Researchers in the Lombardy region in northwest Italy collected data from 30 clinics in the area where people with chronic hepatitis C virus (HCV) used Maviret between October 2017 and January 2018. Participants took Maviret for the following durations:

• eight weeks – 639 people
• 12 or 16 weeks – 84 people

The average profile of participants upon entering the study was as follows:

• age – 58 years
• HCV genotypes 1 to 4 were the most common
• viral load – 1 million IU/mL
• most (83%) had a modest degree of liver injury, graded as F0 to F2
• 50 people had both HCV and HIV
• 71% had other co-existing conditions, including cardiovascular disease, mental health issues and chronic kidney disease
• 26% were on methadone or buprenorphine

Results

Not all the data have been fully analysed; most participants have completed their course of treatment and are being monitored until their final blood test. Preliminary results from the fourth week after cessation of treatment suggests that as many as 97% of participants have been cured.

Here is the distribution of cure rates that are available (12 weeks after the cessation of treatment):

• 8-week regimen – 98% cured (43 of 44 people)
• 12- or 16-week regimen – 100% cured (five of five people)

One person relapsed, as HCV became detectable four weeks after cessation of therapy. This person was 51 years old and had not previously been treated. He had minimal liver injury and was infected with genotype 3a with a pre-study viral load of about 200,000 IU/mL. His adherence to Maviret was considered good. Researchers are unsure why relapse occurred.

Adverse events

Side effects were not common and were distributed as follows:

Lack of energy

• 8-week regimen – 2%
• 12-week regimen – 0%

Nausea

• 8-week regimen – 1%
• 12-week regimen – 2%

Itchy skin

• 8-week regimen – 1%
• 12-week regimen – 7%

Adverse events leading to premature cessation of treatment were uncommon and distributed as follows:

• 8-week regimen – one person
• 12-week regimen – three people

The adverse events that were linked to the premature cessation of treatment were as follows:

• nausea – two people
• itchy skin – one person
• yellowing of skin – one person

Deaths

Three people died while in the study, one on the 8-week regimen and two on the 12-week regimen. Investigation revealed that none of the deaths were due to Maviret but rather to the following causes:

• disseminated blood clots
• stroke
• a severe inflammatory response to bacterial infection

Bear in mind

The interim results from the Lombardy region show high rates of cure and low rates of side effects with Maviret. These results are similar to what was observed in phase III clinical trials.

—Sean R. Hosein

REFERENCE:

D’Ambrosio R, Colli A, Colombo A, et al. Real-life effectiveness and safety of glecaprevir/pibrentasvir among 723 Italian patients with chronic hepatitis C: The Navigator-II study. International Liver Congress, 11-15 April 2018, Paris, France. Presentation GS-013.