"Real world" data from pharmacies show the new hepatitis C protease inhibitors Incivek (telaprevir) and Victrelis (boceprevir) are working as well, and in some cases better, than clinical trials suggested they would, Specialty Pharmacy News reports.
The preliminary results come from Burman's Specialty Pharmacy, based in Brookhaven, Pennsylvania. About 700 pharmacy clients living with genotype 1 hepatitis C virus (HCV) infection were prescribed either drug in combination with pegylated interferon and ribavirin soon after the meds were approved. These clients have now reached week 24 of therapy. This is an important time point, as those who are able to decrease their viral loads to undetectable within the first few months of treatment may qualify for response-guided therapy, meaning that they could discontinue all medications after 24 weeks instead of taking a full 48-week course.
Out of a sample of 77 patients starting HCV treatment for the first time with an Incivek-inclusive regimen, Burman's reports, 75 percent were eligible for response-guided therapy. This is "actually a little bit better than [clinical trial results]," said Steve Burman, CEO of Burman's Medical Supplies and Specialty Pharmacy and president of Burman's Pharmacy.
Among those starting hepatitis C therapy with a regimen that included Victrelis, 66 percent achieved an early viral response (EVR) and thus qualified for response-guided therapy.
Burman's has also followed people living with hepatitis C who were unable to cure their infections after an initial round of pegylated interferon plus ribavirin and who started therapy again with the addition of the protease inhibitors. On par with clinical trial results, roughly 91 percent were eligible for response-guided therapy.
Not only is a shortened treatment regimen personally beneficial to the patient, but it also saves a lot of money in drug costs. One study, Burman noted, indicated that shortened treatment can save the U.S. health care system up to $16,200 per person.
Protease inhibitor dosing is complex, the Specialty Pharmacy News article notes. Victrelis is not added to pegylated interferon and ribavirin until after four weeks of treatment with the other two drugs, while Incivek is started at the same time as the other drugs, but is removed from the pegylated interferon-ribavirin regimen after the first 12 weeks of treatment.
The protease inhibitors can also add to the known, sometimes serious, side effects of pegylated interferon and ribavirin. Both Incivek and Victrelis can increase the risk of anemia and rashes. Of Burman's clients who discontinued Incivek, for example, 44 percent did so because of side effects, while only 30 percent discontinued because they weren't responding to treatment.
Adherence has also been a challenge. One particular issue involves obtaining medications in a timely manner, especially when drugs are procured via mail order. Burman said that 25 percent to 30 percent of patients receiving meds from his company switched to mail order after one to two months but that this can result in orders being delayed or not arriving at all, which disrupts the treatment regimen.
On the plus side, Burman said that the complexities of the new triple therapy actually work in favor of adherence. It's necessary for pharmacies to maintain close contact with patients in order to ensure they take their medications on schedule and come in for lab work. Based on the lab results, patients "at four weeks, at eight weeks will have a good idea of if they will clear the virus," Burman said, and as a result, they "are motivated to finish therapy."