Sofosbuvir and Velpatasvir (Page 10 of 11)

14.5 Clinical Trial in Adult Liver Transplant Recipients without Cirrhosis and with Compensated Cirrhosis

Trial 2104 was an open-label clinical trial that evaluated 12 weeks of treatment with sofosbuvir and velpatasvir tablets (400 mg/100 mg) in 79 HCV-infected treatment-naïve and previously treated adult subjects who had undergone liver transplantation. The proportions of subjects with genotype 1, 2, 3, or 4 HCV infection were 47%, 4%, 44%, and 5%, respectively. The median age was 62 years (range: 45 to 81); 81% were male; 82% were White; 3% were Black; and 15% were Asian; 28% had a baseline body mass index at least 30 kg/m2. At baseline, 18% had compensated cirrhosis, and 60% were treatment experienced (subjects with prior exposure to any HCV NS5A inhibitor were excluded). Immunosuppressants allowed for coadministration were tacrolimus, mycophenolate mofetil, cyclosporine, and azathioprine. The overall SVR12 rate was 96% (76/79). Of the subjects completing 12 weeks of sofosbuvir and velpatasvir, 2 subjects experienced virologic relapse.

14.6 Clinical Trial in Subjects with Severe Renal Impairment Requiring Dialysis

Trial 4062 was an open-label clinical trial that evaluated 12 weeks of treatment with sofosbuvir and velpatasvir tablets (400 mg/100 mg) in 59 HCV-infected adults with ESRD requiring dialysis. The proportions of subjects with genotype 1, 2, 3, 4, 6 or indeterminate HCV infection were 42%,12%, 27%, 7%, 3%, and 8%, respectively. At baseline, 29% of subjects had cirrhosis, 22% were treatment-experienced (subjects with prior exposure to any HCV NS5A inhibitor were excluded), 92% were on hemodialysis, and 8% were on peritoneal dialysis; mean duration on dialysis was 7 years (range: 0 to 40 years). The overall SVR rate was 95% (56/59). Of the subjects completing 12 weeks of sofosbuvir and velpatasvir, 1 subject experienced virologic relapse.

14.7 Clinical Trial in People who Inject Drugs (PWID), Including Those on Medication-Assisted Treatment (MAT) for Opioid Use Disorder

SIMPLIFY was an open-label Phase 2 clinical trial that evaluated 12 weeks of treatment with sofosbuvir and velpatasvir tablets (400 mg/100 mg) in 103 HCV-infected PWID (defined as self-reported injection drug use within previous 6 months), including 58 subjects on MAT for opioid use disorder. The proportions of subjects with genotype 1, 2, 3, and 4 HCV infection were 35%, 5%, 58%, and 2%, respectively. The median age was 48 years (range: 24 to 67); 71% were male; 89% were White; and 2% were Black. At baseline, 74% and 26% of subjects reported injection drug use or daily injection drug use, respectively, in the past month; 56% had baseline HCV RNA levels at least 800,000 IU/mL; 10% had compensated cirrhosis; and all subjects were naïve to prior exposure with SOF or an HCV NS5A inhibitor. Subjects on MAT for opioid use disorder reported concomitant use of methadone (76%) and buprenorphine naloxone (17%) with sofosbuvir and velpatasvir. The overall SVR rate was 94% (97/103). One subject completed sofosbuvir and velpatasvir treatment and was re-infected with a phylogenetically different virus; the other 5 subjects who did not achieve SVR12 did not meet virologic failure criteria.

14.8 Clinical Trial in Pediatric Subjects

The efficacy of sofosbuvir and velpatasvir once daily for 12 weeks was evaluated in an open-label trial (Study 1143) in 214 genotype 1, 2, 3, 4, or 6 HCV treatment-naïve (N=188) or treatment-experienced (N=26) pediatric subjects 3 years of age and older without cirrhosis or with compensated cirrhosis.

Subjects 12 Years to <18 Years of Age: Sofosbuvir and velpatasvir was evaluated in 102 subjects 12 years to <18 years of age with genotype 1, 2, 3, 4, or 6 HCV infection. Among these subjects, 80 (78%) were treatment-naïve and 22 (22%) were treatment-experienced. The median age was 15 years (range: 12 to 17); 51% of the subjects were female; 73% were White, 9% were Black, and 11% were Asian; 14% were Hispanic/Latino; mean body mass index was 23 kg/m2 (range: 13 to 49 kg/m2); mean weight was 61 kg (range: 22 to 147 kg); 58% had baseline HCV RNA levels greater than or equal to 800,000 IU/mL; the proportions of subjects with genotype 1, 2, 3, 4, or 6 HCV infection were 74%, 6%, 12%, 2%, and 6%, respectively; no subjects had known cirrhosis. The majority of subjects (89%) had been infected through vertical transmission.

