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Safety Information

Published: 13 March 2017

Early Warning System - Monitoring Communication

Medsafe emphasises that patients should NOT stop using any medicine or medical device subject to a monitoring communication. If you have any concerns with a medicine or medical device you are using, please contact your health professional. A monitoring communication does not mean that the medicine or medical device causes an adverse event.

M² logo Viekira Pak and Viekira Pak-RBV – Possible effects on blood glucose control when used in patients with type 2 diabetes

13 March 2017

Monitoring finishes 31 December 2017.

Medsafe was recently alerted to a case of a type 2 diabetic who started hepatitis C treatment with Viekira Pak. Eight weeks after starting Viekira Pak, the patient’s blood glucose control had improved (HbA1c almost halved).

Hepatitis C can be treated with pegylated interferon-based therapy or direct-acting antivirals (DAAs). The World Health Organization (WHO) recommends using DAAs. There are case reports in the scientific literature which describe improvement of diabetes with hepatitis C treatment. Patients experienced reduced insulin resistance and improved blood glucose control[1-5].

However, the available information on the association between hepatitis C treatment and effects on blood glucose control in patients with type 2 diabetes is not definitive [2]. There may be differences in effect depending on which hepatitis C virus genotype the patient is infected with, which treatment they undergo and interactions with other factors such as weight. In addition, there are some case reports of increases in blood glucose levels [5].

Products Affected

DAA regimens are used for the treatment of chronic hepatitis C infection. The WHO now recommends that DAA regimens are used for the treatment of hepatitis C rather than regimens with pegylated interferon and ribavirin [6].

There are a number of DAAs approved for use in New Zealand including Viekira Pak and Viekira Pak-RBV (Table 1).

Table 1: Direct-acting antivirals approved and available for use in New Zealand (as at 1 March 2017)

Product name Active ingredients Sponsor
Viekira Pak ombitasvir/paritaprevir/ritonavir copackaged with dasabuvir AbbVie
Viekira Pak-RBV ombitasvir/paritaprevir/ritonavir copackaged with dasabuvir and ribavirin AbbVie
Harvoni ledipasvir/sofosbuvir Gilead
Sovaldi sofosbuvir Gilead
Daklinza daclatasvir Bristol-Myers Squibb
Sunvepra asunaprevir Bristol-Myers Squibb
Zepatier elbasvir/grazoprevir Merck Sharp & Dohme

Additional Information

Actions for healthcare professionals:

The overall benefit-risk balance of Viekira Pak, Viekira Pak-RBV and all other DAA regimens remains positive.

Advice on how to take DAAs and the known side effects can be found in the consumer medicine information (CMI) and data sheets.

Search for consumer medicine information and data sheets

Regulator Actions

Medsafe is placing this safety concern on the medicines monitoring (M² logo) scheme to obtain further information on this issue. Please report any suspected adverse reactions with Viekira Pak, Viekira Pak-RBV and any other DAA regimen, particularly those relating to blood glucose control.

Reporting

Consumers and healthcare professionals are encouraged to send reports of suspected adverse reactions to the Centre for Adverse Reactions Monitoring (CARM)

Medsafe cannot give advice about an individual's medical condition. If you have any concerns about a medicine you are taking Medsafe encourages you to talk to your healthcare professional.

References

  1.  Pashun, R.A., N.T. Shen, and A. Jesudian, Markedly Improved Glycemic Control in Poorly Controlled Type 2 Diabetes following Direct Acting Antiviral Treatment of Genotype 1 Hepatitis C. Case Reports Hepatol, 2016. 2016: p. 7807921.
  2. Vanni, E., E. Bugianesi, and G. Saracco, Treatment of type 2 diabetes mellitus by viral eradication in chronic hepatitis C: Myth or reality? Dig Liver Dis, 2016. 48(2): p. 105-11.
  3. Qing, S., et al., Improvement of glucose and lipid metabolism with pegylated interferon-a plus ribavirin therapy in Chinese patients chronically infected with genotype 1b hepatitis C virus. Ann Saudi Med, 2015. 35(4): p. 293-7.
  4.  Doyle, M.A. and C. Cooper, Successful Hepatitis C Antiviral Therapy Induces Remission of Type 2 Diabetes: A Case Report. Am J Case Rep, 2015. 16: p. 745-50.
  5.  Sarasombath, O., et al., Changes in fasting plasma glucose levels with ribavirin and pegylated interferon treatment in normal and impaired glucose tolerant patients with chronic hepatitis C. Hawaii J Med Public Health, 2012. 71(5): p. 129-31.
  6.  World Health Organization. Guidelines for the Screening Care and Treatment of Persons with Chronic Hepatitis C Infection: Updated Version. 2016 Apr [Accessed 20 July 2016]; Available from: www.who.int/hepatitis/publications/hepatitis-c-guidelines-2016/en/.

 

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