This month’s HCV Drugs has two exciting study results—phase 3 study results of Gilead’s triple combination of sofosbuvir, velpatasvir and voxilaprevir to treat treatment-naïve and treatment experienced patients in patients with genotypes 1 through 6, and the phase 3 study results of AbbVie’s Viekirax plus Exviera to treat treatment naïve genotype 1b patients.
Gilead issued a press release announcing the results of four phase 3 studies (POLARIS) of the triple combination of sofosbuvir (polymerase inhibitor), velpatasvir (NS5A inhibitor), and voxilaprevir (protease inhibitor) or sofosbuvir and velpatasvir (Epclusa). The study included 1,056 patients who received the triple combination (sofosbuvir (SOF), velpatasvir(VEL), plus voxilaprevir (VOX)—611 were treatment naïve and 455 were treatment experienced. The results are listed below:
41 percent (172/415) had cirrhosis
|1, 2, 3, 4, 5, 6||SOF/VEL/VOX||12 Weeks||96%
|POLARIS-4||DAA-experienced (No NS5A inhibitor)
46 percent (153/333) had cirrhosis
|1, 2, 3, 4||SOF/VEL/VOX||12 Weeks||97%
18 percent (174/941) had cirrhosis
|1, 2, 3, 4, 5, 6||SOF/VEL/VOX||8 Weeks||95%
All had cirrhosis
The side effects were similar between the placebo (sugar pills) group, sofosbuvir plus velpatasvir, and the sofosbuvir, velpatasvir plus voxilaprevir groups. The most common side effects were headache, fatigue, diarrhea and nausea. Only one patient in the entire study discontinued therapy due to side effects.
This combination was granted Breakthrough Therapy designation by the Food and Drug Administration (FDA) for those with HCV genotype 1 who had failed a previous course of therapy that contained a NS5A inhibitor.
Gilead is expected to apply to the FDA for marketing approval of this triple combination in the fourth quarter of 2016.
Editorial Comments: These are excellent results and give hope to those who have been treated but have not been cured. Additional results will be released at The Liver Conference at the beginning of November, Stay Tuned.
Source: Company Press release – http://hepatitisc.hcvadvocate.org/2016/10/14901.html
AbbVie also issued a press release about an 8-week treatment of Viekirax (ombitasvir/paritaprevir/ritonavir tablets) plus Exviera (dasabuvir tablets) to treat HCV genotype 1b.
The study included 163 treatment naïve, non-cirrhotic patients who did not have cirrhosis. The treatment duration was 8 weeks. The cure rate was 98% (160 of 163 patients).
The most common side effects were headache, fatigue, nasopharyngitis (cold or cough), itching, nausea, and lack of energy. Only one patient discontinued treatment due to side effects. The combination is already approved in Europe to treat HCV genotype 1.
Editorial Comment: These are great results for HCV genotype 1b.
Source: AbbVie Company Press Release – http://hepatitisc.hcvadvocate.org/2016/09/abbvie-presents-data-eight-week-treatment-viekirax-ombitasvirparitaprevirritonavir-tablets-exviera-dasabuvir-tablets-patients-genotype-1b-chronic-hepatitis-c.html
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