Abstract
BackgroundApproximately 4 million of people are co-infected with HIV and Hepatitis B virus (HBV). In resource-limited settings, the majority of HIV-infected patients initiate first-line highly active antiretroviral therapy containing lamivudine (3TC-containing-HAART) and long-term virological response of HBV to lamivudine-containing HAART in co-infected patients is not well known.Methodology/Principal FindingHIV-HBV co-infected patients enrolled in the PHPT cohort (ClinicalTrials.gov NCT00433030) and initiating a 3TC-containing-HAART regimen were included. HBV-DNA, HIV-RNA, CD4+ T-cell counts and alanine transaminase were measured at baseline, 3 months, 12 months and then every 6 months up to 5 years. Kaplan-Meier analysis was used to estimate the cumulative rates of patients who achieved and maintained HBV-DNA suppression. Of 30 co-infected patients, 19 were positive for HBe antigen (HBeAg). At initiation of 3TC-containing-HAART, median HBV DNA and HIV RNA levels were 7.35 log10 IU/mL and 4.47 log10 copies/mL, respectively. At 12 months, 67% of patients achieved HBV DNA suppression: 100% of HBeAg-negative patients and 47% of HBeAg-positive. Seventy-three percent of patients had HIV RNA below 50 copies/mL. The cumulative rates of maintained HBV-DNA suppression among the 23 patients who achieved HBV-DNA suppression were 91%, 87%, and 80% at 1, 2, and 4 years respectively. Of 17 patients who maintained HBV-DNA suppression while still on 3TC, 4 (24%) lost HBsAg and 7 of 8 (88%) HBeAg-positive patients lost HBeAg at their last visit (median duration, 59 months). HBV breakthrough was observed only in HBeAg-positive patients and 6 of 7 patients presenting HBV breakthrough had the rtM204I/V mutations associated with 3TC resistance along with rtL180M and/or rtV173L.ConclusionsAll HBeAg-negative patients and 63% of HBeAg-positive HIV-HBV co-infected patients achieved long-term HBV DNA suppression while on 3TC-containing-HAART. This study provides information useful for the management of co-infected patients in resource-limited countries where the vast majority of co-infected patients are currently receiving 3TC.
Highlights
In 2010, the World Health Organization (WHO) estimated that 34 million people were HIV infected worldwide [1]; of whom, approximately 4 million have chronic hepatitis B virus (HBV) infection [2]
We report the analysis of virological efficacy of 3TC on Hepatitis B virus (HBV) replication and emergence of 3TC resistance HBV variants in HBV-HIV-coinfected patients receiving up to 5 years of 3TC-containing highly active antiretroviral therapy (HAART) regimens
Thirty patients met all criteria for this analysis i.e. receiving 150 mg twice a day of 3TC as part of HAART, blood samples collected at baseline and on 3TC-based treatment and detectable HBV DNA at baseline (Figure 1)
Summary
In 2010, the World Health Organization (WHO) estimated that 34 million people were HIV infected worldwide [1]; of whom, approximately 4 million have chronic hepatitis B virus (HBV) infection (defined by more than 6 months of hepatitis B surface antigen or HBsAg in the blood) [2]. These HIV-HBV co-infected individuals are at risk of accelerated liver disease progression, aggressive hepatocellular carcinoma and 8-fold increased liverrelated mortality rate [3,4]. In resource-limited settings, the majority of HIV-infected patients initiate first-line highly active antiretroviral therapy containing lamivudine (3TC-containing-HAART) and long-term virological response of HBV to lamivudine-containing HAART in co-infected patients is not well known
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