Здравей Михаела,
При ПСР изследването на 12-тата седмица от започване на лечението се следи за наличието на Ранен Вирусологичен Отговор (на английски: Early Virological Response - EVR). Ранният вирусологичен отговор се дефинира като:
Спадане на HCV RNA (вирусния товар) с 99% (2 лога), или отрицателен HCV RNA, на 12-тата седмица след началото на лечението.
, или това е спадане на вирусния товар от поне 100 пъти. В твоя случай би се говорило за постигнат EVR, ако имаш 1 630 000/100 = 16 300 IU/mL.
За съжаление твоя вирусен товар е 150 000 IU/mL, и това което знам е, че най-вероятно ще трябва да спреш лечението си!
При хепатит C, ранния вирусологичен отговор е много важен критерий за предсказване на постигане на траен вирусологичен отговор, т.е. за успешно лечение. Хората, които не постигнат ранен вирусологичен отговор имат само 3% шанс да постигнат траен вирусологичен отговор:
Термини за отговор на лечението
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Ранен Вирусологичен Отговор (Early Virological Response - EVR):
Спадане на HCV RNA (вирусния товар) с 99% (2 лога), или отрицателен HCV RNA, на 12-тата седмица след началото на лечението. Ако някой не постигне тези стойности, има само около 3% шанс да постигне SVR. Това е широко установен критерий, който се използва, за да се прецени дали лечението трябва да продължи, или да бъде спряно. Пълният ранен вирусологичен отговор (complete EVR - cEVR) се дефинира като неоткриваем HCV RNA (вирусен товар) на 12-тата седмица от началото на лечението, което съответно означава, че пациента има по-голям шанс да постигне SVR.
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Тук искам да пусна цитати към още две публикации, свързани с ранния вирусологичен отговор и отговора на лечението (само, че са на английски):
The NIH Consensus Conference on the Management of Hepatitis C: 2002. Part 3
Utilization of Virologic Testing in the Treatment of Chronic Hepatitis C
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The goal of the current analysis was to determine whether reduction of the level of HCV RNA during the first weeks of PEG-R treatment predicted response and non-response at the end of treatment and whether this information would be used to formulate early stopping rules before 24 weeks of treatment. Data from two recent large international clinical studies of pegylated interferon plus oral ribavirin was made available by the study sponsors, Schering Plough and Roche Pharmaceuticals, after agreement of the study investigators. (1,2)
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The analysis of the 2 data sets with respect to the ability of the week 12 viral response to predict non-response is shown in the table below. The results with the 2 different interferon regimens are nearly identical. Early virologic response (EVR) was best defined as a fall in HCV RNA level after the first 12 weeks of treatment to less than the lower limit of detection (PCR) or by at least 2 logs compared to the pre-treatment level. Overall, 82.7 percent of patients treated with this combination achieved EVR and 68 percent of these cases eventually achieved SVR. SVR was more than 50 percent more likely to occur in patients who were able to receive at least 80 percent of the recommended dose and duration of drugs. Failure to achieve an early virologic response was highly predictive of non-response; only 2 of 161 (1.2 percent) patients without EVR ultimately achieved SVR.
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In summary, most patients who receive treatment with pegylated interferon and ribavirin achieve early virologic response, defined as a fall in HCV RNA level by at least 2 logs or to undetectable by PCR after the first 12 weeks of treatment. About two-thirds of these patients will ultimately achieve SVR, thus providing excellent motivation to continue therapy and not dose reduce unnecessarily.
In contrast, those who fail to achieve an early virologic response have only a very small chance of achieving SVR even if therapy is continued for a full year. Discontinuation of therapy is encouraged in these cases.
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Това изследване е за Пегинтрон и Ребетол, но също е показателно:
Early Virologic Response (EVR) to Treatment with PEG-Intron (peginterferon alfa-2b) Plus Rebetol (ribavirin) in Patients with Chronic Hepatitis C
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The aim of this study was to investigate whether early changes in HCV RNA levels during treatment with pegylated interferon and ribavirin could be used to accurately predict treatment response. Because early discontinuation of treatment in nonresponders could avoid the expense and inconvenience of continuing unnecessary treatment, the researchers also examined the potential cost savings of strategies that would use early virologic response (EVR) to develop early stopping rules for such patients.
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The investigators most closely evaluated treatment responses in the 511 subjects who were randomized to pegylated interferon alfa-2b at a dose of 1.5 microgram/kg each week and 800 mg/d of oral ribavirin (PEG/R) because this regimen was licensed by the Food and Drug Administration.
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The best definition of EVR was a reduction in hepatitis C virus (HCV) RNA by at least 2 logs after the first 12 weeks of treatment compared with baseline. Between 69% and 76% of patients achieved this threshold, depending on the treatment regimen, and sustained virologic response (SVR) occurred in 67% to 80% of these patients. Patients who did not reach EVR did not respond to further therapy.
If treatment had been stopped in patients without EVR, drug costs would have been reduced by more than 20% [Emphasis added-Ed].
In conclusion, the authors state, "Early confirmation of viral reduction following initiation of antiviral therapy for chronic hepatitis C is worthwhile. It provides a goal to motivate adherence during the first months of therapy and a milepost at which to reassess the need for continued treatment. Most patients who are able to complete the first 12 weeks of therapy achieve EVR and have a high probability of SVR."
"Patients who fail to achieve EVR will not clear virus even if additional months of therapy is received. Therapy can be confidently discontinued in those cases."
Моят съвет е да поговориш сериозно с лекуващия те лекар и да обсъдите възможностите и да видиш какво би те посъветвал той. Не бърай да правиш изводи и не взимай никакви решения, преди да говориш с него.
Съжалявам, че трябваше да напиша това, но не трябва да се отчайваш, съвсем скоро на пазара ще се появи ново лекарство (Телапревир), което е доказало своята ефективност точно при най-трудните за лекуване случаи и при хора, при които първото лечение не е било успешно. Така, че просто ти трябва малко търпение, докато се появи това лекарство на пазара. Освен това, дори и без него, много хора повтарят и потретват интерфероновото лечение и в немалко случаи то в крайна сметка подейства, така че не трябва да губиш оптимизъм!!!
Поздрави,
Радо
