Author Topic: I failed my first regimen this week (Read 7686 times)

hotpuppy · « **on:** November 26, 2009, 09:36:22 pm »

Well, it figures that I would fail my first regimen on the 2nd anniversary of realizing I was poz.

I have been on a study regimen of Vicriviroc, Reyataz, and Norvir for 18 months. My VL has been undectectable and life has been good for the most part.

I've known for a while that we had an issue, my ALT/AST and Billirubin have been climbing steadily. We were going to pull me off the study next month and I had coordinated with my pimary care doc to discuss meds next month once my insurance kicked in.

We did another set of bloodwork and all seemed pretty normal. I got an email on Tuesday telling me that my bloodwork was out of bounds and that they wanted me to stop taking my meds. My billirubin was grade 4 and my ALT was grade 3 which simply translates to very bad and bad in my book. I called my primary doc (who is different from the study doc) and made him aware of the situation. He said that it was fine to be off meds for a couple of weeks.

I'm still a bit frustrated. I liked taking an entry inhibitor and a PI. It's a unusual regimen. The only issue I am having is the Reyataz is what we suspect is causing issues. It seems like if Vicriviroc is the study med that they would be happy to swap the PI to make sure it was the problem. On the bright side I did get 18 months of meds out of it. I was hoping to swtich to Mariviroc and a different PI and basically continue the regimen that we know is working.

Anyhow, I'm mainly just venting but figured I would share the frustration.

Inchlingblue · « **Reply #1 on:** November 26, 2009, 10:38:23 pm »

According to aidsmeds.com, increased levels of bilirubin due to Reyataz is not a sign of liver damade:

In people who have taken Reyataz in clinical trials, an increase in bilirubin has not been associated with any other signs of liver damage.

LINK:

http://www.aidsmeds.com/archive/Reyataz_1563.shtml

Many people on Reyataz have elevated bilirubin, my partner being one. I think if everyone with elevated bilirubin were taken off Reyataz then few if any people would be on it. I guess it depends to what level they are elevated?

Ann · « **Reply #2 on:** November 27, 2009, 08:12:05 am »

Hey Pup, you didn't fail your regimen, it failed you. I mean it's not like you weren't being adherent, or drinking loads of alcohol to make your ALT levels rise. (I remember reading a recent post from you where you said you don't like getting drunk.)

Speaking of which, despite having had hep C and knowing more than I care to about things like ALT levels, I've never heard of ALT or bilirubin levels being described in "stages". Stages of liver damage, yes, enzyme levels, no. Do you know what your numbers, as opposed to stages, are?

And by the way, I trust you've been screened for hep B and C? If you haven't been, you should be as one of these could also be the culprit.

Anyway, sorry to hear you've had to withdraw from the trial.

Ann

Miss Philicia · « **Reply #3 on:** November 27, 2009, 08:38:24 am »

Yeah, I don't really look at this as "treatment failure" which I always see as an increase in VL. This is more having to change regimens due to side effect complications, which isn't that abnormal and is why most people currently have to make a switch, and it's why new meds are always better than fewer.

hotpuppy · « **Reply #4 on:** November 27, 2009, 10:16:53 am »

Quote from: Inchlingblue on November 26, 2009, 10:38:23 pm

According to aidsmeds.com, increased levels of bilirubin due to Reyataz is not a sign of liver damade:

In people who have taken Reyataz in clinical trials, an increase in bilirubin has not been associated with any other signs of liver damage.

LINK:

http://www.aidsmeds.com/archive/Reyataz_1563.shtml

Many people on Reyataz have elevated bilirubin, my partner being one. I think if everyone with elevated bilirubin were taken off Reyataz then few if any people would be on it. I guess it depends to what level they are elevated?

