Summary
The year 2023 marked the 25th anniversary of the first detected outbreak of Nipah virus disease. Despite Nipah virus being a priority pathogen in the WHO Research and Development blueprint, the disease it causes still carries high mortality, unchanged since the first reported outbreaks. Although candidate vaccines for Nipah virus disease exist, developing new therapeutics has been underinvested. Nipah virus disease illustrates the typical market failure of medicine development for a high-consequence pathogen. The unpredictability of outbreaks and low number of infections affecting populations in low-income countries does not make an attractive business case for developing treatments for Nipah virus disease—a situation compounded by methodological challenges in clinical trial design. Nipah virus therapeutics development is not motivated by commercial interest. Therefore, we propose a regionally led, patient-centred, and public health-centred, end-to-end framework that articulates a public health vision and a roadmap for research, development, manufacturing, and access towards the goal of improving patient outcomes. This framework includes co-creating a regulatory-compliant, clinically meaningful, and context-specific clinical development plan and establishing quality standards in clinical care and research capabilities at sites where the disease occurs. The success of this approach will be measured by the availability and accessibility of improved Nipah virus treatments in affected communities and reduced mortality.
Introduction
The increase in mpox (formerly known as monkeypox) cases in west Africa in 2017 should have served as a warning sign for potential outbreaks elsewhere. However, it was not until the multicountry outbreak in 2022, when WHO declared a public health emergency of international concern, that the disease received substantial global attention.
This mpox outbreak highlighted two issues in global health that must be addressed: high-consequence infectious diseases receive attention only when they affect high-income countries; and even when interventions are available, they might not reach those who need them most,
,
but are instead stockpiled and reserved for use in high-income countries, as observed during Ebola virus disease
and the COVID-19 pandemic.
We must avoid repeating the same pattern with Nipah virus disease. Recurrent outbreaks in economically disadvantaged rural communities in south and southeast Asia have resulted in few attempts to understand and mitigate the disease. We should not wait until an extensive outbreak affects high-income countries before acting towards developing better treatment options and deploying them when and where they are needed.
Nipah virus is a highly lethal zoonotic paramyxovirus, which can infect humans through contact with infected bats, pigs, or humans or by consuming contaminated raw date palm sap.
,
The virus causes a rapidly progressive illness that affects the respiratory system and CNS, causing respiratory distress and encephalitis, with a very high case-fatality ratio. Since its discovery in 1998 and 1999 in Malaysia and Singapore, respectively, Nipah virus has caused sporadic outbreaks in Bangladesh, India, and the Philippines. Concerns exist about future outbreaks in other regions where Pteropus fruit bats, the zoonotic reservoir of Nipah virus, are found (table 1). The wide geographical distribution of these bats across Africa, south Asia, and Oceania, combined with the virus’ capacity for person-to-person transmission and evidence of ongoing viral evolution, underscores the potential for larger epidemics.
