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Atazanavir is safe and efficacious in HBV and HCV co-infected patients: results of AI424138 (CASTLE)

Background

Chronic HBV and HCV infections are common co-morbidities that can complicate antiretroviral treatment in HIV-infected patients. Information on efficacy and safety are necessary to better define optimal therapeutic options in this population.

Methods

Randomized, open-label prospective study comparing once-daily ATV/r with twice-daily LPV/r, both in combination with once-daily fixed dose combination tenofovir/emtricitabine in antiretroviral-naive HIV-1 infected subjects. Proportion of subjects with HIV RNA <50 c/mL (confirmed virologic response/CVR), changes in CD4 cell count and lipids from baseline, and adverse events (AEs) through 48 weeks are presented among chronic HBV- and/or HCV-infected (Hep+) subjects.

Summary of results

At baseline, 13% of subjects were Hep+ (5% HBV+; 8% HCV+). Overall 9% of females, 14% males, 25% Asians, 15% Blacks, 5% others, and 13% of Whites were Hep+. (Table 1.)

Table 1

Grade 2–4 treatment related hyperbilirubinemia (15% vs. 0) and jaundice (3% vs. 0) were more common on ATV/r. Nausea (8% vs. 2%) and diarrhea (14% vs. 0) were more common on LPV/r. Few SAEs were reported among Hep+ in either treatment arm. Grade 3–4 elevations in liver function tests were reported among the following: 5/60, 8% (ALT), 5/60, 8% (AST) and 23/60, 38% (total bilirubin) in the ATV/r arm and 3/50, 6% (ALT), 0% (AST); 0% (total bilirubin) in the LPV/r arm. (Table 2.)

Table 2 Lipid Mean % Change (+/- SE) from Baseline at Week 48 – As Treated Subjects

Conclusion

Virologic and immunologic response was comparable in Hep+ treated with ATV/r or LPV/r. ATV/r had a more favorable lipid profile (TC, non-HDL, LDL, TG) and fewer gastrointestinal adverse events among Hep+ subjects than LPV/r. While the overall rates of transaminitis in Hep+ were low in this study compared to those observed in other clinical trials, a small number of subjects in the ATV/r and none on LPV/r had grade 3–4 AST elevations. The cause of this higher proportion in the ATV/r treatment arm among this limited number of subjects is unclear. With close monitoring of liver function tests, ATV/r can be considered as part of HAART among treatment-naive Hep+ patients.

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Open Access This article is published under license to BioMed Central Ltd. This is an Open Access article is distributed under the terms of the Creative Commons Attribution 2.0 International License (https://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

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Absalon, J., Thal, G., Thiry, A. et al. Atazanavir is safe and efficacious in HBV and HCV co-infected patients: results of AI424138 (CASTLE). JIAS 11, P136 (2008). https://doi.org/10.1186/1758-2652-11-S1-P136

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  • DOI: https://doi.org/10.1186/1758-2652-11-S1-P136

Keywords

  • Liver Function Test
  • Total Bilirubin
  • Atazanavir
  • Fixed Dose Combination
  • Gastrointestinal Adverse Event