Participants taking tenofovir/emtricitabine (Truvada) for pre-exposure prophylaxis (PrEP) in two major studies experienced modest declines in kidney function that were associated with higher tenofovir drug levels and older age, according to studies presented in a poster discussion session entitled “It’s complicated: renal function and STIs in PrEP users” at the Conference on Retroviruses and Opportunistic Infections (CROI 2016) last week in Boston. Together, these findings indicate that while Truvada PrEP is safe for most people, ongoing kidney function monitoring is important to promptly catch any problems that may occur.

Tenofovir disoproxil (Viread, also in the Atripla, Eviplera or Complera, and Stribild single-tablet regimens) has been used in HIV treatment for more than a decade and is generally considered safe and well-tolerated, but it can cause kidney damage and bone loss in some people.

For this reason, regular kidney function tests are recommended for people taking Truvada for PrEP and those with pre-existing kidney problems are advised not to use it. The US product label for Truvada states that it should not be used for PrEP in people with creatinine clearance below 60 ml/min, and if a decrease is observed providers should “evaluate potential causes and re-assess potential risks and benefits of continued use.”

Reports to date from PrEP clinical trials – which tried to exclude people with known kidney impairment – have not revealed notable kidney problems. But sometimes uncommon toxicities only show up after many more people are using a drug.

Hi Thanks for all interesting answers. I have been on PrEP since a year and I am just fine. I read that Isentress is adding a security since it does stop the viral integration. Why does not a PrEP regim include Isentress since it is recommended as PEP. I have decided to add Isentress for my PrEP regim and I dont feel any side effects.

Response from Dr. Young

Pre-exposure prophylaxis, PrEP is a very highly effective component for prevention of HIV infection. Added to our customary discussion about condoms and safer sex, PrEP adds in excess of 95% additional prevention effectiveness among adherent people.

While three drug therapy is the standard for treatment of HIV infection, pre-exposure prevention of HIV (PrEP) likely only requires 1 or 2 medications.

Large clinical trials among men who have sex with men, transgender women, heterosexuals and injection drug users show us that two drug (and perhaps, even 1 good drug) is enough to prevent HIV infection. That’s good enough data for me.

While raltegravir is an exceptionally well-tolerated HIV medication (and recommended in post-exposure prophylaxis), there’s little data supporting it’s use in PrEP. Adding Isentress to your Truvada adds substantial cost as well as additional pills and an additional dose of medication- perhaps risking the optimal adherence that is so critical to your PrEP success.

So, all that considered, I don’t think that your Isentress is a needed addition to your PrEP regimens.

Good day I’m asking for a friend (I already have HIV so PrEP is not something I need.) Say if my friend go on a months holiday to somewhere he is highly likely to engage in risky sex. Is it viable to use PrEP just for this trip? How long before the first sexual encounter does he need to take PrEP and how long does he need to stay on it after the last sexual encounter? for example in Bangkok PrEP is available from red cross at a cost below a dollar a day. Would this be a good option (together with condoms) for a short trip of say a few weeks to a month?

Response from Dr. Young

While PrEP is typically recommended as a daily medication, for those who have periods of no risk (ie, sexual or injection drug activity), it’s reasonable to consider limiting the treatment time.

I conservatively recommend that people with possible HIV exposures be taking PrEP for at least 1 week prior to the exposure and for a month afterwards.

Is there a difference in protection between Tenvir em and Truvada?

 

Response from Dr. Young

A quick Google search will reveal that Tenvir EM contains tenofovir DF and emtricitabine, and is a generic version of Truvada. There should be no difference in effectiveness between the two.

Hello Dr. I know Isentress is available for once-daily dosing. This new dosage is two 600-mg tablets taken once a day. I am currently on 400 mg tablets taken twice a day. Although it would be easier to take a medication just once a day, wouldn’t I be better off to continue to take it twice a day if I can get the same effect but have to take 400 mg less of the drug daily? Wouldn’t that be a little easier on my kidneys to have to process less of a drug?

 

Response from Dr. Young

Yes, there is a new once-daily formulation of the HIV integrase inhibitor raltegravir, called Isentress HD. Isentress HD differs from the original twice-daily Isentress in formulation, resulting in better drug levels over a 24 hour period. Isentress HD is taken as 2, 600 mg tablets once daily while Isentress is 400 mg twice daily. The two cannot be interchanged. In a large clinical trial, there was no difference in effectiveness toxicity or side effect profile between the two formulations.

