By Michelle Cespedes, MD, MS, as told to Hallie Levine
Michelle Cespedes, MD, MS, is a professor of medicine (infectious diseases) and interim system chief of the Division of Infectious Diseases at the Icahn School of Medicine at Mount Sinai in New York City. The information here reflects her clinical knowledge and experience. She was not involved in the development of dolutegravir/rilpivirine (Juluca).
If you have HIV, your doctor will prescribe drugs to reduce the level of HIV, or "viral load," in your body until it is undetectable. This will protect your immune system, so you are less likely to get sick. If you have an undetectable viral load, it also prevents the passage of HIV from you to someone else during sex.
HIV is a special type of virus known as a retrovirus. This means that it uses RNA, rather than DNA, to make copies in your body. It also means that it requires a specific type of medication, known as antiretroviral (ARV) medication, to treat it.
Juluca, which the FDA approved in 2017, combines two antiretroviral drugs — dolutegravir, an HIV integrase strand transfer inhibitor ((INSTI), and rilpivirine, a non-nucleoside reverse transcriptase inhibitor (NNRTI). They are combined into one pill. Each medication works against HIV in a different way.
Here's what to know about who Juluca may benefit, how well it works, and what taking it may be like.
Who is Juluca for?
Juluca is FDA approved for adults with HIV who have no traces of the virus in their blood for at least six months. It's meant to replace your current treatment. We use it often in patients who take several other medications.
Before you start treatment, your doctor should test you to find out what strain of HIV you have. Some strains of HIV are resistant to certain treatments like Juluca. It's important to do this to make sure you are put on the right medications.
How does Juluca work?
Juluca combines two drugs, dolutegravir and rilpivirine. Dolutegravir blocks an HIV protein, integrase, which is what allows HIV to insert its genetic code into your healthy cells. Rilpivirine interrupts an enzyme called reverse transcriptase, so the virus that causes HIV can't convert its genetic material (RNA) into DNA.
Drugs like dolutegravir and rilpivirine are some of the strongest and safest medications available. They lower HIV levels very quickly. Juluca only combines these two medications, unlike three or four drugs in other antiretrovirals. These medicines also aren't processed by the kidneys, so they don't need to be adjusted if you have kidney disease.
How effective is Juluca?
Since Juluca has been FDA approved since 2017, we've had plenty of time to judge its real-world efficacy and safety. Research shows it works for about 99% of patients over a six-year period.
Your doctor will probably also check your HIV levels four to six weeks after you begin Juluca. The drug works fairly quickly. We often find that we can get patients down to undetectable levels of HIV in their blood within about four weeks.
What sorts of side effects should I expect?
Juluca is considered quite safe. In fact, dolutegravir, one of its two ingredients, is a preferred antiretroviral drug throughout pregnancy. But it does have some side effects. The most common ones are:
- Headache
- Nausea
- Diarrhea
Often, these go away once your body gets used to the drug. We also recommend that you take Juluca with a full meal to help minimize digestive side effects and so your body properly absorbs rilpivirine.
Less commonly, patients notice sleep problems, depression, and fatigue. While research has shown drugs like Juluca can cause weight gain, I personally think that's because many of those studies were done in Kenya, Nigeria, Tanzania, and Uganda, where patients were sicker and malnourished. Once they returned to health, their body naturally gained back weight.
It can be hard to tell if Juluca is the cause of your symptoms, or it's the HIV itself. That's why it's important to tell your doctor, to help figure it out.
How do you take Juluca?
You take one tablet daily with a full meal at the same time each day. You swallow the pill whole. If you miss a dose, take it with your next meal. If it's almost time for your next dose, skip the missed dose and just take your next dose at your usual time.
How often will you need follow-up care?
Your doctor will want to see you at least twice a year. They will run blood tests to make sure your viral load is still undetectable. They may also want to run blood tests to check for rare side effects, such as liver damage or any increase in bilirubin or muscle enzymes.
Who shouldn’t take Juluca?
Juluca works well for many people with HIV. But you shouldn't take it if you:
- Have detectable levels of HIV in your blood (usually defined as HIV-1 RNA that's more than 50 copies per mL)
- Have been on antiretroviral medications for less than six months
- Have had past HIV treatment failure
- Also have hepatitis B. There are other antiretroviral HIV medications available to treat both conditions.
- Take proton pump inhibitors (PPIs) such as omeprazole, or strong enzyme inducers like rifampin or carbamazepine, as these significantly lower Juluca levels in your body
How much does this treatment cost? Will insurance cover it, or are there options for financial assistance?
The retail price of Juluca without insurance is around $4,500 a month. Thankfully, it's usually covered by insurance, including Medicare and Medicaid. If a patient is uninsured or can't afford their insurance copays, there are ways to get financial help, too. There is a federal program called the AIDS Drug Assistance Program (ADAP) that provides FDA-approved medications to people with HIV with limited or no health insurance. You can find your state program at the Directory of AIDS Drug Assistance Programs. ViiV Healthcare, the company that makes Juluca, also offers a ViiVConnect Savings Card for people with commercial insurance to help save on copay costs.
How can I learn more about whether this is a good treatment fit for me?
Talk to your doctor! If you have an undetectable HIV viral load, and don't have hepatitis B, you most likely are a good candidate for Juluca. But since it's one of the newer all-in-one tablets, some providers aren't as familiar with it as others, like bictegravir/emtricitabine/tenofovir alafenamide (Biktarvy).
The key thing for you and your doctor to work through is what other medications you currently take. Juluca doesn't interact with most other drugs, but there are a handful that you do need to be mindful of, like proton pump inhibitors.
Oftentimes, when a person is first diagnosed with HIV, their doctor will test for hepatitis B as a precaution. While they wait for results to come back, they start them on a drug that contains three medicines, including one that covers hepatitis B. But if you don't have hepatitis B, it makes sense to switch to a two-drug medication like Juluca once your viral load becomes undetectable. The fewer medicines you are on, the lower your risk of side effects and overall drug interactions.
