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  • in reply to: Day 1 – let’s the fight begin #28768
    vitrus
    • Topics: 1
    • Replies: 35
    • Total: 36
    • Treatment Warrior
    • ★★★
    @vitrus

    It’s fibrosis score – F0 – healthy liver, F4 – advanced fibrosis.

    Done with liver ultrasound or Fibroscan in like one hour.

    You may actually need to know it now.

    On the one hand, it could be a mistake or another reason for massive liver damage:

    https://www.ueg.eu/education/latest-news/article/article/mistakes-in-liver-function-test-abnormalities-and-how-to-avoid-them/

    The significance of aminotransferase levels in the diagnosis and prognosis of acute liver failure is often misunderstood. Excessive aminotransferase levels occur in acute viral, toxic or ischaemic liver injury. Although impressive, these levels merely reflect acute hepatocellular damage rather than loss of liver function. Consequently, marked aminotransferase elevations in the absence of jaundice, coagulopathy and encephalopathy should not lead to a diagnosis of acute liver failure.

    EASL recommendation:

    Patients with decompensated (Child-Pugh B or C) cirrhosis
    should be treated in experienced centres with easy
    access to liver transplantation and close monitoring during
    therapy is required, with the possibility of stopping
    therapy with evidence of worsening decompensation
    during treatment (A1).

    http://www.easl.eu/medias/cpg/2018/EASL%20Recommendations%20on%20Treatment%20of%20Hepatitis%20C%202018/English-report.pdf

    Nothing else to see here, except for the need for expert monitoring.

    Sof/vel is recommended for the decompensated cirrhosis but it can cause effects of decompensation (liver damage) on-treatment, when treatment should be cancelled and emergent measures should be taken.

    It is actually important to know your liver fibrosis state now.

    Read this.
    https://livertox.nih.gov/Sofosbuvir.htm

    Find out if you have or have had Hepatitis B or cirrhosis. If you do, it could be a serious life-threatening condition.
    If you don’t then probably it is a test mistake.

    You may want to schedule other blood and liver tests corresponding to the findings of the sofosbuvir Drug Record (to confirm or exclude Hep B reactivation or hepatic decompensation).

    You may even need expert monitoring to assess a need for emergent liver transplantation and to see what other tests including blood tests, liver tests should be done. Or to urgently assess other test values to confirm it was a mistake.

    I am not a doctor at all, just would like to say that it’s not okay and you should act quickly. Call ambulance, see a doctor to consult with. Do more tests.

    Only FDA-documented reasons related to sof+vel are Hepatitis B reactivation and cirhosis decompensation in people with cirrhosis.

    https://www.webmd.com/a-to-z-guides/aspartate_aminotransferse-test#2
    Apart from the documented treatment complications, it could be additionally for one of these generic reasons or just a false positive.

    If you had cirrhosis or Hepatitis B, a decision to stop or continue treatment would have to be urgently made by a hepatologist in a hostipal treating people with decompensated cirrhosis.

    If if it is something serious, it must be fixed very soon. Or it’s just a mistake/something else.

    But it’s not okay. No such increase of AST/ALT was documented in the sof+vel FDA sheet, except for the mentioned reasons.


    Gen 1b
    VL pre treatment 29000 ME/ml
    AST 32 ALT 94, F0
    Started treatment 13 January 2017
    Generic sofosbuvir/velpatasvir (Incepta)
    VL 9 days into treatment <300 (undetected)
    AST 13.8 ALT 22
    Side effects: mild dehydration, not a problem at all if I drink water at night, nothing to worry about
    Diet and gastric ph are very important with velpatasvir. One must think what and when to eat to keep gastric pH low. Side effects disappeared 2 weeks after, unless I ate anything < 4hrs before the pill. SVR60.

    in reply to: Day 1 – let’s the fight begin #28766
    vitrus
    • Topics: 1
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    • Total: 36
    • Treatment Warrior
    • ★★★
    @vitrus

    You should do the test again.

    https://www.journal-of-hepatology.eu/article/S0168-8278(16)00010-6/fulltext

    Whatever the cause, the problem of hepatic decompensation during antiviral therapy calls for heightened awareness and careful monitoring of patients with cirrhosis who receive antiviral therapy for hepatitis C. The first appearance of features of decompensation should lead to rapid initiation of appropriate supportive care and early discontinuation of antiviral treatment. For the research community, an important priority is to establish objective criteria for hepatic decompensation to use in describing results and to standardize reporting rates across clinical trials. The episodes of acute decompensation also need to be better described clinically, particularly in the context of other adverse events, timing of viral clearance, serum enzyme changes and serial bilirubin, albumin, ammonia and lactate levels. These studies are of great priority because treatment of patients with advanced hepatitis C cannot be withheld because of concern for this complication.

