6 shots left

yes i have six more to go i been und at week 4 what would my percent be g1 staying und

[annieCinMD]

Can't give you an exact number but und at 4 wks. is RVR, and your chances are pretty damn good.

[vik97]

I'm not an expert, but from what I've read, your chances of achieving SVR (geno 1) after having been UND at week 4 of a 48 week treatment, is about 80 percent or more.

Vik

[chemister]

I had genotype 1 and 2. Because I was a rapid responder (RVR)
Virusload start 2700000 IU/mL
    week 1:            6300 IU/mL
    week 3 and 4 UND
I was recomanded to stop at week 24 and not 48 which is normal at geno 1. SVR is 10 % lower, not 90% but 80%.

Write more about genotype and virusload at the first 4 weeks.

[mj6000]

I've never heard of someone with a genotype 1 stopping at 24 weeks. I thought if you had genotype 1 plus a different type you were treated as a G1 for 48 weeks even with RVR.

[mj6000]

Sorry,my last comment was for chemister.

[WriteItDown]

In Europe SOC now is to stop treatment for Geno 1's who RVR (and maybe also have low viral load -- can't remember) at 24 weeks. Or people who are in certain clinical trials of SOC + PI sometimes stop at 24 weeks as well.

[chemister]

It is normal with 24 weeks Tx when you are a RVR and have genotype 1

http://www.hivandhepatitis.com/hep_c/news/2008/101408_b.html

[cuteus]

24 weeks seem to be enough for a large percentage of G1  around 80%. Are the 7 that did not finish their Tx included in that last count? If they are, it would seem that it would lower the final SVR percentage somewhat. Still, that leaves 20 out of 100 RVR who do not achieve SVR. If I can tolerate the Tx, I would like to ensure complete erradication and not risk Tx again. You do not know if you are part of the 80 or the 20. Just my feeling, especially if for some reason after RVR your dosage is lowered or brain fog sets in and you forget your riba often. I have seen many RVRs, with a couple undetect after Tx, relapse.  If you are having severe physical and mental side effects from Tx, give it a shot and stop at the suggested time. I see we are all pretty much guinea pigs of the Tx companies. That study had about 500 folks, we are a much larger population.

[newleaf09]

Because I was in a trial with a PI, I stopped at 28 wks.  You can't go by my treatment time because of the involvement of the protease inhibitor (adds a big gun to the whole picture).  I would have stopped at 28 weeks if I had not been randomized out of the trial then because I was UD at week one before even starting the PI.  I think odds if you clear at one week are in the 90's, so I never doubted stopping at 24 and just went 28 as a point of honor with the trial.  I was unwilling to keep taking meds with the dangerous hematological side effects (platelets at 30,000, nearly uncontrollable neutrophil slide) and autoimmune side effects that started to develop after 24 weeks.  

[nygirl7]

Stopping at week 24 seems like a great idea.  Until you are one of the folks that don't achieve SVR.  Then that extra 24 weeks seems like it would have been much better than having to do another 48 or 72.

I've never been that fond of the idea but that is probably because I'm a chicken and I didn't want to have to do it ever again.  Once your on the road it seems easier to stay on the road until you reach the destination rather than take a detour, get lost and have to start all over at the beginning of the trip.

Just my opinion. Not worth the risk.

[nygirl7]

PS Cam - your odds are excellent but of course nobody can really guarantee anything with this disease. Just make sure you take the rest of the meds and get every bit of the odds that you can.

[orleans]

This is 1 of many, many trails that show 24 week is as effective as 48 with RVR/low VL g1s. Goggle it.--------High chance of cure in HCV genotype 1 patients with a low viral load achieving an RVR treated for 24 weeks with pegylated interferon alfa-2a (PEGASYS) plus ribavirin (COPEGUS): prospective, randomized, controlled study comparing 24 & 48 weeks of treatment


