BMS Co-Pay Assist Program Update

Today I’ll review the BMS Co-Pay Assist Program which will save you money on Atripla, Reyataz, and Sustiva copays. In fact, the BMS program covers up to the first $400 per monthly co-pay for a year for each of these three medications. Sweet!

Copay cards can reduce or eliminate your monthly co-pays for HIV medication. Please note that they do not work if you are on Medicare, Medicaid, Medigap, VA, DOD, or TriCare.

You can get a BMS Co-Pay Assist Program card from your HIV provider or HIV specialty pharmacy, or you can enroll by phone.  Here’s the link to learn more:  http://www.bms3assist.com/copay/

If you use mail order, check with your mail order pharmacy to see if they accept the cards. If they do not, you can pay for it, save your receipts, and send them to BMS for reimbursement.

What has been your experience, good or bad, using these card programs?

Stribild, New One Pill Per Day Treatment of HIV and Drug Interactions

I’m writing a series of short blogs on the new one pill per day treatment of HIV/AIDS, Stribild.  Stribild has four HIV medications in a single pill, and is also popularly known as the quad pill.

One of the components of Stribild is cobicistat.  Cobicistat is also known as an enhancer of other drugs because it can increase their concentration or level in plasma, part of your blood.  It is a pharmacokinetic enhancer. 

In Stribild, cobicistat enhances elvitegravir, another one of the tablet’s four components.  It does this by inhibiting an enzyme in the liver known as CYP3A.  Because of cobicistat’s effect on CYP3A, elvitegravir drug levels become higher and it lasts longer it the body (known as half-life).  This effect makes it possible to take Stribild just once a day.

The disadvantage of cobicistat is that it also affects other drugs that metabolized by CYP3A, including other HIV medicines, such as protease inhibitors (Prezista, Reyataz, others), non-nucleoside reverse transcriptase inhibitors, (Sustiva, Edurant, Intelence, others), and maraviroc (Selzentry).

Stribild should not be combined with ritonavir (Norvir) or medications containing ritonavir (Kaletra) because both ritonavir and cobicistat inhibit CYP3A.

In addition, giving Stribild with other HIV medications is not recommended at this time.

Tomorrow we’ll continue exploring presciption medications to use with caution and monitoring if combined with Stribild.  Many of these potential drug interactions are a result of the CYP3A-inhibiting effects of cobicistat.

Sound complicated?  It may be complicated for some.  My best advice is to tell your doctor all the medications and herbal products you take, even if different doctors prescribed them, so that he or she can carefully review the list for possible drug interactions.  You can also ask your HIV pharmacist for help.

Who do you go to for help with drug interaction questions?

Have a great day!

Bill

Medications NOT to Combine with Stribild, New One Pill Per Day Treatment for HIV

Stribild is the new one pill per day treatment for HIV and AIDS that contains four medications.

Today we are taking a look at drugs which should not be combined with Stribild.

Two of the medications in Stribild are broken down or metabolized by a specific enzyme in the liver called CYP3A :  elvitegravir and cobicistat.  Therefore, other medications or herbal products that depend on the same enzyme are not recommended, especially if higher drug concentrations in your blood plasma could be serious or life-threatening. 

The following drugs should not be combined with Stribild:  alfuzosin (used for prostate problems), rifampin (tuberculosis), ergot medications (migraines), cisapride (GI motility), St. John’s wort (depression), lovastatin and simvastatin (cholesterol-lowering), pimozide (psychosis), sildenafil when dosed as Revatio for treatment of pulmonary arterial hypertension, triazolam (insomnia) and midazolam when given orally (sedation before surgery).

This list really is not that long.  The most used medications from this list are lovastatin and simvastatin because they are inexpensive, generically-available cholesterol lowering agents, and St. John’s wort because you could pick it up at your local health food store. 

This is why it’s important to let you doctor and pharmacist know about all the medications you are taking, especially if you go to more than one doctor or pharmacy or take supplements.