I have two doctors who specialize in HIV who are pointing to Reyataz.... I'm sure they could be wrong, but I have no reason to doubt them. In a study, they do not want your billirubin to be grade 4.... which in my case is 9.9.

hotpuppy · « **Reply #5 on:** November 27, 2009, 10:35:42 am »

Quote from: Ann on November 27, 2009, 08:12:05 am

Hey Pup, you didn't fail your regimen, it failed you. I mean it's not like you weren't being adherent, or drinking loads of alcohol to make your ALT levels rise. (I remember reading a recent post from you where you said you don't like getting drunk.)

Speaking of which, despite having had hep C and knowing more than I care to about things like ALT levels, I've never heard of ALT or bilirubin levels being described in "stages". Stages of liver damage, yes, enzyme levels, no. Do you know what your numbers, as opposed to stages, are?

And by the way, I trust you've been screened for hep B and C? If you haven't been, you should be as one of these could also be the culprit.

Ann

Ann and Miss P / Thanks for the kind words. Yes I agree, the side effects failed me.

As for Hep, That is set for next week. I was supposed to get screened for that but the paperwork got mixed up and they did a standard blood draw instead of a Hep b/c screen. I asked them and they said they were doing Hep when they were taking blood, so I just sat still. When I went back for the follow up I found out that they had not done the hep screen.

Because my insurance becomes effective next week the advice and consensus was not to mess with it until after the pre-existing clause expires.

I have been vaccinated against Hep A/B. When I became poz they decided my A needed boosting, but the B was sufficiently strong.

As for C, I don't use IV drugs and don't believe I have been exposed. Although, I have had two co-workers who were Hep C poz and there are always sharp objects in the shop. I was alway alert to make sure that if they did cut themselves I didn't come into contact with any blood. As for sex, that is a remote risk according to what I have read (and I don't want to get into that argument).

More importantly, I have not had any of the classic Hep symptoms. I have had two close friends who became infected with Hep B and I saw firsthand what the virus is like. While I do have elivated billirubin it cycles throughout the day and cleared within 24 hours after I stopped taking meds. So it's certainly one of the 3 meds I was on.

I'm scheduled to go back next week for more bloodwork and I believe they will be doing a Hep screen as part of the study bloodwork this time.

The suspected culprit is FLD or Fatty Liver Disease which according to my doc is fairly common in people who are HIV+. The screening for it is to rule out Hep and then to do an ultrasound, which we will do after the Hep panel. FLD is thought to be caused by lipodystrophy which is a known side effect of most PI's (Reyataz is a PI).

I liken drug therapy to flying.... a basically routine process with gradual adjustments punctuated by moments of sheer terror.

I would like to have had the opportunity to swap out the Reyataz and then drop the Norvir to determine if they were the culprit or if the study drug was the culprit. The pool of people who have taken the study drug is still fairly small and there were some isolated Liver issues in the earlier studies. The liver issues were not thought to be attributed to the study drug according to the published reports which are public information.

Anyhow, the feeling is similar to when you do something wrong while riding a mountain bike and find yourself going face first into mud. It's not the end of the world, but it's certainly not something to take a picture of or brag about. You just get up, shake yourself out as much as possible, hide as much evidence as you can, and move away from the scene of the crime.

My understanding is that once you come off of CCR5 inhibitors you aren't supposed to go back on. I'll have that conversation with my Doc when we pick a new regimen in 2 weeks. That's really what I'm bummed out about. I think that EI's (Entry Inhibitors) are neat and make good scientific sense from a treatment perspective. More importantly it keeps other classes of drugs in reserve which makes for a better strategy.

Anyhow, I'm off to do some camping and community service this weekend. I'm going to go cut trees down a chainsaw.... nothing makes you feel better like killing something else. Muhaha. Seriously, I'm helping a non-profit organization remove trees so they can install a septic field and a new bathroom at their private landsite and camp ground. I figure it beats sitting around the house..... I'm sure as hell not going to go shopping .... I don't care for crowds.

hotpuppy · « **Reply #6 on:** November 27, 2009, 10:37:11 am »

Oh and my numbers weren't super sky high, Billi was 9.9 and ALT was 272. The doctor was concerned for my safety and I don't have an issue with that. You can't go to the store and get a new liver and you won't live long without it.

