Hepatitis Drug Sovaldi by Gilead combination therapy with ribavirin

Gilead Earnings Surge As Hep C Drug Shatters Views

Gilead Sciences late Tuesday blew past Q1 revenue and earnings forecasts as sales of its new hepatitis C drug Sovaldi far exceeded expectations, but fellow big biotech Amgen missed expectations. Gilead (GILD) stock was up 2.5% after hours, after its Q1 report included sales of $2.27 billion for the expensive Sovaldi, which it started selling in December.

Important Safety Information

What is the most important information I should know about SOVALDI?
SOVALDI combination therapy with ribavirin or peginterferon alfa and ribavirin can cause birth defects or death of your unborn baby. If you or your sexual partner is pregnant or plans to become pregnant, do not take these medicines.

• You and your sexual partner must use 2 effective forms of birth control and should not become pregnant while being treated with SOVALDI combination therapy and for 6 months after your treatment is over. Talk to your doctor about forms of birth control.
• If you or your partner can become pregnant you must have a pregnancy test before starting treatment with SOVALDI combination therapy, every month while being treated, and for 6 months after your treatment ends.
• Tell your healthcare provider right away if a pregnancy occurs while taking or within 6 months after you stop taking SOVALDI combination therapy. You or your healthcare provider should contact the Ribavirin Pregnancy Registry. If you are also infected with HIV and taking medicines to treat your HIV infection, an Antiretroviral Pregnancy Registry is also available. For contact information, please see full Prescribing Information.

You should not take SOVALDI alone. SOVALDI should be used together with ribavirin or in combination with peginterferon alfa and ribavirin to treat chronic hepatitis C infection.
More Important Safety Information

What should I tell my healthcare provider before taking SOVALDI?

• If you have: liver problems other than hepatitis C infection; had a liver transplant; severe kidney problems or are on dialysis; HIV; any other medical condition; or if you are breastfeeding or plan to breastfeed. You and your healthcare provider should decide if you will take SOVALDI or breastfeed. You should not do both.
• If you take rifampin (Rifadin^®, Rifamate^®, Rifater^®), St. John’s wort or a product that contains St. John’s wort. Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Other medicines may affect how SOVALDI works.

What are the most common side effects of SOVALDI?
For SOVALDI used in combination with ribavirin they include tiredness and headache and for SOVALDI used in combination with peginterferon alfa and ribavirin they include the additional side effects of nausea, difficulty sleeping, and low red blood cell count.

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