,
,
,
Table 1Reported NiVcases by country in years 1998–2023
| Nipah virus strain | Primary source of infection | Predominant clinical presentation | Cases | Deaths | Case fatality ratio (%) | Reporting year | ||
|---|---|---|---|---|---|---|---|---|
| Malaysia | ||||||||
| Lam and Chua (2002)7 | NiV-M | Contact with sick pigs | Acute encephalitis | 265 | 105 | 40 | 1999 | |
| Singapore | ||||||||
| Paton et al (1999)8 | NiV-M | Contact with sick pigs | Acute encephalitis | 11 | 1 | 9 | 1999 | |
| India | ||||||||
| Chadha et al (2006)9 | NiV-B | Unknown | Acute encephalitis | 66 | 45 | 68 | 2001 | |
| Arankalle et al (2011)10 | NiV-B | Unknown | Acute encephalitis | 5 | 5 | 100 | 2007 | |
| Chandni et al (2020)11 | NiV* | Contact with bats or consumption of fruit contaminated by a bat | Acute encephalitis | 18 | 16 | 89 | 2018 | |
| Sahay et al (2020)12 | NiV* | As above | Acute encephalitis | 1 | 0 | 0 | 2019 | |
| Yadav et al (2022)13 | NiV* | As above | Acute encephalitis | 1 | 1 | 100 | 2021 | |
| ProMED (2023)14 | NiV* | As above | Acute encephalitis | 6 | 2 | 33 | 2023 | |
| Bangladesh | ||||||||
| IEDCR (2023)15 | NiV-B | Unknown | Acute encephalitis | 13 | 9 | 69 | 2001 | |
| IEDCR (2023)15 | NiV-B | Unknown | Acute encephalitis | 12 | 8 | 67 | 2003 | |
| IEDCR (2023)15 | NiV-B | Consumption of date palm sap or fruit contaminated by a bat or contact with bats | Acute encephalitis | 67 | 50 | 75 | 2004 | |
| IEDCR (2023)15 | NiV-B | As above | Acute encephalitis | 12 | 11 | 92 | 2005 | |
| IEDCR (2023)15 | NiV-B | As above | Acute encephalitis | 18 | 9 | 50 | 2007 | |
| IEDCR (2023)15 | NiV-B | As above | Acute encephalitis | 11 | 7 | 64 | 2008 | |
| IEDCR (2023)15 | NiV-B | As above | Acute encephalitis | 4 | 1 | 25 | 2009 | |
| IEDCR (2023)15 | NiV-B | As above | Acute encephalitis | 18 | 16 | 89 | 2010 | |
| IEDCR (2023)15 | NiV-B | As above | Acute encephalitis | 43 | 37 | 86 | 2011 | |
| IEDCR (2023)15 | NiV-B | As above | Acute encephalitis | 17 | 12 | 71 | 2012 | |
| IEDCR (2023)15 | NiV-B | As above | Acute encephalitis | 31 | 25 | 81 | 2013 | |
| IEDCR (2023)15 | NiV-B | As above | Acute encephalitis | 37 | 16 | 43 | 2014 | |
| IEDCR (2023)15 | NiV-B | As above | Acute encephalitis | 15 | 11 | 73 | 2015 | |
| IEDCR (2023)15 | NiV-B | As above | Acute encephalitis | 3 | 2 | 67 | 2017 | |
| IEDCR (2023)15 | NiV-B | As above | Acute encephalitis | 4 | 2 | 50 | 2018 | |
| IEDCR (2023)15 | NiV-B | As above | Acute encephalitis | 8 | 7 | 88 | 2019 | |
| IEDCR (2023)15 | NiV-B | As above | Acute encephalitis | 7 | 5 | 71 | 2020 | |
| IEDCR (2023)15 | NiV-B | As above | Acute encephalitis | 2 | 0 | 0 | 2021 | |
| IEDCR (2023)15 | NiV-B | As above | Acute encephalitis | 3 | 2 | 67 | 2022 | |
| IEDCR (2023)15 | NiV-B | As above | Acute encephalitis | 14 | 10 | 71 | 2023 | |
| Philippines | ||||||||
| Ching et al (2014)16 | NiV-M | Contact with horse or contaminated meat consumption | Acute encephalitis | 17 | 9 | 53 | 2014 | |
| Total | .. | .. | .. | 729 | 424 | 58 | .. | |
IEDCR=Institute of Epidemiology Disease Control And Research. NiV=Nipah virus. NiV-B=Nipah virus Bangladesh. NiV-M=Nipah virus Malaysia.
* NiV=Nipah virus Indian isolate.
In 2018, WHO listed Nipah virus as a priority pathogen for urgent research and development and produced a roadmap to address the research needs for Nipah virus, including developing diagnostics, therapeutics, and vaccines.
,
Encouragingly, the Coalition for Epidemic Preparedness Innovations, primarily funded by public and philanthropic organisations, with some contributions from the private sector, has invested in the development of multiple vaccine candidates for Nipah virus. Notable progress has been made, with at least two candidates having reached in-human (phase 1) clinical trials.
