Role of a 48-week pegylated interferon therapy in hepatitis B e antigen positive HIV-co-infected patients on cART including tenofovir: EMVIPEG study

Background & Aims In hepatitis B e antigen (HBeAg) positive-HIV co-infected patients treated with combined antiretroviral therapy (cART), including tenofovir disoproxil fumarate (TDF), the rate of HBe seroconversion remains low. Whether adding pegylated interferon alfa (PegIFN) could increase the likelihood of HBeAg loss and HBe seroconversion has not been assessed. Methods A 48-week PegIFN therapy was added to HBeAg positive-HIV co-infected patients on TDF and emtricitabine, or lamivudine for at least 6months. The primary endpoint was HBV sustained response: HBe seroconversion with undetectable HBV DNA levels 24weeks after completing PegIFN therapy (W72). Results Fifty-one patients (49 men, median age 46years, range: 32–65), were included. Median duration of HIV, HBV infections and TDF therapy was 10.3 (0.6–22), 9.8 (0.5–16), and 3.3 (0.5–6.8)years, respectively. Median baseline CD4 count was 506 (175–1316)/mm 3 . HIV viral load was Nine (18%) patients stopped PegIFN prematurely. Ten (20%) patients experienced HBeAg loss at W72 and four (8%) patients had a HBV sustained response. No HBs seroconversion was observed. Only patients with more than 350CD4/mm 3 at baseline achieved HBe loss. HBeAg level >10PEIU/ml at W12 or a quantitative HBsAg decline Conclusions 48-week PegIFN additional therapy to cART including TDF did not significantly increase the HBe seroconversion rate, despite an HBeAg loss in 20% of the patients. HBe and HBs kinetics may nevertheless be of help in tailoring and optimising this strategy.