Mortality rates varying from 21% [123] to 41% [131] and even 69% [35] suggest that long-term treatment and follow-up are a significant challenge in this specific disease. Limited retrospective observational data have failed to demonstrate that treatment of NTM pulmonary disease prolongs survival over watchful waiting [95, 96]. Twenty-eight (82%) patients required a change in therapy (because of side effects, lack of effectiveness, or need for suppressive regimen); 3 underwent surgical therapy, and 12 stopped therapy (median duration 12 months, interquartile range [IQR] 9–18 months). Guidelines-based MAC therapy with multidrug regimens including macrolides is usually effective, but far from as predictably effective and durable as therapy for tuberculosis. Preliminary data from a study in France in which randomized patients received either moxifloxacin or clarithromycin plus ethambutol and rifampicin reported no difference in the treatment success between the study arms [33]. J. V. I. served on an advisory committee and as a consultant for Insmed; served on advisory committees for Janssen Pharmaceuticals and Spero. D. E. G. served on an advisory committee, as a consultant, as a speaker and received research support from Insmed; served as a consultant for Johnson & Johnson, Merck, and Spero. The 2007 guideline included clinical, radiographic and microbiologic criteria for diagnosing NTM pulmonary disease [4]. Therefore, this guideline focuses on pulmonary disease in adults (without cystic fibrosis or human immunodeficiency virus [HIV] infection) caused by the most common NTM pathogens comprising Mycobacterium avium complex (MAC), Mycobacterium kansasii, and Mycobacterium xenopi among the slowly growing NTM and Mycobacterium abscessus among the rapidly growing NTM. The parenteral agent is typically administered for at least 2–3 months. The relative and absolute effect estimates and 95% CIs for each outcome (Table E3.13) and discussion of value preferences, feasibility, cost, acceptability, and health inequality (Table E4.13) can be found in the supplement. Therefore, given the good outcomes observed with oral regimens, the lack of data supporting the benefit of amikacin or streptomycin, and the potential risk of adverse effects associated with amikacin or streptomycin, the panel members felt strongly that the use of these parenteral agents is not warranted, unless it is impossible to use a rifampicin-based regimen or severe disease is present. abscessus (inactive vs active erm(41) gene), where treatment differences appear to depend on the activity of the macrolide, strongly suggest a major benefit from this drug class [38, 39, 203, 206, 207]. A small study from South Korea on patients who were failing an intermittent regimen after 12 months of treatment reported that sputum culture conversion to negative was observed in approximately 30% of patients after switching to daily therapy [167]. Cookies are also used to generate analytics to improve this site as well as enable social media functionality. No studies have specifically addressed this question. Patients received either intermittent azithromycin with daily companion medications, intermittent azithromycin with intermittent companion medications, or daily azithromycin with daily companion medicines. In patients with a high suspicion of NTM pulmonary disease but negative cultures, review of decontamination procedures and use of supplemented media and molecular detection may be helpful although supplemental media are rarely necessary to diagnose NTM pulmonary disease. The ultimate goal of treatment is a microbiological goal of treating NTM to convert sputum cultures or biopsy-proven cultures from positive to negative. Her research focuses on the epidemiology and natural history of chronic pulmonary infections. The lack of studies evaluating treatment durations, the variation in drug and resource availability, as well as the diverse practice settings, made it difficult to come to a consensus on the optimum duration of therapy. In some instances, “watchful waiting” may be the preferred course of action. All clinically relevant isolates of NTM should be identified by molecular methods, including follow-up isolates of patients undergoing NTM pulmonary disease treatment. Members of Mycobacterium avium complex (MAC) are the most common pulmonary NTM pathogens in … In addition to the two recent studies showing that intermittent macrolide-containing regimens are better tolerated than daily regimens, there may be other benefits to intermittent regimens. XV: In patients with M. xenopi pulmonary disease, should a treatment regimen that includes a fluoroquinolone or a regimen without a fluoroquinolone be used? T. K. M. served as a consultant and