Efficacy and Safety of Abacavir/Lamivudine/Zidovudine Plus Tenofovir in HBV/HIV-1 Coinfected Adults: 48-Week Data



Allan E Rodriguez 1, Edwin DeJesus 2, Vanessa Williams 3, David Irlbeck 3, Lisa Ross 3, Belinda Ha*, 3 , Charles T Lancaster 3
1 University of Miami, Miami, Florida
2 Orlando Immunology Center, Orlando, Florida
3 GlaxoSmithKline, Research Triangle Park, North Carolina, USA


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© Rodriguez et al.; Licensee Bentham Open.

open-access license: This is an open access article licensed under the terms of the Creative Commons Attribution Non-Commercial License (http://creativecommons.org/licenses/by-nc/3.0/) which permits unrestricted, non-commercial use, distribution and reproduction in any medium, provided the work is properly cited.

* Address correspondence to this author at GlaxoSmithKline, 5 Moore Dr, Research Triangle Park, NC 27709, USA; Tel: 919-483-8284; Fax: 919-256-5053; E-mail: belinda.f.ha@gsk.com


Abstract

In HBV/HIV-coinfected patients, the risk of end-stage liver disease and death is increased. This open-label, prospective, pilot study evaluated abacavir/lamivudine/zidovudine twice daily plus tenofovir once daily in HBV/HIV-coinfected antiretroviral-naïve subjects. Nine adults (8 males) enrolled, with baseline mean HIV-1 RNA = 4.5 log10 copies/mL, HBV DNA = 9.0 log10 copies/mL, and median CD4 count =158 cells/mm3. No subject had baseline ALT >5x ULN.

Six subjects completed the study: 1 withdrew due to non-treatment-related toxoplasmosis and 2 were lost-to-follow-up. At week 48, 100% (6/6) of remaining subjects had ≥2 log10 decrease in HBV DNA, and 100% (6/6) and 83% (5/6) had HIV-1 RNA <400 and <50 copies/mL, respectively. Median change from baseline in CD4 count was 157 cells/mm3. One subject experienced treatment-related grade 3 leukopenia. These results demonstrate that abacavir/lamivudine/zidovudine and tenofovir were well tolerated with sustained HIV-1 and HBV antiviral activity through 48 weeks in HBV/HIV-coinfected, antiretroviral-naïve subjects.

Keywords: HIV, coinfection, hepatitis B, abacavir, lamivudine, zidovudine, tenofovir..