Moffie65 · « **Reply #7 on:** November 27, 2009, 10:56:08 am »

Hey Puppy, I just wanted to concur with Miss P and Ann. Treatment failure is somthing most will face a couple of times in their life, so getting it out of the way the first time, lessens the impact the next time. Sort-of.

I also wanted to thank you for signing up for a drug study, as many of us never had the health or immune system function to do such a thing, and I really appreciate all the "Heros" that do so for the rest of us. Kisses on all your openings for doing so!!!!!!!

Ann · « **Reply #8 on:** November 27, 2009, 11:00:26 am »

Hello again, Pup.

I agree that hep C isn't often transmitted sexually, but it does happen now and then. There are a lot of people who never had any of the classic risks for hep C, but have it nonetheless. I suppose it's probably because it's such a tenacious little bugger and remains viable and infectious in the environment for a helluvalot longer than hiv. There's a lot of people out there who have no idea they have - and are possibly spreading - hep C. Did you know there are approximately three times more people living with hep C than there are hiv? Kinda scary, when you think about it, and when you realise how much easier it is to transmit hep C.

Hep C often has no symptoms. I likely became infected in the fall of 1984, but I never had ANY symptoms of infection until after I became poz in 1997. It's sometimes called the silent disease because people have been known to go for as many as 25 years with no symptoms. Hep B tends to have more obvious symptoms.

I'm glad you're getting tested. Hopefully, it will rule hep C out of the picture.

I agree that it would have been nice to swap out for another PI before abandoning the combo completely. I suppose they didn't let you due to the trial's protocol, and it's too bad that the swap couldn't have been arranged with your regular hiv doctor outside the trail, but the trial drug probably isn't available outside the trail. Sucks.

Do you also know your AST levels? Sometimes looking at the ALT/AST ratio can give clues as to what's going on...

* An AST:ALT ratio equal to one (the level of ALT is higher or equal to AST), but the levels are very high, suggests acute viral hepatitis or drug-related hepatitis.
* An AST:ALT ratio higher than 2:1 (two times the level of AST to ALT) is very suggestive of alcoholic liver disease.
* An AST:ALT ratio higher than one (where the level of AST is higher than the ALT) could also indicate cirrhosis in a person that doesn't have alcoholic hepatitis. source

Your ALT is a bit high. Hope you get it sorted out soon. And by the way, congrats on your insurance becoming effective. That must be a load off, especially with this going on.

Ann

Inchlingblue · « **Reply #9 on:** November 27, 2009, 11:31:58 am »

Quote from: hotpuppy on November 27, 2009, 10:16:53 am

I have two doctors who specialize in HIV who are pointing to Reyataz.... I'm sure they could be wrong, but I have no reason to doubt them. In a study, they do not want your billirubin to be grade 4.... which in my case is 9.9.

I'm not suggesting that it is not Reyataz that caused the elevated bilirubin, it likely was Reyataz. I'm just pointing out that, according to aidsmeds, elevated bilirubin due to Reyataz is not a sign of liver damage.

By the way did you see the recent study that found drinking coffee can possibly protect against liver disease?

LINK:

http://forums.poz.com/index.php?topic=29621.0

Dale Parker · « **Reply #10 on:** November 27, 2009, 03:32:59 pm »

You didn't fail at all. I agree with Moffie65. All of the people who are taking or have taken part in the drug trials are the real heros of HIV and Aids. I know that when they test these drugs on people they are pretty sure that they are safe but as they say the proof is in the pudding. It takes guts to take part in drug experiments especially where your life is concerned.
I hope your levels get back to normal soon
Hugs
Dale

hotpuppy · « **Reply #11 on:** November 30, 2009, 04:14:38 pm »

Quote from: Ann on November 27, 2009, 11:00:26 am

Hello again, Pup.
Did you know there are approximately three times more people living with hep C than there are hiv? Kinda scary, when you think about it, and when you realise how much easier it is to transmit hep C.