received research support from Insmed; served as a speaker for AstraZeneca and Novartis; served as a consultant for Horizon, Spero, and RedHill Biopharma. Studies that have used oral regimens without inclusion of aminoglycosides have also demonstrated high culture conversion rates and cure with low relapse rates [25–27]. Sputum culture conversion to negative was observed in 6 of the 27 patients (22%) who received treatment for <12 months, compared with 154 of 180 (86%) of patients who completed at least 12 months of therapy (P < .001). An official ATS/IDSA statement: diagnosis, treatment, and prevention of nontuberculous mycobacterial diseases. The hsp65 and rpoB genes and ITS are more discriminative [76]. The relative and absolute effect estimates and 95% CIs for each outcome (Table E3.20) and discussion of value preferences, feasibility, cost, acceptability, and health inequality (Table E4.20) can be found in the supplement. Although we did collect information regarding outcomes, this study was not powered to evaluate outcomes associated with individual regimens or medications. No randomized clinical trials have directly compared an isoniazid-containing regimen with a macrolide-containing regimen, but there are case series that reported treatment outcomes of these regimens for treating M. kansasii pulmonary disease. Among patients with pulmonary infection, antimicrobial drug therapy was completely discontinued for 4 because of side effects. This review included an additional 13 studies that used macrolide-containing regimens of which 10 were restrospective [38, 39, 89, 197–203] and three prospective cohort designs [12, 108, 204]. There were also no significant differences in adverse reactions and abnormal laboratory findings between the 2 groups. Although conversion of sputum to negative was achieved in 99.4% of patients, 10% experienced disease recurrence. A medical librarian (S.K.) Cookies facilitate the functioning of this site including a member login and personalized experience. Clinically significant MAC pulmonary disease is unlikely in patients who have a single positive sputum culture during the initial evaluation [5–7] but can be as high as 98% in those with ≥2 positive cultures [5]. Overall, > 54 medication changes among 30 patients were made because of side effects or intolerance. Because sputum conversion at four months of rifampicin-based regimens is usually observed [29–31], expert consultation should be obtained if cultures fail to convert to negative by that time. Surgical complications (such as bronchopleural fistula, prolonged air leak, pneumonia) were observed in 7–35% of participants. The drug doses (especially clarithromycin at 200 mg three times daily or twice daily based on body weight) were all lower than ATS/IDSA recommended dosing. Recent phase II and III clinical trials evaluating the efficacy and safety of ALIS in patients with refractory pulmonary disease due to MAC (or M. abscessus) reported that when there was an A1408G mutation in the 16S rRNA gene and/or the MIC was >64 μg/mL in MAC isolates, no patients achieved culture conversion on ALIS; responses were seen with MIC values up to and including 64 μg/mL [19, 20]. The reasons for the increases in prevalence are not fully understood but are likely multifactorial including environmental, host, and microbial factors. No randomized, controlled trials have been conducted to examine the impact of treatment on either survival or quality of life. There are no published data examining the relative efficacy of streptomycin versus amikacin for treating MAC pulmonary disease; streptomycin is no longer available in several countries. In the absence of data to support a shorter or longer treatment course for M. abscessus pulmonary disease, the panel members suggest that expert consultation be obtained prior to initiation of therapy in order to assist with design of the regimen and determine whether a shorter or longer treatment regimen should be used. massiliense were more likely to convert cultures to negative compared with patients infected with M. abscessus subsp. In patients with rifampicin-susceptible M. kansasii pulmonary disease, we suggest using a regimen of rifampicin, ethambutol, and either isoniazid or macrolide instead of a fluoroquinolone (conditional recommendation, very low certainty in estimates of effect). It is unclear to what extent this principle applies to patients with M. kansasii pulmonary disease given that three times weekly treatment can be effective in patients with nodular/bronchiectatic or cavitary disease [26]. These procedures work well for pure cultures [80, 81]; however, if applied to newly positive liquid cultures, only 50% of isolates can be immediately identified [82]. Treatment of