  
  Reported by Jules Levin
AASLD, Nov 2-6, 2007, Boston, MA

M.-L. Yu,1,2 C.-Y. Dai,1,2,3 J.-F. Huang,4 L.-P. Lee,1 M.-Y. Hsieh,1 C.-F. Chiu,5 N.-J. Hou,4 Z.-Y. Lin,1,2 S.-C. Chen,1,2 M.-Y. Hsieh,1,2 L.-Y. Wang,1,2 W.-Y. Chang,1,2 and W.-L. Chuang1,2
1Hepatobiliary Division, Faculty of Internal Medicine, College of Medicine, Kaohsiung Medical University, Kaohsiung, Taiwan; 2Hepatobiliary Division, Department of Internal Medicine, Kaohsiung Medical University Hospital, Kaohsiung, Taiwan;
3Department of Internal Medicine, Kaohsiung Municipal Hsiao-Kang Hospital, Kaohsiung, Taiwan; 4Department of Internal Medicine, Foo Yin Hospital, Pintung, Taiwan; 5Department of Internal Medicine, Paochien Hospital, Pintung, Taiwan

CONCLUSIONS
This study demonstrated that a shorter course of 24-week peginterferon alfa-2a (40KD) plus weight-based ribavirin 1000/1200 mg/day was as effective as a standard 48-week course in patients chronically infected with HCV genotype 1 who had a low baseline viral load (LVL) and achieved an RVR at week 4.

In patients that do not achieve an RVR or have high baseline viral loads (HVL) 48 weeks of therapy with peginterferon alfa-2a still provides the best likelihood of an SVR.

MLR analyses confirmed that achieving an RVR at week 4 is the single best predictor significantly affecting SVR in both 24- and 48-week groups.

Our results provide information necessary for decision-making of individualized treatment based on response at 4 weeks and baseline viral loads in chronic hepatitis C patients with HCV genotype 1 infections.

INTRODUCTION
Peginterferon and ribavirin combination treatment has been recommended for all patients infected with HCV, but the treatment duration varies depending on the HCV genotype. Recommended treatment for patients with HCV genotype 1 (G1) infection is pegylated interferon plus ribavirin (RBV) for 48 weeks and 24 weeks for HCV G2/3.[1,2] A rapid virologic response (RVR; <50 IU/mL HCV RNA at week 4) is a strong predictor of sustained virologic response (SVR; 80% with a shorter treatment duration of 12-16 weeks pegylated interferon alfa-2a (40KD) plus RBV in HCV G2/3 patients with an RVR[5-7] have questioned whether shorter treatment durations can yield high SVR rates for G1 patients with an RVR.

OBJECTIVES
The primary aim of the present study was to evaluate whether treatment with peginterferon and ribavirin for 24 weeks is sufficient to achieve an SVR rate comparable to that observed with the standard treatment duration of 48 weeks, in HCV genotype 1 patients achieving an RVR at 4 weeks.

The secondary aim was to investigate the role of on-treatment virologic responses among patients with 24 or 48 weeks of treatment.

METHODS
Randomized, open-label, active-controlled trial carried out in one medical center and three regional core hospitals in Taiwan from April 2005 to May 2007.

Patients
Eligible subjects were treatment-naive, Taiwanese patients with confirmed chronic hepatitis C (genotype 1) aged 18 to 65 years old. Patients displayed elevated serum alanine aminotransferase (ALT) levels for at least two measurements within 6 months preceding trial entry.

Other eligibility criteria included neutrophil count >1500/mm3, platelet count >9 -104/mm3, hemoglobin level >12 g/dL for men and >11 g/dL for women, serum creatinine level <1.5 mg/dL, no pregnancy or lactation, and the use of a reliable method of contraception.

Exclusion criteria included patients with detectable hepatitis B surface antigen, HIV infection, autoimmune hepatitis, primary biliary cirrhosis, sclerosing cholangitis, Wilson disease, a1-antitrypsin deficiency, decompensated cirrhosis (Child-Pugh class B or C), overt hepatic failure, a current or past history of alcohol abuse (≥20 g daily), psychiatric condition, previous liver transplantation, or evidence of hepatocellular carcinoma.

Treatment
Patients were randomized (1:1) to 24 weeks or 48 weeks peginterferon alfa-2a (40KD) (PEGASYS, Roche, NJ, USA) 180 _g/week plus ribavirin (COPEGUS, Roche, NJ, USA) 1000/1200 mg/day, with a follow-up period of 24 weeks.

The dose modification of peginterferon and ribavirin was according to the strategy described previously.[7]

Adverse events were graded as mild, moderate, severe, or potentially life-threatening.

