Here is the second part of my December HCV Snapshots column, highlighting some of the posters presented at the 2012 Liver Meeting. This was originally published in the December HCV Advocate.
Abstract # 1751 Is There a Real Difference in Viral Response of Chronic Hepatitis C between Men and Women?
Lead Author Stefan Mauss, et al.
Results and Conclusion This investigated previously research reporting that premenopausal women are more likely to have an SVR to HCV treatment. Pre and postmenopausal women were matched with men, creating 2093 matched pairs. Compared to men of similar ages, premenopausal AND postmenopausal women were no more likely to have an SVR. However, age did have an effect on SVR; younger subjects of either gender were more likely to achieve SVR.
Editorial Comments For many years I have repeated data that premenopausal women are more likely to have an SVR to HCV treatment. This study challenges this, but it also makes me more cautious. I am taking a neutral position on this until this research is peer-reviewed, replicated, and published. These data do argue in favor of earlier, rather than later treatment.
This is a good time to mention something I learned at the Liver Meeting from Cynthia Levy of University of Miami. She said that assuming there is no contraindication, that hormone replacement therapy (HRT) seems to lower the risk of fibrosis for menopausal women. This is not necessarily a reason to start HRT, but HCV positive women who wonder if HRT is hurting their livers may rest-assured.
Abstract # 1782 Vitamin D Supplementation Influences Sustained Virological Response Rate in Hepatitis C: A Systematic Review ad Meta-Analysis
Lead Author L.M. Villar, et al.
Results and Conclusion Recently, a number of studies reported that low vitamin D levels decreases the chance of achieving an SVR to HCV treatment. This research reviewed published data that studied the association between serum 25 hydroxyvitamin D (25 D) and SVR among 1546 HCV infected individuals with or without 25 D supplementation. Results showed that baseline 25 D levels did not influence outcome during HCV treatment BUT that vitamin D supplementation was statistically associated to increased SVR rate.
Editorial Comments This adds weight to previous evidence that vitamin D supplementation is associated with improved SVR. However, we need concrete protocols for vitamin D supplementation for HCV treatment patients.
Abstract # 1830 Preliminary Results of Twice Daily Dosing (Q12 hr) of Telaprevir (TVR) for Treatment Naïve and Previously Treated Patients with Genotype 1 HCV: Comparable RVR, eRVR and SVR12 to Standard Daily Dosing at Q8 hr
Lead Author Paul Pockros, et al.
Results and Conclusion Current HCV triple-therapy requires patients to take the protease inhibitor portion of their treatment three times daily (with food, and in the case of Telaprevir (TVR) food must be at least 20 grams of fat). This study enrolled and treated 118 patients with the same total daily dose of TVR, but divided into 2 rather than 3 doses daily. 27 patients stopped therapy prior to week 12 due to a variety of reasons, particularly adverse events. Nearly 45% of participants needed ribavirin dose reductions for anemia (Hgb<10 g) along with the use of EPO.
Not all of the patients have completed the full 24-week post-treatment follow-up and these results are based largely on 12-week post-treatment SVRs. The bottom line is that twice daily TVR dosing was equivalent to or better than those published using 3 times daily dosing. This was a difficult-to-treat population with mostly advanced fibrosis, genotype 1a and unfavorable IL28B genotypes.
- DO NOT do this on your own. This is a preliminary abstract and not an FDA-approved treatment guideline. Plus there was a high dropout rate.
- This is incomplete data. We need final week 24 SVR numbers.
- If this becomes a protocol, it has three advantages:
- It is much easier to remember to take pills twice daily than 3 times, particularly since ribavirin dosing is twice daily.
- Eating 20 grams of fat twice daily would be easier than having to do this 3 times daily.
- Improved adherence could result in better SVR rates.
Abstract # 1834 Does Chemotherapy Cause Hepatitis C Viral Relapse in Cancer Patients Who Achieved Sustained Virological Response?
Authors H.A. Torres and P. Mahale
Results and Conclusion This study looked at medical records of all HCV-infected cancer patients seen at M.D. Anderson Cancer Center from 1/2008 to 12/2011 who had achieved an SVR. No case of post-SVR relapse occurred following chemotherapy of the 48 identified patients.
Editorial Comments Earlier this year I read a report suggesting that chemotherapy may cause a relapse in cancer patients who had an SVR. My heart sank, as this challenged my assertion that SVR equals cure. This study is more assuring, but frankly, it is small. More research is needed, but I am still using the “cure” word.
Abstract # CRW-5 Should We Prioritize Chronic Hepatitis C Patients For Treatment with Direct-Acting Antiviral Agents?
Lead Author J. Chhatwal, et al.
Results and Conclusion A huge increase in patients seeking HCV treatment occurred after the approval of direct-acting antiviral agents (DAAs). Many medical providers cannot manage this surge and have put patients on waiting lists. Another concept is called warehousing (a term I deplore), which means prioritizing patients and wait-listing patients who may be able to wait.
This study developed a decision-analytic Markov model and recommended the following prioritization order (from highest to lowest):
- Cirrhosis[a] younger age, [b] prior relapser, [c] treatment naïve, [d] IL28B genotype C/C, [e] partial responder [f] others)
- METAVIR score F3 [a] younger age, [b] others
- METAVIR score F0–F2
Editorial Comments I hesitated to include this abstract because it raises uncomfortable issues. No one likes to think that they could not get treatment when they want it. In practice, few physicians would turn down a motivated patient. However, when a patient with minimal disease is treated, then someone with more advanced liver disease may have to wait. I am not suggesting that we self-wait list, but I do think we deserve to see the entire picture. As someone with stage 2 fibrosis who is considering HCV treatment for a third time, this study affirms my decision to wait.
One thing I am sure about is that the term warehousing needs to go. How about prioritizing?