Direct-acting antiviral updates: 6 recent reports on drug trials

Direct-acting antivirals present not only a highly successful therapy for treatment-naive patients with hepatitis C but also a curative option for patients who could not undergo treatment with interferon-based regimens or failed prior treatment courses.

The following reports include recent updates on branded DAAs including phase 3 trials in different demographics, additions to the WHO recommendation guidelines, and FDA updates on safety and efficacy data.

Resistance did not affect SVR rates in trials of Vosevi for HCV

Baseline resistance associated substitutions did not impact sustained virologic response among direct-acting antiviral-experienced patients who underwent hepatitis C therapy with Vosevi for 12 weeks, according to a recently published study.

“In contrast to the prior studies of regimens targeting two distinct HCV proteins, the presence of NS3, NS5A and/or NS5B NI RASs did not affect treatment outcome in DAA-experienced patients including those who were previously treated with NS5A inhibitors upon treatment with [Vosevi] for 12 weeks in phase 3 trials,” Christoph Sarrazin, MD, from the Goethe University Hospital in Frankfurt, Germany, and colleagues wrote. Read more

WHO adds ravidasvir to HCV recommendation guidelines

The World Health Organization has added ravidasvir as a future pangenotypic direct-acting antiviral to the list of recommended therapies in their Guidelines for the Care and Treatment of Persons Diagnosed with Chronic Hepatitis C, according to a press release.

“We are so excited that ravidasvir is recommended as a pangenotypic DAA by the WHO HCV guidelines,” Jinzi J. Wu, PhD, founder, president and CEO of Ascletis Pharma, said in the release. “Ravidasvir is not only recognized by international academic communities, but also recognized by an internationally renowned public health organization.” Read more

FDA updates Mavyret label for new safety, efficacy data

The FDA recently approved safety and efficacy revisions to the Mavyret label based on data from a hepatitis C/HIV-1 collection study and a liver and renal transplant study.

Ongoing studies from the past year have shown Mavyret (glecaprevir/pibrentasvir, AbbVie) to be a pangenotypic treatment that is highly effective over an 8-week course for most patients. Read more

Epclusa yields high SVR in HCV genotype 3 with compensated cirrhosis

Patients with hepatitis C genotype 3 with compensated cirrhosis achieved a sustained virologic response rate higher than 90% after treatment with Epclusa with or without ribavirin, according to results of a recently published phase 3 study.

According to Rafael Esteban, MD, from the Hospital Universitario Val d'Hebron in Spain, and colleagues, these results were consistent with previous studies. Additionally, response rates were numerically higher in patients treated with ribavirin, largely due to the impact of baseline NS5A resistance-associated substitutions (RASs). Read more

Harvoni effective for HCV genotype 4, including cirrhotic cases

Patients with hepatitis C genotype 4 had high sustained virologic response rates with Harvoni over 8 weeks in treatment-naive cases without cirrhosis and over 12 weeks with ribavirin regardless of cirrhosis or treatment experience, according to recently published data from a phase 3 study in Egypt.

“Given the high prevalence of HCV in Egypt and the heterogeneity of the HCV-infected population with respect to age, comorbidities and prior HCV therapy, there is a need in Egypt for a highly efficacious, well-tolerated, single-tablet regimen with simple monitoring,” Gamal Shiha, MD, PhD, from the Liver Research Institute and Hospital in Egypt, and colleagues wrote. “With the widespread use of sofosbuvir, an efficacious treatment for those who have failed treatment with a sofosbuvir-based regimen would also be highly desirable.” Read more

Zepatier safe, effective in black patients with HCV, comorbidities

Zepatier was effective and well-tolerated in black patients with hepatitis C genotype 1 and 4 compared with overall reported safety profile, according to recently published data.

“The results from this retrospective analysis of clinical trial data support the use of [elbasvir/grazoprevir (EBR/GZR)] in black individuals with HCV... infection,” Philippe J. Zamor, MD, from the Carolinas HealthCare System in North Carolina, and colleagues wrote. “EBR/GZR showed high efficacy across many subgroups of black participants, including those with cirrhosis, [chronic kidney disease], HIV co-infection, or sickle cell disease, as well as those taking opioid agonist therapy, and was generally well tolerated, with a safety profile similar to that reported in the general population of participants in the EBR/GZR clinical trials.” Read more

Direct-acting antivirals present not only a highly successful therapy for treatment-naive patients with hepatitis C but also a curative option for patients who could not undergo treatment with interferon-based regimens or failed prior treatment courses.

