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Background. Hepatitis C virus (HCV) is a common cause of progressive hepatic fibrosis, cirrhosis, and hepatocellular carcinoma worldwide. Despite the availability of effective direct-acting antivirals, patients often have significant hepatic fibrosis at the time of diagnosis due to delay in diagnosis and comorbidities which promote fibrogenesis. Thus, antifibrotic agents represent an attractive adjunctive therapy. Fuzheng Huayu (FZHY), a traditional Chinese medicine botanical formulation, has been used as an antifibrotic agent in chronic HBV infection. Our aim was to assess FZHY in patients with HCV infection and active viremia. Method. We randomized 118 patients with active viremia from 8 liver centers in the U.S. to receive oral FZHY (n = 59) or placebo (n = 59) for 48 weeks. Efficacy was assessed by histopathologic changes at the end of therapy. A subset of biopsies was further analyzed using qFibrosis to detect subtle changes in fibrosis in different zones of the hepatic lobules. Results. FZHY was well tolerated and safe. Patients with baseline Ishak fibrosis stages F3 and F4 had better response rates to FZHY than patients with baseline F0–F2 (p=0.03). qFibrosis zonal analysis showed significant improvement in fibrosis in all zones in patients with regression of the fibrosis stage. Conclusions. FZHY produced antifibrotic effects in patients with baseline Ishak F3 and F4 fibrosis stages. Reduction in fibrosis severity was zonal and correlated with the severity of inflammation. Based on its tolerability, safety, and efficacy, FZHY should be further investigated as a therapy in chronic liver diseases because of its dual anti-inflammatory and antiibrotic properties. Lay Summary. This is the first US-based, multicenter and placebo-controlled clinical trial that shows statistically significant reduction in fibrosis in patients with active HCV using an antifibrotic botanical formula. This has important implications as there is an immediate need for effective antifibrotic agents in treating many chronic diseases including NASH that lead to scarring of the liver. With artificial intelligence-based methodology, qFibrosis, we may provide a more reliable way to assess the FZHY as a therapy in chronic liver diseases because of its dual anti-inflammatory and antifibrotic properties.

Although clinicians recognize the importance of adherence to HCV therapy, little research has been conducted to determine actual adherence rates or predictors of adherence in this population. Adherence is a challenge in the HCV-infected individual because of the complexities of the drug regimen, side effects from the medication, frequency of clinical monitoring, variable response to therapy, and potential complications. However, because of the time-limited nature of the current medication therapies, multidisciplinary and multifactoral interventional strategies may be designed to positively influence adherence rates and, ultimately, treatment outcomes in this patient population.

Purpose: The purpose of this study was to review the current management of hepatitis C virus (HCV) in persons coinfected with HIV. Data sources: Comprehensive review of current scientific literature derived from electronic databases, article bibliographies, and conference s. Conclusions: HCV treatment is feasible in the individual coinfected with HIV; however, therapy is complex and requires intensive monitoring and support to achieve the outcome of viral eradication. New strategies to improve HCV treatment rates, adherence to therapy, and virological response rates are needed in this patient population. Implications for practice: Nurse practitioners are crucial to the management of the HIV/HCV–coinfected patient. This patient population requires detailed clinical monitoring, education, side effect management, and strategies to improve adherence to therapy.

Background. Hepatitis C (HCV) infection is reported in approximately 30% of HIV infected patients. Treatment of HCV is crucial to prevent liver decompensation and/or liver failure; however, rates of HCV treatment in this patient population are extremely low. Referral rates for HCV evaluation range from 10-40%, with initiation of therapy at <20%. Purpose. To determine the patient factors associated with liver disease referral and evaluation for hepatitis C treatment in a cohort of HIV/HCV coinfected individuals. Methods. A retrospective cohort study was conducted to collect patient demographics, HIV and HCV disease severity, major medical comorbidities, mental health status, substance use, and social context from a group of adult HIV/HCV coinfected individuals seen at a large university based HIV clinic from January 1, 2003 to December 31, 2006. Descriptive statistics, univariate and multivariate logistic regression determined group differences between those referred for HCV evaluation with those not referred (paper three), and between those referred for HCV evaluation who attended their appointment with the group that was nonadherent to liver evaluation (paper four). Findings. A cohort of 538 HIV/HCV coinfected patients were analyzed for this study. A total of 308 patients (57%) were referred for liver disease evaluation by their HIV provider. In the referred group, 224 patients were seen and evaluated for possible HCV treatment, of which 79 patients went on to receive HCV treatment. Of those patients referred, 84 patients did not attend their liver disease clinic appointment. No referral was received in 230 HIV/HCV coinfected patients. In the analysis between the HIV/HCV coinfected patients referred for evaluation with those not referred, significant differences were found in liver disease severity, cardiac disease, history of skin cancer, antiretroviral therapy use, psychiatric evaluation, current substance use, homelessness, and history of incarceration. Factors that remained significant in multivariate analysis included liver disease markers, homelessness, and incarceration. For those patients who did not attend liver disease evaluation, differences included age, cirrhosis, current substance use, incarceration, psychiatric evaluation, and nonadherence to HIV medications and/or visits, with only incarceration and psychiatric evaluation remaining significant in multivariate analysis.