active drug safety monitoring (aDSM) consists of the following 3 core activities: 1. Patients targeted for aDSM should receive active and systematic clinical and laboratory assessment during RR-TB treatment to detect drug toxicity and adverse events. | ACCEPT | train |
6294b8b7b53d4612b75216f711311816 | Updated-RR-TB-Clinical-Guidelines-September-2023.pdf | Adverse Event Reporting in RR-TB Treatment | All severe (Grade 3 and above) adverse events and serious adverse events (SAEs) should be systematically collected in patient files and entered into EDRWeb. These data will be reported to the national pharmacovigilance centre (NPC). The NPC collects this type of data from across the country to characterize the most com... | All severe (Grade 3 and above) adverse events and serious adverse events (SAEs) should be systematically collected in patient files and entered on EDRWeb -these data will be reported to the national pharmacovigilance centre (NPC). The NPC collects this type of data from the entire country and uses it to characterize th... | ACCEPT | train |
688702259eac4f56979678315032b317 | Updated-RR-TB-Clinical-Guidelines-September-2023.pdf | Adverse Events Documentation | All adverse events that lead to the interruption of a drug or the entire treatment regimen must be recorded in the folder and in the EDRWeb, regardless of grading. | All adverse events that lead to interruption of a drug or the entire treatment regimen must be recorded in the folder and in the EDRWeb regardless of grading. | ACCEPT | train |
f18eb347673642b1ab32ef267de5b111 | Updated-RR-TB-Clinical-Guidelines-September-2023.pdf | Drug-Resistant Tuberculosis Treatment and Bacteriological Response | • A pulmonary patient with bacteriologically confirmed drug-resistant tuberculosis (DR-TB) at the beginning of treatment who completed treatment as recommended by national policy, with evidence of bacteriological response and no evidence of failure (clinical deterioration).
• Bacteriological response refers to bacter... | • A pulmonary patient with bacteriologically confirmed DR-TB at the beginning of treatment who completed treatment as recommended by the national policy, with evidence of bacteriological response and no evidence of failure (clinical deterioration). • Bacteriological response refers to bacteriological conversion with no... | ACCEPT | train |
ddf854b322494976b31f655837312dc6 | Updated-RR-TB-Clinical-Guidelines-September-2023.pdf | TB Treatment and Culture Conversion | - A patient with TB culture conversion.
- Two negative TB cultures during treatment.
- Completed treatment as recommended by national policy.
- No evidence of clinical deterioration. | • A patient who has TB culture converted. • Has two negative TB cultures during treatment. • Who completed treatment as recommended by the national policy • No evidence of clinical deterioration. | ACCEPT | train |
d643c3e2a6fc4567a4223ea663b88f79 | Updated-RR-TB-Clinical-Guidelines-September-2023.pdf | Treatment Regimen Changes in Patient Care | • A patient whose treatment regimen needed to be terminated or permanently changed to a new regimen or treatment strategy (change of two or more drugs).
• Reasons for changing treatment include:
o No clinical response and/or no bacteriological response.
o Adverse drug reactions.
o Evidence of additional d... | • A patient whose treatment regimen needed to be terminated or permanently changed to a new regimen or treatment strategy (change of 2 or more drugs). • Reasons for change of treatment include: o no clinical response and/or no bacteriological response. o adverse drug reactions. o or evidence of additional drug resistan... | ACCEPT | train |
f2fd73648a1e409d9f3be6736f98abb7 | Updated-RR-TB-Clinical-Guidelines-September-2023.pdf | Patient Referral and Treatment Outcome Reporting | • Referred from one facility to another within the same district to continue treatment. This is not an outcome but serves to match patients moving within the district to prevent double counting. • The treatment outcome is reported by the facility where the patient is newly registered. | • Referred from one facility to another facility within the same district to continue treatment. This is not an outcome but serves to match patient moving within the district in order to prevent double counting. • The treatment outcome is reported by the facility where the patient is newly registered | ACCEPT | train |
dbbca8f8cbed4e948297aa4d06f808db | Updated-RR-TB-Clinical-Guidelines-September-2023.pdf | Multidrug-Resistant TB Treatment and Dosing Guidelines | • Referred from one facility to another reporting and recording facility in another district, province, or country to continue treatment.
• Treatment outcomes are reported by the facility where the patient is newly registered:
- Died: A patient who dies for any reason during treatment.
