Едно от важните решения, които трябва да вземе всеки болен от хепатит C е дали да започне лечение възможно най-скоро или да изчака, докато се появят по-нови и ефикасни лекарства.
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HCV Advocate.org публикува много хубава статия, точно по темата.
Ще сложа целия и текст по-долу, а за тези които не разбират английски ще се опитам да обобщя най-отдолу кои са най-съществените неща, за които се говори в нея:
Линк към статията: Reality Check!
Reality Check!
Alan Franciscus, Editor-in-Chief
One of the most frequent questions we receive is about making a decision regarding starting HCV drug treatment. The new drugs in clinical development have caused many to question whether it is better to be treated now or to wait until the newer treatments are available. This article will touch on the process of HCV drug development, some of the questions that need to be answered about the new therapies, as well as questions to ponder about starting treatment now versus waiting for the new therapies to be approved. It is important to remember that the decision to treat should always be made in consultation with a medical provider.
New Medications
First let’s take a practical look at the new medications in development. There has been a lot of news about investigational HCV drugs in clinical development within the last year.
We are entering an exciting period of HCV drug discovery that not only offers hope for medications with improved treatment outcomes, but also newer drugs that will have a potential for less side effects than the current HCV medications. However, new antiviral drugs that are farthest along in clinical development are only in phase II studies.
Phase II clinical trials are conducted to obtain preliminary data on the effectiveness of the drug and collect information about the side effects and the risks associated with taking the drug. The number of participants in a phase II study is relatively small (a few hundred to over 500 hundred). At the completion of a phase II study the data is collected and analyzed and a much larger (up to several thousand patients) phase III study is initiated. A larger population of HCV patients treated with a new drug will give us a better picture of the effectiveness of the drug, side effect profile and other important information. Once the phase III study is completed and the data is collected, the pharmaceutical company applies to the Food and Drug Administration (FDA) for marketing approval to treat the general HCV population. The FDA will review the application and data from the clinical trials and will either approve the drug for marketing, request additional studies or more information, or deny approval. It is really difficult to gauge how long it will be before new drugs are available to the general population, but it is estimated that approval of the first new antiviral drug to treat hepatitis C is 3 to 5 years from now. One certainty is that the new drug(s) approved to treat HCV will be used in combination with pegylated interferon or pegylated interferon plus ribavirin – at least for many years to come.
The Media Hype
The media has done a great job of making us believe that new and better drugs are going to be available soon. Almost every day we hear of a new drug that is sure to ‘cure’ hepatitis C and we are led to believe that the ‘cure’ is right around the corner. Another reason why we all want new medications is the hope that we will discover new medications that will effectively treat everyone with hepatitis C. If you have already been treated and did not respond, the new drugs offer much needed hope for the future. Due in part to the media hype and our own hopes for more effective treatment, many people believe that the newer drugs will be available in the very near future. Unfortunately, treating a disease such as HCV is a complex issue and while it is a certainty that new and improved drugs will be developed, the development process will be slower than many of us want or have been led to believe.
Unresolved Questions
There are many issues that need to be resolved that will be answered during and after the development process. The potential of drug resistance will be at the forefront of research since we are entering an era of medications to treat hepatitis C that directly attack the virus and interfere with the HCV viral replication process. Adherence to the current indirect HCV medications (pegylated interferon plus ribavirin) is important because 100% adherence increases the chances for a successful sustained virological response by increasing the drug concentrations in the blood. Adherence to the new direct antivirals will also be critical for making sure there is the highest possible drug concentration in the blood; but adherence will become even more critical for preventing drug resistance that could render the drug ineffective. The new drugs will also have to be taken three or four times a day (at the same time every day). Most people think this is a simple matter, but it has been shown that adherence is one of the most difficult issues facing successful management and treatment of any disease.
There are many additional questions that need to be resolved including:
• What is the most effective dose and how often will it have to be taken (once every 6 hours, 8 hours, etc.)?
• What is the optimal duration of treatment?
• Will a sustained virological response translate into a durable or long-lasting response?
• If someone develops drug resistance to a new medication, will it mean that they will not be able to be treated with the same drug or class of drugs?
