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Middle-aged adults with diabetes more likely to develop age-related ailments

September 18, 2017

In the HCV SPRINT-2 study in treatment-na??ve patients, the five most common treatment-related adverse events reported for patients receiving VICTRELIS in RGT, VICTRELIS in a 48-week treatment regimen and control, respectively, were: fatigue (53, 57 and 60 percent), headache (46, 46 and 42 percent), nausea (48, 43 and 42 percent), anemia (49, 49 and 29 percent) and dysgeusia (bad taste) (37, 43 and 18 percent). Serious adverse events were reported in 11, 12 and 9 percent of patients in the study arms, respectively. There were six deaths during the study: four patients in the control group died, as did two patients in the VICTRELIS groups. Two suicides (one patient in the control group and one patient receiving VICTRELIS in RGT) were judged to have possibly been related to peginterferon. No other deaths were considered to be drug-related.

In HCV SPRINT-2, treatment discontinuations due to adverse events over the total course of all treatment were 12 percent and 16 percent for patients receiving VICTRELIS in RGT and VICTRELIS in a 48-week treatment regimen, respectively, compared to 16 percent for control. Treatment discontinuations due to anemia were 2 percent for each of the treatment groups receiving VICTRELIS compared to 1 percent for control. EPO for management of anemia was allowed at the discretion of the investigator per the study protocol, and was used by 43 percent of patients in each of the treatment groups receiving VICTRELIS compared to 24 percent for control.

In the HCV RESPOND-2 study in treatment-failure patients, the five most common treatment-related adverse events reported for patients receiving VICTRELIS in RGT, VICTRELIS in a 48-week treatment regimen and control, respectively, were: fatigue (54, 57, and 50 percent), headache (41, 39 and 48 percent), nausea (44, 39 and 38 percent), anemia (43, 46 and 20) and chills (35, 30 and 30 percent). Serious adverse events were reported in 10, 14 and 5 percent of patients in the study arms, respectively. There was one death in the study, a suicide in the group receiving VICTRELIS in RGT, which occurred 18 weeks after the end of the study treatment and was considered to be unrelated to the study treatment.

In HCV RESPOND-2, treatment discontinuations due to adverse events over the total course of all treatment were 8 percent and 12 percent for patients receiving VICTRELIS in RGT and VICTRELIS in a 48-week treatment regimen, respectively, compared to 2 percent for control. Treatment discontinuations due to anemia were 0 percent and 3 percent for the treatment groups receiving VICTRELIS, respectively, compared to 0 percent for control. Erythropoietin (EPO) for management of anemia was allowed at the discretion of the investigator per the study protocol, and was used by 41 and 46 percent of patients receiving VICTRELIS in RGT and VICTRELIS in a 48-week treatment regimen, respectively, compared to 21 percent for control.

Merck's global commitment to advancing hepatitis therapy

Merck is committed to building on its strong legacy in the field of viral hepatitis by continuing to discover, develop and deliver vaccines and medicines to help prevent and treat viral hepatitis. In hepatitis C, company researchers developed the first approved therapy for chronic HCV in 1991 and the first combination therapy in 1998. 2011 marks the 10-year anniversary of the introduction of PEGINTRON and ribavirin in combination therapy, a current standard therapy for chronic HCV worldwide. In addition to ongoing studies with VICTRELIS, extensive research efforts are underway to develop additional innovative oral therapies for viral hepatitis care.

Source: Merck