Persistence of Improved Adherence and Quality of Life with Cognitive Behavioral

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Persistence of Improved Adherence and Quality of Life with Cognitive

Behavioral Therapy in Patients Receiving PEG-Intron Plus Ribavirin

Improved medication adherence significantly increases sustained

virologic response (SVR). Thus, techniques are sought to improve

medication adherence and quality of life (QOL) for pts treated for

HCV.

Prior studies have previously reported improved medication adherence

and QOL with active intervention through wk 12 of treatment (rx).

The aim of the present study was to determine if improved medication

adherence and QOL persist through wk 48 of rx utilizing pt education,

aggressive side-effect management and expanded supportive nursing

intervention with cognitive behavioral rx by telephone in patients

treated with PEG IFN alfa 2b (PEG-Intron) + ribavirin.

Pts with HCV for whom medical rx was planned were eligible. 10

GI/hepatology groups were selected for participation. 5 groups were

randomized to the active intervention (AI) arm and 5 groups to the

standard of care (SC) for that group.

Patients enrolled prior to receiving PEG IFN alfa 2b (1.5 mcg/kg/wk)

+ ribavirin (800-1400mg/day) for 48 wks.

The AI arm consisted of the following: Experienced nurses who help

pts with HCV on medical rx by telephone (Be In Charge) were taught

behavioral rx techniques by an experienced therapist.

Pts in the AI arm were to call these nurses on 10 defined occasions

from prior to beginning medical rx until week 12 of rx. Aggressive

medication side effect management was undertaken.

Pts in the SC arm received routine supportive care used by their

physician.

SR rates, AE profiles, and QOL measurements (SF 36) were determined

in both groups. Drop-out rates and quality of life measurement

results through wk 48 are reported.

Results

The 5 groups randomized to SC enrolled 39 patients. One group

randomized to AI group did not recruit pts and was eliminated. The

other 4 groups randomized to AI enrolled 38 pts.

14/37 (38%) in SC discontinued rx by wk 48 vs 8/36 (22%) in AI. 10/37

(27%) discontinued due to AE vs. 4/36 (11%) in SC.

Regarding health-related QOL, substantial improvement (33-75%) in 5/8

domains of SF 36 persisted through wk 48. 20/36 (56%) of pts in AI

were HCV RNA(-) at wk 48 vs 16/37 (43%) in SC.

Conclusions

AI utilizing pt education, aggressive side-effect management and

nursing support by telephone, using cognitive behavioral therapy

yields a decrease in overall drop-out rate and drop-outs related to

AE through wk 48 of rx.

2) AI results in improvements in physical-related and mental health-

related QOL which persist through wk 48 of rx. 3) There is a trend to

improved ETR with AI.

05/19/04