![]() The 5-year data is not presented in the VEMLIDY label. Open-label VEMLIDY phase for an extension trial that is still ongoing. However, before implementation of the amendment protocol, 540 patients entered the open-label phaseĪt Week 96 (360 patients remained on VEMLIDY and 180 patients switched from TDF to VEMLIDY).Īt Week 144, all 1137 remaining HBeAg– and HBeAg+ patients (out of the original 1298) entered the The original protocol was amended to extend the double-blind phase from 96 weeks to 144 weeks. Hepatitis B envelope antigen (HBeAg) loss and seroconversion were also assessed in Trial 110. Hepatitis B surface antigen (HBsAg) loss and seroconversion.Alanine aminotransferase (ALT) normalization.Proportion of patients with HBV DNA Noninferiority to tenofovir disoproxil fumarate (TDF) (10% margin 95% confidence interval Īdditional efficacy endpoints evaluated at Week 48, Week 96, and Week 144 for both studies include: The primary endpoint for both studies was HBV DNA <29 IU/mL and Noninferiority trials: Trial 108 (N=425 HBeAg– treatment-naïve and treatment-experienced patients)Īnd Trial 110 (N=873 HBeAg+ treatment-naïve and treatment-experienced patients). The efficacy and safety of VEMLIDY 25 mg once daily in the treatment of CHB in adults withĬompensated liver disease were evaluated in 2 randomized, double-blind, active-controlled, Including hepatomegaly and steatosis in the absence of marked transaminase elevations. If clinical or laboratory findings suggestive of lactic acidosis or pronounced hepatotoxicity develop, With the use of nucleoside analogs, including tenofovir disoproxil fumarate (TDF). Lactic Acidosis and Severe Hepatomegaly with Steatosis: Fatal cases have been reported.Monitor renal function in all patients – See Dosage and Administration. Taking nephrotoxic agents (including NSAIDs) are at increased risk of renal-related adverse reactions.ĭiscontinue VEMLIDY in patients who develop clinically significant decreases in renal function orĮvidence of Fanconi syndrome. Patients with impaired renal function and/or Including acute renal failure, proximal renal tubulopathy (PRT), and Fanconi syndrome have been reported ![]() New Onset or Worsening Renal Impairment: Postmarketing cases of renal impairment,.Offered to all HBV-infected patients before initiating therapy with VEMLIDY, and, if positive, anĪppropriate antiretroviral combination regimen that is recommended for HBV/HIV-1 coinfected patients VEMLIDY have not been established in HBV/HIV-1 coinfected patients. Risk, VEMLIDY alone should not be used for the treatment of HIV-1 infection. Risk of Development of HIV-1 Resistance in HBV/HIV-1 Coinfected Patients: Due to this.
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