5 курс / Пульмонология и фтизиатрия / Clinical_Tuberculosis_Friedman_Lloyd_N_,_Dedicoat

risk of developing active TB (sensitivity and specificity of 80%). However, the aforementioned correlates of risk-based tests represent recent significant advances that likely outperform interferongamma release assays, which do not meet minimum diagnostic test characteristic criteria for active TB, are undergoing evaluation in clinical trials.184,267,268

While averting progression to disease from latency is beneficial for individuals affected, the projected epidemiological impact of such an intervention is dependent on the proportion of total TB incidence that is due to reactivation from latency as compared to recent infection and rapid progression or reinfection. This proportion differs between settings and depends on local forces of infection; where the prevalence of disease is high and the risk of infection (and reinfection) is substantial, preventing cases of reactivation disease may not have as marked an impact on TB control as other interventions. However, synergistic effects can be realized when efforts to reduce reactivation are combined with other control efforts that reduce transmission.

Reducing the spread of infection: Why have recent significant advances in diagnostics struggled to show impact?

The End TB Strategy, like its predecessors the DOTS and Stop TB strategies, emphasizes the detection and rapid initiation of effective treatment for individuals with infectious TB. Xpert MTB/ RIF, in terms of sensitivity (60%–80% for smear-negative TB), degree of automation (reduced reliance on scarce skilled personnel), and the simultaneous detection of resistance, has doubtless been a major advance. However, in contrast to what had been projected, multiple randomized-clinical trials showed no impact of Xpert MTB/RIF on long-term patient health (morbidity, mortality), despite significant improvements in rates of bacteriological diagnosis, treatment initiation, and time-to-treatment initiation.269–272 In addition to Xpert MTB/RIF not being a true point of care test (it does not meet the target product profile criteria194), there are additional overarching reasons for this apparent lack of impact that we only partly understand. In many high burden settings, rapid empiric treatment was (and still continues to be) frequent (due to deficiencies in previous microscopybased diagnostic algorithms) and Xpert MTB/RIF’s main effect appeared to be the displacement of true-positive empiric treatment decision making.273 Furthermore, poor linkage to care, which resulted in diagnostic capacity outstripping capacity for effective treatment initiation (including for MDR) undermined Xpert MTB/RIF’s impact.274 In a routine health systems context, national programs also faced challenges with implementation (e.g., training, quality assurance, technical support) and did not have data systems in place to easily assess Xpert MTB/RIF’s effect in this context. This latter aspect represents a major missed opportunity: early adopters of Xpert MTB/RIF like South Africa could be useful—to researchers, other national programs, and policy makers—as massive natural experiments in TB control interventions. However, the type, quality, and accessibility of data is restricted.

Xpert MTB/RIF has recently been succeeded by Xpert MTB/ RIF Ultra, which offers an important incremental (but likely not transformative) improvement.275 The obvious importance of the context in which the test is placed adds considerable complexity to the projection and evaluation of the impact of new tests and underscores how linkage to care must be emphasized. This difficulty in detecting long-term impact has, given patients’ complex and highly varied pathways to care, led to calls that the importance of long-term surrogate endpoints in diagnostic studies is overstated.276

New drug regimens

Epidemiologically, not only are drugs important for reducing morbidity, but they are likely the most rapid way to render a patient non-infectious and thereby directly curtail transmission (provided the strain is susceptible to the regimen). Optimized regimens will also reduce non-adherence driven by side effects, however, regimen efficacy is likely the single most important characteristic of long-term impact on incidence and mortality (e.g., more so than regimen duration).277 Recent drug development and evaluation activity has focused on shorter regimens for both drug-susceptible and drug-resistant TB. For drug-susceptible TB, shorter fluoroquinolone-containing regimens have generated mixed evidence but overall failed to show superiority to the standard six-month regimen. For drug-resistant TB, regimens to improve poor cure rates lead to serious side effect profiles stemming from use of the second-line injectables. The new shortened regimen for drug-resistant TB should help close the MDR diag- nosis-treatment gap and high burden countries need to focus on improving access to effective drugs.

CONCLUSIONS

Overall, our assessment of the current scale and direction of the TB epidemic is a mixed report. The positive news is that the global TB epidemic is declining, but progress has been slow and not shared equally across the world. Incidence and death rates grew during the 1990s, due mainly to the spread of HIV in Africa and to social and economic decline in former Soviet countries, but reached a maximum before 2005.

While the sustained decline in incidence and mortality rates of TB overall is encouraging, these declines must be greatly accelerated to reach the End TB goals.278 Given that such a rapid rate of decline has never been achieved, new perspectives, tools and strategies will be needed to meet this goal, while re-doubling our focus on traditional key priorities for TB control (i.e., early diagnosis and effective treatment). Key to accelerating TB’s decline is embracing the principles of universal health coverage in the context of the Sustainable Development Goals. This requires accepting that modifiable poverty and social economic factors are critical drivers of the TB epidemic that need to be integrated into TB reporting, research, and local context-aware interventions. Broader initiatives that modify population-level risk factors (e.g., nutrition) will also doubtless improve TB control and should be encouraged. Gaps in the TB care cascade—and the requisite

health systems strengthening—remain key priorities and are most acute for drug-resistant TB where the MDR epidemic is unlikely to abate unless many more cases can be correctly diagnosed and effectively treated each year.

Innovative technologies, especially within the diagnostics sphere, continue to arrive and the TB community must be poised to rapidly evaluate these tools and determine the places and strategies in which such technologies can deliver sufficient health benefits to balance costs. The comparative lack of activity in the TB drug pipeline and the absence of a promising late-phase vaccine candidate stand out as major deficiencies (the latter especially as most models suggest that global control targets are unlikely to be met without an improved vaccine). Nevertheless, far better control of the epidemic can be achieved with existing and near-future technologies, including addressing the underlying causes of TB. Epidemiologists must provide the evidence to promote uptake of these tools and strategies and motivate further for the resources needed to help End TB.

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