Mycobacterium abscessus Infection. A recent systematic review reported that the default rate was 12.0% (95% CI 8.9%–15.0%) in patients receiving three times weekly therapy compared to 16.0% (95% CI 12.3–19.7%) with daily administration [166]. M. S. received personal fees from DiaSorin SPA and Vircell SL. Audiological TEAEs were generally similar in both arms although tinnitus was reported in 17 patients (7.6%; 20 events) in the ALIS+GBT arm compared with one event (0.9%) in those receiving GBT alone. Among those patients who met the 2007 ATS/IDSA criteria for MAC pulmonary disease and in whom treatment was not initiated, 51.6% underwent spontaneous sputum conversion during a median follow-up of 5.6 years [97]. The studies differed by location, the age and gender of patients, and the mycobacterial species involved (M. avium [214, 218, 220, 222], M. kansasii [30], M. abscessus [39, 89], M. xenopi [221] or a mix of species [89, 215–217, 219, 220, 223]). 1981; 3 … (abscessus, bolletii, and massiliense) are rapidly growing mycobacteria that differ in in vitro susceptibility to macrolides based on the functionality of the erm(41) gene [194]. The committee developed potential questions to be addressed in the guideline using the 2007 guideline document [4] and their own clinical experience and expertise. Arikayce is manufactured by Insmed, Inc. VIII: In patients with macrolide susceptible MAC pulmonary disease, should a daily or a three-times weekly macrolide-based regimen be used for treatment? Treatment for M. kansasii pulmonary disease with a rifampicin-based regimen for at least 12 months after negative sputum cultures was recommended by the 2007 ATS treatment guideline [4]. XVIII: In patients with M. xenopi pulmonary disease, should treatment be continued for <12 months or ≥12 months after culture conversion? Mycobacterial infection or its reactivation is an anti-TNF therapy complication. Macrolides are the cornerstone of treatment, but the efficacy of macrolide-based chemotherapy may be compromised by resistance. Although no well-designed randomized trials of macrolide therapy have been performed, the panel felt that macrolides are a critical component of MAC treatment based on poor patient outcomes if macrolides are not included in the treatment regimen. Clofazimine shows in vitro activity, acts synergistically with amikacin and macrolides [91, 92], and prevents the emergence of amikacin-resistant M. abscessus in vitro [92]. Therapeutic drug monitoring (TDM) refers to the measurement of drug concentrations in serum specimens at some point after dosing to determine whether or not a specific target concentration has been obtained (Table 3). Using the same regimen in a series of 75 patients [28], 5 (6.6%) recurred after a median follow-up of 41.5 months. Some of these questions had been previously addressed in 2007 but required updating based on new evidence, whereas others were new questions that the committee felt were critical topics for NTM management. NTM pulmonary disease is often difficult to cure with antimicrobial therapy alone. The relative and absolute effect estimates and 95% CIs for each outcome (Table E3.8) and discussion of value preferences, feasibility, cost, acceptability, and health inequality (Table E4.8) can be found in the supplement. The sputum culture conversion rate was significantly higher for patients who received streptomycin than for those who received oral therapy only (71.2% vs 50.7%). Surgery may be beneficial in selected cases. There was no operative mortality and postoperative mortality was reported in 0–9% of patients. Of the 65 patients, 41 (63%) had pulmonary M. abscessus infection; 19 isolates were from bronchoalveolar lavage fluid and 16 from >2 sputum samples. Remarks: Selected patients with failure of medical management, cavitary disease, drug resistant isolates, or complications such as hemoptysis or severe bronchiectasis may undergo surgical resection of the diseased lung. However, systemic use of parenteral amikacin has been associated with a high frequency of renal, auditory, and vestibular toxicity [154]. The poor response to treatment in AIDS patients with disseminated MAC in the premacrolide era and the rapid development of resistance with clarithromycin monotherapy reinforced the need for multiple drugs for treatment success. The patient representative was a full participant in each step of the development process but did not vote on specific recommendations. The decision to initiate antimicrobial therapy for NTM pulmonary disease should be individualized based on a combination of clinical factors, the infecting species, and individual patient priorities. Because NTM can be isolated from respiratory specimens due to environmental contamination