In contrast, investment and progress in therapeutics development is less advanced; there are no approved therapies available for Nipah virus disease.
Clinical outcomes in patients with Nipah virus disease
Nipah virus mortality varies widely, from 9% in Singapore (the only high-income country reporting Nipah virus cases), to 100% in some transmission clusters,
,
and has remained essentially unchanged from the initial outbreaks in Malaysia (40%), Bangladesh (70%), and India (68%; table 1).
,
The reasons for the differences in mortality rates between countries, which require further investigation, are presumably multifaceted and might include variations in the infecting Nipah virus strains (Nipah virus Malaysia vs Nipah virus Bangladesh),
,
route of infection (respiratory vs gastrointestinal),
,
patient characteristics, and access to adequate supportive care. In 2023, Bangladesh had the largest Nipah virus outbreak since 2015, with a case-fatality ratio of 71% with ten (71%) deaths out of 14 reported cases.
Furthermore, a new outbreak in Kozhikode district (Kerala, India) in 2023, had six confirmed infections including two fatalities.
The continued high mortality is possibly a result of several factors, including delays in diagnosis, absence of specific therapies, and poorly effective supportive care.
The absence of laboratory infrastructure and diagnostic capabilities in rural areas where Nipah virus outbreaks occur creates challenges in early diagnosis, thereby impeding timely treatment.
Additionally, the non-specific initial signs and symptoms of Nipah virus infection, combined with the absence of point-of-care rapid diagnostic tests, often lead to delays in diagnosis in endemic areas, where many patients present with encephalitis of various causes. Distinguishing Nipah virus infection, representing only about 3% of all encephalitis cases in Bangladesh, from other causes of encephalitis is, therefore, challenging.
,
,
The clinical management of patients with encephalitis, including those whose illness is caused by Nipah virus, is primarily supportive.
Treatment involves administration of oxygen, fluids, and nutritional support, and resuscitation as needed, alongside symptomatic treatment, including the use of antipyretics, anticonvulsants, medication for raised intracranial pressure, hypoglycaemia, and shock. Empirical treatment is typically initiated with antibiotics (intravenous ceftriaxone), antivirals (intravenous aciclovir), and steroids.
Patients with worsening conditions, such as deteriorating levels of consciousness, uncontrolled seizures, haemodynamic instability, and multiorgan failure are assessed for transfer to an intensive care unit or tertiary centre.
Improving patient outcomes in ongoing Nipah virus outbreaks remains a major challenge because there is no standardised supportive care available to patients in endemic areas, including timely access to intensive care units. Advancing knowledge to guide clinical care and improve outcomes for isolated Nipah virus infections and small clusters will be good preparation for a potential larger epidemic in the future.
Why is there so little progress in improving patient outcomes?
There are several key barriers to identifying and evaluating therapeutic interventions for Nipah virus disease.
Epidemiological challenges
Nipah virus disease is characterised by low prevalence even in endemic areas, with sporadic cases and unpredictable outbreaks in terms of location, size, and timing.
These characteristics present enormous methodological and operational challenges for clinical trials. Bangladesh, where the epidemiology of Nipah virus is well understood, and which has had the highest number of reported outbreaks, is a suitable site for potential Nipah virus therapeutic trials.
However, even in Bangladesh, Nipah virus infections remain infrequent and geographically dispersed, with an average of 14 confirmed cases reported each year.
The current epidemiological conditions make doing traditional phase 3 efficacy trials impossible.
Operational challenges
Nipah virus disease outbreaks occur in areas with little research infrastructure and clinical research capacity, leading to poor understanding of the clinical characteristics and outcomes of the disease and hindering the implementation of effective clinical trials. In addition, the shortage of laboratory and clinical infrastructure in rural communities in Bangladesh and India creates challenges for timely diagnosis and enrolment into research studies.
Moreover, the absence of biosafety level 4 facilities in Bangladesh to manage the high-level biocontainment requirements for handling Nipah virus, impedes locally led research on disease pathogenesis and the in-vitro and in-vivo evaluation of therapeutics.
