New analysis supports the use of Maviret for people with hepatitis C virus infection (HCV) and comorbidities
June 16, 2026
CATIE
- The antiviral drug Maviret is highly effective at curing acute and chronic hepatitis C infection
- Researchers studied its use with co-existing health conditions and other medicines
- Most participants tolerated the drug, stayed in the study and were cured of hepatitis C
Hepatitis C virus (HCV) infection infects the liver and causes inflammation in this vital organ. In some people, the immune system can contain and destroy HCV during this initial, or acute, phase of infection. However, in cases where the immune system is not able to contain acute HCV, it becomes a chronic infection. Over time, healthy liver tissue is replaced with scar tissue. Gradually, the liver becomes increasingly dysfunctional, and a variety of problems ensue. Some people develop persistent fatigue. Later, they can develop internal bleeding, fluid buildup in the abdomen and serious abdominal infections. Eventually, difficulty thinking clearly and problems with memory occur. As the liver becomes increasingly unable to filter the blood of waste products, the skin gradually turns yellow (jaundice). The risk of liver cancer increases as the amount of scar tissue expands. Thus, if HCV is left undiagnosed and untreated, it can result in death.
HCV can be detected with blood tests. Furthermore, the health of the liver can be assessed with additional blood tests and a specialized ultrasound called Fibroscan. As chronic HCV infection can have mild symptoms (similar to a flu-like illness) or even no noticeable symptoms in some people, testing is essential for revealing the presence of this virus. Making access to HCV testing more widely available can help uncover HCV infection.
Types of infection
Chronic infection
Several powerful treatments for chronic HCV infection are available in pill form. These are called direct-acting antivirals (DAAs) and can be taken once daily. Two commonly used DAAs are as follows:
The use of HIV medicines to help prevent contracting HIV is called pre-exposure prophylaxis (PrEP).
Currently approved options for PrEP include the following:
- Epclusa – a pill containing sofosbuvir + velpatasvir
- Maviret – a pill containing glecaprevir + pibrentasvir
These drugs are associated with high rates of cure (95%) after a course of treatment, which is usually eight to 12 weeks. They are generally safe and well tolerated.
In Canada, DAAs for the treatment of chronic HCV first became available in 2014, with restrictions on who could access them through public subsidies. By 2018, these restrictions were lifted.
Acute infection
The early course of HCV infection during the first six months is called the period of acute HCV infection. As mentioned previously, symptoms of acute HCV can sometimes be like a flu or so mild that they are not noticeable. As a result, some people may not realise that they have a new infection.
Earlier this year, AbbVie, the manufacturer of Maviret, announced that Health Canada had approved the use of Maviret for the treatment of acute HCV infection. In a clinical trial of acute HCV, Maviret was found to be highly effective, with at least 96% of participants being cured.
Safety in different populations
A team of researchers in several countries participated in a review of clinical trials of Maviret for the treatment of chronic HCV infection. The researchers were interested in the safety and tolerability of Maviret in people who had chronic health conditions in addition to chronic HCV. They were also interested in finding out how people who were taking multiple medications for these other chronic health conditions tolerated Maviret.
In an analysis of 6,547 participants in 21 clinical trials, the researchers found that despite many participants having co-existing conditions (comorbidities), overall Maviret was highly effective and well tolerated, with relatively few people discontinuing this treatment. What’s more, the researchers stated that “potential drug-drug interactions between [Maviret and a range of the following medicines should not be a barrier to initiating HCV treatment]:
- antipsychotics
- calcium channel blockers (a group of medicines used to treat high blood pressure and irregular heart rhythms)
- beta blockers (a group of medicines used to treat abnormal heart rhythms and anxiety)
- other medicines used to treat high blood pressure
- drugs to lower cholesterol levels
- opioids
Study details
Researchers analyzed information from 21 randomized clinical trials from around the world that had enrolled 6,547 participants. In these studies, Maviret tablets were taken once daily with food.
The research teams that performed the analysis were in the following countries:
- Canada
- France
- United Kingdom
- United States
The distribution of comorbidities was as follows:
- cardiovascular disease – 32%
- neuro-psychiatric issues – 28% (including depression, sleeping problems and anxiety)
- extensive scarring of the liver with minimal symptoms – 18%
- HIV coinfection – 4%
Other issues
About 30% of participants either had a history of injecting drugs or currently injected drugs.
Prescribed medicines
The researchers stated that, overall, 69% of participants were taking one or more medicines to help manage their comorbidities.
Results
Cure rates
In their initial analysis, researchers found that 94.3% of participants were cured. However, when researchers removed participants who prematurely left the study (for reasons other than virological failure), the overall cure rate rose to 99%.
Safety and tolerability
Overall, 25% of participants experienced treatment-related side effects. The lowest rate of side effects from HCV treatment were among people with HIV coinfection at 22%. People who injected drugs had the highest rate of HCV-treatment-related side effects at 42%. However, most participants were able to tolerate Maviret, stay in the study and achieve a cure of HCV. This suggests that, in most cases, side effects related to HCV treatment were not serious and were likely temporary.
Indeed, the researchers found that serious treatment-related side effects occurred in only about 0.1% of participants. Examples of these are as follows:
- two people with HIV coinfection developed swelling in the tissues under their skin (angioedema) related to Maviret; this was classed as serious by investigators
- two people who injected drugs developed either angioedema or mini stroke
In total, 30 people (about 0.5%) left the study prematurely because of complications. Among these 30 people, 17 (0.3%) left due to HCV-treatment-related side effects.
In general, the more medicines participants took for comorbidities, the greater the risk of adverse effects. Among people who were not taking any medicines for comorbidities, the researchers found that HCV-treatment-related adverse effects were uncommon, ranging from none to 0.3% depending on the trial.
