Discoveries in HCV

Discoveries in HCV

Issue: January 2022
Source:

Saxena V, et al. Parallel 14: Hepatitis C oral session. Presented at: The Liver Meeting Digital Experience; Nov. 12-15, 2021 (virtual meeting).

Disclosures: Saxena reports no relevant financial disclosures.
December 02, 2021
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HCV retreatment regimen safe, effective for chronic infection

Issue: January 2022
Source:

Saxena V, et al. Parallel 14: Hepatitis C oral session. Presented at: The Liver Meeting Digital Experience; Nov. 12-15, 2021 (virtual meeting).

Disclosures: Saxena reports no relevant financial disclosures.
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In patients with hepatitis C infection who failed treatment with Vosevi, retreatment with a regimen of Sovaldi plus Mavyret plus ribavirin for 16 to 24 weeks was safe and effective, researchers reported.

“At this point, it is well known that direct-acting antivirals against chronic HCV are efficacious and safe. However, rarely, patients undergo multiple DAA treatments and do not achieve HCV cure,” Varun Saxena, MD, MAS, division chief at Kaiser Permanente South San Francisco and assistant clinical professor at the University of California, San Francisco (UCSF), said during a presentation at The Liver Meeting Digital Experience. “Currently, both the American Association for the Study of Liver Diseases and the European Association for the Study of the Liver guidelines recommend use of sofosbuvir, glecaprevir/pibrentasvir and ribavirin for 16 to 24 weeks for patients who have failed the salvage regimen of sofosbuvir/velpatasvir/voxilaprevir.”

These recommendations, however, are based on limited case reports and larger experience with this regimen is currently lacking, according to Saxena.

In this retrospective cohort study, Saxena and colleagues identified all patients with HCV who failed Vosevi (sofosbuvir/velpatasvir/voxilaprevir, Gilead Sciences) and underwent retreatment with Sovaldi (sofosbuvir, Gilead Sciences) plus Mavyret (glecaprevir/pibrentasvir, AbbVie) plus ribavirin. Of the 12 patients identified, the median age was 66 years, 10 were men, 10 were white patients, one was a Black patient, one was a Native American patient and two patients were of Hispanic ethnicity. Slightly less than half had diabetes and slightly more than half had hypertension. The median BMI was 28 kg/m2 and all patients had a baseline estimated glomerular filtration rate greater than 60 mL/min/1.73 m2.

Two-thirds of patients had HCV genotype 1a, whereas one-third had genotype 3. Six patients had pretreatment stage 4 fibrosis, or cirrhosis, one had received a liver transplant and one had received a kidney transplant. Among the six patients with cirrhosis, half had Child-Turcotte-Pugh class A5 cirrhosis and six had class A6 cirrhosis. Half also had esophageal varices and half had hepatocellular carcinoma.

Per Kaiser Permanente and UCSF treatment protocol, these patients with HCC had to have at least 3 months of radiographic HCC remission before HCV retreatment, Saxena noted.

All 12 patients achieved sustained virologic response at 12 weeks after treatment, according to the data.

Seven patients achieved SVR at 12 weeks with 16 weeks of retreatment with sofosbuvir plus glecaprevir/pibrentasvir plus ribavirin, including one patient with a Y93N pretreatment resistance-associated substitution (RAS) and one patient who had received a kidney transplant. Five patients achieved SVR at 12 weeks with 24 weeks of retreatment, including one who had received a liver transplant. Given extensive treatment history, the 24-week duration of retreatment was planned for one patient who had a Y93H pretreatment RAS and had been unsuccessfully treated five times. The decision to treat the other four patients for 24 weeks was largely based on the fact that they were some of the first to undergo retreatment with sofosbuvir plus glecaprevir/pibrentasvir plus ribavirin at Kaiser Permanente Northern California and UCSF, according to Saxena.

“Inexperience with the regimen and wanting to try to ensure SVR12 given the lack of further retreatment options factored heavily in this decision,” Saxena said.

Based on the preference of the treating hepatologist, half of patients were started on weight-based ribavirin dosing and half were started on ribavirin at 600 mg daily. Although ribavirin dose reductions were common, epoetin alfa was not needed and the researchers observed no early treatment discontinuations or adverse events requiring hospitalization.

“We conclude in the largest reported cohort to date of sofosbuvir/velpatasvir/voxilaprevir HCV treatment failures, sofosbuvir plus glecaprevir/pibrentasvir plus ribavirin for 16 to 24 weeks resulted in 100% SVR12 rates without any safety concerns,” Saxena said.