    What is your HCV genotype?
    Do you have cirrhosis? What F-score do you have for your liver?

    This is an emergency at least to take another urgent test and schedule an emergent consultation with a hepatologist to see if another test for hepatic decompensation or liver damage is available.


    Gen 1b
    VL pre treatment 29000 ME/ml
    AST 32 ALT 94, F0
    Started treatment 13 January 2017
    Generic sofosbuvir/velpatasvir (Incepta)
    VL 9 days into treatment <300 (undetected)
    AST 13.8 ALT 22
    Side effects: mild dehydration, not a problem at all if I drink water at night, nothing to worry about
    Diet and gastric ph are very important with velpatasvir. One must think what and when to eat to keep gastric pH low. Side effects disappeared 2 weeks after, unless I ate anything < 4hrs before the pill. SVR60.

    in reply to: EOT Redemption Trial Panovir – undetected!!! #25863
    vitrus
    • Topics: 1
    • Replies: 35
    • Total: 36
    • Treatment Warrior
    • ★★★
    @vitrus

    I’m also UND at EOT.
    Now I’ll just maintain healthy lifestyle and do blood tests regularly.


    Gen 1b
    VL pre treatment 29000 ME/ml
    AST 32 ALT 94, F0
    Started treatment 13 January 2017
    Generic sofosbuvir/velpatasvir (Incepta)
    VL 9 days into treatment <300 (undetected)
    AST 13.8 ALT 22
    Side effects: mild dehydration, not a problem at all if I drink water at night, nothing to worry about
    Diet and gastric ph are very important with velpatasvir. One must think what and when to eat to keep gastric pH low. Side effects disappeared 2 weeks after, unless I ate anything < 4hrs before the pill. SVR60.

    in reply to: Voxilaprevir (akaGS-9857) – A new Protease Inhibitor #25403
    vitrus
    • Topics: 1
    • Replies: 35
    • Total: 36
    • Treatment Warrior
    • ★★★
    @vitrus

    Greedfighter, it means intermediate is for factories, home compounding is not possible, unlike with some other drugs.
    The quality of drug depends on quality control and chemical processes employed by both ingredient and pill manufacturer. Every factory is different, but both Bangladeshi manufacturers have been successful so far at ensuring the quality of the final product.

    Gilead produces api in factories in many countries, the data is publicly available.


    Gen 1b
    VL pre treatment 29000 ME/ml
    AST 32 ALT 94, F0
    Started treatment 13 January 2017
    Generic sofosbuvir/velpatasvir (Incepta)
    VL 9 days into treatment <300 (undetected)
    AST 13.8 ALT 22
    Side effects: mild dehydration, not a problem at all if I drink water at night, nothing to worry about
    Diet and gastric ph are very important with velpatasvir. One must think what and when to eat to keep gastric pH low. Side effects disappeared 2 weeks after, unless I ate anything < 4hrs before the pill. SVR60.

    vitrus
    • Topics: 1
    • Replies: 35
    • Total: 36
    • Treatment Warrior
    • ★★★
    @vitrus

    FDA grants priority review designation to glecaprver/pibrentasvir.
    It means it may get registered in the US late June.
    Canada and the EU also recently granted it expedited review for approval.

    https://news.abbvie.com/news/us-fda-grants-priority-review-to-abbvie-for-its-investigational-regimen-glecaprevirpibrentasvir-gp-for-treatment-chronic-hepatitis-c-in-all-major-genotypes-gt1-6.htm


