The Food and Drug Administration has given its approval for the expanded private labeling of Gilead Sciences, Inc. (NASDAQ:GILD) Epclusa. Previously it was only approved for treating adult patients suffering from chronic hepatitis C but can now be used in patients who have been co-infected with the Human Immuno-Deficiency Virus.
Epclusa got the approval of U.S. regulators in treating hepatitis C last year in June. However, users of epclusa are at risk of hepatitis B being reactivated in their system.
“Epclusa has already helped further simplify HCV treatment among mono-infected patients, and we are pleased that HCV/HIV co-infected patients can benefit from this pan-genotypic single tablet regimen,” said the chief executive officer and president of Gilead Sciences, John Milligan.
Phase 3 study
The development comes after a phase 3 study was conducted for a period of 12 weeks on patients who were suffering from hepatitis C and who were also co-infected with the HIV virus. One of the conditions for participating in the study was that patients had to be on an antiretroviral therapy. Results of the study showed that 95% of the participants were able to achieve the primary endpoint which was a viral load that was undetectable after completing therapy for a period of 12 weeks.
Some of the adverse events that were observed among participants of the study include headaches and fatigue. Headaches were observed in 10% of the participants while fatigue was observed in 22% of the participants.
In order to offer support to patients as well as their families in the United States, Gilead runs a program which offers information concerning reimbursement coverage options for those who require assistance. The assistance that may be provided includes co-pay assistance for patients who are eligible and who possess private insurance and need aid in meeting the medication costs that are out-of-pocket.
Gilead Sciences has also pledged commitments towards ensuring epclusa is available across the globe. In that regard the generic versions of epclusa will be distributed to 101 countries in the developing world.
On Tuesday shares of Gilead Sciences fell by 0.51% to close the day at $75.70.