NATAP
Reports

Highlights from
Digestive Disease Week

May 20-23, 2001
Atlanta, Georgia

Impact of Hiv Infection On Health-Related Quality of Life In Patients with Chronic Hepatitis C: An Unexpected Finding

Fatigue and emotional or psychological stress have been found to be associated with chronic HCV infection. Importantly, it's also been reported that elimination of the the virus improves quality of life. Viral nonrsponders may or may not improve quality of life.

In this study presented at DDW May 2001, study investigators measured health-related quality of life for HCV/HIV coinfected patients. They compared 121 patients infected with HIV alone to 52 HCV/HIV coinfected patients. Analysis revealed patients with coinfection had reduced sense of physical well-being compared to patients with HIV alone. Coinfection with HCV affects fatigue and energy: the testing found coinfected patients had more decreased energy, feels ill more often, spent more time in bed, tires more easily). But, cognitive and emotional scores (emotionally, functionally, socially or cognitively) were the same for both groups. The authors concluded that reduced quality of life is physical but not psychological. Other preliminary studies, however, suggest that cognitive functioning and perhaps emotional well being are affected by HCV. Perhaps this study merely finds that cognitive function & emotional well being is not worse in HCV/HIV coinfected than HIV infected. The author suggests that improved quality of life is a potential goal of HCV therapy. The authors do not reveal information about the background of the patients they studied. Were the HIV+ patients different than the HCV/HIV coinfected patients? For example, were the coinfected patients former IVDUs and the HIV-infected were not? Not being able to compare the patient groups makes full interpretation of the results more difficult.

An important aspect of assessing the impact of chronic HCV infection is determining whether the reduction in the patient's quality of life is caused by the HCV or the comorbidities associated with the illness. For example, patients with HCV frequently have history of alcohol and drug abuse and may be coinfected with hepatitis B virus. In one study, the investigators adjusted for some of these comorbidities, whereas another study excluded patients with a history of drug

abuse from analysis. The results showed that despite exclusion of such confounding factors, patients with HCV infection had a greater reduction in their quality of life scores.

The authors also conclude that the role of depression and substance abuse should be further studied. I think patients with current or recent substance abuse may have more difficulties with emotional or psychological issues, and perhaps with energy and fatigue. Patients with former or current substance abuse may also have depression problems. These concerns may affect quality of life and the side effects and the ability to withstand side effects a patient may experience during IFN/RBV therapy. As well, thresold for discomfort may also play a role in a patient’s willingness or capacity to withstand HCV therapy side effects. It may be helpful to select the therapy easiest to tolerate. Preliminary studies suggest Pegasys alone may be the most tolerable, followed by Pegasys+RBV. The dose of RBV may also play a role in tolerability as 800 mg of RBV may be less fatigueing than 1000 or 1200 per day. Early studies suggest that PegIntron+RBV may be comparable in tolerability to the standard IFN a-2b+RBV.

Fatigue, Emotional and Psychological Disturbances in HCV-Infected Patients: depression, fatigue, anger and hostility

A recent study was published in the Journal of Clinical Gastroenterology (2001;32;413-417) comparing patients with chronic HCV to patients with non-liver chronic diseases (diabetes, hypertension, heart disease) and healthy patients and patients with alcohol liver disease. But patients with HIV were not included in this study as opposed to the DDW study.

Subgroup analysis in this study showed that all aspects of fatigue, such as the impact and consequence of fatigue on the individuals' general health, the response to relieving factors (such as rest and sleep), and the effect of triggering influences (such as stress and work), were worse in patients with HCV than in the other patient groups.

This study finds feelings of anger and hostility were significantly greater in patients with chronic HCV infection, whether they were completely abstinent or indulging in heavy alcohol use compared with patients with non-liver chronic systemic illnesses.

In summary, the current study has shown that compared with healthy individuals, both fatigue and psychologic disturbances are more severe in patients with chronic illnesses and that the most severe abnormalities occur in HCV infection. The study authors feel the study results show that the fatigue experienced by HCV-infected patients is not only more severe but also is more intransigent, responding less well to relieving factors such as rest and sleep. Moreover, patients with HCV infection appear more depressed and exhibit greater feelings of anger and hostility. Our findings have important therapeutic implications because effective treatment of the psychologic disturbances may improve patients' fatigue and, thus, may have a beneficial impact on the quality of life of patients with HCV.