Since raltegravir (like other HIV integrase inhibitors) is metabolized by the liver, there’s no effect on kidneys.

We’ve found that our clinic patients who are taking twice daily Isentress have successfully transitioned to the newer, once-daily Isentress HD without issue, and indeed, most prefer the once-daily dosing, even if their daily pill number didn’t change.

HI, I AM FROM INDIA .MY FATHER IS 62 YEARS AND IS A CARDIAC PATEINT WITH DIABETES AND IS DIAGNOSED WITH HIV1 6 MONTHS BACK. WE STARTED THE TREATMENT WITH VIRADAY (CIPLA) (ATRIPLA) BUT AFTER 1.5 MONTHS OF MEDICATIONS SIDE EFFECTS WE REALISED IT WAS DUE TO VIRADAY SO WE CHANGED TO ON TENVIR EM (TRUVADA I.E TENOFOVIR AND EMTRICITABID) FOR ALMOST 3 MONTHS HIS CD 4 COUNTS AT BEGINNING WAS 267 VIRAL LOAD WAS 46,990 COPIES. AFTER 1.5 MONTHS OF ATRIPLA HIS CD4 WAS 218 AND VIRAL LOAD WAS 257 COPIES THEN WE SWITCHED TO TRUVADA I.E TENVIR EM AFTER 3 MONTHS OF IT HIS CD4 IS 459 AND VIRAL LOAD IS BELOW 20 COPIES. NOW THE DOCTOR IS SAYING IS TO ADD RALTEGRAVEER AS ITS NOT SUGGESTED TO BE ON 2 DRUGS . HE IS EMPHASIZING TO BE ON 3 DRUGS AND DOSAGE SHOULD RALTEGRAVEER IN MORNING AND TENVIR EM IN EVENING 12 HOURS GAP IS NECCESARY. I REQUEST TO SUGGEST ME WHAT SHOULD I DO AS ITS DIFFICULT TO FIND A GENUINE ADVICE HERE AND HAS VERY LIMITED DOCTORS IN THE CITY. THE ONLY HOPE IS THE ONLINE FORUM AND GENUINE FORUMS LIKE YOURS.

REGARDS AND THANKS IN ADVANCE. NAMS

 

Response from Dr. Young

Hello Nams and thanks for posting from India.

The use of Tenvir EM (tenofovir+emtricitabine) we call it Truvada here) alone is definitely suboptimal for the treatment of HIV; two drug therapy is not recommended as the risk of developing drug resistance is greater.

It’s not certain from your post if the <20 copy VL was obtained before or after the Tenvir EM alone- if it’s the former, I’d have concern about if the viral load was still suppressed prior to the addition of raltegravir. If it’s the later, this is excellent news- as it indicates that there was no emergence of virus or drug resistance.

Regarding the current regimen, Tenvir EM is dosed once daily, raltegravir twice daily (they can be taken together); and the timing of the second dose need not be exactly 12 hours apart; I recommend in the morning and evening only.

Isentress 400mg (Raltegravir)
Product Name
Isentress 400mg (Raltegravir) 60 Tablets/Pack

Active Ingredient
Raltegravir

Manufacturer
Merck Sharp & Dohme

Product Type
Antiretroviral (HIV)

 

Isentress tablets 400mg contain the antiretroviral drug raltegravir that is used to treat Human Immunodeficiency Virus (HIV) infection in combination with other HIV medications.

Isentress general information

What is Isentress used for?

Isentress tablets 400mg are used to treat Human Immunodeficiency Virus (HIV) infection, in combination with other HIV medications.  This combination therapy is known as highly active antiretroviral therapy (HAART).  HIV impairs the immune system by attacking specific immune cells called CD4⁺ cells that are involved in fighting infection, which can lead to opportunistic life-threatening infection (infections that would not normally be harmful).  If too many CD4⁺ cells are destroyed this can result in acquired immune deficiency syndrome (AIDS).  Isentress tablets 400mg help prevent or slow down the ability of HIV to replicate, which reduces the viral load by keeping the amount virus down to a low level and this results in an increase in CD4 cell numbers, so that the immune system can recover reducing the risk of disease progression.

How does Isentress work?