Tomorrow we’ll look at possible drug interactions and which ones to watch out for.

Yours,

Bill

Stribild, New One Pill Treatment for HIV and Side Effects

Stribild is a new one pill therapy for HIV.  It contains four medications.  In previous blogs, I discussed studies comparing it to Atripla and Reyataz.  We’ve discussed dosing and some precautions.

Today, let’s look at side effects.  

Hmmm, there really is not much to say about Stribild and side effects, which is good!

In a group of 701 people treated with Stribild, 16% had nausea and 12% had diarrhea.  This does not mean you wiill develop these side effects or that they will continue, but they are possible. In a group of 35s people treated with Atripla, 9% had nausea and 11% had diarrhea.  In a group of 355 people treated with Reyataz, Norvir and Truvada, 13% had nausea and 16% had diarrhea.  So these side effects were not that different for the three HIV medications

For central nervous system disorders, 7% had a headache in the Stribild group, compared to 4% of Atripla and 6% for Reyataz.  Stribild cause much less dizziness than Atripla (3% vs 20%).  Abnormal dreams were reported in 26% of the Atripla group, and 9% of the Stribild group.

Here’s the percentages of people developing a rash on the three medications:  3% for Stribild, 15% of Atripla, and 6% for Reyataz.

In summary, Stribild does not have a lot of side effects associated with it, other than some nausea, diarrhea, and headache in a small percentage of people. Stribild  can cause abnormal dreams, but much less than Atripla.

If you have started Stribild, please share with us your experiences.

Tomorrow I’ll write about drug interactions with Stribild

Yours,

Bill

Stribild, New One Pill Per Day Treament of HIV: What are the Precautions?

This week I’m writing about the new one pill per day treatment of HIV  150 mg elvitegravir, 150 mg of cobicistat, 200 mg emtricitabine, and 300 mg tenofovir. The dosasge of Stribild, formerly known as “quad” because it contains four medications, is just one tablet once a day.

The other two one pill per day medications for HIV, Atripla and Complera, contain three medications.

Are there any precautions for using Stribild?  The answer is yes, but nothing really unexpected or alarming.

Stribild has the same “black box” warning about lactic acidosis and enlarged liver as other HIV medications in its class.  It is not approved for treatment of chronic hepatitis B, and the hepatitis B could get worse if you were treated with Stribild and then stopped it.

It does have an interesting warning about its use in people with  kidney problems.  If  you doctor has told you that you have mild or moderate kidney changes and your creatinine clearance is below 70 ml per minute, you should not start Stribild.  Creatinine is a blood test that your doctor can easily order. If you start Stribild and your creatinine clearance drops below 50 ml per minute, you should stop Stribild.  This is because the dosages of two of the component medications, emtricitabine and tenofovor, should be adusted dowwnard, and that is not possible with a single tablet formulation.

Gilead recommends that your doctor check your estimated creatinine clearance, urine glucose, and urine protein before starting Stribild.  These are all standard lab tests.

Cobicistat, one of the components of Stribild, may cause a slight increase in serum creatinine and make it appear that your kidneys are not working  as effectively.  However, it does not actually affect how the kidney glomeruli function.  Still, if your creatinine increased more than 0.4 mg/dl from when you started Stribild, your  kidney function should be more closely monitored.

Any other warnings?

Tenofovir (Viread), part of Stribild, has been associated with decreases in bone mineral desnsity.  The effects of these changes on future bone fractures are unknown.  Supplmentation with calcium and vitamin D is a good idea, so discuss this with your doctor.

Fat redistribution, including central obesity, thinning of your arms and legs, and facial wasting, has been observed in patients who take HIV medications.  We don’t know what causes this, but  it could happen with any HIV medication or from the illness itself.  People with HIV get understandably freaked out about these changes, but in my opinion, these are not reasons to avoid an otherwise life-saving medication.