To read more details about this study: Assessment of Fatigue and Psychologic Disturbances in Patients with Hepatitis C Virus Infection...>

Abstract from DDW Conference (May 2001):
     Edmund J Bini, VA New York Harbor Healthcare System & NYU Sch of Medicine, New York, NY; Michael A Baskies, NYU Sch of Medicine, New York, NY; Jacqueline M Achkar, Melanie J Maslow, VA New York Harbor Healthcare System & NYU Sch of Medicine, New York, NY

Background: Several studies have evaluated health-related quality of life (HRQOL) in patients with hepatitis C (HCV) or HIV. However, a direct comparison of HRQOL in these two groups of patients and the impact of coinfection on HRQOL has not been studied.

Our aims were 1) to compare HRQOL in patients with HCV and HIV, 2) to determine whether patients coinfected with HCV and HIV have a worse HRQOL than patients with either HCV or HIV alone, and 3) to determine whether HRQOL correlates with clinical characteristics in coinfected patients.

Methods: 360 patients with HCV (n = 160), HIV (n = 100), and coinfection (n = 100) were enrolled from the GI, ID, and primary care clinics. All HCV and coinfected patients were viremic by HCV PCR, were otherwise healthy, and had not taken anti-HCV medications in the last 6 months. Patients with comorbid medical or psychiatric disease, decompensated cirrhosis, coinfection with hepatitis B, or active drug or alcohol abuse ( 30 grams/day) were excluded. HRQOL was measured using the validated short form 36, which measures quality of life across 8 domains on a scale of 0 (worst) to 100 (best). Correlation between HRQOL and clinical characteristics in coinfected patients was tested using Pearson's correlation.

Results: There were no significant differences in age (51.0 ±8.7 years) or gender (97.5% male) between the 3 groups. The comparison of HRQOL between patients with HCV, coinfection, and HIV is shown in the table below. HRQOL in patients with coinfection was no different between those who were and those who were not referred to the GI clinic for evaluation and possible treatment. The following variables showed a statistically significant (P < 0.05) correlation with HRQOL [r = Pearson's correlation coefficient]: physical functioning correlated with prothrombin time [PT] (r = -0.30); social functioning with CD4 count (r = +0.22); role limitation - emotional with PT (r = -0.29) and necroinflammatory score (r = -0.43); energy & fatigue with PT (r = -0.25); and general health with PT (r = -0.26), ALT (r = -0.23), and alkaline phosphatase (r = -0.28).

Conclusions: Patients with chronic hepatitis C have a significantly reduced HRQOL compared to those with HIV. Surprisingly, HRQOL in patients who are coinfected with HCV and HIV is not worse than those with HCV alone and falls somewhere between the HRQOL of patients with HCV and those with HIV. Reasons for this unexpected finding warrant further investigation.

HCV Coinfection HIV
HCV load, copies/ml x 106 1.5±1.6 1.2±1.0 ---
HCV genotype 1a or 1b 75.0% 69.3% ---
HIV load, copies/ml ---   7,149±32,427   8,438±21,622
CD4 count, cells/mm3 --- 338±221 335±204
Physical functioning 67.8±25.5 73.2±21.4 82.3±23.8
Social functioning  47.3±13.3*† 53.9±19.9 61.9±20.5
Role limitation: physical 48.0±38.1 58.0±42.5 75.0±37.3
Role limitation: emotional  51.9±36.0*† 65.0±41.1  82.7±33.0
Mental health 61.6±11.7    61.6±12.2 64.0±10.1 
Energy & Fatigue 55.8±24.1 59.4±23.6 67.5±23.5 
Pain 55.5±27.7    58.8±28.7 65.2±33.7 
General health perception 54.3±24.0 53.8±23.3  63.6±23.3

* P <0.05 compared to HIV;
P<0 05 compared to coinfection

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