Trend to Improved SVR among African-Americans Receiving High Dose Induction Therapy with Conventional Interferon + Ribavirin

Chronic HCV has increased prevalence in the VA population and is responsible for great morbidity and mortality. There is evidence that IFN alfa 2b (Intron A) antiviral treatment regimens in standard dosages are less effective in the African-American (AA) group.

There is a large AA population in the VA system. It is postulated that high dose induction rx with IFN alfa based medication regimens may benefit the AA population.

In this study, researchers sought to determine the efficacy of standard dosage IFN alfa 2b (Intron A) + ribavirin in the AA population in comparison to the Caucasian (C) population and determine SVR to a HD induction IFN alfa 2b + ribavirin regimen.

VA pts with chronic HCV infection (+ HCV RNA & elevated ALT) who were not previously treated were identified in this prospective, randomized, controlled, multicenter trial. Demographic information (including race), serological parameters (viral load and genotype) and histological data were obtained.

Pts were randomized to receive standard (SD) IFN alfa 2b (3 MU TIW) + ribavirin for 48 wks vs. high-dose induction (HD) IFN alfa 2b (5 MU daily 6 wks followed by 3 MU TIW 42 wks) + ribavirin.

Sustained response rate (SVR) data (undetectable HCV RNA) are reported. 273 pts including 84 AA and 157 C were enrolled. SVR data are available in 70 AA and 136 C.

Results

15/70 (21%) of AA and 27/136 (20%) of C discontinued treatment and were considered non-responders. Overall SVR in the AA group was 4/70 (5%) in comparison to 36/136 (26%) in the C group (p<0.05).

In the AA population 1/40 (2.5%) achieved SVR vs. 3/30 (10%) in the HD group.

In the C population 18/69 (26%) in the SD group achieved SVR in comparison to 18/67 (27%) in the HD group.

Of note, significantly more AA had GT 1,4 (93%) vs. C 62%).

As previously reported, the VA population in general had significant psychosocial discord (low income, significant hx of IV drug use, incarceration and significant hx of alcohol abuse).

Conclusions:

• There was a trend to increased SVR in the AA population with HD induction IFN alfa 2b + ribavirin therapy;

• The C population had significantly improved SVR in comparison to the AA population;

• The VA population has poor treatment response (SVR) to antiviral medications in comparison to the general population; and

• There is a high dropout rate among pts in the VA population receiving antiviral therapy. This is likely secondary to psychosocial comorbidity and may be responsible for lower SVR.

05/19/04

Reference
S Flamm and others. There Is a Trend to Improved SVR for African-Americans Receiving High Dose Induction IFN alfa 2b + Ribavirin Therapy for Chronic HCV: Final Results of a Prospective, Randomized, Controlled, Multicenter Trial in a VA Population. Abstract 1144 (poster). Digestive Disease Week. May 15-20, 2004. New Orleans, LA.