Do you also know your AST levels? Sometimes looking at the ALT/AST ratio can give clues as to what's going on...

* An AST:ALT ratio equal to one (the level of ALT is higher or equal to AST), but the levels are very high, suggests acute viral hepatitis or drug-related hepatitis.
* An AST:ALT ratio higher than 2:1 (two times the level of AST to ALT) is very suggestive of alcoholic liver disease.
* An AST:ALT ratio higher than one (where the level of AST is higher than the ALT) could also indicate cirrhosis in a person that doesn't have alcoholic hepatitis. source

Your ALT is a bit high. Hope you get it sorted out soon. And by the way, congrats on your insurance becoming effective. That must be a load off, especially with this going on.

Ann

My AST is around 72 and my ALT is around 272. No alcohol here..... I simply don't drink. Don't like the taste or the price.

And wow, I had no idea so many people were affected by Hep C. That's a real tragedy. It doesn't have nearly the outreach or testing.

Should get new numbers later this week and we'll see what happened.

My hunch is that the Hep panel will come back fine and that the billirubin (at 9.2) will be nearly normal. My skin changed colors (lightened) and my eyes have completely cleared the occassional yellow tint that they had.

I am dissappointed that we couldn't sort out which med was causing the issue. None of the meds have any warnings about liver toxicity, but I seem to recall both docs saying that Reyataz bothers some people more than others.

hotpuppy · « **Reply #12 on:** November 30, 2009, 04:29:22 pm »

Quote from: Inchlingblue on November 27, 2009, 11:31:58 am

I'm not suggesting that it is not Reyataz that caused the elevated bilirubin, it likely was Reyataz. I'm just pointing out that, according to aidsmeds, elevated bilirubin due to Reyataz is not a sign of liver damage.

By the way did you see the recent study that found drinking coffee can possibly protect against liver disease?

LINK:

http://forums.poz.com/index.php?topic=29621.0

No I had not seen that study, but I did see somewhere on a google search where Caffeine is thought to help the breakdown of billirubin.

The billirubin levels just indicate that my body didn't kick in the alternate process for dealing with billirubin. AST and ALT levels indicate that my liver is stressed and has incurred some damage.

Only a sonic image (can't remember the actual name) can point towards liver damage. A MRI is also sometimes used. a biopsy is the most definitive test to determine if liver damage is present.

If I had to bet...(NOTE I'm cheap and conservative so I don't bet much)..... I would bet that I have Fatty Liver Disease which is a buildup of fat in the liver. I would bet that it is a result of an increase in fat in my body due to a combination of diet, lipodistrophy, and metabolism changes. The latter two being med-related. The diet issue being something I can control by cutting out drinking Coca-Cola, eating a little better, and working out more regularly.

Ordinarily, putting on 30 or 40 pounds shouldn't trigger FLD. I went from 180ish at the low point to 200 then to 216 recently. 180 is the result of my "crash" diet of becoming poz and feeling like crap. Not eating is a wonderful way to lose weight.. but it's not recommended for long term health. I was about 195# prior to becoming poz. I put on the last 16 pounds in the last 6 to 9 months when I cut back on working out and was working alot more.

hotpuppy · « **Reply #13 on:** November 30, 2009, 04:32:05 pm »

Quote from: Dale Parker on November 27, 2009, 03:32:59 pm

You didn't fail at all. I agree with Moffie65. All of the people who are taking or have taken part in the drug trials are the real heros of HIV and Aids. I know that when they test these drugs on people they are pretty sure that they are safe but as they say the proof is in the pudding. It takes guts to take part in drug experiments especially where your life is concerned.
I hope your levels get back to normal soon
Hugs
Dale

Dale,
I appreciate the support from you and Moffie. I really don't feel like a hero. In my eyes, the Heros are the guys who have lived 15 and 20 years, who survived monotherapy, watched all their friends and lovers die, and are still here with a upbeat attitute and live life to the fullest. I'm just doing my part to help. It would be alot harder without the longterm survivors who show me that it can be done.

