HIV is a lifelong infection that affects many people. People with HIV take many different types of medicines to help control their condition and to prevent the infection from developing into AIDS. People can take pills that contain one medicine or combination pills that contain multiple medicines. Many combination HIV pills have three to four different medicines that each work in different ways to help control the virus.
Dovato (doe VAH toe) was approved in 2019 as the first complete HIV treatment that contains two medicines. A complete treatment is a fixed-dose combination of HIV medicines that works to manage the virus without needing other HIV medicines.
How Does It Work for HIV?
HIV is a virus that is found in blood, breast milk, and sexual fluids. HIV weakens your immune system by attacking certain white blood cells, making it harder for your body to fight off an infection. HIV can turn into AIDS when you start becoming sick because your body can no longer fight off infections, but HIV does not always turn into AIDS.
HIV is commonly spread through sex with a person who has the virus as well as from sharing needles. Children can get HIV from their mothers though a few ways:
- Before birth through the placenta
- During childbirth
- After childbirth through the mother’s breast milk
HIV cannot be cured, meaning your body can never get rid of the virus. Taking medicines can help manage the amount of virus that is in your body. There are two types of HIV: HIV-1 and HIV-2. HIV-1 is the most common type of HIV, while HIV-2 is less common, with most cases being in West Africa.
HIV symptoms are similar to flu symptoms and can include fever, rash, chills, tiredness, and muscle aches.
Dovato contains two medicines: dolutegravir and lamivudine. Dovato works by blocking the virus from growing and infecting more cells. This can lower people’s virus levels to undetectable and keep them there. Undetectable levels of the virus means the amount of virus in the blood is below the level that can be measured by a lab test.
Dovato is used in people 12 years of age and older in two ways.
- In people with HIV-1 who have never taken an HIV-1 medicine
- To replace people’s HIV regimen if they meet certain requirements (the amount of virus in your body is undetectable, have had no history of HIV treatment failure, and have had no history of the medicines in Dovato not working for you)
How Do I Take It?
Dovato tablets contain 50 milligrams of dolutegravir and 300 milligrams of lamivudine, respectively. Dovato is taken once a day with or without food. Do not change your dose or stop taking Dovato without first talking to your health care provider. Make sure you do not run out of Dovato. If you are running low on the medicine, get more from your pharmacy or health care provider. Missing a dose can cause the virus to increase, which may make it harder to treat.
How Was It Studied for HIV-1?
Two clinical studies were done in adults 18 and over to look at the safety and efficacy of Dovato.
The first study looked to see the number of people whose virus level in the blood was less than 50 copies/mL at week 48. People in the study had never taken medicine for their HIV-1 and either took Dovato (a two-drug regimen) or a three-drug regimen of dolutegravir plus tenofovir disoproxil fumarate and emtricitabine. The median age of people in the study was 33 years old, with 85% of people being male. The study also included White Americans, African Americans, Asian Americans, Native Americans, Alaska Natives, Native Hawaiian, Hispanics, and those classified as “multiracial.”
Another study looked at the number of people who had virus levels greater than or equal to 50 copies/mL at week 48. Adults in the study either stayed on their HIV medicine (which was classified as a tenofovir alafenamide-based treatment) or switched from their tenofovir alafenamide-based treatment to Dovato. People in the study were classified as having their virus levels below 50 copies/mL, meaning their virus levels were low enough to be undetectable. The median age of people in the study was 39 to 40 years old with 92% of people being male. The study also included White Americans, African Americans, Asian Americans, Hispanics, and those classified as “Other.”
A study was done in children 12-18 years of age who had not taken medicine for their HIV-1. Everyone in the study took Dovato. The study looked to see the number of children who had less than 50 copies/mL of the virus in their blood at week 48. The median age of children in the study was 17 and included Asian Americans and Black Americans.
What Benefits Were Seen?
The results of the first study done in adults showed that 91% percent of people who took Dovato had less than 50 copies/mL of the virus in their blood compared to 93% of people who took the three-drug regimen. Both medicines showed similar results in regards to lowering the amount of virus in the blood.
The results of the second clinical study done in adults showed that less than 1% of people in the Dovato group compared to 1% of people in the tenofovir alafenamide-based treatment group had virus levels greater than or equal to 50 copies/mL. This means people who were switched from their existing treatment to Dovato had similar results to those who stayed on their existing treatment.
Ninety-two percent of children who took Dovato had virus levels that were less than 50 cells/mL. The results of the study showed that Dovato worked to lower virus levels and maintain low virus levels in children.
