Simeprevir with Sofosbuvir (Complete Regimen) + Dolutegravir/Rilpivirine = Precautionary

Effect on Concentration

Simeprevir with Sofosbuvir (Complete Regimen)
Unknown
Applies within class?
No
Dolutegravir/Rilpivirine
Unknown
Applies within class?
No

Pharmacologic Effects

Simeprevir with Sofosbuvir (Complete Regimen)
Effect
N/A
Applies within class?
No
Dolutegravir/Rilpivirine
Effect
N/A
Applies within class?
No

Interaction History

N/A

Last Updated 22-Nov-2022

Summary

Co-administration of DTG+RPV-based regimens with SMV+SOF in HIV/HCV co-infected patients appeared to be safe and effective. Monitoring for adverse effects related to increased exposure to these antivirals may be warranted until more data become available in this population.

Sources

Dolutegravir/rilpivirine vs simeprevir/sofosbuvir ^

Study Design

This study was conducted to evaluate the plasma concentrations of dolutegravir (DTG) and rilpivirine (RPV) when used in combination with simeprevir (SMV) plus sofosbuvir (SOF) in HIV/HCV co-infected patients with advanced liver disease. Participants had a HIV RNA 50 copies/ml and were taking an HIV regimen containing DTG + RPV. In addition, participants were started on HCV treatment with SMV+SOF (with or without ribavirin) for 12 weeks.

Study Results

11 subjects were evaluated. Although no specific geometric mean ratio values were reported, the investigators reported that plasma concentrations were in the expected range for all 4 antivirals even though they tended to be slightly higher compared to those previously reported in non-cirrhotic patients.. There were no significant changes observed during the first 4 weeks in DTG and RPV Ctrough with initiation of a SMV+SOF HCV regimen. Additionally, GS-331007 (circulating metabolite for SOF) and SMV Ctrough did not vary between week 2 and 4.All patients completed the full course of anti-HCV treatment, with 100% achieving HCV virologic suppression by the end of 12 weeks and 100% achieving SVR24.

Study Conclusions

References

M Merli, L Galli, L Marinaro, et al. Pharmacokinetics of dolutegravir and rilpivirine in combination with smv/sof. Conference On Retroviruses And Opportunistic Infections. Boston, MA. ; 2016.