    Gen 1b
    VL pre treatment 29000 ME/ml
    AST 32 ALT 94, F0
    Started treatment 13 January 2017
    Generic sofosbuvir/velpatasvir (Incepta)
    VL 9 days into treatment <300 (undetected)
    AST 13.8 ALT 22
    Side effects: mild dehydration, not a problem at all if I drink water at night, nothing to worry about
    Diet and gastric ph are very important with velpatasvir. One must think what and when to eat to keep gastric pH low. Side effects disappeared 2 weeks after, unless I ate anything < 4hrs before the pill. SVR60.

    in reply to: REDEMPTION 4 – Epclusa – 12 week course – Experience #25293
    vitrus
    • Topics: 1
    • Replies: 35
    • Total: 36
    • Treatment Warrior
    • ★★★
    @vitrus

    Hi!
    I was gen 1b and the results are being updated in my signature. I’m 1m into treatment.
    I read of several (>5) gen 3 people who were cured with sofosvel on hcv.ru Probably no difference btw the two generics (sofosvel and panovir – which I’m being cured with now).
    Otherwise, check the trial results. On sof/vel and on pibrentasvir/glecaprevir.
    As far as I see, there is no reason to defer treatment as many retreatment options are coming – and you never know what works.
    If I were you I’d sof/vel. And if were unsuccessful, retreat with abbvie’s combination. However, read everything carefully. Individual experience does not count. Trial data is a bit more reliable.
    There is few data and you can just read through and see what works for you.
    Wish you best luck with your treatment.


    Gen 1b
    VL pre treatment 29000 ME/ml
    AST 32 ALT 94, F0
    Started treatment 13 January 2017
    Generic sofosbuvir/velpatasvir (Incepta)
    VL 9 days into treatment <300 (undetected)
    AST 13.8 ALT 22
    Side effects: mild dehydration, not a problem at all if I drink water at night, nothing to worry about
    Diet and gastric ph are very important with velpatasvir. One must think what and when to eat to keep gastric pH low. Side effects disappeared 2 weeks after, unless I ate anything < 4hrs before the pill. SVR60.

    vitrus
    • Topics: 1
    • Replies: 35
    • Total: 36
    • Treatment Warrior
    • ★★★
    @vitrus

    99% SVR in Japanese CERTAIN-1 trial (January 2017) of glecaprevir/pibrentasvir.
    (Gen 1 only, 8 weeks, 106 people).
    The 1 remaining percent is one patient lost to follow-up.
    http://www.businesswire.com/news/home/20170109005300/en/Enanta-Announces-High-SVR12-Rates-Achieved-Genotype

    In previous November trials, SVR12 in 97.5% people across all genotypes.
    https://news.abbvie.com/news/eight-weeks-treatment-with-abbvies-investigational-pan-genotypic-regimen-glecaprevirpibrentasvir-gp-achieved-high-svr-rates-across-all-major-genotypes-chronic-hepatitis-c.htm


    Gen 1b
    VL pre treatment 29000 ME/ml
    AST 32 ALT 94, F0
    Started treatment 13 January 2017
    Generic sofosbuvir/velpatasvir (Incepta)
    VL 9 days into treatment <300 (undetected)
    AST 13.8 ALT 22
    Side effects: mild dehydration, not a problem at all if I drink water at night, nothing to worry about
    Diet and gastric ph are very important with velpatasvir. One must think what and when to eat to keep gastric pH low. Side effects disappeared 2 weeks after, unless I ate anything < 4hrs before the pill. SVR60.

    vitrus
    • Topics: 1
    • Replies: 35
    • Total: 36
    • Treatment Warrior
    • ★★★
    @vitrus

    Glecaprevir pibrentasvir will probably get FDA approval soon. https://news.abbvie.com/news/abbvie-submits-new-drug-application-to-us-fda-for-its-investigational-regimen-glecaprevirpibrentasvir-gp-for-treatment-all-major-genotypes-chronic-hepatitis-c.htm
    Abbvie filed for FDA approval, days after Gilead. The timeframe is about 8 months.
    This combination is even more potent than sof/vel/vox for retreatment, has a different resistance profile.
    That said, sof/vel/vox does have 97% SVR for retreating many cases.
    The more different drugs for retreatment – the better. Some failed combinations require retreatment with drugs having a different mechanism of action and resistance profile. And if one doesn’t work, it may be good to try chances with another one (although, there’s debate if one should wait for a year before retreatment, especially when one has a s282t rav).

