Caitlin Reed and colleagues' description of a severe case of extensively drug-resistant tuberculosis emphasises the emerging issue of access to newly developed second-line drugs for difficult-to-treat or even untreatable tuberculosis cases1 and 2 from the perspective of both affected patients and health-care providers. As the authors correctly point out, the potential benefits of accessing effective treatment go beyond the individual, and extend to public health because of the risk of transmission of a potentially lethal strain. Our understanding is that the reason for denial of delamanid to a patient already treated with bedaquiline was based on existing policies on the rational use of new drugs.3 and 4 Recent WHO guidance stated that there are no data on the simultaneous use of bedaquiline and delamanid in the same patient and that until such data become available, no recommendation on their joint administration is possible. However, the policy guidance, although accounting for the potential additive cardiac toxic effects, and aimed at minimising harms to those treated within a public health perspective, did not forbid the combined use of the two drugs in individual cases. We recall that when a similar discussion took place about allowing procurement of second-line antituberculosis drugs at discounted prices via the Green Light Committee in the context of the risk of increasing the prevalence of drug resistance, important organisations were against it. Once again, we need to balance the patient's right to access a new, potentially life-saving drug against the risk of unknown, potentially life-threatening, adverse events, which might severely affect its future use. Similar cases,2 although sporadic, will probably appear again in the future. In our opinion, since the rational use of new drugs (aimed at protecting both the patient and the drug) is an internationally agreed milestone, the simultaneous use of delamanid and bedaquiline might be considered if several conditions are met: an effective treatment cannot be designed by using only one new drug in addition to the optimised background regimen, the clinical centre is qualified, informed consent and pharmacovigilance are in place, and new drug use is supported by expert opinion
Compassionate and optimum use of new tuberculosis drugs
MATTEELLI, Alberto;
2015-01-01
Abstract
Caitlin Reed and colleagues' description of a severe case of extensively drug-resistant tuberculosis emphasises the emerging issue of access to newly developed second-line drugs for difficult-to-treat or even untreatable tuberculosis cases1 and 2 from the perspective of both affected patients and health-care providers. As the authors correctly point out, the potential benefits of accessing effective treatment go beyond the individual, and extend to public health because of the risk of transmission of a potentially lethal strain. Our understanding is that the reason for denial of delamanid to a patient already treated with bedaquiline was based on existing policies on the rational use of new drugs.3 and 4 Recent WHO guidance stated that there are no data on the simultaneous use of bedaquiline and delamanid in the same patient and that until such data become available, no recommendation on their joint administration is possible. However, the policy guidance, although accounting for the potential additive cardiac toxic effects, and aimed at minimising harms to those treated within a public health perspective, did not forbid the combined use of the two drugs in individual cases. We recall that when a similar discussion took place about allowing procurement of second-line antituberculosis drugs at discounted prices via the Green Light Committee in the context of the risk of increasing the prevalence of drug resistance, important organisations were against it. Once again, we need to balance the patient's right to access a new, potentially life-saving drug against the risk of unknown, potentially life-threatening, adverse events, which might severely affect its future use. Similar cases,2 although sporadic, will probably appear again in the future. In our opinion, since the rational use of new drugs (aimed at protecting both the patient and the drug) is an internationally agreed milestone, the simultaneous use of delamanid and bedaquiline might be considered if several conditions are met: an effective treatment cannot be designed by using only one new drug in addition to the optimised background regimen, the clinical centre is qualified, informed consent and pharmacovigilance are in place, and new drug use is supported by expert opinionI documenti in IRIS sono protetti da copyright e tutti i diritti sono riservati, salvo diversa indicazione.