Serum HCV RNA levels at baseline and during treatment week 4 were measured using the branched DNA assay (Versant HCV RNA 3.0, Bayer, Tarrytown, NJ, USA). Serum HCV RNA at baseline, during treatment weeks 4 and 12, at the end of treatment, and at 24 weeks after therapy was determined by standardized automated qualitative PCR.

Liver histology was graded and staged according to the scoring system described by Knodell and Scheuer by a single pathologist who was blinded to the treatment of each patient.

Outcomes

The primary end point of this study was to assess SVR, which was defined as PCR-negative serum HCV RNA (<50 IU/mL) by the end of treatment and throughout the follow-up period.

RVR was defined as PCR-negative serum HCV RNA at 4 weeks of therapy.

Early virologic response (EVR) was defined as PCR-negative or at least 2 log10 decline from baseline of serum HCV RNA at 12 weeks of treatment.

End-of-treatment virologic response (EoT) was defined as PCR-negative serum HCV RNA at end of treatment.

Relapse was defined as HCV RNA reappearance during the follow-up period in patients who achieved an end-of-treatment virologic response.




Similar rates of RVR (45% and 42%) and EVR (96% and 93%) were observed for 24 and 48 weeks of therapy, respectively (Table 2).

Overall, the 48 week arm had a significantly lower relapse rate and a higher SVR rate than the 24 week arm (ITT).




Patients with an RVR had a significantly higher SVR rate than patients without an RVR in both treatment arms. Eighty-nine percent and 100% of patients who achieved an RVR achieved an SVR over 24 weeks and 48 weeks of therapy, respectively. Of patients who did not achieve an RVR, 35% and 64% of patients achieved an SVR over 24 weeks and 48 weeks of therapy, respectively (Table 2).

Among patients that at baseline demonstrated low viral load (LVL, <400 000 IU/mL) and achieved an RVR, the relapse rate and SVR rate in the 24-week group (3.6% and 96.4%, respectively) was comparable with responses seen in the 48-week group (0% and 100%, respectively) (Figure 2A).

Multiple logistic regression (MLR) analysis in all patients showed that an RVR was the strongest independent factor associated with achieving an SVR, followed by treatment duration, baseline viral load and ribavirin exposure (Table 3).

[cuteus]

When looking at studies, you have to remember that they choose the candidates with the best possible profile that might ensure a positive outcome.  The population at large have variables that are not part of trials: someone monitoring your compliance and accurate administration of meds, possible assistance with blood boosters that might not be available to the large population on Tx,  stage 4 liver damage,etc. Interesting that in the above study there is no mention of liver damage scoring, only VL and liver profile. We don't know how much liver damage the RVRs and SVR had. Out in the large population, RVRs with stage 4 might actually have a higher % of relapse than the stage 1 RVRs in the study.  Liver scarring can still harbor remnants of hcv that  might trigger a relapse. We have to look at those studies carefully, especially the data not mentioned. See if you can actually apply it to yourself. I had to read many studies before determining if the results could be applied to my individual circumstances.
Unless you have a PCR immediately preceding your Tx, no one can accurately determine if a log drop  was correctly measured, so I don't place much wt on log drops. If RVR now places G1s in the same line of SVR as G2/3, you are still looking at around 20% that don't make the SVR.  Like NYG said, not having to start at square one is the best reason to go as far as you can.
I was just reading about one of our friends here, Greg, who was early und, SVR for follow ups up to a 18 post tx and at that anniversary or  shortly after, he became detectable again. It happens. The environment outside trials is different for most of those on Tx, more variables. Go as far as you can, is my feeling.  I don't think we can call ending tx at 24wks normal yet. We are still part of the larger experiment.  How long is the follow up in these trials anyway?  Go as far as you can, you only want to do this once!

[cuteus]

..."Overall, the 48 week arm had a significantly lower relapse rate and a higher SVR rate than the 24 week arm (ITT)."

[cuteus]

correction; Greg relapsed at the year mark, after been und at day18 of Tx.  He did the 48 wks tx but somewhere, hcv was waiting to resurface. Hit the bug hard and long, kick it while is down, no one will accuse you for cruelty to viruses