Prime Therapeutics recently announced that 97% of hepatitis C patients who were treated with Gilead’s Harvoni (ledipasvir/sofosbuvir) were cured of the virus in a new real-world study. The results obtained are similar to those previously found in clinical trials, which ranged from 94% to 99%.
Prime, a pharmacy benefit manager (PBM), will present the study data at the Academy of Managed Care Pharmacy’s 2017 Annual Meeting (AMCP 2017) March 27-30 in Denver, Colorado.
Harvoni is a prescription medicine used with or without ribavirin to treat chronic hepatitis C virus (HCV) infection with the viral genotypes 1, 4, 5 or 6.
The objective of the study was to examine the real-world hepatitis C sustained virologic response (SVR) rate – used to determine treatment response – among commercially insured members completing at least eight weeks of Harvoni treatment.
Researchers reviewed data from 311 patients who completed at least eight weeks of treatment with Harvoni and had an SVR laboratory test completed between 12 and 24 weeks after they completed the treatment. The SVR reflects a successful hepatitis C treatment outcome; for example, an SVR 12 means that virus is undetectable for 12 or more weeks after the end of treatment.
Of the 311 patients in the study, 301 (96.8%) had a SVR result indicating a cure of infection. Ten of the patients had an SVR result indicating active HCV infection despite treatment.
“Prime’s real-world data reflect findings from clinical trials. Our members who received at least eight weeks of Harvoni through Prime Therapeutics Specialty Pharmacy had a very high likelihood of being cured of this disease,” Cathy Starner, PharmD, principal health outcomes researcher at Prime, said in a press release.
Here is the distribution of SVR rates by duration of therapy:
- Eight weeks (56 days): 94% achieved SVR indicative of cure (77 of 82 people);
- Twelve weeks (84 days): 98% achieved SVR indicative of cure (187 of 191 members);
- More than 12 weeks (between 112 and 196 days): 97% achieved SVR indicative of cure (37 of 38 members).
However, one-third of the individuals did not voluntarily report SVR lab results to the specialty pharmacy providing care, meaning that further assessment is needed to identify alternative processes that can ensure that individuals completing their HCV treatment are cured.
And, the team suggests that health insurers should consider implementing care-centered contracts focused on hepatitis C cure rates based on SVR laboratory data to ensure that members are receiving the best possible care.
The study was limited in that there was no comparison group with patients who did not receive specialty pharmacy services. Therefore, no direct comparisons can be drawn.