Real-world Study Shows Lab-made Kovaltry Works Better for Hem A

Vanda Pinto, PhD avatar

by Vanda Pinto, PhD |

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Kovaltry real-world study | Hemophilia News Today | illustration of patient in chair receiving intravenous therapy

Patients with hemophilia A who switched to Kovaltry (octocog alfa) — a recombinant, or lab-made, factor VIII (rFVIII) replacement therapy given at home — had significantly fewer bleeds than with their previous standard half-life replacement therapies, a real-world study in Italy reported.

The therapy also reduced the frequency of infusions and the overall consumption of rFVIII.

Overall, after at least one year of treatment, the proportion of patients with zero bleeds increased by more than 50%, the data showed.

“To our knowledge, this is the first Italian study assessing the real-world impact of [Kovaltry], one of the first rFVIII products to offer patients the possibility to be treated even with two administrations per week [as preventive treatment],” the researchers wrote.

The study, “Real-World Clinical Outcomes and Replacement Factor VIII Consumption in Patients with Haemophilia A in Italy: A Comparison between Prophylaxis Pre and Post Octocog Alfa (BAY 81-8973),” was published in the Journal of Clinical Medicine.

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Hemophilia A is caused by a deficiency in FVIII, a blood-clotting protein. One of the standard treatments for the disorder is replacement therapy, which involves the infusion of an altered version of FVIII, to stop or prevent bleeds. The therapy can be given either on-demand or as prophylaxis.

Marketed by Bayer, Kovaltry is a recombinant replacement therapy given as an into-the-vein (intravenous) at-home infusion. Treatment frequency and dosing depend on the needs of the patient, and their symptom severity.

Kovaltry was one of the first rFVIII concentrates that allowed a twice-a-week prophylaxis regimen in some patients. This therapy is a standard half-life (SHL) product, meaning it works for shorter periods of time than the more recent extended half-life products. Yet, it has a longer half-life than other standard half-life FVIII replacement therapies.

Thus far, only a few studies have compared the effectiveness of prophylaxis with Kovaltry in real-world settings with other standard half-life treatments.

To address this gap, researchers in Italy now analyzed data from patients followed at five hemophilia centers in the country, who had been enrolled between January 2019 and April 2020. All had switched to Kovaltry after being on preventive standard half-life FVIII replacement therapies with other products.

The study included hemophilia A patients, independent of age or disease severity, on prophylaxis with Kovaltry for at least a year.

A total of 44 patients — all men, ranging in age from 12 to 72 (mean of 37.2 years) — were ultimately included in the analysis. Nearly all (95.5%) had severe hemophilia.

Before switching to Kovaltry, 33 patients received Kogenate FS and eight were treated with Helixate Nexgen. Three patients used Advate, Refacto AF, or more than one product. The median prophylaxis treatment period before the switch was nine years.

The most common reason for switching, indicated by 59.09% of patients, was the need for more protection against bleeds. Another factor, reported by 36.36% of patients, was an intention to increase compliance by reducing the frequency of infusions.

Data analysis showed the mean annualized bleeding rate (ABR) was significantly reduced following the switch to Kovaltry (1.76 vs. 0.23). Additionally, the percentage of patients with zero bleeds increased from 54.5% to 84.1%. Before and after the switch, most breakthrough bleeds were joint bleeds.

A 7.2% reduction in overall FVIII consumption also was observed after the change to Kovaltry (355,066 IU vs. 329,524 IU). In fact, the annual FVIII consumption for on-demand treatment of bleeds significantly decreased by 87% (from 13,746 IU to 1,817 IU). On the other hand, consumption for the prophylaxis regimen was only slightly lower (4%) after the switch.

Other analyses showed the percentage of patients treated every three days or twice-weekly increased from 0% to 27.3% after changing to Kovaltry.

“Our study provided new evidence to understand the real-world impact of prophylaxis with [Kovaltry], a non-modified [standard half-life] rFVIII product with indication also for a two-times-a-week regimen,” the researchers wrote.

The use of [Kovaltry] in patients enrolled in our study resulted in an improvement in ABR and a reduction in both frequency of administration and overall FVIII consumption, highlighting the possibility of a more flexible dosing regimen,” they wrote.

According to the researchers, the study suggests that Kovaltry worked better than other standard half-life treatments for hemophilia A patients.

“An approach that reduces the number of infusions, such as that shown for [Kovaltry], could lead to an improvement in the patient quality of life, as well as inducing potential savings for the National Health System,” the team added.

Several authors of this study received grants from Bayer.