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Exciting New Hepatitis C Therapies Approved at the End of 2017

FEB 15, 2018 | KRISTINE LA, PHARMD CANDIDATE 2018; AND LEONOR ROJAS, PHARMD, BCPS
In 2017, research on 3 drug combinations for the treatment of hepatitis C virus (HCV), which were in phase 2 studies, was discontinued,1 meaning that there are no longer direct acting antivirals (DAAs) in the pipeline for HCV treatment and cure in the foreseeable future. Thankfully, in 2017, 2 new drug therapies, Vosevi (sofosbuvir/ velpatasvir/voxilaprevir; Gilead) and Mavyret (glecaprevir/pibrentasvir; AbbVie) were approved by the US Food and Drug Administration (FDA) for the treatment and cure of HCV.2,3

Vosevi, a combination of sofosbuvir and velpatasvir, 2 previously approved drugs, with the new drug voxilaprevir, offers a new treatment option for patients who previously failed regimens that included a nonstructural protein 5A (NS5A) drug or sofosbuvir without an NS5A inhibitor.4 In clinical studies, Vosevi was compared in adults with HCV genotypes 1 through 6 against placebo and in adults with genotypes 1 through 3 against sofosbuvir and velpatasvir.3 In both trials, approximately 96% of the patients who received Vosevi were considered cured, which was defined as having undetected viral levels within the blood after 12 weeks of treatment.3

The release of Vosevi on the market as a fixed-dose, 1-pill, once-daily regimen is significant in the fact that it provides another therapy option that effectively cures hard-to-treat patients infected with the most common genotypes of HCV (see Table 1 for indications).4 This newly developed drug is unique in being the only drug available on the market for treatment-experienced patients with genotypes 4 through 6 who previously failed a DAA.5 It also stands out from Harvoni (ledipasvir/ sofosbuvir) in its inclusion of patients with genotype 3. Overall, it has become the recommended drug of choice for DAA treatment-experienced patients with genotypes 1, 3, 4, 5, and 6 per American Association for the Study of Liver Diseases (AASLD) and Infectious Diseases Society of America (IDSA) updates on the HCV Guidelines website.5 However, Vosevi is not recommended in the guideline updates in treatment-experienced patients with genotype 2; Epclusa (sofosbuvir/ velpatasvir) remains the preferred recommendation.5 It is also important to note that unlike Harvoni, Vosevi is only approved for patients without cirrhosis or with compensated cirrhosis, whereas Harvoni can be used to treat patients with decompensated cirrhosis.4 Lastly, testing for resistance-associated substitutions is not recommended in patients prescribed Vosevi as this has not been shown to affect sustained viral response rates.5

A few months after the approval of Vosevi, AbbVie was granted FDA approval for its new HCV treatment, Mavyret.2 A combination of glecaprevir and pibrentasvir, Mavyret is the first HCV treatment regimen with a potential duration of 8 weeks.6 Other FDA-approved treatment options have a standard regimen duration of 12 weeks. Mavyret treats and cures treatment-naïve patients with genotypes 1 through 6 without cirrhosis and with compensated cirrhosis (Child- Pugh A) and patients with genotype 1 who were previously treated with either a NS5A inhibitor or a nonstructural protein 3/4A (NS3/4A) protease inhibitor.2 It is important to note that the indication for previous treatment does not include a regimen containing a combination of a NS5A inhibitor and a NS3/4A protease inhibitor.2 In addition, Mavyret treatment regimens are available for patients who are diagnosed with moderate to severe kidney disease or those receiving hemodialysis.6 The AASLD and IDSA HCV Guidelines website has strongly recommended Mavyret as a treatment option since its release, and with the allure of a brief 8-week treatment duration, it is likely Mavyret will be used more frequently in the future.5

In clinical trials, when Mavyret was used to treat patients with genotypes 1 through 6 without cirrhosis or with mild cirrhosis for 8, 12, or 16 weeks, no virus was detected in the blood samples of 92% to 100% of patients, indicating that the HCV infection was cured.2 Thus depending on indication, the duration varies for these 3-pill, once-daily regimens, as depicted in Tables 26 and 36.

 




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