If you are using injection drugs you would be at risk of reinfection with hepatitis c after curing with Epclusa. Curing hep c May effect dosing of other medications as your liver would be able to function better and metabolize drugs differently.
Gilead Sciences, Inc. is providing this document to you, a US Healthcare Professional, in response to your unsolicited request for medical information. Some of the data may be outside of the US FDA-approved Prescribing Information. Gilead Sciences, Inc. does not intend to offer an opinion regarding the clinical relevance of these data or the advisability of administering any drug in a manner inconsistent with its approved labeling.
This letter summarizes available information about Epclusa® (sofosbuvir/velpatasvir [SOF/VEL]) and coadministration with methamphetamine.
PK DDI Evaluation
Drug interaction studies have not been conducted between the single-tablet regimen SOF/VEL and methamphetamine. Based on the PK profile of each active ingredient within SOF/VEL and methamphetamine, a PK interaction would not be predicted. Please note that the PK profile of methamphetamine was based on the available prescription strength methamphetamine, which is a pure form of methamphetamine that is produced in a safe, sterile and regulated environment. Prescription methamphetamine would not contain additional additives and adulterants that crystal methamphetamine may possess. For more information about prescription methamphetamine, please refer to its product labeling.1,3
Relevant SOF/VEL Label Information1
There is no information in the SOF/VEL product labeling about the coadministration of SOF/VEL and methamphetamine.
Clearance of HCV infection with direct acting antivirals may lead to changes in hepatic function, which may impact safe and effective use of concomitant medications. Frequent monitoring of relevant laboratory parameters (INR or blood glucose) and dose adjustments of certain concomitant medications may be necessary. For more information, please refer to Section 7.3 of the Epclusa US Prescribing Information (Established and Potentially Significant Drug Interactions).
Study Design and Demographics2
SIMPLIFY is an ongoing, open-label, phase 4, multi-site study assessing the efficacy and safety of SOF/VEL in HCV-infected participants reporting recent IDU, including methamphetamine. Participants receive a weekly supply of SOF/VEL in an electronic blister pack with an integrated sensor grid for a 12-week course.”