A Solicitation of the National Institutes of Health (NIH) and The Centers for Disease Control and Prevention (CDC) for Small Business Innovation Research (SBIR) Contract Proposals

Active
No
Status
Closed
Release Date
August 25th, 2023
Open Date
August 25th, 2023
Due Date(s)
November 14th, 2023
Close Date
November 14th, 2023
Topic No.
NIH/NIAID 125

Topic

Development of Long-Acting Treatments for HCV Cure

Agency

Department of Health and Human ServicesNational Institutes of Health

Program

Type: SBIRPhase: BOTHYear: 2023

Summary

The Department of Health and Human Services, specifically the National Institutes of Health (NIH) and The Centers for Disease Control and Prevention (CDC), are seeking proposals for the development of long-acting treatments for HCV cure. The goal is to address the global issue of chronic hepatitis C virus (HCV) infection, which affects an estimated 58 million people worldwide. The solicitation aims to support research that can provide a one-dose alternative to cure HCV infection, potentially overcoming challenges related to access to diagnosis and treatment, as well as compliance with multiple drug regimens. The anticipated awards include 2-3 projects, with a budget of $300,000 for Phase I (up to 2 years) and $1 million for Phase II (up to 3 years). The development of long-acting treatments for HCV could simplify test and treat strategies, reduce healthcare infrastructure needs, and mitigate concerns about drug resistance. Ultimately, these treatments could contribute to the eradication of Hepatitis C.

Description

Phase I and Fast Track proposals will be accepted Direct-to-Phase II proposals will not be accepted Number of anticipated awards: 2-3 Budget (total costs): Phase I: $ 300,000 for up to 2 years Phase II: $ 1 million for up to 3 years. Page 105 Background Globally, an estimated 58 million people have chronic hepatitis C virus (HCV) infection, with about 1.5 million new cases occurring per year. Among people living with human immunodeficiency virus (HIV), morbidity and mortality are increasingly driven by coinfections. For such individuals, the odds of acquiring HCV are six times higher than for their HIV-negative counterparts. In the United States, an estimated 15 to 30% of persons living with HIV have HCV coinfection, but these rates vary significantly based on the individual's risk factor for acquiring HIV. WHO-recommended direct-acting antiviral (DAA) drug combination therapy can cure up to 95% of persons with hepatitis C infection, and treatment duration is usually 8-12 weeks (in the absence of cirrhosis). However, access to HCV diagnosis and treatment, although improving worldwide, remains limited, especially in low-income and lower-middle-income countries. Compliance is also of concern in treatment success, particularly in people co-infected with HIV-HCV who are required to adhere to co-administration of multiple drugs. These challenges may potentially be overcome by the use of long-acting (LA) treatments for HCV to allow intermittent dosing intervals, and, ideally, a one-dose alternative to cure the HCV infection. It is anticipated that LA treatments will be more expensive than standard drug regimens due to increased costs in manufacture, storage, and delivery. However, such LA products, now being highly acceptable by patients and providers, offer notable advantages as (1) they would allow a much-simplified test and treat strategies, (2) reduce the health care infrastructure needs for HCV medicines thereby enabling treatments to be deployed even in very remote settings, and (3) significantly mitigate concern about drug resistance development due to non-compliance. Thus, in the long term, the LA drug products could potentially help to eradicate Hepatitis C.