-Brian

max123 · « **Reply #14 on:** November 30, 2009, 05:12:59 pm »

Quote from: hotpuppy on November 30, 2009, 04:32:05 pm

It would be alot harder without the longterm survivors who show me that it can be done.

that's right on the money, but give yourself some credit as well...you too are a pioneer

hotpuppy · « **Reply #15 on:** December 11, 2009, 10:29:52 pm »

Well, a few weeks later and we have bloodwork and new numbers.

All hep tests (a, b, and C) came back negative.

Billi is .7 (which is normal)

and ALT/AST have dropped about half.

The conclusion from the doc was drug toxicity. We do not know which med is the culprit though.

I'm meeting monday with my primary doc to discuss a new regimen.

Ann · « **Reply #16 on:** December 12, 2009, 08:03:54 am »

Hey Pup, thanks for the update. I'm so happy to hear your hep tests were negative. Good also to hear your other labs are back down to more normal levels. Fingers crossed your next combo doesn't do this to you.

Ann

Miss Philicia · « **Reply #17 on:** December 12, 2009, 09:20:10 am »

Good results with the hep C -- all of the posts about this lately made me get my doctor to recheck me when I had my last labs a couple weeks ago and mine came out clear as well.

tednlou2 · « **Reply #18 on:** December 15, 2009, 12:05:59 am »

My HIV doc told me one of the HIV drugs we've picked out may cause an increase in bilirubin and I may get some yellowing of the eyes. He said this is not dangerous or a sign of liver damage. He said the only problem would be cosmetic. Is this correct info?

The lab I do bloodwork at says AST should be between 10-50 and ALT should be 20-70. My AST was recently a little high for the first time at 75. I was reading that AST/ALT numbers 4 times the normal values would be considered severe liver toxicity.

I'm glad you're numbers have returned to normal. By the way, I was just reading either here on poz.com or thebody that a new study suggests getting Hep C from sex is very unlikely. They said they believe it happens with very rough sex and fisting--where blood may get involved. Basically, they believed Hep C is not transmitted via semen or vaginal fluids--just blood. That was one study though.

edfu · « **Reply #19 on:** December 15, 2009, 01:47:21 am »

Quote from: tednlou2 on December 15, 2009, 12:05:59 am

By the way, I was just reading either here on poz.com or thebody that a new study suggests getting Hep C from sex is very unlikely. They said they believe it happens with very rough sex and fisting--where blood may get involved. Basically, they believed Hep C is not transmitted via semen or vaginal fluids--just blood. That was one study though.

However, I don't believe the study addresses the fact that blood may be involved in "regular," not even "rough," anal sex that doesn't involve fisting. The anal mucosa are extremely fragile.

hotpuppy · « **Reply #20 on:** December 15, 2009, 10:25:03 pm »

I think that, sadly, the CDC has sketchy data where gay sex and Hep C is concerned. The official stance is that sex has a low risk of transmission.

However, the UK had a study suggesting that it was much more common in gay men.

I'm not taking a side on this, just suggesting you should be careful. The odds are that the truth is somewhere between the UK study and the CDC data. If it could be transmitted, gay men in the US would be swapping it because unprotected sex is rather common based on my observations.

hotpuppy · « **Reply #21 on:** December 15, 2009, 10:30:19 pm »

Quote from: Ann on December 12, 2009, 08:03:54 am

Hey Pup, thanks for the update. I'm so happy to hear your hep tests were negative. Good also to hear your other labs are back down to more normal levels. Fingers crossed your next combo doesn't do this to you.
Ann

Thank you! I had another tidbit of interesting news today. My viral load came back undetectable after being off meds for 10 days. We (study doc and I) had been expecting it to be around 10K to 50K. That was a pleasant surprise.

We just redrew bloodwork at my primary doctor's office yesterday and we'll see what it looks like in a couple of weeks. My primary physician and I wanted to see what my liver enzymes look like and get a VL from the lab he is used to. The study used their own lab which is high end.