• Will treatment for some people consist of the long-term use of a certain drug if viral eradication can not be achieved?
• What are the drug interactions between the new medications and any medications people are currently taking for other conditions?
• Will the drugs create any short- or long-term health consequences?
Hopefully, these questions and more will be answered as the new drugs advance through clinical trials.
Should I be Treated?
Most experts would agree that a person with moderate to severe liver fibrosis should be treated now rather than waiting until the newer medications are approved for treatment. Of course there are other considerations for seeking treatment, including quality of life issues (such as severe fatigue), personal issues (starting a family, career goals), insurance issues (comprehensive insurance coverage, part time disability insurance), and other personal issues.
Should I Wait?
Since hepatitis C is a slowly progressive disease (for most people), most experts would recommend that someone with mild liver damage could safely wait until the newer medications are approved. Unfortunately, there is no “one size fits all” for hepatitis C. For instance, minimal liver damage is a predictor of successful treatment outcome. This means that a person with minimal liver damage who has that opportunity to wait for new medications should weigh the predictive factor against the possibility of waiting for the new drugs to be approved. Another issue for consideration is genotype – since the chances of achieving an SVR in people with genotype 2 and 3 are so high, many experts recommend that these individuals should be treated now.
Living with hepatitis C forces us to make many health-related decisions every day. In order to make the best possible decision it is important to educate ourselves with the facts as much as possible and carefully weigh the pros and cons before we decide on a certain course of action. This course of action should always include a discussion with a medical provider, but it is important to remember that the final decision is yours.
Predictors of Treatment Response:
• Genotype 2 or 3
• HCV RNA or Viral Load under 800,000 IU/mL
• Age: Under 40 years old
• Gender: Females respond better than males
• Minimal liver disease
• Little or no steatosis
• Healthy weight or non-obese
• Asian or Caucasian race
Едно от важните неща, за които се говори в статията е конкретнот време, когато ще се появят следващите лекарства, които са надеждата за по-леко и същевременно по-ефективно лечение. Според автора те ще се появят най-рано след 3 до 5 години. Тези нови лекарства, които са в период на 2 фаза на клинични изпитания ще бъдат използвани в комбинация с пегилиран интерферон. Доста време след това пегилирания интерферон ще продължава да се използва като един от основните компоненти при лекуване на хепатит C.
Много от експертите биха препоръчали хората с умерено (mild) увреждане на черния дроб по-скоро да изчакат да се появят новите лекарства. Но няма универсално правило, от друга страна пък всеки, който има малко увреждане има много по-голям шанс за излекуване от хората, които са с по-голяма степен на увреждане на черния дроб. Затова всеки болен трябва да прецени дали да се лекува сега с повече странични ефекти, докато има малко увреждане или да изчака за ново лекарство с по-малко странични ефекти /и съответно по-ефективно/, но пък с по-силно увреден черен дроб.
За да вземе такова решение всеки човек трябва да бъде максимално информиран и разбира се, да се консултира с лекуващия си лекар. Но решението винаги остава лично и се взима от болния.
Едни от факторите, от които зависи как ще се отрази лечението на болния и дали ще има по-големи шансове да се излекува са:
• Генотип 2 или 3
• Количество на вируса (измерено с PCR теста - HCV RNA) под 800,000 IU/mL
• Години: възраст, по-ниска от 40 години
• Пол: Жените отговарят по-добре на лечението от мъжете
• Минимална степен на увреждане на черния дроб
• Little or no steatosis /не съм сигурен за конкретния термин на български, но доколкото чета стеатоза е наличието на големи количества тлъстини в клетките на черния дроб/
• Хората, които имат тегло в нормата и са без наднормено тегло отговарят по-добре на лечението
• Раса: Азиатците и хората с бяла кожа
Всички тези фактори са плюс, който показва по-големи шансове човек да се излекува с помощта на сегашния стандарт за лечение на хепатит C - пегилиран интерферон + рибавирин. На колкото повече от тях отговаря даден болен, толкова по-сериозни шансове има да се излекува с помощта на пегилиран интерферон + рибавирин.
Поздрави,
Радо
