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Wednesday May 29, 2024

Treatment of Hepatitis-C: effective and safe option available

By our correspondents
January 14, 2016

Islamabad

Pakistan has the second-highest prevalence of Hepatitis-C in the world. The disease is more prevalent among people of poor socioeconomic status. According to careful estimates, more than 20 million people in the country are infected with Hepatitis-C. Of these, 6 million can be labeled as having serious liver disease, and 1 million are known to being at a greater risk of developing liver cancer. As such, the treatment of this disease should be as significant for Pakistan as perhaps the eradication of polio. The only difference is that polio eradication is driven by international pressure, while hepatitis is not. 

Till recently, Hepatitis-C treatment involved a 6-12 month treatment plan with an Interferon-based regimen that provided cure rates of 60% or less, and was associated with severe side effects including anemia, depression, severe rashes, nausea, diarrhoea, and fatigue.

Oral Sofosbuvir therapy for Hepatitis-C is undoubtedly a huge breakthrough in medical science, but for a country like Pakistan, affordability is one of the biggest issues as the disease is more prevalent in the poor population.

A study authored by Hill et al. in 2013 indicated that the actual cost of manufacturing Sofosbuvir is relatively low (an estimated $101 (Rs10,605) for a 12-week treatment course. According to this study, the price per tablet of Sofosbuvir should come at Rs117 per tablet. This study was done in 2013, and today, if one were to apply the basic principle of economics, then the marketed prices for these drugs should be far lower due to open generic competition.

In Pakistan, only one study has been conducted on the use of Sofosbuvir in the Hepatitis-C population. The investigators of this study are two gastroenterologists of Pakistan namely, Professor Dr. Zafar Iqbal, (Sitara-e-Imtiaz) ex-chairman and dean of Shaikh Zayed Medical Institute, principal of Shaikh Khalifa Bin Zayed Medical and Dental College; and Professor Dr. Aftab Mohsin, principal, Gujranwala Medical College. In view of the importance of the availability of low-priced generic drugs for the population at large, they used a generic drug Sovir in chronic liver disease.

According to Dr. Zafar, a careful evaluation of the stability data was done. “Patients who were put on Sovir (Sofosbuvir) were difficult to treat as these patients were either ineligible to receive interferon therapy or were interferon non-responders. Sovir (Sofosbuvir) 400 mg along with Ribavirin (dose adjustment according to weight of patient) was prescribed to these cases. The treatment was initiated after proper approval of Institutional Review Board of Gujranwala Medical College and informed consent was taken before starting the treatment,” he shared.

A total of 50 patients were treated in each centre. “Out of these 50 patients, 49 had a 100% Sustained Virological Response (SVR). I also used Sovaldi (Sofosbuvir) in the same number of patients with a similar diagnosis and demographic data. In these patients, 3 patients out of 50 were non-responders. It is pertinent to mention here that international trials done on Sovaldi (Sofosbuvir) document 8% non-responder with the drug. In my experience, Sovir (Sofosbuvir) has a 98% SVR with a 2% non-responder, and Sovaldi has a 94% SVR and 6% non-responder. This clearly shows that Sovir is not only an effective and safe medicine for the treatment of Hepatitis C but is also better than Sovaldi at SVR stage. As such, Sovir (sofosbuvir) has proven efficacy, safety, quality and tolerability in patients of chronic liver disease,” Professor Zafar Iqbal maintained.