I want to continue using a CCR5 inhibitor, so that shifts me to marivaroc (Selzentry). We haven't discussed what we would pair it with. The thinking was that it is working and we should keep using it and save other classes of drugs for later.

hotpuppy · « **Reply #22 on:** December 15, 2009, 10:36:05 pm »

Quote from: tednlou2 on December 15, 2009, 12:05:59 am

My HIV doc told me one of the HIV drugs we've picked out may cause an increase in bilirubin and I may get some yellowing of the eyes. He said this is not dangerous or a sign of liver damage. He said the only problem would be cosmetic. Is this correct info?

The lab I do bloodwork at says AST should be between 10-50 and ALT should be 20-70. My AST was recently a little high for the first time at 75. I was reading that AST/ALT numbers 4 times the normal values would be considered severe liver toxicity.

Yes, your Doctor is correct that you can have elevated billirubin and it's okay. Mine was as high as 9.9 and I had some occassional yellowing of the eyes. Nobody ever said anything and if they had I would have told them either A) stuff it, or B) a sad story about fatal liver damage.... and when they fell for it I would have told them of course not, and that it was under my doctors care and none of their damn business.

Yes, grade 3 numbers were considered dangerous and I stopped meds after talking to both doctors. I trust both doctors and can't emphasize enough that it is important to have doctors you are comfortable with and trust. I see myself as part of the treatment team and I ask questions and make suggestions when I think its appropriate. I also do what I'm told when it comes to taking meds.

I'd also like to point out that I ask my pharmacist alot of questions. I ask them to check for interactions and give them a list of everything I'm taking including things that I didn't get there. I let them know I was on a drug study as well. Your pharmacist is part of your safety net and it is their duty to answer questions about drugs, safety, side effects, and to help catch prescribing mistakes.

Most of the time they are fascinated by the study aspect and ask lots of questions.

tednlou2 · « **Reply #23 on:** December 15, 2009, 11:31:41 pm »

I am confused about the bilirubin issue. While they say eyes and skin turning yellow is harmless while on certain HIV meds, I know I've always heard jaundice is a sign of liver damage. I guess this means increased bilirubin could be a sign of liver damage, but not always??

max123 · « **Reply #24 on:** December 16, 2009, 12:53:53 pm »

Quote from: tednlou2 on December 15, 2009, 11:31:41 pm

I am confused about the bilirubin issue. While they say eyes and skin turning yellow is harmless while on certain HIV meds, I know I've always heard jaundice is a sign of liver damage. I guess this means increased bilirubin could be a sign of liver damage, but not always??

hi ted.

with primary organic disease (hepato-biliary), jaundice is an indicator of liver disease. in the case of certain hiv meds, they have the potential of causing jaundice, mimicking primary liver disease or actually causing primary liver disease. hence the importance of trusting that a good doc will know how to competently assess the difference between the two, as pup said. it's a fine line & an important one to distinguish.

hi pup,

that's great that your vl is still ud. i'm really interested in the ccr5 inhibitor thing and that's a great plan to continue on the meds class that are cworking for you. hang in there and best of luck with finding your new perfect combo

hotpuppy · « **Reply #25 on:** December 17, 2009, 11:03:10 pm »

Quote from: tednlou2 on December 15, 2009, 11:31:41 pm

I am confused about the bilirubin issue. While they say eyes and skin turning yellow is harmless while on certain HIV meds, I know I've always heard jaundice is a sign of liver damage. I guess this means increased bilirubin could be a sign of liver damage, but not always??

Hi Ted,
Certain HIV meds interfere with the process that breaks down billirubin. This is what causes billi levels to rise. Doc says it is harmless, and I can vouch that it clears the system as soon as you stop the meds.

The key is to make sure your ALT and AST numbers don't climb too far as well. They are signs of damage to the liver.

Forums Index

Welcome

Author Topic: I failed my first regimen this week (Read 7686 times)