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Impact of lamivudine (3TC)-containing combination antiretroviral therapy (cART) in South African patients co-infected with HIV and hepatitis B virus (HBV); a randomised, controlled trial (PHIDISA II)
P. Manzini, The Phidisa II Study Group
South African Miltary Health Service, Pretoria, South Africa
Background: Treatment guidelines advocate use of anti-HBV active cART in co-infected patients. Evidence for these recommendations, particularly in the developing world, from long-term, randomised trials is limited.
Methods: Phidisa II was a randomised clinical trial comparing four regimens of ART (two with 3TC, two without) in South African patients (n=1771) with symptomatic HIV disease and/or CD4+ counts < 200 cells/mL. Patients with a positive hep BsAg result prior to randomisation were identified as co-infected. Baseline (BL) characteristics were compared. CD4+ cell count and HIV-RNA responses during follow-up were compared among patients receiving 3TC-cART versus non-3TC cART. Episodes of hepatic flare (BL ALT > 5 X ULN, or >3.5 X BL if abnormal) were also compared.
Results: 106 (6%) patients were co-infected with HIV/HBV. Median follow-up was 24.7 months. At BL, patients with HIV-HBV coinfection were significantly more likely to be male (p< 0.0001), have lower platelet counts (p=0.002), serum albumin (p< 0.0001) and higher ALT levels (p< 0.0001) than mono-infected patients. BL characteristics for recipients of 3TC-cART (n=57) vs non-3TC cART (n=49) were well balanced. Median change from BL CD4+ counts in coinfected subjects at 6, 12, 24 and 36 months were 105, 136, 126 and 271 cells/µL for recipients of 3TC-cART and 84, 127, 191 and 217 cells/µL for recipients of non-3TC-cART (p>0.05 for all comparisons) . There were no significant differences between treatment groups in either HIV-RNA or median ALT change. Hepatic flare was observed in 12 patients (24.5%) receiving non-3TC cART and in 6 (10.5%) patients receiving 3TC-cART.
Conclusions: These preliminary data show no differences in CD4 counts or HIV suppression over 24 months following treatment with 3TC-cART versus non-3TC cART in patients with HIV/HBV co-infection. Fewer episodes of hepatic flare were observed in patients treated with 3TC-cART.
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