Lack of significant viral load alterations of hepatitis B virus (HBV) and hepatitis C virus (HCV) during treatment with interleukin-2 and HAART

This small study attempted to look at the safety of IL-2 in combination with HAART in individuals co-infected with either HCV or HBV. Of the 9 involved in the study 5 had HCV, 3 HBV and 1 was infected with both. A mean of 6.3 cycles ( 9 MU IL-2 for 5days every 6-8 weeks) was administered over a year in conjunction with a pre-existing HAART regimen of AZT/3TC/saquinavir.

No significant change in HBV or HCV load was seen during treatment, however one individual with HCV had a load drop below the level of detection. In all nine patients no significant changes were noted in liver function (ALT, ST, bilirubin, alkaline phosphatase and coagulation).

The HIV-1 reduction from 18,613 ± 36, 355 pre-treatment to 5448 ± 5220 did not show statistical significance. There was however a 22% increase in CD4 cells from 389 ± 186 to 472 ± 226 and a relative increase of CD4 cells from 22.2 ± 10.1 to 25.6 ± 11.0 % during the study.

The results suggest that IL-2 therapy can be safely administered to individuals co-infected with either HBV or HCV and that they can be safely enrolled in phase III trials of IL-2 (SILCAAT & ESPRIT).

Comment

This study is very welcome, as co-infected individuals have generally been excluded from many trials. The use of IL-2 could prove beneficial in those co-infected with low CD4 where treatment is indicated for HCV.

The use of 3TC in HBV is not now generally recommended due to early resistance and the use of SQV HG as opposed to SQV SG appears to be down to availability at the time of the study.