Isentress tablets 400mg contains the antiretroviral raltegravir, an integrase strand transfer inhibitor.  Raltegravir in Isentress tablets 400mg inhibits the catalytic activity of HIV integrase, an HIV-encoded enzyme that is required for viral replication.  HIV is a retrovirus, which is an RNA virus that produces an enzyme called reverse transcriptase to transcribe its RNA into DNA.  Another viral enzyme, integrase, is used to insert or integrate viral DNA into the host cell genome during the early phase of infection.  By blocking the action of viral integrase, raltegravir in Isentress tablets 400mg prevents replication of the virus and thereby inhibits production of new infectious viral particles.  Isentress tablets 400mg slow down the replication of HIV within your body but does not kill the virus already incorporated in the CD4⁺ cells or prevent the spread of the infection to others.

What does Isentress contain?

Isentress tablets 400mg contain the active ingredient raltegravir, an antiretroviral used in the treatment of Human Immunodeficiency Virus (HIV) infection.  They also contain microcrystalline cellulose, lactose monohydrate, calcium phosphate dibasic anhydrous, hypromellose 2208, poloxamer 407, sodium stearyl fumarate, magnesium stearate.

Treating HIV infection with Isentress

Isentress tablets 400mg contain the antiretroviral drug raltegravir, an inhibitor of the viral integrase enzyme.  HIV impairs the immune system by attacking specific immune cells called CD4⁺ cells that are involved in fighting infection, and this can lead to opportunistic life-threatening infection (infections that would not normally be harmful), including pneumonia, herpes virus infections, and Mycobacterium avium complex (MAC) infection.  If too many CD4⁺ cells are destroyed this can result in acquired immune deficiency syndrome (AIDS).  HIV is a retrovirus, which is an RNA virus that produces an enzyme called reverse transcriptase to transcribe its RNA into DNA.  Another viral enzyme, integrase, is used to insert or integrate viral DNA into the host cell genome during the early phase of infection.  Raltegravir in Isentress tablets 400mg works by blocking the action of the viral integrase and this inhibits viral replication and thereby inhibits production of new infectious viral particles.  Isentress tablets 400mg are used in combination with other HIV medications to slow down the replication of HIV within your body but they do not kill the virus already incorporated in the CD4⁺ cells or prevent the spread of the infection to others.

What are the side effects of Isentress?

The most commonly reported side effects when taking Isentress tablets 400mg include: nausea, vomiting, headaches, tiredness, inflammation of the nasal passages and throat, trouble sleeping, upper respiratory tract infection, cough, fever, bronchitis, back pain and depression.  A more serious but less common side effect is a condition is a severe skin reaction including Stevens-Johnson syndrome and toxic epidermal necrolysis.

When should Isentress not be used?

You should not use Isentress tablets 400mg if you:

• are allergic to raltegravir or any ingredients in Isentress
• are pregnant or are breastfeeding
• are taking medicines that interact with Isentress, including antacids containing aluminium and/or magnesium, the anti-infective rifampicin

How should Isentress be taken?

You should take your Isentress tablets 400mg with a glass of water twice daily, with or without food and in combination with other antiretroviral drugs that have been prescribed.  You should continue to take your Isentress tablets 400mg for as long as recommended by your doctor, and you will be monitored carefully to ensure that you do not develop any serious side effects, in which case your doctor will probably recommend that you stop taking your Isentress tablets 400mg.

How long should you take Isentress?

You should continue to take your Isentress tablets 400mg for as long as recommended by your doctor, and you will be monitored carefully to ensure that you do not develop any serious side effects, in which case your doctor will probably recommend that you stop taking your Isentress tablets 400mg.

Missed dose of Isentress

If you miss a dose of Isentress tablets 400mg take it as soon as you remember, unless it is time to take the next dose, then skip the missed dose.  Do not take a double dose.

How should Isentress be stored?

You should store your Isentress below 25°C in a cool dry place.

Product Name
Tenvir-EM 30 Tablets/Pack [PrEP]
Also known as Truvada or PrEP

Active Ingredient
Emtricitabine and Tenofovir Disoproxil Fumarate

Manufacturer
Cipla Pharmaceuticals

Product Type
Antoretroviral (HIV)

Tenvir-EM tablets contain emtricitabine and tenofovir, which are antiretroviral drugs used to treat HIV infection, to prevent or slow down the spread of infection.

