Suchergebnisse

AbstractIntroductionEmerging long‐acting (LA) prevention and treatment medicines, technologies and regimens could be game‐changing for the HIV response, helping reach the ambitious goal of halting the epidemic by 2030. To attain this goal, the rapid expansion of at‐scale, sustainable, quality‐assured, and affordable supplies of LA HIV prevention and treatment products through accelerated and stronger competition, involving both originator and generic companies, will be essential. To do this, global health stakeholders should take advantage of voluntary licensing of intellectual property (IP) rights, such as through the United Nations‐backed, not‐for‐profit Medicines Patent Pool, as a proven mechanism to support broad access to existing HIV medicines across low‐ and middle‐income countries (LMICs).DiscussionWhile voluntary licensing may unlock the possibility for generic competition to take place ahead of patent expiry, there are additional elements—of amplified importance for more complex LA HIV medicines—that need to be taken into consideration. This paper discusses 10 enablers of voluntary licensing of IP rights as a model to rapidly expand at‐scale, sustainable, quality‐assured, and affordable supplies of LA HIV prevention and treatment regimens in LMICs:
Identifying promising LA technology platforms and drug formulations at an early developmental stage and engaging with patent holders
Consolidating a multidisciplinary network and strengthening early‐stage coordination and collaboration to foster innovation
Embedding public health considerations in product design and delivery
Building innovative partnerships for product development and commercialization
Raising awareness of and creating demand for emerging LA products
Estimating the market size, ensuring sufficient competition and protecting sustainability
Using technology transfer and hands‐on technical support to reduce product development timelines and costs
Exploring de‐risking mechanisms and financial incentives to support generic manufacturers
Optimizing strategies for generic product development and regulatory filings
Aligning and coordinating efforts of stakeholders across the value chain.
ConclusionsRapid access to emerging LA prevention and treatment regimens and technologies can be facilitated by voluntary licensing—catalyzed and supplemented by enabling collaborative and non‐duplicative efforts of various other stakeholders. This can effectively lead to improved—accelerated and cheaper—access to quality‐assured medicines for populations in LMICs.

AbstractIntroduction: Globally, there is a considerable burden of HCV and HIV infections among people who inject drugs (PWID) and transmission of both infections continues. Needle and syringe programme (NSP) and opioid substitution therapy (OST) coverage remains low, despite evidence demonstrating their prevention benefit. Direct‐acting antiviral therapies (DAA) with HCV cure >95% among PWID provide an opportunity to reverse rising trends in HCV‐related morbidity and mortality and reduce incidence. However, HCV testing, linkage to care, and treatment remain low due to health system, provider, societal, and patient barriers. Between 2015 and 2030, WHO targets include reducing new HCV infections by 80% and HCV deaths by 65%, and increasing HCV diagnoses from <5% to 90% and number of eligible persons receiving HCV treatment from <1% to 80%. This commentary discusses why PWID should be considered as a priority population in these efforts, reasons why this goal could be attainable among PWID, challenges that need to be overcome, and key recommendations for action.Discussion: Challenges to HCV elimination as a global health concern among PWID include poor global coverage of harm reduction services, restrictive drug policies and criminalization of drug use, poor access to health services, low HCV testing, linkage to care and treatment, restrictions for accessing DAA therapy, and the lack of national strategies and government investment to support WHO elimination goals. Key recommendations for action include reforming drug policies (decriminalization of drug use and/or possession, or providing alternatives to imprisonment for PWID; decriminalization of the use and provision of sterile needles‐syringes; and legalization of OST for people who are opioid dependent), scaling up and improving funding for harm reduction services, making health services accessible for PWID, supporting community empowerment and community‐based programmes, improving access to affordable diagnostics and medicines, and eliminating stigma, discrimination, and violence against PWID.Conclusions: The ambitious targets for HCV elimination set by WHO are achievable in many countries, but will require researchers, healthcare providers, policy makers, affected communities, advocates, the pharmaceutical and diagnostics industries, and governments around the world to work together to make this happen.