    I wonder who will be the first one to copycat it. The retreatment market is about 18 million people – and there are no good options on the market currently.


    Gen 1b
    VL pre treatment 29000 ME/ml
    AST 32 ALT 94, F0
    Started treatment 13 January 2017
    Generic sofosbuvir/velpatasvir (Incepta)
    VL 9 days into treatment <300 (undetected)
    AST 13.8 ALT 22
    Side effects: mild dehydration, not a problem at all if I drink water at night, nothing to worry about
    Diet and gastric ph are very important with velpatasvir. One must think what and when to eat to keep gastric pH low. Side effects disappeared 2 weeks after, unless I ate anything < 4hrs before the pill. SVR60.

    in reply to: Just received my generic Epclusa through Remdenption Trial 4 #24770
    vitrus
    • Topics: 1
    • Replies: 35
    • Total: 36
    • Treatment Warrior
    • ★★★
    @vitrus

    Drink LOTS of water! Litres of it to stay hydrated.
    Get a bottle to your backpack! :)


    Gen 1b
    VL pre treatment 29000 ME/ml
    AST 32 ALT 94, F0
    Started treatment 13 January 2017
    Generic sofosbuvir/velpatasvir (Incepta)
    VL 9 days into treatment <300 (undetected)
    AST 13.8 ALT 22
    Side effects: mild dehydration, not a problem at all if I drink water at night, nothing to worry about
    Diet and gastric ph are very important with velpatasvir. One must think what and when to eat to keep gastric pH low. Side effects disappeared 2 weeks after, unless I ate anything < 4hrs before the pill. SVR60.

    in reply to: Voxilaprevir (akaGS-9857) – A new Protease Inhibitor #24635
    vitrus
    • Topics: 1
    • Replies: 35
    • Total: 36
    • Treatment Warrior
    • ★★★
    @vitrus

    Gilead filed for FDA approval. The approval is expected in several months.
    The market is about 18 million people.
    http://www.gilead.com/news/press-releases/2016/12/gilead-submits-new-drug-application-to-us-food-and-drug-administration-for-the-investigational-single-tablet-regimen-sofosbuvirvelpatasvirvoxilaprevir
    P.S. Likely to be approved either in July or October, 2017 depending on designation.


    Gen 1b
    VL pre treatment 29000 ME/ml
    AST 32 ALT 94, F0
    Started treatment 13 January 2017
    Generic sofosbuvir/velpatasvir (Incepta)
    VL 9 days into treatment <300 (undetected)
    AST 13.8 ALT 22
    Side effects: mild dehydration, not a problem at all if I drink water at night, nothing to worry about
    Diet and gastric ph are very important with velpatasvir. One must think what and when to eat to keep gastric pH low. Side effects disappeared 2 weeks after, unless I ate anything < 4hrs before the pill. SVR60.

    in reply to: Voxilaprevir (akaGS-9857) – A new Protease Inhibitor #24628
    vitrus
    • Topics: 1
    • Replies: 35
    • Total: 36
    • Treatment Warrior
    • ★★★
    @vitrus

    Found data on voxilaprevir pharmacokinetics!
    http://regist2.virology-education.com/2016/17HIVHEPPK/40_Kirby.pdf
    Reference AUC and Cmax profiles!
    TODO: share with all researchers, the data was hard-to-find. (To be done by someone).


    Gen 1b
    VL pre treatment 29000 ME/ml
    AST 32 ALT 94, F0
    Started treatment 13 January 2017
    Generic sofosbuvir/velpatasvir (Incepta)
    VL 9 days into treatment <300 (undetected)
    AST 13.8 ALT 22
    Side effects: mild dehydration, not a problem at all if I drink water at night, nothing to worry about
    Diet and gastric ph are very important with velpatasvir. One must think what and when to eat to keep gastric pH low. Side effects disappeared 2 weeks after, unless I ate anything < 4hrs before the pill. SVR60.

    vitrus
    • Topics: 1
    • Replies: 35
    • Total: 36
    • Treatment Warrior
    • ★★★
    @vitrus

    Thank you for information!
    J. Eugene, RAVs matter mostly in those with fibrosis.
    The study found that baseline RAVs significantly influence SVR in people with decompensated cirrhosis. Baseline RAVs do matter for non-cirhotic people, esp. for 3 patients (and slightly, for gen 1a). But for other genotypes (like 2,4,1b) they matter less. It’s not all black-and-white, of course, and baseline RAVs do have an influence for certain combinations of genotype and fibrosis level, but the statistics in the EMA report was for participants with decompensated cirhosis.