Tenvir-EM general information

What is Tenvir-EM used for?
Tenvir-EM tablets are a fixed dose combination treatment for Human Immunodeficiency Virus (HIV) infection in adults over age 18. Tenvir-EM tablets are used combination with other medications that have a different mechanism of action to the components in Tenvir-EM, and are used to treat patients with HIV infection who have either already received treatment with other medications for HIV or as first line therapy for treatment-inexperienced patients. HIV impairs the immune system by attacking specific immune cells called CD4+ cells that are involved in fighting infection and this can lead to opportunistic life-threatening infection (infections that would not normally be harmful); also if too many CD4+ cells are destroyed this can result in acquired immune deficiency syndrome (AIDS). Tenvir-EM tablets prevent or slow down the ability of HIV to replicate and spread, which keeps the amount of virus down to a low level and this results in an increase in CD4 cell numbers, so that the immune system can recover, reducing the risk of disease progression. Tenvir-EM may be used for Pre-exposure prophylaxis (PrEP) treatment. PrEP is a new prevention method in which people who do not have an HIV infection, but may be at high risk, take a Tenvir-EM tablet every day to reduce their risk of becoming infected. Anyone undergoing PrEp treatment should see their healthcare provider every three months for follow-up and testing.

What is PrEP?
PrEP stands for Pre-exposure Prophylaxis. PrEP is a new treatment to help prevent the spread of the human immunodeficiency virus (HIV-1) that causes AIDS. Taken as a once-a-day tablet, along with safe sex practices, Tenvir-EM can help reduce the risk of contracting HIV-1, the virus responsible for AIDS. PrEP is for… 1. HIV-negative men who have sex with men and who are at high risk of contracting HIV-1. 2. Male-Female sex partners where one partner has HIV-1 and the other doesn’t. 3. Males or females that have sex with intravenous drug users at risk of contracting HIV-1. You must commit to taking Tenvir-EM every day and seeing your doctor every three months for follow up care and testing. How to Get Started: Please contact your doctor to discuss and have a HIV test as soon as possible. Tenvir-EM is for individuals for high exposure risk for HIV-1. Tenvir-EM must be taken every day along with safer sex practices. Please take the time to educate yourself about safe sex and ask your doctor for advice.

How does Tenvir-EM work?
Tenvir-EM tablets contain a combination of two antiretroviral drugs, emtricitabine and tenofovir disoproxil fumarate, which are only effective against RNA viruses (retroviruses) like Human Immunodeficiency Virus (HIV). These drugs each work by inhibiting the action of the viral-specific enzyme reverse transcriptase (RT), which is needed for the virus to be able to replicate. Retroviruses convert RNA to DNA, which is then integrated into the DNA of infected immune cells so that the virus can replicate. Emtricitabine and tenofovir disoproxil fumarate are both nucleoside analogue reverse transcriptase inhibitors (NRTI), which means that they block the action of RT by competing with one of the nucleosides needed to transcribe the viral RNA into DNA, becoming incorporated into the chain of newly synthesized viral DNA and preventing it from growing (chain termination). Emtricitabine is an analogue of cytidine and tenofovir is an analogue of adenosine. The combined action of these two antiiretroviral drugs in Tenvir-EM tablets prevents the integration of the virus into the DNA of the infected CD4+ immune cell, which inhibits the replication of HIV so that no more virus can be produced and this reduces the viral load (amount of virus). Tenvir-EM tablets slow down the replication of HIV within your body but does not kill the virus already incorporated in the CD4+ cells or prevent the spread of the infection to others.

What does Tenvir-EM contain?
Tenvir-EM tablets contain two active ingredients, the antiretrovirals emtricitabine (200mg) and tenofovir disoproxil fumarate (300mg) and used to treat HIV infection.

Treating HIV infection with Tenvir-EM
Tenvir-EM tablets contain a combination of two antiretroviral drugs, emtricitabine and tenofovir disoproxil fumarate, which are only effective against RNA viruses (retroviruses) like Human Immunodeficiency Virus (HIV). HIV impairs the immune system by attacking specific immune cells called CD4+ cells that are involved in fighting infection and this can lead to opportunistic life-threatening infection (infections that would not normally be harmful), including pneumonia, herpes virus infections, and Mycobacterium avium complex (MAC) infection. If too many CD4+ cells are destroyed this can result in acquired immune deficiency syndrome (AIDS). The two antiretroviral drugs in Tenvir-EM tablets each work by inhibiting the action of the viral-specific enzyme reverse transcriptase (RT) which is needed for the virus to be able to replicate. Retroviruses convert RNA to DNA, which is then integrated into the DNA of infected immune cells so that the virus can replicate. The combined action of the two antiretroviral drugs in Tenvir-EM tablets prevents the integration of the virus into the DNA of the infected CD4+ immune cell, which inhibits the replication of HIV so that no more virus can be produced and this reduces the viral load (amount of virus). Tenvir-EM tablets slow down the replication of HIV within your body but does not kill the virus already incorporated in the CD4+ cells or prevent the spread of the infection to others.