The following reports include recent updates on branded DAAs including phase 3 trials in different demographics, additions to the WHO recommendation guidelines, and FDA updates on safety and efficacy data.

Resistance did not affect SVR rates in trials of Vosevi for HCV

Baseline resistance associated substitutions did not impact sustained virologic response among direct-acting antiviral-experienced patients who underwent hepatitis C therapy with Vosevi for 12 weeks, according to a recently published study.

“In contrast to the prior studies of regimens targeting two distinct HCV proteins, the presence of NS3, NS5A and/or NS5B NI RASs did not affect treatment outcome in DAA-experienced patients including those who were previously treated with NS5A inhibitors upon treatment with [Vosevi] for 12 weeks in phase 3 trials,” Christoph Sarrazin, MD, from the Goethe University Hospital in Frankfurt, Germany, and colleagues wrote. Read more

WHO adds ravidasvir to HCV recommendation guidelines

The World Health Organization has added ravidasvir as a future pangenotypic direct-acting antiviral to the list of recommended therapies in their Guidelines for the Care and Treatment of Persons Diagnosed with Chronic Hepatitis C, according to a press release.

“We are so excited that ravidasvir is recommended as a pangenotypic DAA by the WHO HCV guidelines,” Jinzi J. Wu, PhD, founder, president and CEO of Ascletis Pharma, said in the release. “Ravidasvir is not only recognized by international academic communities, but also recognized by an internationally renowned public health organization.” Read more

FDA updates Mavyret label for new safety, efficacy data

The FDA recently approved safety and efficacy revisions to the Mavyret label based on data from a hepatitis C/HIV-1 collection study and a liver and renal transplant study.

Ongoing studies from the past year have shown Mavyret (glecaprevir/pibrentasvir, AbbVie) to be a pangenotypic treatment that is highly effective over an 8-week course for most patients. Read more

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Epclusa yields high SVR in HCV genotype 3 with compensated cirrhosis

Patients with hepatitis C genotype 3 with compensated cirrhosis achieved a sustained virologic response rate higher than 90% after treatment with Epclusa with or without ribavirin, according to results of a recently published phase 3 study.

According to Rafael Esteban, MD, from the Hospital Universitario Val d'Hebron in Spain, and colleagues, these results were consistent with previous studies. Additionally, response rates were numerically higher in patients treated with ribavirin, largely due to the impact of baseline NS5A resistance-associated substitutions (RASs). Read more

Harvoni effective for HCV genotype 4, including cirrhotic cases

Patients with hepatitis C genotype 4 had high sustained virologic response rates with Harvoni over 8 weeks in treatment-naive cases without cirrhosis and over 12 weeks with ribavirin regardless of cirrhosis or treatment experience, according to recently published data from a phase 3 study in Egypt.

“Given the high prevalence of HCV in Egypt and the heterogeneity of the HCV-infected population with respect to age, comorbidities and prior HCV therapy, there is a need in Egypt for a highly efficacious, well-tolerated, single-tablet regimen with simple monitoring,” Gamal Shiha, MD, PhD, from the Liver Research Institute and Hospital in Egypt, and colleagues wrote. “With the widespread use of sofosbuvir, an efficacious treatment for those who have failed treatment with a sofosbuvir-based regimen would also be highly desirable.” Read more

Zepatier safe, effective in black patients with HCV, comorbidities

Zepatier was effective and well-tolerated in black patients with hepatitis C genotype 1 and 4 compared with overall reported safety profile, according to recently published data.

“The results from this retrospective analysis of clinical trial data support the use of [elbasvir/grazoprevir (EBR/GZR)] in black individuals with HCV... infection,” Philippe J. Zamor, MD, from the Carolinas HealthCare System in North Carolina, and colleagues wrote. “EBR/GZR showed high efficacy across many subgroups of black participants, including those with cirrhosis, [chronic kidney disease], HIV co-infection, or sickle cell disease, as well as those taking opioid agonist therapy, and was generally well tolerated, with a safety profile similar to that reported in the general population of participants in the EBR/GZR clinical trials.” Read more