Tag Archives: velpatasvir

Quick Hits: New Breast Cancer Drugs Have Fewer Side Effects, Antidepressant Use in Pregnancy and Autism & More

A new class of oral drugs for treating the most common type of breast cancer, known as cyclin-dependent kinase (CDK) inhibitors, appears to have fewer adverse events and side effects for most patients compared to other treatments. There are 2 CDK inhibitors currently on the market: Ibrance (palbociclib), approved in February 2015, and Kisqali (ribociclib), which was just approved in March. Both are used to treat hormone receptor-positive (HR+) metastatic breast cancer. A third CDK inhibitor, abemaciclib, is in late-stage development. Researchers examined all publicly available trials for the 3 drugs. The most common side effect was low white blood cells, a condition known as neutropenia that can lead to infection, though it was seen less in abemaciclib. However, neutropenia was usually temporary or resolved with a dose reduction. Other, more common side effects seen with the medications were diarrhea and fatigue. Less common side effects observed were nausea and alopecia (hair loss), though these were mild and treated through a dose reduction or a break from the drug. Posted July 14, 2017. Via The Oncologist.

Children exposed to antidepressants during pregnancy may have a slightly higher risk of developing autism than children of mothers with mental illness who didn’t receive the drugs. Researchers, however, stress that the absolute risk of autism was small, so the results should not be considered alarming. A team at the University of Bristol (UK) analyzed data from 254,610 individuals aged 4-17 of which 5,378 had autism. Of the 3,342 children exposed to antidepressants during pregnancy, 4.1% (136) had a diagnosis of autism compared with 2.9% (353) in 12,325 children not exposed to antidepressants whose mothers had a history of a psychiatric disorder. Researchers noted that overall, 95% of women who took antidepressants did not have a child with autism. An accompanying editorial noted that the results should not dissuade women with depression from using antidepressants in pregnancy since untreated depression can lead to “ substantial health consequences.” Posted July 19, 2017. Via The BMJ.

The FDA has approved a new hepatitis C (HCV) medication, Vosevi. The drug is actually a combination of two existing anti-viral treatments, sofosbuvir and velpatasvir (sold as Epclusa), and a new drug, voxilaprevir. Vosevi is for patients with HCV without liver disease (cirrhosis) or with a mild form of cirrhosis. Results from 2 late-stage trials demonstrated that 96-97% of patients who received Vosevi had no HCV detected in their blood 12 weeks after finishing treatment, an indication the infection has been cured. The most common side effects in patients taking Vosevi were headache, fatigue, diarrhea and nausea. Posted July 18, 2017. Via FDA.

 

FDA Approves First Pill to Treat All Types of Hepatitis C

The FDA has approved the first drug to treat all 6 forms of the hepatitis C virus, though it won’t come cheap: A 12-week treatment course has a list price of $74,760.

Epclusa (sofosbuvir/velpatasvir) was approved to treat chronic hepatitis C virus (HCV), both with and without cirrhosis of the liver. Sofosbuvir, better known under its brand name Solvadi, was already approved back in 2013 to treat 4 genotypes of the HCV. Velpatasvir is an entirely new drug.

The approval of the combination pill, taken once a day, is considered a boost for patients because other oral HCV treatments require genetic testing to determine if a particular drug will work on them.

Epclusa was tested in 3 late-stage clinical trials that included more than 1,500 people with mild liver cirrhosis or no cirrhosis at all. Results indicated that between 95% and 99% of patients who received Epclusa had no HCV detected in the blood 12 weeks after finishing treatment, an indication the infection has been cured.

Side Effects

The most common side effects seen in these trials were headache and fatigue. However, Epclusa’s labeling also includes a warning that serious slowing of the heart rate, a condition known as symptomatic bradycardia, has occurred. Additionally, there are cases in which some patients have needed a pacemaker when sofosbuvir was used in combination with Corderone or Pacerone (amiodorone), a medication used to treat abnormal heart beat.

Epclusa’s label carries a warning not to use with certain drugs that may reduce the amount of Epclusa in the blood, which could minimize its efficacy. The other drugs include the anticonvulsant and mood stabilizer Tegretol (carbamazepine); Rifadin (rifampin), an antibiotic used to treat tuberculosis; and the herbal supplement St. John’s wort.

HCV affects between 130 million and 150 million people worldwide, according to the World Health Organization.