    Gen 1b
    VL pre treatment 29000 ME/ml
    AST 32 ALT 94, F0
    Started treatment 13 January 2017
    Generic sofosbuvir/velpatasvir (Incepta)
    VL 9 days into treatment <300 (undetected)
    AST 13.8 ALT 22
    Side effects: mild dehydration, not a problem at all if I drink water at night, nothing to worry about
    Diet and gastric ph are very important with velpatasvir. One must think what and when to eat to keep gastric pH low. Side effects disappeared 2 weeks after, unless I ate anything < 4hrs before the pill. SVR60.

    vitrus
    • Topics: 1
    • Replies: 35
    • Total: 36
    • Treatment Warrior
    • ★★★
    @vitrus

    The official quality control certificate containing solubility data I was asking for.
    https://www.facebook.com/891416184251194/photos/a.991496270909851.1073741831.891416184251194/1259908390735303/?type=3&theater
    Looks good.


    Gen 1b
    VL pre treatment 29000 ME/ml
    AST 32 ALT 94, F0
    Started treatment 13 January 2017
    Generic sofosbuvir/velpatasvir (Incepta)
    VL 9 days into treatment <300 (undetected)
    AST 13.8 ALT 22
    Side effects: mild dehydration, not a problem at all if I drink water at night, nothing to worry about
    Diet and gastric ph are very important with velpatasvir. One must think what and when to eat to keep gastric pH low. Side effects disappeared 2 weeks after, unless I ate anything < 4hrs before the pill. SVR60.

    in reply to: How long to wait before retreatment #24358
    vitrus
    • Topics: 1
    • Replies: 35
    • Total: 36
    • Treatment Warrior
    • ★★★
    @vitrus

    Many NS3 RAVs resulting from treatment generally disappear by themselves in about more than 1 year. Ns5b sofosbuvir-emergent RAVs – in about less than 1 year.
    However, acquired NS5A RAVs persist, requiring retreatment with drugs having considerably different resistance profile/mechanism of action/high bareer to resistance.
    Results from a small 3-year follow-up study (presented at AASLD 2016).

    http://www.natap.org/2016/AASLD/AASLD_61.htm

    There are drugs in development that target not the virus, but host proteins, and were shown to work in early trials. However, different direct acting antiviral drug combinations were also shown to be effective for retreatment in many cases.


    Gen 1b
    VL pre treatment 29000 ME/ml
    AST 32 ALT 94, F0
    Started treatment 13 January 2017
    Generic sofosbuvir/velpatasvir (Incepta)
    VL 9 days into treatment <300 (undetected)
    AST 13.8 ALT 22
    Side effects: mild dehydration, not a problem at all if I drink water at night, nothing to worry about
    Diet and gastric ph are very important with velpatasvir. One must think what and when to eat to keep gastric pH low. Side effects disappeared 2 weeks after, unless I ate anything < 4hrs before the pill. SVR60.

    vitrus
    • Topics: 1
    • Replies: 35
    • Total: 36
    • Treatment Warrior
    • ★★★
    @vitrus

    People report having few side effects with epclusa.
    It is very important, however, to drink lots of water to avoid dehydration and to take pills at one time of the day. Lots of water is a must with velpatasvir due to its taste and so as to compensate for the dehydration that cases the side effects (light headaches, fatigue).
    Just a caution about dehydration.


    Gen 1b
    VL pre treatment 29000 ME/ml
    AST 32 ALT 94, F0
    Started treatment 13 January 2017
    Generic sofosbuvir/velpatasvir (Incepta)
    VL 9 days into treatment <300 (undetected)
    AST 13.8 ALT 22
    Side effects: mild dehydration, not a problem at all if I drink water at night, nothing to worry about
    Diet and gastric ph are very important with velpatasvir. One must think what and when to eat to keep gastric pH low. Side effects disappeared 2 weeks after, unless I ate anything < 4hrs before the pill. SVR60.

Viewing 15 posts - 1 through 15 (of 35 total)