Sovaldi: A clear step forward in Hep C treatment

SOVALDI combination therapy cure rates in clinical studies

SOVALDI is a groundbreaking hepatitis C (Hep C) treatment. Clinical studies have shown that SOVALDI combination therapy can be effective for people with genotypes 1, 2, 3, and 4.

SOVALDI combination therapy is the first all-oral treatment for genotypes 2 and 3.

What is a genotype?

Just as there are different blood types, there are also different types of Hep C, called genotypes. There are 6 main genotypes. SOVALDI has been shown to work in genotypes 1, 2, 3, and 4. SOVALDI combination therapy is the first all-oral treatment for genotypes 2 and 3.

Your healthcare provider can use a simple blood test to find out your type. Knowing your genotype can help your healthcare provider choose the right treatment for you. It can also affect the length of your treatment and your chance of being cured. Cure means the Hep C virus is not detected in the blood when measured 3 months after treatment is completed.

Hep C percentages in the U.S. by genotype

  • Genotype 1—78%
  • Genotype 2—13%
  • Genotype 3—6%
  • Other Genotypes—3%

The table below includes the percentages of patients, in SOVALDI clinical studies, who were cured of the Hep C virus. Cure means the Hep C virus is not detected in the blood when measured 3 months after treatment is completed.

GENOTYPE DURATION TREATMENT CURE RATE
1 OR 4 12 WEEKS SOVALDI + ribavirin + peginterferon alfa 90% / 96%
2 12 WEEKS SOVALDI + ribavirin 93%
3 24 WEEKS SOVALDI + ribavirin 84%

Clinical study details

CURE RATES

Genotype 1 (GT1) and genotype 4 (GT4):
In a clinical study of 327 patients, among those with Hep C genotypes 1 and 4 without prior Hep C treatment taking SOVALDI + ribavirin + peginterferon alfa for a treatment duration of 12 weeks, the cure rate was 90% (289 out of 320 patients studied).

Specifically for GT1 the cure rate was 90% (262 out of 292 patients studied), and for GT4 the cure rate was 96% (27 out of 28 patients studied).

CURE RATES

Genotype 2 (GT2) and genotype 3 (GT3):
In a clinical study of patients with Hep C genotypes 2 or 3 with and without prior Hep C treatment taking SOVALDI + ribavirin, the cure rate for patients with GT2 was 93% (68 out of 73 patients studied) and the cure rate for patients with GT3 was 84% (210 out of 250 patients studied).

Other Hep C clinical studies in GT2 patients with and without prior Hep C treatment:

For patients with GT2, cure rates ranged from 82% to 95% for a treatment duration of 12 or 16 weeks of SOVALDI + ribavirin. For GT2, the approved treatment duration is 12 weeks of SOVALDI + ribavirin

SOVALDI is a prescription medicine used with other antiviral medicines to treat chronic (lasting a long time) hepatitis C genotype 1, 2, 3, or 4 infection in adults. It is not known if SOVALDI is safe and effective in children under 18 years of age.

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; are pregnant or plan to become pregnant; or if you are breastfeeding or plan to breastfeed. It is not known if SOVALDI passes into your breast milk.
  • If you take amiodarone (Cordarone®, Nexterone®, Pacerone®), 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.

You should not take SOVALDI if you also take other medicines that contain sofosbuvir (HARVONI®).

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.

SOVALDI, the SOVALDI logo, HARVONI, ONWARD, the ONWARD logo, SUPPORT PATH, the SUPPORT PATH logo, GILEAD, and the GILEAD logo are trademarks of Gilead Sciences, Inc., or its related companies. All other trademarks referenced herein are the property of their respective owners.
©2016 Gilead Sciences, Inc. All rights reserved. SVDC0295 06/16

SEE MORE  +

SOVALDI is a prescription medicine used with other antiviral medicines to treat chronic (lasting a long time) hepatitis C genotype 1, 2, 3, or 4 infection in adults. It is not known if SOVALDI is safe and effective in children under 18 years of age.

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; are pregnant or plan to become pregnant; or if you are breastfeeding or plan to breastfeed. It is not known if SOVALDI passes into your breast milk.
  • If you take amiodarone (Cordarone®, Nexterone®, Pacerone®), 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.

You should not take SOVALDI if you also take other medicines that contain sofosbuvir (HARVONI®).

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.