AbstractIntroductionWorldwide, 71 million people are infected with hepatitis C virus (HCV), which, without treatment, can lead to liver failure or hepatocellular carcinoma. HCV co‐infection increases liver‐ and AIDS‐related morbidity and mortality among HIV‐positive people, despite ART. A 12‐week course of HCV direct‐acting antivirals (DAAs) usually cures HCV – regardless of HIV status. However, patents and high prices have created access barriers for people living with HCV, especially people who inject drugs (PWID). Inadequate access to and coverage of harm reduction interventions feed the co‐epidemics of HIV and HCV; as a result, the highest prevalence of HCV is found among PWID, who face additional obstacles to treatment (including stigma, discrimination and other structural barriers). The HIV epidemic occurred during globalization of intellectual property rights, and highlighted the relationship between patents and the high prices that prevent access to medicines. Indian generic manufacturers produced affordable generic HIV treatment, enabling global scale‐up. Unlike HIV, donors have yet to step forward to fund HCV programmes, although DAAs can be mass‐produced at a low and sustainable cost. Unfortunately, although voluntary licensing agreements between originators and generic manufacturers enable low‐income (and some lower‐middle income countries) to buy generic versions of HIV and HCV medicines, most middle‐income countries with large burdens of HCV infection and HIV/HCV co‐infection are excluded from these agreements. Our commentary presents tactics from the HIV experience that treatment advocates can use to expand access to DAAs.DiscussionA number of practical actions can help increase access to DAAs, including new research and development (R&D) paradigms; compassionate use, named‐patient and early access programmes; use of TRIPS flexibilities such as compulsory licences and patent oppositions; and parallel importation via buyers' clubs. Together, these approaches can increase access to antiviral therapy for people living with HIV and viral hepatitis in low‐, middle‐ and high‐income settings.ConclusionsThe HIV example provides helpful parallels for addressing challenges to expanding access to HCV DAAs. HCV treatment access – and harm reduction – should be massively scaled‐up to meet the needs of PWID, and efforts should be made to tackle stigma and discrimination, and stop criminalization of drug use and possession.

AbstractIntroductionDespite the coordinated efforts by several stakeholders to speed up access to HIV treatment for children, development of optimal paediatric formulations still lags 8 to 10 years behind that of adults, due mainly to lack of market incentives and technical complexities in manufacturing. The small and fragmented paediatric market also hinders launch and uptake of new formulations. Moreover, the problems affecting HIV similarly affect other disease areas where development and introduction of optimal paediatric formulations is even slower. Therefore, accelerating processes for developing and commercializing optimal paediatric drug formulations for HIV and other disease areas is urgently needed.DiscussionThe Global Accelerator for Paediatric Formulations (GAP‐f) is an innovative collaborative model that will accelerate availability of optimized treatment options for infectious diseases, such as HIV, tuberculosis and viral hepatitis, affecting children in low‐ and middle‐income countries (LMICs). It builds on the HIV experience and existing efforts in paediatric drug development, formalizing collaboration between normative bodies, research networks, regulatory agencies, industry, supply and procurement organizations and funding bodies. Upstream, the GAP‐f will coordinate technical support to companies to design and study optimal paediatric formulations, harmonize efforts with regulators and incentivize manufacturers to conduct formulation development. Downstream, the GAP‐f will reinforce coordinated procurement and communication with suppliers. The GAP‐f will be implemented in a three‐stage process: (1) development of a strategic framework and promotion of key regulatory efficiencies; (2) testing of feasibility and results, building on the work of existing platforms such as the Paediatric HIV Treatment Initiative (PHTI) including innovative approaches to incentivize generic development and (3) launch as a fully functioning structure.ConclusionsGAP‐f is a key partnership example enhancing North‐South and international cooperation on and access to science and technology and capacity building, responding to Sustainable Development Goal (SDG) 17.6 (technology) and 17.9. (capacity‐building). By promoting access to the most needed paediatric formulations for HIV and high‐burden infectious diseases in low‐and middle‐income countries, GAP‐f will support achievement of SDG 3.2 (infant mortality), 3.3 (end of AIDS and combat other communicable diseases) and 3.8 (access to essential medicines), and be an essential component of meeting the global Start Free, Stay Free, AIDS Free super‐fast‐track targets.