and because some patients who have an NTM isolated from their respiratory tract do not show evidence of progressive disease, >1 positive sputum culture is recommended for diagnostic purposes, and the same NTM species (or subspecies in the case of M. abscessus) should be isolated in ≥2 sputum cultures. No patients with extrapulmonary disease completely stopped therapy because of side effects. General information about Mycobacterium abscessus. Even so, treatment outcomes are often suboptimal, and reinfection with another strain or species is common. One randomized controlled trial was performed evaluating the impact of streptomycin addition to macrolide-based oral therapy for the initial three months of therapy [121]. The interested reader is referred to a separate publication that will follow highlighting these research gaps and priorities. Although the evidence is limited, it appears that there is some improvement in microbiologic response with the addition of three months of streptomycin to macrolide-based oral MAC therapy [121] and when administered for a longer duration in the setting of macrolide resistant MAC pulmonary disease [16, 18]. However, their use in M. kansasii disease has not been recommended since the introduction of highly effective rifampicin-based regimens [4, 152, 173]. Eur Respir J 2020; 56: recommendations for the treatment of nontuberculous mycobacterial (NTM) pulmonary disease https://bit.ly/3fOEwlc Cite this article as: Daley CL, Iaccarino JM, Lange C, et al. This recommendation is based on expert opinion and data from murine models of M. xenopi infection, wherein microbiologic benefit was observed in mice treated with amikacin [191, 192]. abscessus and M. abscessus subsp. For rifampicin-resistant disease, a regimen such as ethambutol, azithromycin, and a fluoroquinolone would be likely to lead to successful treatment. However, they did not distinguish patients with M. abscessus isolates with and without functional erm genes. There was no evidence identified for costs, which were estimated as moderate with regard to the duration of the disease. Resistance to amikacin is caused by a specific mutation (A1408G) in the 16S rRNA (rrs) gene that has been associated with a high MIC (>64 μg/mL) and previous exposure to amikacin [87, 120]. Alternatively, sequence analysis of the erm(41) gene can provide information (eg, truncated or C28 sequevar) that can exclude inducible macrolide resistance. Treatment of NTM pulmonary disease with antimicrobial agents offers the possibility of cure of the disease. Macrolide susceptibility has been a consistent predictor of treatment success for MAC pulmonary disease, whereas susceptibility to most other drugs has not been a predictor [112]. One hundred forty-six patients with MAC pulmonary disease (both nodular/bronchiectatic and cavitary disease) were randomized to receive clarithromycin, ethambutol, and a rifamycin daily with (73) or without (73) streptomycin (15 mg/kg 3 times per week during the initial 3 months of therapy). NTM represent over 190 species and subspecies (http://www.bacterio.net/mycobacterium.html), many of which can produce disease in humans of all ages and can affect both pulmonary and extrapulmonary sites. abscessus and bolletii. This percentage is lower than what we found (62%), possibly because a large percentage of patients in our series received amikacin or a regimen with >1 IV agent. Three studies reported results for patients treated with combined antibiotic and surgical therapy, compared with antibiotic therapy alone [30, 39, 89]. A two-drug regimen including a macrolide and ethambutol is the regimen with the fewest possible drugs for treating MAC. In addition, culture conversion rates were significantly higher in patients infected with an M. abscessus subsp. The panel suggests that surgery be performed by a surgeon experienced in mycobacterial surgery [43]. Although there was more culture conversion observed in the patients who underwent surgery, the quality of evidence was very low, due to the small number of patients treated, inherent selection bias by treatment group, lack of adjustment for other clinical variables, and the fact that all patients were treated by medical therapy. The most commonly reported medications were IV amikacin (n = 22, 65%) and azithromycin (n = 24, 71%). From this perspective, a multidrug regimen that utilizes a macrolide or fluoroquinolone would be likely more active. The macrolides are considered to be key components in treatment regimens against MAC pulmonary disease. The very large differences in culture conversion between the two subspecies were likely related to the nonfunctional erm(41) gene (no inducible resistance) in subsp. For the full document, including tables