How Long Does It Take to Work?
Dovato works as soon as you take the medicine. Results from clinical studies show that undetectable levels of the virus can be achieved as early as a few weeks after starting the medicine. You will not feel any effects of Dovato, but your health care provider will monitor virus levels while taking the medicine.
How Can I Manage Side Effects?
The most common side effects seen with Dovato are headache, nausea, diarrhea, trouble sleeping, tiredness, and anxiety.
If you are experiencing headaches because of Dovato, taking over-the-counter medicines such as acetaminophen or ibuprofen can help. Talk to your health care provider if your headaches do not go away or if they are getting worse.
If you experience diarrhea while taking Dovato, stay hydrated by drinking plenty of water. Certain foods such as bananas, rice, and toast or over-the-counter diarrhea medicines may help. Call your health care provider if your diarrhea does not get better or gets worse.
If you experience nausea, take these steps to lessen the symptoms:
- Avoid greasy food
- Eat bland food such as toast and crackers
- Avoid strong smells
- Eat slowly
Dovato can cause trouble sleeping. There are techniques that you may be able to implement to help manage this. Drinking less caffeine, including soda or coffee, sticking to a sleep schedule, and limiting screen time before bedtime can help.
Dovato can cause tiredness. Do not drive or operate heavy machinery until you know how Dovato affects you.
You may experience anxiety while on Dovato. Focusing on deep breathing, limiting caffeine, and getting enough sleep may help. Talk to your health care provider if your anxiety does not go away or gets worse for you.
What Type of Drug Interactions Can Happen?
Dofetilide is a medicine used to treat heart rhythm problems. Taking Dovato with dofetilide can increase the blood levels of dofetilide and increase the risk of side effects, which can be serious and life-threatening. These medicines should not be taken together.
It is not recommended to take other medicines for HIV while taking Dovato. Dovato is classified as a complete HIV regimen that contains two medicines.
It is not recommended to take certain medicines for seizures such as oxcarbazepine (Trileptal), phenytoin (Dilantin, Phenytek, and others), or phenobarbital with Dovato. Taking these medicines with Dovato can lower the blood levels of Dovato and may cause it to not work as well.
It is not recommended to take St. John’s wort, an herbal supplement that may be used to treat depression, with Dovato. It is also not recommended to take medicines that contain sorbitol with Dovato. These medicines can cause Dovato to not work as well. Talk to your health care provider about all the medicines you are taking. Your health care provider will determine if you are taking any sorbitol-containing medicines.
Taking Dovato with dalfampridine (Ampyra), a medicine used in multiple sclerosis, and metformin (Glumetza), a medicine used for diabetes, can cause an increase in blood levels in these medicines and can increase the risk of developing side effects. An increase in dalfampridine levels can increase the risk of having seizures.
Taking carbamazepine (Tegretol), a medicine for seizures, or rifampin (Rifadin), a medicine for tuberculosis, with Dovato can cause Dovato to not work as well. Your health care provider may ask you to take a medicine called dolutegravir (which is one of the medicines in Dovato) to help with this. If you have to take Dovato with dolutegravir, you may be asked to take them 12 hours apart.
Taking Dovato with certain medicines such as antacids (Tums or Mylanta), laxatives for constipation (Milk of Magnesia), medicines like Alka-Seltzer (which contains aspirin), medicines that contain aluminum or magnesium, or sucralfate for stomach ulcers can cause Dovato to not work as well. It is recommended to take Dovato 2 hours before or 6 hours after these medicines.
Taking Dovato with calcium or iron supplements or multivitamins containing calcium or iron can cause Dovato to not work as well. When taken with food, Dovato along with iron or calcium-containing supplements can be taken at the same time. If you are taking Dovato on an empty stomach, it is recommended to take Dovato 2 hours before or 6 hours after taking the calcium or iron-containing supplements.
What Are Other Unique Considerations to Be Aware Of?
Dovato is for adults as well as children 12 years old and older who weigh at least 55 pounds (25 kilograms). It is not known if Dovato is safe and effective in children less than 12 years old or less than 55 pounds.
Is There a Cost-Savings Program?
There is a savings card offered by the manufacturer that may allow you to pay as little as $0 per prescription. Whether you are eligible depends on if you have commercial insurance and if your pharmacy participates in the manufacturers savings card program. You can find out more at myviivcard.com or by calling 877-844-8872.