The SVR rate was 93% (71/76) in subjects with genotype 1 HCV infection and 100% in subjects with genotype 2 (6/6), genotype 3 (12/12), genotype 4 (2/2), and genotype 6 (6/6) HCV infection. One subject discontinued treatment at Week 4 and subsequently relapsed; the other four subjects who did not achieve SVR12 did not meet virologic failure criteria (lost to follow-up).

Subjects 6 Years to <12 Years of Age: Sofosbuvir and velpatasvir was evaluated in 71 subjects 6 years to <12 years of age with genotype 1, 2, 3, or 4 HCV infection. Among these subjects, 67 (94%) were treatment-naïve and 4 (6%) were treatment-experienced. The median age was 8 years (range: 6 to 11); 54% of the subjects were female; 90% were White, 6% were Black, and 1% were Asian; 10% were Hispanic/Latino; mean body mass index was 17 kg/m2 (range: 13 to 31 kg/m2); mean weight was 30 kg (range: 18 to 78 kg); 48% had baseline HCV RNA levels greater than or equal to 800,000 IU per mL; the proportions of subjects with genotype 1, 2, 3, or 4 HCV infection were 76%, 3%, 15%, and 6%, respectively; no subjects had known cirrhosis. The majority of subjects (94%) had been infected through vertical transmission.

The SVR rate was 93% (50/54) in subjects with genotype 1 HCV infection, 91% (10/11) in subjects with genotype 3 HCV infection, and 100% in subjects with genotype 2 (2/2) and genotype 4 (4/4) HCV infection. One subject had on-treatment virologic failure; the other four subjects who did not achieve SVR12 did not meet virologic failure criteria (lost to follow-up).

Subjects 3 Years to <6 Years of Age: Sofosbuvir and velpatasvir was evaluated in 41 treatment-naïve subjects 3 years to <6 years of age with genotype 1, 2, 3, or 4 HCV infection. The median age was 4 years (range: 3 to 5); 59% of the subjects were female; 78% were White, 7% were Black; 10% were Hispanic/Latino; mean body mass index was 17.0 kg/m2 (range: 13.9 to 22.0 kg/m2); mean weight was 19 kg (range: 13 to 35 kg); 49% had baseline HCV RNA levels greater than or equal to 800,000 IU per mL; the proportions of subjects with genotype 1, 2, 3, or 4 HCV infection were 78%, 15%, 5%, and 2%, respectively; no subjects had known cirrhosis. The majority of subjects (98%) had been infected through vertical transmission.

The SVR12 rate among all subjects was 83% (34/41); with 88% (28/32) in subjects with genotype 1 HCV infection, 50% (3/6) in subjects with genotype 2 HCV infection, and 100% in subjects with genotype 3 (2/2) and genotype 4 (1/1) HCV infection. None of the 34 subjects who completed the treatment had virologic failure. Of the remaining seven subjects who did not achieve SVR12, five discontinued treatment on Day 1, one on Day 7, and one on Day 20 [see Adverse Reactions (6.1)].

16 HOW SUPPLIED/STORAGE AND HANDLING

Each sofosbuvir and velpatasvir tablet contains 400 mg of sofosbuvir and 100 mg of velpatasvir, is pink, diamond-shaped, film-coated, debossed with “ASE” on one side and “9761” on the other. Each carton contains 28 tablets (2 blister cards each containing 14 tablets) (NDC 72626-2701-1).

Store below 30 °C (86 ºF).

17 PATIENT COUNSELING INFORMATION

Advise the patient to read the FDA-approved patient labeling (Patient Information and Instructions for Use).

Risk of Hepatitis B Virus Reactivation in Patients Coinfected with HCV and HBV

Inform patients that HBV reactivation can occur in patients coinfected with HBV during or after treatment of HCV infection. Advise patients to tell their healthcare provider if they have a history of HBV infection [see Warnings and Precautions (5.1)].

Serious Symptomatic Bradycardia When Coadministered with Amiodarone

Advise patients to seek medical evaluation immediately for symptoms of bradycardia such as near-fainting or fainting, dizziness or lightheadedness, malaise, weakness, excessive tiredness, shortness of breath, chest pain, confusion, or memory problems [see Warnings and Precautions (5.2), Adverse Reactions (6.2), and Drug Interactions (7.3)].