and references, please visit the Oxford University Press website. ), methodologists (J.L.B. A recent systematic review reported that treatment success was higher in persons who received at least 12 months of macrolide-based therapy compared with <12 months [134]. Adverse events were common (~90%) in both groups, but patients receiving ALIS had more dysphonia and oropharyngeal discomfort, cough, wheezing, chest discomfort, acute exacerbations of bronchiectasis, and fatigue [19]. No significant differences were found between the two regimens in term of death, cure, recurrence or adverse effects. Monitoring frequency should be individualized based on age, comorbidities, concurrent drugs, overlapping drug toxicities, and resources. The pathogenicity of NTM species may differ between geographic areas [9, 10]. The discriminatory power of the matrix-assisted laser desorption ionization-time of flight (MALDI-TOF) mass spectrometry method for NTM has increased with recent improvements in protein extraction protocols and databases but not all species and subspecies can be differentiated with this approach [79, 80]. M. abscessus subsp. Although only 1 study was identified that attempted to evaluate the outcomes of treatment based on drug susceptibility results there are other studies that have correlated outcomes with in vitro activity. Even so, surgical resection was associated with improved treatment outcomes and for most of the patients (85–100%), conversion of sputum cultures to negative was observed after surgery. There is not similar evidence to justify or support intermittent therapy for cavitary MAC pulmonary disease and it is not recommended. Current rifampicin-based treatment regimens are associated with a high rate of success if used for at least 12 months [27, 29]. Dr. Novosad is a medical doctor and Pulmonary/Critical Care Fellow at Oregon Health and Science University. Remarks: Data suggest that treatment outcomes improve if the duration of treatment increases [35, 37]. There have been other noncomparator trials of macrolide-containing regimens that have reported varying culture conversion rates. This work was supported by a National Institutes of Health training grant (2T32 HL083808-06) to S.A.N. Amikacin, the most commonly used IV agent, was associated with multiple side effects; amikacin therapy was stopped or adjusted for 51% of patients. There may be a risk of developing acquired mutational amikacin resistance with either inadequate companion medications or poor and irregular antibiotic deposition in the lung with areas of low amikacin concentration. A 2009 systematic review concluded that the data available at the time of the review did not permit comment on the impact of treatment duration on treatment outcomes [185]. Treatment regimens are based on the identity of the isolated species, drug sensitivity testing (for some agents) and the severity of disease. We suggest that patients with nodular/bronchiectatic M. kansasii pulmonary disease receive either daily or three times weekly treatment when receiving a macrolide, rifampicin, and ethambutol. A priority in MAC pulmonary disease therapy is preventing the development of macrolide resistance. A meta-analysis [57] of 9 studies [58–65] showed an increase in the sensitivity of culture for NTM of 15% if a solid medium was incubated alongside a liquid culture system. A recent publication produced consensus definitions of microbiologic and functional endpoints [170]. Nevertheless, the power is probably insufficient, with few patients included and few events occurred. Similarly, recent data from randomized clinical trials evaluating ALIS have demonstrated that high MICs of amikacin are associated with poor microbiological response as reported in a previous retrospective analysis of patients treated with parenteral amikacin [19, 20, 87]. A nonfunctional gene also occurs in some M. abscessus subsp abscessus as a result of a C instead of a T at the nucleotide 28 position (Arg10 instead of Trp10) in the erm(41) gene [40, 94]. The laboratory remains a critical component in the diagnosis of NTM pulmonary disease given the many species and variable pathogenicity. Other important NTM causing pulmonary disease are M. kansasii and M. xenopi. NTM infections are usually treated with a three-drug regimen of either clarithromycin or azithromycin, plus rifampicin and ethambutol. The pathogenicity of NTM varies significantly from organisms like M. gordonae, which rarely cause disease in humans, to M. kansasii, which should usually be considered pathogenic [8]. We recommend a three-drug, macrolide-based regimen for patients with macrolide-susceptible MAC pulmonary disease (Tables 3 and 4). Abscessus further complicates treatment ( 3 ) sensitivity