Effects of preventive versus "on-demand" nutritional support on paid labour productivity, physical exercise and performance status during PEG-interferon-containing treatment for hepatitis C.

BACKGROUND AND OBJECTIVE: Deterioration of nutritional status during PEG-interferon containing therapy for chronic hepatitis C can be ameliorated by preventive nutritional support. We aimed to explore whether such support also affects paid labour productivity, physical exercise and performance status. METHODS: In this prospective randomized controlled trial (J Hepatol 2012;57:1069-75), 53 patients with chronic hepatitis C had been allocated to "on demand" support (n=26: nutritional intervention if weight loss>5%) or preventive support (n=27: regular dietary advice plus energy- and protein-rich evening snack) during PEG-interferon-containing therapy. Paid labour productivity, physical exercise and performance status were evaluated at baseline, after 24 and (if applicable) after 48 weeks of treatment. RESULTS: At baseline, 46% of patients performed paid labour and 62% performed some kind of physical exercise. Furthermore, most patients were able to carry out normal activity with only minor symptoms of disease (mean Karnofsky performance score: 94). Decreases of paid labour productivity (-21% vs. -70%, P=0.003), physical exercise activity (-43% vs. -87%, P=0.005) and Karnofsky performance scores (-12% vs. -24%, P<0.001) were less in the preventive than in "on demand" group after 24 weeks of treatment. Effects of preventive nutritional support were even more pronounced after 48 weeks. CONCLUSIONS: Preventive nutritional support markedly ameliorates decreases of paid labour productivity, physical exercise and performance status during PEG-interferon-containing treatment for chronic hepatitis C.

Preventive versus "on-demand" nutritional support during antiviral treatment for hepatitis C: a randomized controlled trial.

BACKGROUND & AIMS: Although antiviral treatment for hepatitis C (HCV) is highly effective, side effects often occur, including weight loss, digestive symptoms, and impaired quality of life. We aimed at exploring the beneficial effects of preventive nutritional support. METHODS: In a randomized controlled trial, 53 HCV patients were allocated to "on demand" support (n=26: nutritional intervention if weight loss >5%) or preventive support (n=27: regular dietary advice plus energy- and protein-rich evening snack). Nutritional state (including validated Jamar Hand Grip Strength), digestive symptoms (visual analog score), and quality of life (SF-36 survey) were evaluated at baseline, and after 24 and 48 weeks of peginterferon α-2b and ribavirin treatment. RESULTS: The primary end point (weight loss at 24 weeks) was reached in 22 patients in both groups. Weight decreased markedly in the "on demand" group (decrease at 24 weeks: 5.4 kg or 6.9%, p<0.001), but not in the preventive group (decrease 0.3 kg or 0.3%, p=n.s.). Jamar Hand Grip Strength deteriorated in the "on demand" group (from 40.3 ± 15.5 kg to 32.0 ± 13.1 kg, p<0.001) but not in the preventive group (from 40.7 ± 10.4 kg to 39.7 ± 8.9 kg, p=n.s.). Intake of energy, proteins, and fat decreased markedly in the "on demand" group but increased in the preventive group. Although digestive symptoms and quality of life deteriorated, impairment was significantly less in the preventive group. CONCLUSIONS: Preventive nutritional advice plus supplementation prevents weight loss and catabolic state during HCV antiviral therapy, with improved digestive symptoms and quality of life.