- Still on treatment: A p... | • Referred from one facility to another reporting and recording facility in another district, province or country to continue treatment. • The treatment outcome is reported by the facility where the patient is newly registered Died A patient who dies for any reason during treatment Still on treatment Still on treatment... | ACCEPT | train |
fd1a5e63e6904e14bbffe3e0e3001a47 | Updated-RR-TB-Clinical-Guidelines-September-2023.pdf | Dosing Guidelines for BPaL-L/BPaL Regimen | 1 mL od M/W/F
b ≥ 3 months: 6 mL od for 2 weeks; then 2 mL od
b 0 to <3 months: 3 mL od for 2 weeks; then 1 mL od
b 3 to <6 months: 6 mL od for 2 weeks; then 2 mL od
b ≥ 6 months: 8 mL od for 2 weeks; then 4 mL od
b 3 to <6 months: 6 mL for 2 weeks; then 2 mL od
b ≥ 6 months: 12 mL od for 2 weeks; then 6 mL... | 1 mL od M/W/F b ≥ 3 months: 6 mL od for 2 weeks; then 2 mL od M/W/F b 0 to <3 months: 3 mL od for 2 weeks; then 1 mL od M/W/F b 3 to <6 months: 6 mL od for 2 weeks; then 2 mL od M/W/F b ≥ 6 months: 8 mL od for 2 weeks; then 4 mL od M/W/F b 3 to <6 months: 6 mL 2 weeks; then 2 mL od M/W/F b ≥ 6 months: 12 mL od for 2 we... | REJECT | train |
0036fe266cfc471697d453562d158ca4 | Updated-RR-TB-Clinical-Guidelines-September-2023.pdf | Dosage and Administration of Antitubercular Medications in Children | Usually given in divided doses, Bedaquiline adult tablets (100 mg) crushed and suspended in water have been shown to be bioequivalent to tablets swallowed whole. Vigorous stirring or shaking is needed prior to administering the 100 mg tablet crushed and suspended in water. When using the 600 mg tablet and the 150 mg di... | Usually given in divided doses. d Bedaquiline adult tablets (100 mg) crushed and suspended in water have been shown to be bioequivalent to tablets swallowed whole. Vigorous stirring/shaking is needed prior to administering the 100 mg tablet crushed and suspended in water. e When using the 600 mg tab and the 150 mg dt t... | ACCEPT | train |
97bbad81a32f46158831d03dd1b0ab8d | Updated-RR-TB-Clinical-Guidelines-September-2023.pdf | Dosing Guidelines for MDR-TB in Children | and C, due to a lack of data from the latest analysis on longer MDR-TB regimens in adults (isoniazid). Specific comments on dosing children with medicines used in second-line MDR-TB regimens:
- For dosing premature and low birth weight infants weighing <3 kg, advice should be sought from a pediatric DR-TB expert.
- ... | and C, because of a lack of data from the latest analysis on longer MDR-TB regimens in adults (isoniazid). Specific comments on dosing children with medicines used in second-line MDR-TB regimens: • For dosing of premature and low birth weight infants weighing <3 kg, advice should be sought from a paediatric DR-TB exper... | ACCEPT | train |
80e6ffd1c23c4b5b8d2f3d86b8e3681f | Updated-RR-TB-Clinical-Guidelines-September-2023.pdf | Clinical Guidance Update Status | This section has been included in this clinical guidance because it is essential. However, there is no update here. The information is based on the existing clinical reference guide [11]. | • This section has been included in this clinical guidance because it is essential. However, there is no update here. The information is based on existing clinical reference Guide [11] . | REJECT | train |
bc0041f86e5044f490d5b0a11c0fd32f | Updated-RR-TB-Clinical-Guidelines-September-2023.pdf | Diabetes Management and Monitoring | Diabetes mellitus:
- Excellent glucose control (may require insulin).
- Close monitoring of blood glucose and HbA1C.
- Monitor for adverse events that may be more common (e.g., peripheral neuropathy, renal failure).
- Do not exceed a dose of 500 mg twice daily when using metformin with dolutegravir. | Diabetes mellitus • Excellent glucose control (may need insulin). • Close monitoring of blood glucose and HbA1C. • Close monitoring for adverse events that may be more common (i.e. peripheral neuropathy, renal failure). • Do not exceed a dose of 500 mg twice daily when using metformin with dolutegravir. | ACCEPT | train |
78ce6ee814024ad9b8d57290dc62c0ad | Updated-RR-TB-Clinical-Guidelines-September-2023.pdf | Substance Use and TB Treatment Strategies | Refer to the annex in the full guidance document.
- Brief counseling intervention with motivational interviewing.
- Initiate RR-TB treatment even if there is not complete sobriety.
- Enhanced adherence support.
- Harm reduction counseling.
- Referral to a substance use treatment center.
