In the Journals

Two DAA regimens produce high SVR12 rates in HCV genotype 4

Treatment with Technivie plus ribavirin or Harvoni plus ribavirin were effective in patients with hepatitis C genotype 4, according to a recently published study.

“Worldwide, an estimated 15 million people are infected with hepatitis C virus (HCV) genotype 4 (GT 4). Because there is only moderate response to interferon-based therapy in these patients, this infection has been considered more difficult to treat,” the researchers wrote. “Although scarcer than for GT 1 patients, data from clinical trials on the efficacy of direct-acting antiviral agents (DAAs) in GT 4 patients suggest that interferon-free regimens with DAAs have the potential to achieve high rates of sustained virologic response (SVR) in GT 4 patients.”

The researchers retrospectively analyzed data from 122 patients treated with Technivie (ombitasvir/paritaprevir/ritonavir, OMV/PTVr; AbbVie) plus ribavirin (and 130 patients treated with Harvoni (ledipasvir/sofosbuvir, LDV/SOF; Gilead Sciences) with or without ribavirin between Apr. 1, 2015, and Feb. 28, 2016. They did not directly compare the results between the two regimen groups.

Among the patients treated with OMV/PTVr, 96.2% of overall patients achieved SVR12. More patients without cirrhosis achieved SVR12 (98.4%) vs. those with cirrhosis (93.3% at 12 weeks and 89.5% at 24 weeks), though the comparison was not significant.

Regarding the four cases of treatment failure in patients prescribed OMV/PTVr, two patients withdrew due to an adverse event, one patient experienced virologic failure and one patient discontinued voluntarily. There were seven patients with serious adverse events, but no deaths during treatment or follow-up.

The overall SVR12 success rate in patients treated with LDV/SOF was 95.4%. Like the OMV/PTVr group, there was a lower rate of success in patients with cirrhosis compared with all patients without cirrhosis achieving SVR12. All patients with cirrhosis treated with LDV/SOF achieved SVR12, while patients with cirrhosis treated with LDV/SOF plus ribavirin had a success rate of 87.9%.

Four patients in the LDV/SOF treatment group relapsed, one withdrew early due to an adverse event and one discontinued voluntarily. There were six patients with serious adverse events, but no deaths during treatment or follow-up.

The LDV/SOF group had significantly more patients with cirrhosis than the OMV/PTVr group (73 vs. 43; P < .001), and higher mean elastography scores (20.3 vs. 13.2; P < .001), higher mean bilirubin levels (1.01 vs. 0.78 mg/dL; P = .01), lower mean albumin levels (4.1 vs. 4.3 g/dL; P = .004) and a higher proportion of treatment-naive patients (70 vs. 40; P = .006).

“Our study provides insight into clinician prescribing practice for GT 4 patients,” the researchers concluded. “OMV/PTVr-based and LDV-SOF-based regimens yielded high rates of SVR12, comparable with the limited results from clinical trials, in both cirrhotic and non-cirrhotic HCV GT 4 patients managed in a real-world setting. The safety profiles of both regimens were good and comparable with those reported for other HCV genotypes.” – by Talitha Bennett

Disclosure: Crespo reports grants or consulting fees from AbbVie, Gilead Sciences, Bristol-Myers Squibb, Janssen and MSD. Please see the full study for the other researchers’ relevant financial disclosures.

Treatment with Technivie plus ribavirin or Harvoni plus ribavirin were effective in patients with hepatitis C genotype 4, according to a recently published study.

“Worldwide, an estimated 15 million people are infected with hepatitis C virus (HCV) genotype 4 (GT 4). Because there is only moderate response to interferon-based therapy in these patients, this infection has been considered more difficult to treat,” the researchers wrote. “Although scarcer than for GT 1 patients, data from clinical trials on the efficacy of direct-acting antiviral agents (DAAs) in GT 4 patients suggest that interferon-free regimens with DAAs have the potential to achieve high rates of sustained virologic response (SVR) in GT 4 patients.”

The researchers retrospectively analyzed data from 122 patients treated with Technivie (ombitasvir/paritaprevir/ritonavir, OMV/PTVr; AbbVie) plus ribavirin (and 130 patients treated with Harvoni (ledipasvir/sofosbuvir, LDV/SOF; Gilead Sciences) with or without ribavirin between Apr. 1, 2015, and Feb. 28, 2016. They did not directly compare the results between the two regimen groups.

Among the patients treated with OMV/PTVr, 96.2% of overall patients achieved SVR12. More patients without cirrhosis achieved SVR12 (98.4%) vs. those with cirrhosis (93.3% at 12 weeks and 89.5% at 24 weeks), though the comparison was not significant.

Regarding the four cases of treatment failure in patients prescribed OMV/PTVr, two patients withdrew due to an adverse event, one patient experienced virologic failure and one patient discontinued voluntarily. There were seven patients with serious adverse events, but no deaths during treatment or follow-up.

The overall SVR12 success rate in patients treated with LDV/SOF was 95.4%. Like the OMV/PTVr group, there was a lower rate of success in patients with cirrhosis compared with all patients without cirrhosis achieving SVR12. All patients with cirrhosis treated with LDV/SOF achieved SVR12, while patients with cirrhosis treated with LDV/SOF plus ribavirin had a success rate of 87.9%.

Four patients in the LDV/SOF treatment group relapsed, one withdrew early due to an adverse event and one discontinued voluntarily. There were six patients with serious adverse events, but no deaths during treatment or follow-up.

The LDV/SOF group had significantly more patients with cirrhosis than the OMV/PTVr group (73 vs. 43; P < .001), and higher mean elastography scores (20.3 vs. 13.2; P < .001), higher mean bilirubin levels (1.01 vs. 0.78 mg/dL; P = .01), lower mean albumin levels (4.1 vs. 4.3 g/dL; P = .004) and a higher proportion of treatment-naive patients (70 vs. 40; P = .006).

“Our study provides insight into clinician prescribing practice for GT 4 patients,” the researchers concluded. “OMV/PTVr-based and LDV-SOF-based regimens yielded high rates of SVR12, comparable with the limited results from clinical trials, in both cirrhotic and non-cirrhotic HCV GT 4 patients managed in a real-world setting. The safety profiles of both regimens were good and comparable with those reported for other HCV genotypes.” – by Talitha Bennett

Disclosure: Crespo reports grants or consulting fees from AbbVie, Gilead Sciences, Bristol-Myers Squibb, Janssen and MSD. Please see the full study for the other researchers’ relevant financial disclosures.