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r r C . . 1 Genot Genot 1 Genot Genot 1 1 Genot 1 h h W a cirrh 65 Side for Sof o d compensated cirr M food, for 1 Some people h **R How ar gets appr T * combination of th combination Wha (sofos low 2 fatigue, and nausea, us T 1 Wha The goal of (HCV) treatment is a cure (when there is no HCV in a person’s bloodstream at least 12 weeks at least person’s bloodstream in a is no HCV (when there is a cure treatment (HCV) C virus of hepatitis The goal ) is finished treatment after Does sofosbuvir/daclatasvir work with HIV drugs? Sofosbuvir/daclatasvir can be used with some HIV medicines, but doses may need to be adjusted from the standard 60 mg/day adult dose. Check with your doctor prior to taking sofosbuvir/daclatasvir regarding possible drug interactions. SOFOSBUVIR/DACLATASVIR Sofosbuvir/daclatasvir and other medications: Sofosbuvir/daclatasvir can be coadministered with opiate substitution medicines (e.g., buprenorphine or ) with no dose adjustments needed. Combining medications can increase or decrease drug levels (called drug-drug interactions). An increase can make side effects worse. A decrease can prevent a drug from working, putting people at risk for resistance or not being cured.

Sofosbuvir/daclatasvir should not be used in people taking the heart rhythm medication because sofosbuvir in combination with amiodarone can cause life-threatening heart problems. Do not take St. John’s wort herbal supplements with sofosbuvir/daclatasvir, and tell your doctor if you are taking statins or medications for cancer, seizures, bacterial infections or heartburn/acid reflux.

Talk with your health care provider before starting or stopping any medications, supplements, or herbal remedies.

Sofosbuvir/Daclatasvir and HIV Treatments (Antiretrovirals)

HIV protease inhibitors Atazanavir/ or atazanavir/cobicistat Reduce daclatasvir to 30 mg. (Reyataz) HIV integrase inhibitors Fixed-dose combination of elvitegravir, cobicistat, Reduce daclatasvir to 30 mg. , and tenofovir DF (Stribild) HIV non-nucleoside reverse transcriptase inhibitors (Sustiva, Atripla) Increase daclatasvir to 90 mg. Etravirine or nevirapine (Intelence, Viramune) Not recommended for use with sofosbuvir/daclatasvir. Tenofovir DF (Viread, Truvada, Atripla, Complera, No dose adjustment required. No known issue with TDF and Stribild) daclatasvir.

Storing sofosbuvir/daclatasvir: Keep sofosbuvir and daclatasvir at room temperature (below 30°C [86°F]).

Sofosbuvir/daclatasvir in people with kidney disease: Sofosbuvir/daclatasvir is not recommended for use in persons with severe renal impairment (chronic kidney failure grades 4 and 5).

Sofosbuvir/daclatasvir in people with : HCV treatment guidelines recommend that people with serious liver damage (Child-Pugh Class B or C) be treated by a specialist. Use of sofosbuvir/daclatasvir has been demonstrated to be generally safe and effective in people with cirrhosis (compensated and decompensated), but treatment duration may need to be adjusted based on the hepatitis C genotype. In addition, may be added to the treatment regimen.

Sofosbuvir/daclatasvir during pregnancy or nursing and in children: It is not known whether sofosbuvir/ daclatasvir causes harm to unborn babies or passes into breast milk. If you are pregnant or breast feeding, or planning for either, talk with your health care provider about the risks and benefits of HCV treatment. In animal studies of pregnant rats and rabbits, very high doses of sofosbuvir/daclatasvir caused birth defects, miscarriage, and maternal death. No harm was seen at lower doses.

Sofosbuvir/daclatasvir is currently being tested in children younger than 18 years old, but is not yet recommended for use in this age group.

Access to sofosbuvir/daclatasvir may be restricted by public and private payers. The criteria differ depending on the type of coverage and the state in which the coverage is issued. Support Path is Gilead’s patient assistance program for Sovaldi. People with private insurance may be eligible for assistance with copayments. Uninsured people may be eligible for medication at no charge. Information about Support Path is available by phone at 1-855-769-7284, Monday through Friday between 9:00 a.m. and 8:00 p.m. (Eastern Time), or online at https://www.gilead.com/purpose/medication-access/us-patient-access.

This fact sheet is current as of May 2019. Always check for updated information.