- Consider pharmacot... | Refer to Annex in full guidance document. • Brief counselling intervention with motivational interviewing. • Should initiate RR-TB treatment even if there is not complete sobriety. • Enhanced adherence support. • Harm reduction counselling. • Referral to substance use treatment center. • Pharmacotherapy-assisted treatm... | ACCEPT | train |
13826710bb074596aaede8d30ee4171f | Updated-RR-TB-Clinical-Guidelines-September-2023.pdf | Access to Medications and Support for Incarcerated Individuals | - Should have access to all medications and therapeutic innovations.
- Enhanced counseling and adherence support, especially around the time of release from prison or movement within the prison system. | • Should have access to all medications and therapeutic innovations. • Enhanced counselling and adherence support, especially around time of release from prison or movement within the prison system. | ACCEPT | train |
4d71d8389fa84a6cac7d446c1113d027 | Updated-RR-TB-Clinical-Guidelines-September-2023.pdf | Access to Therapy and Adherence Support | - Access to therapy regardless of province or country of origin.
- Prioritize the use of shorter regimens when possible.
- Enhanced adherence support. | • Access to therapy regardless of province or country of origin. • Prioritize use of shorter regimen when possible. • Enhanced adherence support. | ACCEPT | train |
002094d0733c4f83ac022d83c115eb96 | Updated-RR-TB-Clinical-Guidelines-September-2023.pdf | Smoking Cessation Strategies | - Screen for active smoking at each visit.
- Provide counseling to reduce or stop cigarette smoking.
- Consider pharmacotherapy or nicotine replacement therapy. | • Screen for active smoking at each visit. • Counselling to reduce or stop cigarette smoking. • Consider pharmacotherapy or nicotine replacement therapy. | ACCEPT | train |
ebb50fc8e5564b63bc6bfdb27bef7a1e | Updated-RR-TB-Clinical-Guidelines-September-2023.pdf | Severity Impact of symptoms Mild (Grade 1) | Symptoms cause no or minimal interference with usual, age-appropriate social and functional activities (e.g., going to work, shopping, cooking, using transport, hobbies). | Symptoms cause no or minimal interference with usual, age appropriate, social and functional activities (e.g. going to work, shopping, cooking, using transport, hobbies) | ACCEPT | train |
9094825edcd24bbcb027b626ab89db5d | Updated-RR-TB-Clinical-Guidelines-September-2023.pdf | Severe (Grade 3) | Symptoms can cause an inability to perform usual, age-appropriate social and functional activities (e.g., going to work, shopping, cooking, using transport, engaging in hobbies). | Symptoms cause inability to perform usual, age appropriate, social and functional activities (e.g. going to work, shopping, cooking, using transport, hobbies) | ACCEPT | train |
2422a8d14122493eb1b6bdc070928bb2 | Updated-RR-TB-Clinical-Guidelines-September-2023.pdf | Potentially lifethreatening (Grade 4) | Symptoms cause an inability to perform basic, age-appropriate self-care functions (e.g., bathing, dressing, toileting, continence, feeding, movement); or medical or operative intervention is required to prevent permanent impairment, persistent disability, or death. | Symptoms cause inability to perform basic, age-appropriate, self-care functions (e.g. bathing, dressing, toileting, continence, feeding, movement); OR Medical or operative intervention required to prevent permanent impairment, persistent disability, or death | ACCEPT | train |
51d7f7805e1d401b9ca39c54d1ec0e8b | Updated-RR-TB-Clinical-Guidelines-September-2023.pdf | Post-treatment follow up | All patients who successfully complete treatment need to be evaluated twice, at 6 and 12 months post-treatment. During these visits, a physical examination must be conducted, and a sputum sample must be collected for TB microscopy and culture. Laboratory results must be documented in the patient folder and the electron... | All patients who successfully complete treatment need to be evaluated twice, 6 and 12 months post-treatment. During these visits a physical examination must be conducted; and a sputum must be collected for TB microscopy and TB culture. Laboratory results must be documented in the patient folder and the electronic treat... | ACCEPT | train |
13b42338bb2a41b3af4b9cabb2667dee | Updated-RR-TB-Clinical-Guidelines-September-2023.pdf | Depression/anxiety | - Counseling, antidepressants, anxiolytics.
- Management in primary health care (PHC), with access to psychiatry services.
- Right heart failure (cor pulmonale).
- Tailored therapy with diuretics, inotropes, and afterload reduction.
- Management in PHC, with access to cardiology services. | • Counselling, antidepressants, anxiolytics. • Management in PHC, with access to psychiatry services. Right heart failure (core pulmonale) • Tailored therapy with diuretics, inotropes, afterload reduction. • Management in PHC, with access to cardiology services. | ACCEPT | train |
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