In Bangladesh, where Nipah virus is endemic, surveillance of Nipah virus disease relies on a central laboratory located in the capital city, Dhaka. As a result, confirming a diagnosis can take several days or weeks.
Therefore, the development of rapid, ideally point-of-care, diagnostic tests and improved laboratory infrastructure and diagnostic capabilities is key for the accurate diagnosis and timely treatment of patients and prevention of disease spread.
Market and policy challenges
Apart from one inconclusive open-label trial with ribavirin during the Malaysian outbreak and a phase 1 study with the monoclonal antibody m102.4 done in healthy volunteers in Australia, no other human clinical trials have been done for any potential Nipah virus therapeutic candidates.
,
Little progress in therapeutic development reflects both a market failure and a global health policy failure. The small number of Nipah virus infections in countries unable to provide the substantial financial resources required to invest in the research and development process or to pay for stockpiling therapeutics, means that there is no financial incentive for profit-driven private sector investments. Equally, there have been few public investments made both at the local level and globally to support the discovery and development of new therapeutics and attract private sector actors into the types of public–private partnerships that have pushed drugs through the research and development pipeline in other disease areas, ideally creating affordable products and a sustainable local market.
Way forward
There are potential therapeutic candidates for henipaviruses, including Nipah virus, currently progressing through the research and development pipeline, including at least eight small molecules and four monoclonal antibodies, which are mainly in the preclinical stage (table 2).
Only the monoclonal antibody m102.4 has phase 1 data available, and both m102.4 and ribavirin have been used on a compassionate basis during outbreaks.
To effectively evaluate potential interventions for improving patient outcomes in light of the aforementioned challenges, a coordinated, public health-focused approach must be adopted that maximises the chance of identifying and progressing the best therapeutic options in a timely way, that emphasises fairness, transparency, and equitable access to interventions for Nipah virus-affected communities.
,
Table 2Development status of small molecule and monoclonal antibody candidates against Nipah virus
| Current regulatory status or development stage | Reference of preclinical studies against Nipah virus | ||
|---|---|---|---|
| Ribavirin | Approved for hepatis C virus and respiratory syncytial virus in several countries | Chong et al (2001)40 | |
| Remdesivir | Approved for COVID-19 by the US FDA. Emergency use authorisation for COVID-19 in Australia, Bangladesh, India, Singapore, Japan, Taiwan, and the EU | Lo et al (2019) 41 | |
| Favipiravir | Approved for influenza A in Japan, and for COVID-19 in several countries. Emergency use authorisation for COVID-19 in India | Dawes el at (2018)42 | |
| Chloroquine | Approved for malaria in several countries | Pallister et al (2009)43 | |
| Heparin | Approved for coagulopathies in several countries; experimental: preclinical (study on Syrian golden hamster) | Mathieu el al (2015)44 | |
| Rintatolimod | Approved for chronic fatigue syndrome in Argentina; experimental (phase 1 and phase 2 trials) for HIV and chronic fatigue syndrome | Georges-Courbot et al (2006)45 | |
| Griffithsin | Experimental: phase 1 trials for HIV | Lo et al (2020)46 | |
| VIKI-dPEG4-Toco and VIKI-PEG4-chol | Experimental: preclinical | Mathieu et al (2018)47 | |
| Gliotoxin | Experimental: exploratory | Aljofan et al (2009)48 | |
| Bortezomib | Approved for multiple myeloma and mantle cell lymphoma by the US FDA | Wang et al (2010)49 | |
| Balapiravir R1479 | Experimental, discontinued in phase 1 trials for dengue virus and hepatitis C virus | Hotard et al (2017)50 | |
| Lumicitabine and ALS-8112 | Experimental: phase 1 and phase 2 trials for respiratory syncytial virus | Lo et al (2020)51 | |
| CH25H | Experimental: exploratory | Liu et al (2013)52 | |
| KIN1408 | Experimental: exploratory | Pattabhi et al (2015)53 | |
| AB00991123, AB00992391, and AB00993210 | Experimental: exploratory | Tigabu et al (2014)54 | |
| mAb | |||
| mAb m102.4 | Phase 1 | Playford et al (2020)37 | |
| mAb 5B3 and mAb h5B3.1 | Preclinical | Dang et al (2019)55 and Mire at al (2020)56 | |
| mAb HENV-26 and mAb HENV-32 | Preclinical | Dong et al (2020)57 | |
| Anti-G mAb (Nip GIP 1.7 and Nip 3B10) and anti-F mAb (Nip GIP 35 and Nip GIP 3) | Preclinical | Guillaume et al (2006)58 | |
mAb=monoclonal antibodies. US FDA=US Food and Drug Administration. Adapted from Roman and colleagues.