Drug Interactions

Inform patients that sofosbuvir and velpatasvir may interact with other drugs. Advise patients to report to their healthcare provider the use of any other prescription or nonprescription medication or herbal products including St. John’s wort [see Warnings and Precautions (5.2, 5.3) and Drug Interactions (7)].

Administration

Advise patients to take sofosbuvir and velpatasvir once daily on a regular dosing schedule with or without food. Inform patients that it is important not to miss or skip doses and to take sofosbuvir and velpatasvir for the duration that is recommended by the physician.

For sofosbuvir and velpatasvir (EPCLUSA) oral pellets, advise patients or caregivers to read and follow the Instructions for Use for preparing the correct dose [see Dosage and Administration (2.4, 2.5)].

Pregnancy

Advise patients to avoid pregnancy during combination treatment with sofosbuvir and velpatasvir and ribavirin and for 6 months after completion of treatment. Inform patients to notify their healthcare provider immediately in the event of a pregnancy [see Use in Specific Populations (8.1)].

Manufactured for:
Asegua Therapeutics LLC
An affiliate of Gilead Sciences, Inc.Foster City, CA 94404

Asegua is a trademark of Asegua Therapeutics LLC. All other trademarks referenced herein are the property of their respective owners.

208341-AG-010

This Patient Information has been approved by the U.S. Food and Drug Administration. Revised: 06/2021
PATIENT INFORMATIONSofosbuvir and Velpatasvir(soe fos’ bue vir and vel pat’ as vir)Tablets (400 mg/100 mg)Authorized generic of EPCLUSA®
Important: If you take sofosbuvir and velpatasvir with ribavirin, you should also read the Medication Guide for ribavirin.
What is the most important information I should know about sofosbuvir and velpatasvir?Sofosbuvir and velpatasvir can cause serious side effects, including: Hepatitis B virus reactivation: Before starting treatment with sofosbuvir and velpatasvir, your healthcare provider will do blood tests to check for hepatitis B virus infection. If you have ever had hepatitis B virus infection, the hepatitis B virus could become active again during or after treatment of hepatitis C virus with sofosbuvir and velpatasvir. Hepatitis B virus becoming active again (called reactivation) may cause serious liver problems including liver failure and death. Your healthcare provider will monitor you if you are at risk for hepatitis B virus reactivation during treatment and after you stop taking sofosbuvir and velpatasvir. For more information about side effects, see the section “What are the possible side effects of sofosbuvir and velpatasvir?
What is sofosbuvir and velpatasvir? Sofosbuvir and velpatasvir is a prescription medicine used to treat adults and children 3 years of age and older with chronic (lasting a long time) hepatitis C virus (HCV) genotype 1, 2, 3, 4, 5, or 6 infection:
  • without cirrhosis or with compensated cirrhosis.
  • with advanced cirrhosis (decompensated) in combination with ribavirin.
It is not known if sofosbuvir and velpatasvir is safe and effective in children under 3 years of age.
Before taking sofosbuvir and velpatasvir, tell your healthcare provider about all of your medical conditions, including if you:
  • have ever had hepatitis B virus infection
  • have liver problems other than hepatitis C infection
  • have had a liver transplant
  • have kidney problems or you are on dialysis
  • have HIV-1 infection
  • are pregnant or plan to become pregnant. It is not known if sofosbuvir and velpatasvir tablets will harm your unborn baby.
    • Females who take sofosbuvir and velpatasvir in combination with ribavirin should avoid becoming pregnant during treatment and for 6 months after stopping treatment. Call your healthcare provider right away if you think you may be pregnant or become pregnant during treatment with sofosbuvir and velpatasvir in combination with ribavirin.
    • Males and females who take sofosbuvir and velpatasvir in combination with ribavirin should also read the ribavirin Medication Guide for important pregnancy, contraception, and infertility information.
  • are breastfeeding or plan to breastfeed. It is not known if sofosbuvir and velpatasvir passes into your breast milk.
    • Talk to your healthcare provider about the best way to feed your baby during treatment with sofosbuvir and velpatasvir.
Tell your healthcare provider about all of the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Sofosbuvir and velpatasvir and other medicines may affect each other. This can cause you to have too much or not enough sofosbuvir and velpatasvir or other medicines in your body. This may affect the way sofosbuvir and velpatasvir or your other medicines work or may cause side effects.Keep a list of your medicines to show your healthcare provider and pharmacist.
  • You can ask your healthcare provider or pharmacist for a list of medicines that interact with sofosbuvir and velpatasvir.
