# Optimizing Care for HIV/HCV-Coinfected Patients in the New HCV Treatment Era

> **NIH NIH K01** · HARVARD PILGRIM HEALTH CARE, INC. · 2020 · $108,403

## Abstract

PROJECT SUMMARY/ABSTRACT
This K01 award will provide the training and mentored research experience needed for me to become an
independent researcher with a focus on improving the health outcomes of patients with or at risk for chronic
viral infections. Chronic hepatitis C virus (HCV) infection affects over 3 million people in the U.S., with 80,000
HCV-related deaths per year. The health impacts of HCV are more severe in human immunodeficiency virus
(HIV) patients, in whom HCV-associated liver disease is the leading cause of non-AIDS-related death.
HIV/HCV coinfection has also been linked to an increased risk of extrahepatic outcomes, including
cardiovascular and kidney disease. With the emergence of interferon-free regimens, most HCV patients can
now be cured, regardless of HIV status. However, critical questions remain about 1) the effect of the timing of
HCV treatment on hepatic and extrahepatic outcomes, 2) the ongoing risk of hepatic and extrahepatic
outcomes after HCV cure, and 3) whether the clinical benefits of HCV treatment in early stages of liver disease
warrant the use of costly new regimens in these patients. The high-risk population of HIV/HCV-coinfected
patients is ideal for investigating these questions for two reasons. First, because HIV/HCV-coinfected patients
are a priority group for HCV treatment, they will have received treatment over a range of liver disease stages,
offering a unique opportunity to investigate the clinical and economic impacts of HCV treatment decisions.
Second, ongoing risk of HCV-related outcomes after HCV cure may be more readily detectable in HIV/HCV-
coinfected patients, for whom increased immune activation and inflammation may cause lasting damage. The
proposed research will consist of cohort studies among members of Kaiser Permanente Northern California.
The strengths of this setting include a diverse and generalizable population of 3.8 million members, internal
HCV- and HIV-monoinfected comparison groups, an electronic health record (EHR) for identification of key risk
factors, and infectious disease registries for high-quality ascertainment of HCV and HIV cases. The specific
aims are to 1) determine the effect of early versus deferred HCV treatment on hepatic and extrahepatic
outcomes among HCV-monoinfected and HIV/HCV-coinfected patients; 2) evaluate the risk of hepatic and
extrahepatic outcomes among HCV-monoinfected and HIV/HCV-coinfected patients after HCV cure, and in a
matched group of HIV patients without HCV infection; and 3) determine the cost-effectiveness of HCV
treatment for all HCV-monoinfected and HIV/HCV-coinfected patients compared with deferral of treatment to
later stages of liver disease. This career development award will provide training in 1) HCV and HIV/HCV
epidemiology, treatment, and outcomes; 2) leveraging the EHR for infectious disease research; 3) advanced
causal inference methods; and 4) cost-effectiveness analysis. This mentored research and training will directly
inform...

## Key facts

- **NIH application ID:** 9920080
- **Project number:** 5K01AI122853-06
- **Recipient organization:** HARVARD PILGRIM HEALTH CARE, INC.
- **Principal Investigator:** Julia L. Marcus
- **Activity code:** K01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $108,403
- **Award type:** 5
- **Project period:** 2017-02-01 → 2021-06-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/9920080

## Citation

> US National Institutes of Health, RePORTER application 9920080, Optimizing Care for HIV/HCV-Coinfected Patients in the New HCV Treatment Era (5K01AI122853-06). Retrieved via AI Analytics 2026-05-25 from https://api.ai-analytics.org/grant/nih/9920080. Licensed CC0.

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