Odefsey is a complete single-tablet regimen used for the treatment of HIV. It was approved for use by the U.S. Food and Drug Administration in 2016.
What are the drugs in Odefsey?
Odefsey contains three medications: rilpivirine (RPV), tenofovir alafenamide (TAF), and emtricitabine (FTC).
RPV is in the class of drugs called NNRTIs (short for “non-nucleoside reverse transcriptase inhibitors”), which stop HIV from making copies of itself.
TAF and FTC are both in the class of drugs called NRTIs (short for “nucleoside reverse transcriptase inhibitors”), which also block HIV from making copies of itself.
Can Odefsey be used for any other conditions besides HIV treatment?
Yes: Because it contains the two medications that make up Descovy (TAF and FTC), Odefsey can be a good fit for people living with HIV who also have hepatitis B. Check with your physician to make sure you have been vaccinated or tested for hepatitis B before you stop or start taking Odefsey.
How often is Odefsey taken?
Odefsey is normally taken by mouth once a day, with a meal. Try to take it at the same time every day.
Does Odefsey have any side effects I should worry about?
Odefsey is usually very well tolerated. In clinical studies, the most common side effects were headache and difficulty sleeping. In earlier clinical trials of RPV (brand name Edurant), the most common side effects were depression, headache, insomnia, and rash. You should tell your medical provider if you develop any side effects.
Odefsey is a single-tablet regimen (STR) taken as one pill once a day. Odefsey includes a three-drug combination of emtricitabine (FTC), rilpivirine (RPV), and tenofovir alafenamide (TAF).
All three drugs in Odefsey are reverse transcriptase (RT) inhibitors; they block the action of RT, a viral enzyme necessary for HIV to make new copies of itself (replicate). TAF and FTC are in a class of RT inhibitors called nucleoside reverse transcriptase inhibitors (NRTIs), while RPV is in a class called non-nucleoside reverse transcriptase inhibitors (NNRTIs).
Odefsey was first approved for use by the U.S. Food and Drug Administration (FDA) in 2016. It is approved as a first-line HIV treatment only for people with a viral load less than or equal to 100,000 copies/mL, and CD4 cell count greater than or equal to 200 cells/mm3. This is because, in clinical trials, Odefsey did not work as well in people with a viral load greater than 100,000 copies/mL or with a CD4 cell count less than 200 cells/mm3.
Odefsey is also approved for people who want to switch to the drug when their HIV has been undetectable on another HIV treatment regimen for at least six months, provided they have no history of treatment failure on past regimens and no history of viral mutations that make HIV resistant to any of the drugs in Odefsey.
How to Take Odefsey
Odefsey is FDA-approved in the United States to be taken once daily with a meal containing at least 400 calories (that means solid food, not just a light snack). Absorption of the RPV component of Odefsey is reduced 40% if taken without food. Reduced absorption can lead to viral resistance, meaning Odefsey may stop working. Taking Odefsey with a meal is especially important during the first few months of treatment, when it is still beginning to get a foothold against HIV in a person’s body.
If you have insurance, monthly copays for Odefsey can typically run between $50 and $100 depending on the plan, though you may qualify for cost-sharing assistance provided by the manufacturer. If you don’t have insurance or your insurance won’t cover the majority of the cost of Odefsey (you are “underinsured”), there is a patient assistance program that can help reduce or eliminate the cost, depending on your financial situation.
There is no generic version of Odefsey in the U.S. at this point, which can be a deterrent when considering it as an option for HIV treatment.
Side Effects of Odefsey
As with many antiretroviral regimens, there is the potential for mild side effects, particularly when first starting treatment or when switching from a previous regimen to Odefsey. The most common side effects in clinical trials of Odefsey were headache and difficulty sleeping. In earlier clinical trials of RPV specifically, the most common side effects were depression, headache, insomnia, and rash.
Odefsey may increase the risk of developing new or worsening liver problems in people with a history of hepatitis B or C, or who have certain liver enzyme changes. Liver problems may also arise during treatment with Odefsey in those with no history of liver disease. If you have hepatitis B and take Odefsey, your hepatitis B may flare up if you stop taking Odefsey. If you have hepatitis B, don’t stop taking Odefsey without first telling your health care provider.