What are the side effects of Tenvir-EM?
The most commonly reported side effects when taking Tenvir-EM include: headache, gastrointestinal upset (nausea, diarrhoea, constipation, stomach pain), dizziness, fatigue, rash, difficulty sleeping, abnormal dreams, depression. A more serious but less common side effect is a condition called lactic acidosis which is excess lactic acid in the blood due to liver damage, which may cause pancreatitis, liver failure, or renal failure.

What are the health risks when taking Tenvir-EM?
Lactic acidosis is a rare but potentially fatal condition that has been reported when taking Tenvir-EM tablets. It is caused by a build up of excess of lactic acid in the blood due to liver damage, which is usually associated with hepatomegaly (liver enlargement) with steatosis (build up of fat in the liver) and may cause pancreatitis, liver failure, or renal failure. Symptoms begin within a few months of treatment and include: nausea, vomiting and abdominal pain, difficulty breathing, loss of appetite, weight loss, motor weakness.

When should Tenvir-EM not be used?
You should not use Tenvir-EM if you:

• are allergic to emtricitabine or tenofovir or any ingredients in Tenvir-EM
• are pregnant or are breastfeeding
• have kidney or liver disease
• have chronic hepatitis B (HBV) infection
• have a bone disease like osteoporosis without discussion with your doctor
• are using antiretroviral drugs containing lamivudine or other antiretroviral drugs that work by the same mechanism (nucleoside analogue
• reverse transcriptase inhibitors NRTI)
• are taking medicines that interact with Tenvir-EM, including:other retrovirals like didanosine, atazanavir, and ritonavir

What medications interact with Tenvir-EM?
Several medications interact with Tenvir-EM and should either not be taken while you are taking Tenvir-EM or only after discussion and instruction from your doctor:

Drugs that cause a serious reaction with Tenvir-EM: didanosine for HIV
Drugs that affect Tenvir-EM: other retrovirals like ritonavir
Drugs that are affected by Tenvir-EM: atazanavir for HIV

How should Tenvir-EM be taken?
You should take your Tenvir-EM tablets with a glass of water once a day with or without food. You should continue to take your Tenvir-EM tablets regularly for as long as your doctor recommends, and you condition should be monitored. Do not suddenly stop taking your Tenvir-EM tablets as this may increase risk of HIV resistance.

How long should you take Tenvir-EM?
You should continue to take your Tenvir-EM tablets regularly for as long as your doctor recommends, and you condition should be monitored. Do not suddenly stop taking your Tenvir-EM tablets as this may increase risk of HIV resistance.

Missed dose of Tenvir-EM
If you miss a dose of Tenvir-EM take it as soon as you remember, unless it is time to take the next dose, then skip the missed dose. Do not take a double dose.

How should Tenvir-EM be stored?
You should store your Tenvir-EM below 25°C in a cool dry place.

Ricovir-EM is one of the generic drugs that has the same active ingredients as Truvada, but made by a different company. It is being used by people all over the world as a way to access PrEP when Truvada is not readily available or affordable. Although there have no effectiveness studies on Ricovir-EM or Tenvir-EM, they both contain the same ingredients as Truvada, and there has been no reason or hypothesis to suggest one is more effective than the other.

Hope this answers your doubts.

* Tenofovir Disoproxil Fumarate (Tenvir EM)

Tenvir-EM

Product Name
Tenvir-EM 30 Tablets/Pack [PrEP]

Also known as Truvada or PrEP

Active Ingredient
Emtricitabine and Tenofovir Disoproxil Fumarate

Manufacturer
Cipla Pharmaceuticals

Product Type
Antoretroviral (HIV)

 

Note: If you can afford Isentress is better but also more expensive than this.

 

Let’s look at Isentress

Isentress 400mg (Raltegravir)

Product Name
Isentress 400mg (Raltegravir) 60 Tablets/Pack

Active Ingredient
Raltegravir

Manufacturer
Merck Sharp & Dohme (MSD)

Product Type
Antiretroviral (HIV)