What’s more, when researchers analysed data focusing on medicines with the potential to interact with Maviret, they found that “overall, serious adverse events were not observed in participants [who used] antipsychotics, calcium channel blockers, beta blockers, other [medicines to lower blood pressure, and cholesterol-lowering medicines].”
HCV treatment interruption
In general, in people who are being treated for multiple comorbidities, it is relatively common to be taking many medicines. In the present study, nearly 70% of participants were taking at least one medicine prescribed for the treatment of comorbidities.
Among people who were taking fewer than 15 medicines for the treatment of comorbidities, about 2% had to interrupt their course of HCV treatment because of issues (likely side effects). Rates of HCV treatment discontinuation rose with the number of medicines prescribed. However, the proportion of participants taking more than 15 medicines was relatively small compared to the overall population in the present analysis.
Age
Researchers found that the risk of HCV treatment interruption (1%) was heightened in people aged 65 and older. The reason for this is not certain but may have been due to their increased use of medicines to treat comorbidities.
Another study was done in Italy with 570 participants whose average age was 80. Researchers found that 463 people (81%) were taking at least one medicine for comorbidities, and 144 (25%) of these people were taking five or more other drugs for comorbidities. Overall, 48 participants (8%) reported side effects. Of these, 10 (2%) participants prematurely stopped taking HCV treatment. This finding suggests that elderly people can largely tolerate Maviret.
Focus on liver enzyme levels
During the treatment of HCV infection, levels of liver enzymes in the blood rise, suggestive of inflammation in that organ. This is not surprising, as HCV-infected liver cells die and release their contents into the blood. In general, the increase in liver enzyme levels in the blood associated with treatment is temporary. Less than 1% of participants had significantly elevated levels of liver enzymes or the waste product bilirubin in their blood.
Why is the present analysis important?
The World Health Organization (WHO) has called for the elimination of HCV as a public health issue by 2030. WHO encourages cities, regions and countries to try to achieve this goal.
Researchers with the Public Health Agency of Canada (PHAC) estimate that there are at least 200,000 people in Canada who have HCV. Efforts to reach this population with opportunities for HCV testing followed by swift referral for care and treatment will need to be intensified if WHO goals are to be achieved. To get more people with HCV into treatment, the researchers encourage health systems to deploy non-specialist healthcare personnel. These would be people other than liver specialists, infectious disease specialists, gastroenterologists, and so on.
The researchers stated that in order to expand the pool of healthcare personnel who can treat people with HCV, “simplified [treatment] regimens with manageable safety profiles” are important. They stated that this would particularly be the case for people with HCV who have “limited exposure to the traditional healthcare system.”
In the everyday world of people with HCV who have comorbidities, the present study’s findings are encouraging. In general, participants who took a wide range of medicines for various comorbidities were able to tolerate HCV treatment. Nevertheless, it is likely useful to check for potential drug interactions with a pharmacist before initiating additional medicines. This way, potential side effects can be anticipated by healthcare providers and, if necessary, any adjustments to medicines for comorbidities can be made to minimize side effects.
—Sean R. Hosein
Resources
Global Health Sector Strategies on, respectively, HIV, viral hepatitis and sexually transmitted infections for the period 2022-2030 — World Health Organization
Hepatitis C Treatment Self-Directed Course – CATIE
Hepatitis C Key Messages - Treatment – CATIE
New hepatitis C point-of-care tests approved by Health Canada – CATIE News
Health Canada approves Maviret for the treatment of acute hepatitis C infection – CATIE News
Large study finds many benefits arise from curing hepatitis C virus – CATIE News
Patient navigator services needed to link people to hepatitis C care and treatment after release from incarceration – CATIE News
Canadian Coinfection Cohort
Integration of hepatitis C testing and treatment in OAT clinics – CATIE News
Increased risk of death in Canadian study of people who fall out of care for HIV and hepatitis C – CATIE News
“One-stop” health service in England
achieves high rates of hepatitis C cure – CATIE News
REFERENCES:
- Cooper C, Raina SA, Johnson L, et al. Efficacy and safety of glecaprevir/pibrentasvir in participants with chronic HCV infection and comorbidities or multiple concomitant medications: an integrated analysis. Infectious Diseases and Therapy. 2026; in press.
- Conway B, Yi S, Yung R, et al. GRAND PLAN: Safety and efficacy of Glecaprevir/Pibrentasvir for the treatment of hepatitis C virus infection among people initially disengaged from health care who use drugs – a systematic multidisciplinary approach. Open Forum Infectious Diseases. 2024 Mar 5;11(3): ofad638.
- Mukherjee D, Collins M, Dylla DE, et al. Assessment of drug-drug interaction risk between intravenous fentanyl and the glecaprevir/pibrentasvir combination regimen in hepatitis C patients using physiologically based pharmacokinetic modeling and simulations. Infectious Diseases and Therapy. 2023 Aug;12(8):2057-2070.
- Pugliese N, Calvaruso V, Masarone M, et al. Glecaprevir/pibrentasvir is safe and effective in Italian patients with chronic hepatitis C aged 75 years or older: A multicentre study. Liver International. 2023 Jul;43(7):1440-1445.
From Canadian AIDS Treatment Information Exchange (CATIE).
This content was originally published by CATIE, Canada’s source for HIV and hepatitis C information.
Source: CATIE:
https://www.catie.ca/catie-news/new-analysis-supports-the-use-of-maviret-for-people-with-hepatitis-c-virus-infection-hcv
For more information visit CATIE's Information Network at www.catie.ca
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