In the Journals

8-week Harvoni cost-effective alternative to 12-week regimen

An 8-week course of Harvoni for hepatitis C virus infection in both black and nonblack patients was a cost-effective alternative to a 12-week course, according to researchers.

Shorter course therapy may be a viable option under a constrained budget and can benefit patients who are treatment-naive and noncirrhotic, they wrote in Open Forum Infectious Diseases.

“While highly efficacious therapies can cure HCV with few side effects in as little at 8 weeks, many individuals and payers are struggling with the cost,” researcher Jake R. Morgan, PhD, of Boston Medical Center, and colleagues wrote. “For [Harvoni (ledipasvir/sofosbuvir, Gilead Sciences)], our results indicate that 8-week therapy is cost-effective and can result in better population outcomes in both black and nonblack patients compared with 12-week therapy, even with lower rates of SVR.”

The researchers noted that DAAs, although very effective, are expensive. Shortening the course of treatment from 12 weeks to 8 weeks can significantly lower costs, they said, but shorter courses may be ineffective in black patients and those with HIV coinfection, among other factors.

A newly FDA-approved 8-week regimen — Mavyret (glecaprevir/pibrentasvir, AbbVie) — is choice for some physicians, but many payers still prefer ledipasvir/sofosbuvir based on negotiated prices, according to the researchers.

“Understanding the trade-offs between cost and efficacy for 8- and 12-week treatment courses is critical,” they said.

In a simulation model — called the Hepatitis C Cost-Effectiveness Model — researchers examined the economic value associated with 8- and 12-week treatment courses of ledipasvir/sofosbuvir.

They found that treating eligible patients — treatment-naive, noncirrhotic, and with HCV RNA of less than 6 million copies — with 8-week courses under a fixed budget constraint was cost-effective and increased the number of both black and nonblack patients who achieved SVR by roughly 50% compared with the 12-week regimen.

Although shorter courses resulted in more treatment failures, resources invested in extending therapy to 12 weeks “would likely be more productively invested in other HCV-related health care interventions, such as expanding HCV screening or improving HCV linkage to care,” the researchers said.

Morgan and colleagues also evaluated the cost-effectiveness of testing patients for resistance to NS5A inhibitors.

“We found that NS5A testing was cost-effective as long as the SVR rate for 8 weeks of therapy in patients with [resistance-associated substitutions] conferring more than 100-fold resistance to ledipasvir was 88% or less,” they wrote.

“Future research demonstrating the real-world effectiveness of NS5A testing could improve outcomes still further while controlling cost,” they continued. “This analysis provides an evidence base supporting the movement of the 8-week regimen to the preferred regimen list for appropriate patients in the HCV treatment guidelines. Wider use of the similarly effective, significantly less expensive 8-week regimen could result in the ability to treat more individuals and improve population health.” – by Joe Green

Disclosures: Morgan reports no relevant financial disclosures. Please see the study for all other authors’ relevant financial disclosures.

An 8-week course of Harvoni for hepatitis C virus infection in both black and nonblack patients was a cost-effective alternative to a 12-week course, according to researchers.

Shorter course therapy may be a viable option under a constrained budget and can benefit patients who are treatment-naive and noncirrhotic, they wrote in Open Forum Infectious Diseases.

“While highly efficacious therapies can cure HCV with few side effects in as little at 8 weeks, many individuals and payers are struggling with the cost,” researcher Jake R. Morgan, PhD, of Boston Medical Center, and colleagues wrote. “For [Harvoni (ledipasvir/sofosbuvir, Gilead Sciences)], our results indicate that 8-week therapy is cost-effective and can result in better population outcomes in both black and nonblack patients compared with 12-week therapy, even with lower rates of SVR.”

The researchers noted that DAAs, although very effective, are expensive. Shortening the course of treatment from 12 weeks to 8 weeks can significantly lower costs, they said, but shorter courses may be ineffective in black patients and those with HIV coinfection, among other factors.

A newly FDA-approved 8-week regimen — Mavyret (glecaprevir/pibrentasvir, AbbVie) — is choice for some physicians, but many payers still prefer ledipasvir/sofosbuvir based on negotiated prices, according to the researchers.

“Understanding the trade-offs between cost and efficacy for 8- and 12-week treatment courses is critical,” they said.

In a simulation model — called the Hepatitis C Cost-Effectiveness Model — researchers examined the economic value associated with 8- and 12-week treatment courses of ledipasvir/sofosbuvir.

They found that treating eligible patients — treatment-naive, noncirrhotic, and with HCV RNA of less than 6 million copies — with 8-week courses under a fixed budget constraint was cost-effective and increased the number of both black and nonblack patients who achieved SVR by roughly 50% compared with the 12-week regimen.

Although shorter courses resulted in more treatment failures, resources invested in extending therapy to 12 weeks “would likely be more productively invested in other HCV-related health care interventions, such as expanding HCV screening or improving HCV linkage to care,” the researchers said.

Morgan and colleagues also evaluated the cost-effectiveness of testing patients for resistance to NS5A inhibitors.

“We found that NS5A testing was cost-effective as long as the SVR rate for 8 weeks of therapy in patients with [resistance-associated substitutions] conferring more than 100-fold resistance to ledipasvir was 88% or less,” they wrote.

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“Future research demonstrating the real-world effectiveness of NS5A testing could improve outcomes still further while controlling cost,” they continued. “This analysis provides an evidence base supporting the movement of the 8-week regimen to the preferred regimen list for appropriate patients in the HCV treatment guidelines. Wider use of the similarly effective, significantly less expensive 8-week regimen could result in the ability to treat more individuals and improve population health.” – by Joe Green

Disclosures: Morgan reports no relevant financial disclosures. Please see the study for all other authors’ relevant financial disclosures.