Long-Term Safety Data for Vemlidy in Chronic Hepatitis B Added to Labeling
The Food and Drug Administration (FDA) has approved updated labeling for Vemlidy (tenofovir alafenamide; Gilead) to include long-term safety data and new drug interaction data between Vemlidy and Vosevi (sofosbuvir/velpatasvir/voxilaprevir) when tenofovir alafenamide is given as part of the fixed-dose combination Odefsey (emtricitabine/rilpivirine/tenofovir alafenamide).
Vemlidy, a nucleoside analogue (reverse transcriptase inhibitor), is currently approved to treat chronic hepatitis B virus (HBV) infection in adults with compensated liver disease.
The Adverse Reactions section now includes pooled safety data from Study GS-US-320-0108 and Study GS-US-320-0110 in adults with chronic hepatitis B and compensated liver disease who continued to receive their original blinded treatment through Week 120, as well as from adult patients who received open-label Vemlidy from Weeks 96 through 120. The Week 96 analysis showed the most common adverse reaction reported was headache (occurring in ≥10% of patients). The proportion of patients who discontinued Vemlidy or tenofovir disoproxil fumarate (TDF) therapy due to adverse reactions of any severity was 1.5% and 0.9%, respectively.
At Week 120, the safety profile of Vemlidy appeared similar in patients who continued to receive blinded treatment as seen in Week 96. Moreover, the safety profile in patients who remained on Vemlidy during the open-label phase was similar to that in patients who switched from TDF to Vemlidy at Week 96.
Additional safety data regarding renal laboratory changes and bone mineral density (BMD) effects were also included in the updated labeling. In a pooled analysis, median change from baseline to Week 96 in eGFR was -1.2mL per minute in the Vemlidy group vs -4.8mL per minute in those receiving TDF. The mean percentage change in BMD from baseline to Week 96 as assessed by dual-energy X-ray absorptiometry (DXA) was -0.7% with Vemlidy vs -2.6% with TDF at the lumbar spine and -0.3% vs -2.5% at the total hip. The revised labeling also includes the frequency of laboratory abnormalities (ALT, LDL-C, glycosuria, AST, creatine kinase, serum amlyase) in Studies 108 and 110 for both Vemlidy and TDF.
In addition, the Drug Interactions section was updated to add that sofosbuvir/velpatasvir (Epclusa) and sofosbuvir/velpatasvir/voxilaprevir (Vosevi) do not have clinically significant interactions with Vemlidy.
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