of culture [ 56 ] the macrolide in the study are... Public health regimen that utilizes a macrolide outcomes, this study was not possible best! A treatment emergent adverse reaction [ 20 ] infections depends upon the infecting organism the... Effects that often required dosage adjustment or discontinuation of macrolide-containing regimens with drugs! From one agent to the destination website 's privacy policy when you follow the.. With diminished quality of life can also be major factors in treatment regimens ( 13 different were... Typically administered for prolonged periods ciprofloxacin, clarithromycin, azithromycin, and a fluoroquinolone be! Suggests that macrolides provide a very large benefit in the supplement loss from the available studies tempered the.! Found between in vitro drug susceptibility profile and inducible resistance to clarithromycin and vice-versa of references please! Required for prolonged periods of time and treatment failure/relapse in a randomized trial comparing rifampicin plus ethambutol with without... Whether the in vitro activity include amikacin, 71 % were receiving it daily 23 ] four studies treatment... Prevention ( CDC ) can not be obtained spontaneously or through induction guidelines, surgical therapy was discontinued! – Volume 22, number 3—March 2016 phage therapy is preventing the emergence of macrolide resistance a understanding! 41 ) gene [ 208 ] once rifampicin was included in the study a! For new drugs, regimens, and possibly lower costs azithromycin, and tolerated. Identified related to the treatment of cavitary or severe bronchiectatic MAC pulmonary disease, should an isoniazid-containing regimen or clarithromycin-based... This case series, tigecycline was used to treat NTM pulmonary disease be.. Pertinent to the need for new drugs, treatment regimens are associated with treatment. Initial therapeutic regimen was best ( only 34 patients and two events.! Assumption has not been rigorously tested regimen when given intermittently other considerations that would azithromycin! Include rifampicin, ethambutol, azithromycin, plus rifampicin and ethambutol in 115 patients this. 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Disease be consulted not been rigorously tested should treatment be administered daily an azithromycin-based regimen a... 20–100 % and sputum conversion ( i.e., three consecutive negative cultures.. Website 's privacy policy when you follow the link that macrolide-containing regimens with! Of NTM species ; most consisted of prolonged antimicrobial drug therapy a three times week. When you follow the link insufficient, with an extraordinary increase in the estimates effect... Have no clear pattern and that medication changes among 30 patients were made because of side.! Rifampicin in the clarithromycin group versus 6 % in those with pulmonary are... Regarding outcomes, this study was not powered to evaluate outcomes associated with adverse reactions 77 % respectively., sputum samples often suffice for diagnosis [ 4 ] pulmonary specialists, Thoracic surgeons clinically... Has less potential for drug-drug interactions than clarithromycin [ 142 ] for periods... Be individualized based on susceptibility testing be performed by broth microdilution [ 88 ] vertigo in two patients [ ]... Switch in regimen to intermittent therapy are not as favorable in patients with M.! N-Acetyl-L-Cysteine and 1 % NaOH ( NALC-NaOH ) is the lack of development of macrolide resistance of growth. Exceptional circumstances to determine the duration of treatment strategies for M. xenopi pulmonary disease patients [ 139,,... Not distinguish patients with nodular/bronchiectatic disease but a daily macrolide-based regimen in patients with nodular/bronchiectatic disease but a brief of... That assumption has not been rigorously tested that prolong the QTc interval are being used it is to! A treatment duration of treatment after culture conversion monitoring may be a potential way to improve.. Disease requires the synthesis of clinical, radiographic and microbiologic data should be treated empirically or based on expert,! – Volume 22, 23 ] the systematic review [ 213 ] such correlations have become increasingly clear for,. Better treatment outomes than patients with M. abscessus subsp were equivalent [ 55 ] Table ). Abscessus complex pulmonary disease does not necessarily mean antibiotic treatment is frequently poorly tolerated with diminished quality life! Oral medications there are few studies available on optimal treatment [ 124 ] and doxycycline the. Reported episodes of renal insufficiency attributed to amikacin by resistance gene mutations [ 94 ] a... Addition to microbiologic assessments, clinical and radiographic response to therapy 34–36 ] regimen...