We propose a model, similar to the West Africa Lassa fever Consortium, to generate essential elements of a pathway to develop and make available new treatments to people in need.
This model includes: laying out a clinical development plan that is regulatory-compliant, clinically meaningful, and context-specific; strengthening research sites’ capacity to meet regulatory quality standards (good clinical practices and good clinical laboratory practices); and ensuring good participatory practice for trials.
Moreover, the model recognises the need for involving key stakeholders both in Nipah virus-endemic countries and internationally, and establishing an end-to-end partnership and financing structure, in which all actors commit to the collective end goal of equitable access to effective treatments. The key aspects of this plan are summarised in the following sections.
Enhanced clinical epidemiology
A key clinical difference between Nipah virus outbreaks is that despite a consistently high proportion of patients presenting with encephalitis (about 97%), in Malaysia, fewer people had concomitant respiratory symptoms (14–29%),
compared with Bangladesh (62–69%)
and India (51%),
where Nipah virus sometimes leads to acute respiratory distress syndrome.
Two (18%) of 11 patients in the Malaysian outbreak among abattoir workers in Singapore presented with pneumonia without encephalitis.
Similarly, in the current Kerala outbreak in India, patients also had pulmonary presentation alongside encephalitis presentation.
The variation in pulmonary involvement is possibly caused by differences in Nipah virus strains and the route of infection. Experimental evidence indicates that the Nipah virus-B strain replicates more efficiently in human tracheal and bronchial epithelium than the Nipah virus-M stain.
,
Whether early ribavirin treatment during the Malaysian outbreak might have had a role in controlling virus replication in the lung, thus accounting for lower mortality, is unclear.
,
To gain a comprehensive understanding of the clinical characteristics and natural history of Nipah virus disease, including both encephalitis and pulmonary presentations, prospective observational clinical research is essential. This research can form the foundation for developing standardised clinical trial methodologies.
Such enhanced clinical epidemiology studies should also document current clinical care practices to identify gaps and inform the development of context-specific standard-of-care guidelines. During the Malaysian outbreak in 1998–99, ten (91%) of 11 patients cared for in a Singapore hospital survived,
suggesting that improving elements of supportive care can greatly improve patient outcomes.
Defining use cases and target product profile (TPP) for Nipah virus therapeutics
Developing safe and effective therapeutic agents to treat acute Nipah virus disease and acceptance of these agents by clinicians and patients is crucial for improving survival rates and reducing Nipah virus-associated morbidity and long-term disability. However, to design and select therapeutics that meet these objectives, we need to define use cases and a clear criterion for down-selection and prioritisation of candidate products for clinical trials.
Defining use cases of potential therapeutic options (figure) is essential to support the development of the TPP that serves as a guide for drug developers and other actors in the clinical development pathway, indicating the necessary and suitable characteristics for future therapeutic candidates after consultation with key stakeholders and end users.
The methodology for developing a TPP for Nipah virus disease should adhere to WHO principles, encompassing a major public-health need, considering end users’ perspectives, promoting access and equity, and fostering consensus among stakeholders for ethical research and drug development.
The TPP development process should also incorporate an end-to-end perspective connecting product development and regulatory, policy, and financing considerations.
