Effectiveness of pegylated interferon alfa plus HAART in HIV/HBV treatment-naïve coinfected patients
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KeywordsHuman Immunodeficiency Virus Efavirenz HBeAg Seroconversion Positive HBeAg Viral Effectiveness
To our knowledge, the antiviral activity of pegylated interferon alfa plus HAART has not been studied in patients with human immunodeficiency virus type 1 (HIV-1) coinfected with chronic hepatitis B virus (HBV).
To evaluate the effectiveness of pegylated interferon alfa plus HAART in HIV/HBV treatment-naïve coinfected patients.
We performed a prospective cohort study in HIV/HBV treatment-naïve coinfected patients taking care at "La Raza" National Medical Center, Mexico City. Patients were treated with Efavirenz or Lopinavir-ritonavir, each with tenofovir/emtricitabine plus pegylated interferon alfa-2b (1.5 µg/kg/week) or pegylated interferon alfa-2a (180 µg/week) during 48 weeks. HBV genetic analysis was obtained. The study had a primary measure of effectiveness assessed at 24 and 48 weeks of treatment: suppression of HIV RNA to levels below 50 IU/ml. Secondary endpoints were increased in CD4+ cells count, HBV DNA to levels below 60 IU/ml, HBeAg seroconversion (defined by the loss of HBeAg and the presence of anti-HBe antibody) and HBsAg seroconversion (defined by the loss of HBsAg and the presence of anti-HBs antibody). Cumulative incidence with 95% confidence interval (95%CI) were calculated.
We enrolled 18 subjects, 1 patient discontinued treatment because adverse events related to PEG-IFN. The mean (± SD) age was 30.3 ± 6.9 years old, all patients were men. The median (interquartile range) basal CD4+ cells count was 112 (61 to 300), RNA HIV 163,000 copies/ml (9,545 to 636,500 copies/ml), DNA HBV 20,200,000 IU/ml (627,500 to 480,500,000 IU/ml). All patients had positive HBeAg and were negative to HDV serology. HBV genotype distribution was H 9 (52%), G 6 (35%), A 1 (6%) and F 1 (6%). Primary endpoint (RNA HIV < 50 copies/ml) was present in 100% of our patient at 24 and 48 weeks; the median increased in CD4+ cells count was 231 cells/ml at 24 weeks and 322 cells/ml at 48 weeks; cumulative incidence of secondary endpoints were: DNA HBV < 60 UI/ml was present in 8 patients [47% CI95% 26-69%)] at 24 weeks and 17 patients (100 %) at 48 weeks; HBeAg seroconversion was in 8 patients [47% CI95% 26-69%)] at 24 weeks and 16 patients [94% CI95% 73-98%)] at 48 weeks, HBsAg seroconversion was in 0 patients (0%) at 24 weeks and 6 patients [35% CI95% 17-58%)] at 48 weeks.
Pegylated interferon alfa plus HAART were well tolerated and exhibited high viral effectiveness in HIV/HBV treatment-naïve coinfected patients.
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