Telaprevir

The studies showed a 75 percent cure rate for hepatitis C in patients treated with a telaprevir-containing regimen over 24 weeks. The numbers are impressive, but TheStreet.com says they are largely what investors were expecting for a viral cure rate. About 55 percent of patients treated with telaprevir overall achieved viral cure within the 24-week treatment, a drop in what was observed in previous phase II studies.

Another concern is the development of SJS in a patient enrolled in the phase III study. The condition was diagnosed 11 weeks after telaprevir dosing had ended. The patient was hospitalized and eventually made a full recovery, but the question is how the FDA will react to the report. SJS, an allergic reaction to medication linked to numerous drugs, can be life threatening. It presents with a rash that can occur during use or even weeks or months after the medication has been discontinued.

Only 1.4 percent of the patients treated with telaprevir reported having discontinued the medication because of rash. While the number is low, rash is still an adverse event and, TheStreet.com says, “the disclosure of even one case of SJS puts the drug’s safety profile under further scrutiny.”

SOURCE: Stevens Johnson Syndrome › Study on new hepatitis C drug shows possible SJS link

The study is the largest conducted to-date focusing on Latino patients with the hepatitis C virus. The virus is a blood-borne infectious disease of the liver that can lead to cirrhosis, liver cancer and the need for liver transplants. Hepatitis C is reported to affect Latino patients differently than non-Latino patients. The Latino population is the largest-growing minority in the United States and has a higher prevalence of hepatitis C. The virus also has a faster progression and a much higher mortality among Latinos than non-Latinos.

PEGASYS is produced by New Jersey-based Hoffman-La Roche Inc. It can be used alone or in combination with COPEGUS, for the treatment of adults with chronic hepatitis C who have compensated liver disease. The medication was found most effective in patients with compensated liver disease and histological evidence of cirrhosis.

However, erythema multiforme major, also known as SJS, was reported among the serious adverse events that occurred during post-approval use of PEGASYS therapy. SJS is a rare but life-threatening reaction to medication that begins as a rash that blisters over, causing the skin to peel off in sheets. It also affects the mucus membranes, such as eyes, mouth and vagina, which can blister over and lead to dehydration, infection and serious eye problems such as blindness. More than 200 medications have been linked to SJS.

If you experience a rash or blistering while taking PEGASYS or any other medication, healthcare officials advise you contact your doctor and go to the emergency room.

SOURCE: Stevens Johnson Syndrome › Hepatitis C treatment proven effective but linked to SJS