This process should involve relevant stakeholders from national and international regulatory agencies, ethics boards, ministries of health, and clinicians experienced in treating Nipah virus disease. The needs and preferences of end users, clinicians, and survivors should also be incorporated into the TPP development process to define ideal treatment characteristics.
Developing rapid point-of-care diagnostics
Rapid diagnostic capability, including point-of-care testing, is needed for early case detection and optimal deployment strategies for diagnostics in different geographical areas. Local laboratories must be able to do proficiency testing to monitor the reproducibility and performance of diagnostic field assays. National laboratory strategies for Nipah virus diagnosis and detection in the countries most affected by the virus should also be established.
Clinical trial design
To progress effectively, we need therapeutic candidates to advance through preclinical research, early human safety testing, and manufacturing, so that they can be tested clinically. Clinical trial protocols are also essential to ensure a coordinated and standardised assessment of the candidate drugs’ clinical safety and efficacy.
Pharmacometric trial
Repurposing existing marketed compounds for treating Nipah virus disease is a potential alternative or complement to developing new drugs, as this strategy capitalises on the existing compounds’ established safety profiles and reduces costs and time. Similar approaches were successfully used for COVID-19.
Pharmacometric modelling and simulation can be used to model in-vitro activity of potential repurposed therapeutic candidates targeting Nipah virus disease to evaluate the likelihood of clinically significant antiviral activity in vivo.
With potential preclinical data in animal models for Nipah virus therapeutic candidates (eg, remdesivir and favipiravir), pharmacometric evaluation of Nipah virus clearance rate from serial oral swabs quantitative PCR viral density estimates might offer a cost-effective and time-efficient method to prioritise potential candidates for further evaluation in clinical trials.
,
,
Core outcome sets, data variables, and phase 2/3 trial protocol
To establish a basis for the development of clinical trial methods, a core set of data variables and outcome measures should be developed and incorporated into trial protocols.
Consultation and consensus with stakeholders, such as clinicians, statisticians, clinical researchers, patients and public health representatives, regulators, and ethics boards are crucial to obtain their views on the trial design. The goal should be to use tools that are freely and publicly available, and ready ahead of time to be implemented in phase 2/3 therapeutic trials for Nipah virus disease. Although containing a recommendation for a core method, the tools should allow for context-specific adaptation and use by any member of the Nipah virus research community.
Given the challenges of phase 3 Nipah virus-specific trials in the current epidemiological conditions, a patient-centred syndromic approach appears to be pragmatic. By concentrating on encephalitis, the primary and predominant clinical presentation of Nipah virus disease patients (97% in India, 90% in Bangladesh, 88% in Singapore, 64% in the Philippines, and 55% in Malaysia), and doing trials to assess therapeutic approaches for all-cause encephalitis in endemic regions, we could substantially improve the management and clinical outcomes of encephalitis at large (figure). Previous encephalitis treatment trials, although low in number, have not succeeded in improving clinical outcomes. This two-pronged approach integrating Nipah virus-specific interventions into a broader syndromic strategy does not only address encephalitis in a patient-centred manner, but also provides a practical solution for dealing with low Nipah virus caseloads and builds clinical research capabilities that could respond to a change in epidemiology.
,
,
Creating a clinical trial platform that evaluates therapeutics to treat all-cause encephalitis, complete with a network of strategically positioned sites that have enhanced capacity, capability, and essential infrastructure required for trials, would be essential to empower local actors to assess clinically the candidate treatments selected. Given the low number of patients and available sites where trials can be done, the trials should adopt a portfolio approach, in which multiple drug candidates can be prioritised and evaluated under a single protocol.
An adaptive design should be used to allow inclusion of new drugs as they become available, either sequentially or simultaneously, and to drop that fail to meet efficacy and safety criteria and are not accepted by the patient community.
Capacity strengthening plan for clinical trials in endemic countries
To ensure effective clinical trials for Nipah virus disease, adequate research, clinical care, and diagnostic capabilities at participating sites are essential. The trial capacity assesment would involve mapping out potential study sites and assessing their capacity, including facilities, equipment, human resources, research infrastructure, and background information on Nipah virus disease case management. Capacity gaps should be identified, and capacity strengthening requirements should be defined to assess individual, organisational, and environmental capacity needs, along with the required investments to upgrade. These assessments should be done using standardised methods.