  • Do not start taking a new medicine without telling your healthcare provider. Your healthcare provider can tell you if it is safe to take sofosbuvir and velpatasvir with other medicines.
How should I take sofosbuvir and velpatasvir?
  • Take sofosbuvir and velpatasvir exactly as your healthcare provider tells you to take it. Do not change your dose unless your healthcare provider tells you to.
  • Do not stop taking sofosbuvir and velpatasvir without first talking with your healthcare provider.
  • Take sofosbuvir and velpatasvir by mouth, with or without food.
  • For adults the usual dose of sofosbuvir and velpatasvir is one 400/100 mg tablet each day.
  • For children 3 years of age and older your healthcare provider will prescribe the right dose of sofosbuvir and velpatasvir based on your child’s body weight.
  • Do not miss a dose of sofosbuvir and velpatasvir. Missing a dose lowers the amount of medicine in your blood. Refill your sofosbuvir and velpatasvir prescription before you run out of medicine.
  • If you take too much sofosbuvir and velpatasvir, call your healthcare provider or go to the nearest hospital emergency room right away.
How should I give sofosbuvir and velpatasvir (EPCLUSA) oral pellets to my child?See the detailed Instructions for Use for information about how to give or take a dose of sofosbuvir and velpatasvir (EPCLUSA) oral pellets.
  • Administer sofosbuvir and velpatasvir (EPCLUSA) oral pellets exactly as instructed by your healthcare provider.
  • Sofosbuvir and velpatasvir (EPCLUSA) oral pellets can be taken with food or directly in the mouth.
  • For children younger than 6 years, take sofosbuvir and velpatasvir (EPCLUSA) oral pellets with food.
  • Sofosbuvir and velpatasvir (EPCLUSA) oral pellets should be swallowed whole. Do not chew sofosbuvir and velpatasvir (EPCLUSA) oral pellets to avoid a bitter aftertaste.
  • Do not open the sofosbuvir and velpatasvir (EPCLUSA) oral pellets packet until ready to use.
What are the possible side effects of sofosbuvir and velpatasvir? Sofosbuvir and velpatasvir can cause serious side effects, including:
  • Hepatitis B virus reactivation. See “What is the most important information I should know about sofosbuvir and velpatasvir?
  • Slow heart rate (bradycardia). Sofosbuvir and velpatasvir treatment may result in slowing of the heart rate along with other symptoms when taken with amiodarone (Cordarone® , Nexterone® , Pacerone®), a medicine used to treat certain heart problems. In some cases bradycardia has led to death or the need for a heart pacemaker when amiodarone is taken with medicines similar to sofosbuvir and velpatasvir tablets that contain sofosbuvir. Get medical help right away if you take amiodarone with sofosbuvir and velpatasvir tablets and get any of the following symptoms:
  • fainting or near-fainting
  • dizziness or lightheadedness
  • not feeling well
  • weakness
  • extreme tiredness
  • shortness of breath
  • chest pains
  • confusion
  • memory problems
  • The most common side effects of sofosbuvir and velpatasvir in adults and children 6 years of age and older include headache and tiredness.
  • The most common side effects of sofosbuvir and velpatasvir when used with ribavirin in adults with decompensated cirrhosis are tiredness, low red blood cells, nausea, headache, trouble sleeping, and diarrhea.
  • The most common side effects of sofosbuvir and velpatasvir in children younger than 6 years of age are vomiting and problems with spitting up the medicine.
These are not all the possible side effects of sofosbuvir and velpatasvir.Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
How should I store sofosbuvir and velpatasvir tablets?
  • Store sofosbuvir and velpatasvir tablets below 86°F (30°C).
Keep sofosbuvir and velpatasvir tablets and all medicines out of the reach of children.
General information about the safe and effective use of sofosbuvir and velpatasvir Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use sofosbuvir and velpatasvir for a condition for which it was not prescribed. Do not give sofosbuvir and velpatasvir to other people, even if they have the same symptoms you have. It may harm them. You can ask your healthcare provider or pharmacist for information about sofosbuvir and velpatasvir that is written for health professionals.
What are the ingredients in sofosbuvir and velpatasvir tablets (400 mg/100 mg)? Active ingredients: sofosbuvir and velpatasvirInactive ingredients: copovidone, croscarmellose sodium, magnesium stearate, and microcrystalline cellulose.The tablet film-coat contains: iron oxide red, polyethylene glycol, polyvinyl alcohol, talc, and titanium dioxide.Manufactured for:Asegua Therapeutics LLC, an affiliate of Gilead Sciences, Inc., Foster City, CA 94404For more information, call 1-800-445-3235 or go to www.asegua.com.Asegua is a trademark of Asegua Therapeutics LLC. All other trademarks referenced herein are the property of their respective owners.208341-AG-010

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