Immune Reconstitution Syndrome may occur when starting any HIV medication.  This is due to an inflammatory response of your immune system to certain infections that lay dormant while you were untreated, such as Mycobacterium avium infection, cytomegalovirus, or Pneumocystis jirovecii penumonia, better known as PCP pneumonia.

So that’s about it for the scary stuff.  Overall, there’s nothing alarming in this list, other than to make sure your doctor is following your kidney function both before and during treatment with Strilbild, but this is a good idea for any HIV medication regimen.

Tomorrow, we’ll look at adverse effects from Stribild.

Yours,

Bill

Stribild, a New Treatment for HIV-Comparing it to Atripla

This week I’m writing about Stribild, a new one pill per day treatment for HIV that contains four medications.

One of the questions on everyone’s mind is, “Does it work as well as the other medications?  Is it better?”

Let’s compare it to Atripla, one of the most used treatments for HIV, and a preferred treatment according to DHHS recommendations. The other one pill per day treatment for HIV is Complera, and the two medications have not been compared in a study to my knowledge.

In a study presented at CROI in 2012, a big US conference on HIV and related infections, Dr. Paul Sex from Boston reported 48-week data from a Phase 3 trial comparing Stribild and Atripla.  The study enrolled 700 participants.  Ninety percent of the participants were men.  Two-thirds were white, and the average age was 38 years.  All were starting HIV treatment for the first time.  Participants were randomly assigned to Atripla or Stribild.

Both Atripla and Stribild performed well through 48 weeks.  The study concluded  that Stribild demonstrated non-inferior efficacy to Atripla, meaning it worked as well as Atripla.  Similar numbers of participants had viral loads <50 copies, virologic failure was the same, and both were safe and well-tolerated.  Both Atripla and Stribild performed equally well in demographic subgroups.

Both Atripla and Stribild were similarly effective in people with high baseline viral loads, but Stribild did just a bit better in people with CD4 counts above 350 cells/mm3.

Similar proportions of participants from both the Atripla and Stribild group discontinued the study early, but fewer in the Stribild group stopped early due to adverse events (12 vs 18).

A little more nausea was reported with Stribild compared to Atripla (21% vs 14%)

Several other side effects occurred more often in the Atripla group, such as abnormal dreams, insomnia, and dizziness.  These are well-known side effects from efavirenz, contained in Atripla and Sustiva.  Skin rash occurred more frequently with Atripla than Stribild.

Stribild particiants had smaller increases in total, LDL (bad) and HDL (good) cholesterol compared to Atripla, with similar increases in triglycerides.

Stribild participants had a larger increase in serum creatinine, which is a marker of possible kidney damage, early on, but this stabilized and did not progress over time.  This is likely due to cobicistat, the new boosting agent, which affects how the kidneys handle creatinine.  Cobicistat does not appear to cause kidney damage, however.  I’ll be writing more about cobicistat and the kidney in upcoming blogs.

So compared to Atripla, Stribild did at least as well in this study.  I could see Stribild being used in people who do not like the way Atripla makes them feel, such as the dizziness, sleep disturbances, and vivid dreams often seen with Atripla.  In many people, these side effects of Atripla go away or get better over time, but sometimes they persist.

If you are on Atripla on, would you consider switching to Stribild?

In future blogs, I’ll write about how Stribild compares to Reyataz in a different study.

Yours,

Bill

Stribild, a New One Pill Option for HIV

Stribild is a new one pill option for treatment of HIV.  As I explained yesterday, it contains four medications, and so it was dubbed for years as the “quad” pill while under development.

The dosage of Stribild is simple:  Take one tablet of Stribild once a day with food.  Food boosts the absorption of elvitegravir and tenofovir.  In studies, a 373 calorie meal with 20% fat boosted elvitegravir by 34% and tenor by 24%.  Elvitegravir absorption is boosted even higher with an 800 calorie meal of 50% fat, but Gilead is not recommending this amount of food.  Just take it was a meal.

