Tolerability and safety of Sofosbuvir/Velpatasvir for hepatitis C virus infection: Pooled Analysis

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Created On: 10/05/2023

In people with and without compensated cirrhosis, a pooled safety analysis aimed to assess the tolerability and safety of Sofosbuvir/Velpatasvir (SOF/VEL) combination for the management of hepatitis C virus (HCV) infection in three Phase III trials.

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Key take away

The safety/tolerability profile of Sofosbuvir/Velpatasvir for hepatitis C virus management is not affected by baseline factors like the presence of compensated cirrhosis, advanced age, or mild renal impairment.

Background

Method

By treatment regimen, data from 3 registrational studies were pooled. People who were randomly assigned to receive single-tablet, fixed-dose SOF/VEL or a placebo for twelve weeks in ASTRAL-1 and SOF/VEL for twelve weeks in ASTRAL-2 and ASTRAL-3 were evaluated for lab anomalies and treatment-emergent adverse events (TEAEs).

Result

A total of 1035 volunteers got SOF/VEL treatment, whereas 116 volunteers were given a placebo. In people who were administered SOF/VEL (79.4%) and those getting placebo (76.7%), a comparable rate of TEAE was observed. Majority of TEAEs were moderate to mild, however, among individuals receiving SOF/VEL, there were 23 (2.2%) treatment-emergent serious AEs. None of these severe AEs that developed during treatment resulted in early study termination, nor were they thought to be linked to the medication.

Greater age, minor renal impairment, and compensated cirrhosis did not affect the frequency or severity of TEAEs with SOF/VEL use. In patients who received SOF/VEL, headache, tiredness, nausea, and nasopharyngitis were the most frequent TEAEs (incidence ≥10%); comparable rates were seen in individuals receiving placebo. Among volunteers treated with SOF/VEL, 3 fatalities (less than 1%) were documented; all occurred post-treatment, and none were thought to be connected to study medication.

Conclusion

While treating HCV infection with SOF/VEL, the safety/tolerability profile was comparable to that of placebo and was unaffected by baseline factors like advanced age, mild renal impairment, or compensated cirrhosis.