In Categories: Economic Impact

While our mission at Virta is to reverse type 2 diabetes in 100 million people by 2025, we’ve also shown promising results in related chronic diseases for people living with type 2 diabetes. Our latest peer-reviewed results continue this trend. Today, BMJOpen published changes in surrogate markers of non-alcoholic fatty liver disease (NAFLD) at 1 year in patients with type 2 diabetes (T2D) from Virta’s ongoing clinical trial. The results demonstrate the promise of the Virta Treatment as one of the most effective therapies for NAFLD for people living with T2D.

Why is this significant? NAFLD is a particularly devastating disease, costing the U.S. an estimated $103 billion per year. Nearly 60% of people living with type 2 diabetes also have NAFLD. Despite these alarming statistics, there are currently no approved pharmaceuticals to treat the the disease.

Furthermore, most people living with NAFLD do not know they have it: NAFLD is often asymptomatic until it has progressed to cirrhosis or liver failure. In addition to patients, clinician awareness of NAFLD as a disease is also low. NAFLD as a term is less than 20 years old, and diagnostic criteria only started to be developed in 2005.

Here are 3 reasons I am excited about the Virta Treatment’s effect on NAFLD:

NAFLD is a common comorbidity of T2D

NAFLD describes a spectrum of disease states that vary in severity of liver fat content (steatosis), inflammation, and scarring (fibrosis). Over time, the damage from NAFLD may progress to cirrhosis or even liver failure, the latter of which requires a liver transplant for survival.

NAFLD is particularly concerning for people living with T2D because it is directly correlated with poor glycemic control, and the prevalence rate of NAFLD is significantly higher in people living with T2D compared to the general population.

Additionally, an individual living with T2D and NAFLD as comorbidities has an increased susceptibility of developing more severe forms of NAFLD, such as NASH and liver fibrosis, as well as an increased likelihood of macro- and microvascular complications like cardiovascular disease and retinopathy.

In total, the direct medical cost of managing NAFLD and its associated complications are estimated to be over $100 billion per year in the United States, and they are projected to further increase.

There is only one treatment option for NAFLD

There are currently no approved pharmacological interventions for NAFLD or its more severe variant, NASH. And even though NAFLD is very common in people with type 2 diabetes, the current ADA guidelines do not require screening for NAFLD. The only approved treatment approach for NAFLD set forth by the AASLD and EASL (American Association for the Study of Liver Diseases and European Association for the Study of the Liver) is to lose weight through lifestyle intervention: >5% weight loss is associated with improvement in steatosis, and >7% is necessary for improvement of NASH. These degrees of weight loss have been associated with improvements in different stages of NAFLD, with greater weight loss effective in resolving inflammation, NASH, and regressing fibrosis.

The Virta Treatment exceeds NAFLD treatment guidelines

At 1 year, Virta’s clinical trial patients not only met, but exceeded, AASLD and EASL guidelines, and our trial patients experienced significant improvements in non-invasive scores for steatosis and fibrosis.

On average, our clinical trial patients were able to maintain a 12% loss of their starting weight at 1 year. That means more than half of Virta’s trial patients lost more than the weight necessary for improvement of NASH. We used non-invasive scores to measure the Virta Treatment’s effect on steatosis and fibrosis with the NAFLD Liver Fat Score (N-LFS) and NAFLD Fibrosis Score (NFS), respectively.

We have already demonstrated that the Virta Treatment can reverse type 2 diabetes, while simultaneously improving inflammation, cardiovascular disease risk factors, and BMI. These latest results have us incredibly excited about the Virta Treatment’s promise for improving liver function, too, all while safely reducing, rather than adding, to a person’s prescriptions.

We will be publishing other results from our clinical trial and commercial populations soon. In the meantime, if you want to become or refer a patient to our treatment, please apply at https://www.virtahealth.com/.

7 Comments

  1. Avatar

    Great results. There has been a focus on hepatitis, particularly now that there is a one-treatment cure. Fatty liver is actually a bigger problem.

    Reply

  2. Avatar

    Great article! But the prevalence data should be markedly higher! The quoted data very likely resulted from applying plasma aminotransferases, which are poor markers of NAFLD, or from imaging techniques, such as ultrasonography or conventional computed tomography which cannot reliably quantify hepatic fat, particularly when fat content is low. When applying the most reliable magnetic resonance imaging techniques the prevalence of NAFLD in the general population in western industrialized countries like USA or Germany is around 40 % and in patients with T2DM it is around 70%!
    http://care.diabetesjournals.org/content/40/3/419.long
    and
    https://pubs.rsna.org/doi/10.1148/radiol.2017161228?url_ver=Z39.88-2003&rfr_id=ori%3Arid%3Acrossref.org&rfr_dat=cr_pub%3Dpubmed

    Reply

  3. Avatar

    Great article! But the prevalence data seem too low. When applying the most reliable diagnostic tools for NAFLD as MRS or MRI, the prevalence of NAFLD is about 70% in patients with T2DM and around 40 % in the general population of western industrialized countries as Germany or USA (1, 2).

    1. Kühn JP, et al. Prevalence of Fatty Liver Disease and Hepatic Iron Overload in a Northeastern German Population by Using Quantitative MR Imaging. Radiology. 2017 Sep;284(3):706-716.

    2. Bril F, Cusi K. Management of Nonalcoholic Fatty Liver Disease in Patients With Type 2 Diabetes: A Call to Action. Diabetes Care. 2017 Mar;40(3):419-430.

    Reply

  4. Avatar

    My Dr. informed me about 18 months ago I was showing signs of NAFLD. After 9 months of NSNG, in a follow up exam, this status was changed to resolved. This approach works. No question in my mind.

    Reply

  5. Avatar

    My Success Story after learning about Phinney’s and Volek’s work years ago…

    ALT 43 / AST 35 in 2012 (High Carb) vs ALT 16 / AST 17 in 2017 (Low Carb)
    CRP 2.81 in 2011 (High Carb) vs CRP 0.2 in 2017 (Low Carb)

    Reply

  6. Avatar

    So only MRI is required to diagnose NAFLD in children ? Blood test will show what ? I read GGT is the indicator also though obviously not as accurate as MRI. We need easier way to early diagnosis

    Reply

    1. Virta Health

      Thank you for your patience in waiting for a reply! Dr. Phinney responded to your question with the following: There are a number of methods to assess the liver’s risk of fatty infiltration NAFLD or steatohepatitis (NASH). These can range from measuring liver enzymes in the blood (ALT, AST, Alk Phos, and GGT) or imaging by ultrasound or MRI. In our blog post, we reported marked improvement in the liver score for NAFLD and NASH using a validated equation based upon ALT, AST, and Alk Phos; but as the questioner notes, other techniques can be used as well.

      Reply

Leave a reply

Your email address will not be published.