Published: 13 March 2017
Revised: 31 January 2018
Safety Information
Early Warning System - Monitoring Communication
Viekira Pak and Viekira Pak-RBV – Possible effects on blood glucose control
when used in patients with type 2 diabetes
Update to Original Communication
31 January 2018
During the medicines monitoring period (13 March 2017 to 31 December 2017), no further cases were reported to the Centre for Adverse Reactions Monitoring (CARM). The safety concern has been investigated and the association of direct-acting antiviral (DAAs), including Viekira Pak and Viekira Pak-RBV, and effects on blood glucose control when used in patients with type 2 diabetes could not be confirmed.
The balance of benefits and risks of harm for DAAs remains positive and no further action is required at this time.
Medsafe will re-investigate this concern should more information become available.
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:
- Identify patients eligible for DAA treatment who also have type 2 diabetes.
- Warn patients with type 2 diabetes starting on hepatitis C treatment about possible changes to their blood glucose levels.
- Remind patients of the symptoms of low blood glucose such as feeling sweaty, weak and dizzy.
- Remind patients of the symptoms of high blood glucose such as feeling very thirsty, urinating frequently and blurred vision.
- Ask patients to contact you as soon as possible if they experience these symptoms.
- Monitor blood glucose more closely particularly if the patient is using insulin or a sulfonylurea. HbA1c should be checked during treatment. Tailor treatment accordingly.
- Do not adjust the dose of the DAA regimen as this may make it ineffective.
- Consult data sheets prior to prescribing for more information.
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 ()
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
- 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.
- 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.
- 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.
- 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.
- 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.
- 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/.