The RPV component of Odefsey can potentially worsen existing depression and other mood problems, and may even cause people to think about harming themselves or even killing themselves (this side effect is called suicidality). In addition, RPV may increase the risk of a heart rhythm irregularity called QT prolongation, which in turn increases the risk of a dangerous heart condition called torsades de pointes; thus, RPV should probably not be used in people who are already at risk for QT prolongation or who are taking other medications that increase their risk. RPV is also among a number of HIV medications that have significant interactions with rifamycin antibiotics, which are used to treat tuberculosis and other bacterial infections.
Finally, although this is not common, some people on treatments that include RPV have had skin reactions that can be mild to severe. In extremely rare cases, this can include a hypersensitivity reaction (similar to an allergic reaction) called “drug reaction with eosinophilia and systemic symptoms” (DRESS). DRESS may appear as a fever or flu-like symptoms with a red or purple rash that may turn into blisters or peeling skin. There may be swelling of the face and lips, or swollen lymph nodes in your neck or under your arms. Contact your health provider immediately if you have any of these symptoms while taking Odefsey.
Interactions Between Odefsey and Other Drugs
Taking Odefsey while taking certain other medications may make Odefsey less effective against HIV and may lead to viral resistance to Odefsey, meaning Odefsey may stop working. These medications include:
Some of the medications and supplements listed above are available over the counter, so people taking Odefsey need to be especially aware of these. St. John’s wort is an herbal supplement that anyone can purchase at a pharmacy, health food store, or supermarket. Similarly, the proton pump inhibitors listed above include common, over-the-counter antacids such as Nexium, Prevacid, and Prilosec.
When to Consider Odefsey for HIV Treatment
To understand the role Odefsey has in HIV treatment, it is helpful to understand why Odefsey was developed. In effect, Odefsey is a new and improved version of the HIV treatment Complera, a pill that contains three drugs: FTC, RPV, and tenofovir disoproxil fumarate (TDF). Complera was approved by the FDA in 2011.
Both Odefsey and Complera contain FTC and RPV. What makes the two different is that Odefsey contains TAF instead of TDF. TDF is known for potentially causing kidney and bone problems, so TAF was developed to overcome these negative effects. (You may have heard about this before if you are familiar with the story of Descovy as a possible replacement for Truvada).
In addition, Odefsey is a smaller pill than Complera. Thus, for people who are taking Complera and whose HIV is undetectable, switching to Odefsey may offer a safer and more tolerable option for preserving their undetectable viral load with fewer side effects and safety risks.
What’s the Verdict on Odefsey as an Anti-HIV Treatment Regimen?
Based on the HIV treatment guidelines issued by the U.S. Department of Health and Human Services, Odefsey would not be the first choice for most people starting HIV treatment for the first time. On the other hand, for people who are on older regimens, such as Complera or Atripla (efavirenz/tenofovir disoproxil fumarate/FTC), and who want to reduce the risk of long-term side effects associated with those drugs, Odefsey can provide a safer alternative.
The reason why Odefsey is not a recommended first choice for HIV treatment is that, while the regimen is effective and does not have a lot of side effects for most people, it does have some disadvantages compared to other available treatments. Most of these disadvantages have to do with the RPV component of Odefsey.
In clinical trials, Odefsey did not work as well in people with viral load greater than 100,000 copies/mL or with a CD4 cell count less than 200 cells/mm3. Because of how the body metabolizes (i.e., processes) RPV, Odefsey must be taken with a solid, substantial meal of at least 400 calories (not just a light snack). Although this requirement is not as strict once a person has been taking Odefsey for a while and has an undetectable viral load, it’s very important when first starting treatment.
As we noted earlier, the RPV component of Odefsey can also potentially cause any of a number of concerning side effects, including worsening depression and a heart rhythm irregularity called QT prolongation.
Nonetheless, Odefsey may be a good choice for first-line treatment in those with a viral load less than or equal to 100,000 copies/mL and CD4 cell count greater than or equal to 200 cells/mm3. Odefsey may also be a good switch option for people whose HIV is undetectable on another HIV treatment. For such people, Odefsey may offer a safe and effective treatment with relatively few side effects and the convenience of a single-tablet regimen taken once a day.
The choice of which HIV treatment to take is a very personal decision, and not everyone responds to treatment the same way, so be sure to weigh the pluses and minuses of Odefsey versus other potential regimens with a knowledgeable HIV care provider.