Getting Ready; Telaprevir or Boceprevir ?

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Getting Ready; Telaprevir or Boceprevir ?

You know folks, as I begin writing this (and I have no talent for writing by the way) I can't help but wonder if hepatitis C patients who are preparing to treat are ready to choose between the two new drugs; Telaprevir "INCIVEK" or Boceprevir "VICTRELIS". More importantly I wonder if patients understand the dire need for an experienced physician to be on board for this complicated three drug regimen of difficult to tolerate drugs (maybe more including rescue drugs) which will involve treating for 24 to 48 weeks.

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I ask you, are you ready ? Do you have an experienced physician ? Have you moved your family out of the house and into the garage in order not to hurt them, kidding. You, the patient will decide which drug to use, a difficult decision no doubt. Both drugs are so close in comparison, with each drug closely being scrutinized, your decision will be determined by the efficacy and safety provided by the recent clinical data. Although, the final decision for some patients may hinder on either enrolling in a clinical trial (when available) or taking advantage of the drug companies patient assistance programs(when in place).

Yes, boceprevir is here,(FDA Approved) and the temptation to begin treatment is upon us, with telaprevir only a whisper away you may be asking yourself what to do, which drug to use, or wishing someone would make a decision for you. Nope, that's up to you and only you. Coupled with the assistance from your physician, and your own particular scenario, you will ultimately make the final decision. That's how the medical world works today, the same is true for all medical care from cancer treatments to knee surgery, its up to you folks, so lets get started. What we know to date is that clinical data has suggested that telaprevir is significantly more effective in comparison to boceprevir. If we look at patients who were

not previously treated, we know that telaprevir achieved a sustained virologic response of 79 percent when used along with standard treatment. Boceprevir also used in combination with standard therapy has a 63 percent sustained virologic response in naïve patients. As for duration of treatment, in telaprevir 58% of naïve patients can shorten treatment to 24 weeks, compared to 28 weeks in 44% of boceprevir patients. If we check out the stats in patients that have treated previously the SVR for telaprevir is 65% and boceprevir is 66%. As mentioned on the blog

boceprevir did not include null responders in their trial. Vertex’s phase III REALIZE trial did test telaprevir in null responders, which produced a 31% SVR rate..

Author McQueen from The AIDS Beacon writes;

Although the rates for telaprevir appear higher than those for boceprevir, it is not clear whether telaprevir is actually more effective.Patients who received the standard treatment of just ribavirin plus Pegasys in the telaprevir trials had a higher cure rate than patients in the boceprevir trials who received just ribavirin plus PegIntron. As a result, it is possible that the differences in cure rates between the trials are actually due to Pegasys versus PegIntron, or other differences between the studies. Some studies have found that Pegasys is more effective than PegIntron.Trials in which telaprevir and boceprevir are compared directly will be necessary before determining whether one drug is more effective than the other.

The concern in relation to side effects or safety in telaprevir is the significance of the rash, which was reported in 56% of patients using telaprevir. We can compare that to 32% of patients reporting a rash receiving standard of care. The rash was found to be mild to moderate although severe in 1% of patients and resulted in stopping treatment for 6% of patients. You must be aware of the symptoms of the rash, which will add to the stress often experienced with treating HCV. The drug ribavirin also causes a rash, what seasoned patients refer to as the "Riba Rash", hated it. Physicians will be on alert folks, but you must also be persistent and diligent in reporting it to your treatment nurse and doctor..

Anemia was seen more often in patients receiving telaprevir then those treating only with standard therapy. (36% telaprevir vs.15% standard of care patients) and sometimes more severe. In 3% of patients telaprevir was discontinued because of anemia.(remember that 3%).

In boceprevir anemia was seen in about 50 % of patients compared to 30% receiving standard therapy. This is important, in the telaprevir trials patients were not allowed rescue drugs, in that they were not allowed to treat the anemia with erythropoietin (EPO)-a drug that stimulates the production of red blood cells. In comparison the boceprevir trials did allow rescue drugs and (EPO) was used, or patients were able to lower their dose of ribavirin . This raises the question of how severe the anemia could have been in the boceprevir clinical trials. So in retrospect those 3% of patients who had to discontinue telaprevir because of anemia were real numbers. This is the second time boceprevirs stats have not been clear, the same applies to those SVR numbers in previously treated patients, as mentioned null responders were not included in boceprevir trials. .

The protocol for treating with boceprevir can be viewed here and here. *After FDA approval of telaprevir this blog will post the prescribing information. .

The newly FDA approved boceprevir has been projected to cost around $1,100 per week, with telaprevir costing close to the same.(Not including Interferon/ribavirin). According to consumers reports the cost of standard of care is at roughly $600 per week which breaks down to $500 for the Peginterferon and $100 for ribavirin.Reuters reported yesterday that Merck the maker of Boceprevir made a deal with Roche to promote Victrelis/boceprevir in the US and research treatments for hepatitis c.

http://Hepatitis Cnewdrugs.blogspot.com/2011/05/getting-ready-telaprevir-or-boceprevir.html