Stribild should not be typically be combined with any other HIV medications.  It is considered a complete regimen.  You certainly would not combine it with Truvada, Emtriva, or Viread, because Stribild already contains those components.

So Stribild sounds really convenient, right?   Do you think this is the HIV medication for you?

Tomorrow we will look at how it compared to Atripla in a study.

Bill

The “Quad” Pill Arrives, and it’s called Stribild

For years we have heard about a new one pill per day option under development for HIV.  It was popularly called the “quad pill” because it would contain four HIV medications in one pill.  Previous one pill per day options had three medications, Atripla and Complera,  so four medications definitely was a new concept.

The quad pill has finally arrived, and it’s brand name is Stribild.  It is made by Gilead Sciences.

I’ll be exploring the latest information on Stribild in days to come.  Let’s start at the beginning.

Stribild contains four medications, a new integrase inhibitor called elvitegravir, a new drug level enhancer called cobicistat, emtricitabine (also known as Emtriva), and tenofovir (also known as Viread).  Emtricitabine and tenofovir are found in the combination product Truvada.  In addition, they are components of Atripla and Complera, the other one pill options for HIV.

As you can see from the photograph, Stribild are green, capsule-shaped tablets.

In the coming days, I’ll be telling you more about this exciting new one pill option for treatment of HIV.  I’d like to know what you think.

Is this a treatment you’ve been waiting for?

Yours,

Bill

Stribild, a New One Pill Per Day Therapy for HIV

Next week I’ll be blogging all week about Stribild, the new one pill per day therapy for treatment of HIV.  So please check back often!  Let me know what you would like to know about Striblid.  Previously available one pill per day treatments for HIV are Atripla and Complera.

Yours,

Bill

Is Complera better than Atripla? Update

Recently, the FDA announced approval of a new one pill, once-a-day drug regimen for HIV:  Complera.

What’s Complera?  It combines  rilpivirine (Edurant), a new HIV medication from the NNRTI class, and Truvada (tenofovir and emtricitabine), a commonly used combination pill.  It will compete with Atripla, the other one pill once-a-day option (efavirenz and Truvada).

Is Complera better than Atripla?  Complera’s effectiveness is “non-inferior,” meaning “just as good,”  in people with pre-treatment viral loads less than 100,000.

Study participants with higher pretreatment viral loads (>100,000 copies/mL),were more likely to fail on Complera, however.  Doctors call this “virologic failure.”  If Complera fails to control your HIV, and viral resistance develops, it might also eliminate Intelence and Viramune as future drug possibilities.    Doctors call this “cross resistance.”    This is not a good thing.

Remember that viral resistance does not happen all by itself.   The number one reason for a failing HIV drug regimen is missing too many doses.

Complera causes fewer central nervous side effects, such as dizziness and dreams, than Atripla.   If you are experiencing these side effects from Atripla, Complera may be an excellent option for you.

There are some unique features of Complera that make it a bad choice for some.  You must eat when you take it, preferably a high fat meal, to absorb it adequately.   Drinking a can of Ensure was found to be inadequate.

It’s ALSO not absorbed well if you are taking acid lowering medications, such as antacids or Zantac.  Prilosec (omeprazole) or similar acid blockers can NOT be used with it.

In the updated DHHS “Guidelines for the Use of AntiretroviralAgents in HIV-1 Infected Adults and Adolescents,” Complera is an “alternative” treatment for HIV, and Atripla is still “preferred.”

Complera is approved for use for people with HIV who have not been other previous treatements for it.  Studies are underway to see if people on other HIV medications can be safely switched to Complera.   The providers I work with are quite comfortable switching their patients to Complera if they are well controlled on their current regimen.

So what’s the bottom line? 

Complera is a great new choice for HIV, but it will not replace Atripla.   Complera causes less dizziness and dreams than Atipla.  If you have a high viral load, tend to miss doses, eat irregularly, or take acid-lowering stomach medication, Atripla is still a better choice for you.