Investments should be made to boost sustainable research capacity across the Nipah virus research landscape, including training of clinicians and researchers, development of data platforms for observational and multicounty research, outreach, education, and enhancing capacity for data sharing and analysis. Meeting good clinical practice, good laboratory practice, and good participatory practice for trials will be a prerequisite for research centres to participate in these trials.
Community outreach and engagement
Understanding the expectations of the Nipah virus-affected communities and involving their members in the research is essential for successful and impactful research. Furthermore, as research interventions aim to improve the outcomes of people affected by Nipah virus, patients and Nipah virus survivors should be involved in the decision-making processes, the results of which will ultimately affect them and future patients. Examples of this engagement could include community involvement in the TPP development process of new therapeutics, where factors such as acceptable drug administration and side-effects can be advised from a community standpoint.
These engagement initiatives will also lead to a greater chance of acceptance and implementation of any potential therapeutic interventions. However, social and behavioural barriers might also affect the implementation of interventions through preventing patients from accessing health care. Nipah virus-related stigma is one such barrier. Tools are being developed in collaboration with the International Centre for Diarrhoeal Disease Research, Bangladesh to measure the types and extent of stigmatisation associated with Nipah virus disease to reduce this issue.
The International Centre for Diarrhoeal Disease Research in Bangladesh in collaboration with the Institute of Epidemiology Disease Control and Research, the Ministry of Health and Family Welfare, and Government of the People’s Republic of Bangladesh, has developed a Nipah virus survivor support programme. This programme involves following up a cohort of Nipah virus survivors to monitor the long-term consequences of Nipah virus disease. By involving these survivors in research design and gaining insights into their lived experiences, valuable information can be gathered to inform strategies aimed at helping communities access the health care they need while promoting the uptake of potential treatments.
Developing a viable value proposition and ensuring access to potential therapeutics
To effectively respond to the urgent public health needs for Nipah virus therapeutics, a comprehensive approach is required that includes securing funding from multiple sources, advocacy to policy makers and global stakeholders, and the development of a clinical trial platform embedded in the local health system that serves as the central asset around which value is created.
,
The value proposition should be informed by a robust assessment of the risk of future Nipah virus outbreaks and the economic, societal, and health effects that such outbreaks could generate. A partnership between drug developers and the trial sites platform should be defined upfront to serve public health goals, leveraging different capabilities and financing opportunities towards ultimate availability and access to potential Nipah virus treatment. Having pre-established agreements in place for drug availability and pricing will avoid repeating the inequalities seen in cases, such as Ebola virus disease and COVID-19.
Conclusions
Ebola virus disease, COVID-19, and mpox epidemics have underscored the importance of a coordinated, public health-centred, and end-to-end research and development ecosystem that can deliver appropriate countermeasures to address outbreaks where and when they occur.
This approach will help to ensure equitable access to adequate health care for neglected populations, and to prevent onward wider transmission and spillover.
In addressing the challenges posed by Nipah virus, a coordinated public health approach is essential to prioritise fairness, transparency, and equitable access to interventions for Nipah virus-affected communities. The clinical development plan for Nipah virus therapeutics should be co-developed with the leadership and ownership of the Nipah virus-endemic country. Collaboration among researchers and institutions within affected nations should empower local communities and ensure they are the primary beneficiaries of research outcomes when needed. To address concerns about equitable access to potential interventions in Nipah virus-endemic countries, especially where trials are done, post-trial access and benefit-sharing commitments must be integrated into trial protocols, financing contracts, and collaboration agreements upheld by local authorities and ethics committees. International research institutions and funding bodies must design funding mechanisms with clear conditionalities that prioritise the development of suitable treatment and enable their availability and equitable access.
ARYAN'S BLOG 
00707-7&id=gr1.jpg){kind=link}