It’s well-known that antiretroviral therapy (or ART for short) is a big help for people living with HIV. It helps them live longer and healthier lives. Patients are advised to start ART as soon as possible after they find out about their health status. ART is considered necessary because it reduces the number of virus copies to an undetectable level. The viral load remains undetectable in the blood, semen, vaginal fluids, etc. As long as it stays this way, the risk of HIV transmission is minimized, or even eliminated.

If you want to monitor viral load and be sure that it’s undetectable, you should visit your doctor on a regular basis and get medical assistance. The doctor can prescribe you Tivicay, which was certified by the American Food and Drug Administration in August 2013, and since then people use it with other HIV medicines as a part of post-exposure prophylaxis, and highly active ART (HAART). So let’s see what kind of medicine it is, and how it works.

What Is Tivicay Used For?

Tivicay is a certified brand name of dolutegravir marketed in the USA. The active ingredient belongs to a class of integrase inhibitors, which are used as a part of complex therapy in people of all ages who require HIV treatment. Integrase inhibitors are the medications that suppress the action of the special enzyme that facilitates the integration of the viral genome into the DNA of the attacked cell. Regarding HIV, it means that dolutegravir does not let the infection get into the CD4 leukocytes.

It stops the process of virus replication at the very beginning, thus the amount of HIV in human blood goes down and allows the number of immune cells to increase. Usually, integrase inhibitors are taken with the reverse-transcriptase inhibitors, the drugs that do not let HIV replicate itself inside the white blood cell. Eventually, if used correctly and regularly, this combination lessens the chances of having acquired immunodeficiency syndrome (AIDS) and life-threatening opportunistic infections. The risk of HIV transmission is reduced, too, because the amount of viral copies is too low.

The post-exposure prophylaxis, or PEP for short, is used to define the measures taken to prevent the infection after contact with an HIV positive person. Dolutegravir taken with other antiretroviral meds eliminates the risk of viral transmission. To be more exact, even if the virus spreads from one host to another, the drugs kill it in the early stages of the infection. Its genome cannot enter the cells, does not replicate, and the person remains healthy.

Tivicay and Side Effects: Main Information

Usually, integrase inhibitors are well tolerated by the human body. They are mostly safe and effective, and the most frequent adverse effects are reported by 1-3% of people who take this medication. There were lots of studies researching the adverse reactions on the human’s body from dolutegravir. This drug may cause different side effects, from light and quite manageable to more serious ones. People complain about having a headache and difficulties with falling asleep, as well as such less pleasant things as nausea and diarrhea. Feeling tired is also a usual problem. Let’s keep in mind that we are all different and you can have other health issues. Always tell your doctor if you feel any of the symptoms we’ll talk about further, and especially if they become severe or permanent.

Common Complaints

Most people who take Tivicay and generics complaint of the same mild adverse response on their bodies when taking the drug. These reactions usually pass with time and do not last long. However, in case you experience them for several months, this is a reason to talk to your doctor. Do not panic and do not discontinue dolutegravir by yourself. Let the specialist make this decision. Light side effects of the medication include such symptoms, as:

• occasional dizziness;
• insomnia;
• headache;
• fatigue;
• depression;
• low energy;
• nightmares;
• muscle pain;
• itching.

However, in most cases, it may be uncomfortable, but rarely unbearable. The benefits of the therapy still outweigh these negative effects.

Severe Adverse Reactions

At the same time, there are more serious side effects which you should know about. You can have fever, numbness and tingling, hypotension, joint and extremity swelling that hurt, cardiovascular disease. Such undesirable Tivicay side effects like problems with the bladder or bowel, up to the loss of control over them, and digestion problems can seriously worsen the quality of everyday life. Hypersensitivity is reported to be one of the adverse drug reactions. It happens rarely, only in less than 1% of people, according to clinical trials.

Its symptoms include severe rash, sometimes with a fever, along with tiredness and low energy. Some may also feel muscle and joint aches. There may also be shortness of breath, cough, or sore throat. Additionally, people complain of peeling skin, fever blisters, eyes, and face swelling. Some had problematic breathing and stomach cramps. In such cases, it is advised to immediately stop using the drugs.

If dolutegravir gives you such symptoms, it may not be recommended for use again. If you use it after a severe allergic reaction, it can lead to extremely low blood pressure and even death. Some patients also face changes in their immune system, which is called immune reconstitution syndrome. The immunity gets stronger and starts fighting hidden infections you had before and didn’t know about. In any case, your doctor will advise you of what to do if something like that happens to you.

Long-Term Consequences

Some side effects occur with time. You should remember that along with adverse reactions that became known after clinical trials, the long-term reactions are delivered by people who report side effects of their own free will. And it is not always easy to determine whether there is a traceable connection between the drug exposure and side effects, and how reliable the information is. The following conditions can be called long-term consequences: hepatotoxicity that may lead to acute liver failure, neutropenia, arthralgia, and myalgia. Also, people reported increased weight, along with changes in mood and behavior.

Liver is a weak point for many people, and dolutegravir sometimes causes the dysfunction of this organ. If you suffer from hepatitis B or C, you are under risk that transaminase elevations will develop or worsen. Especially if the anti-hepatitis therapy was stopped before. If there were no problems with liver function before, or the risk factors didn’t exist at all, cases of hepatic toxicity are still possible. People may suffer from hepatic troubles, thus regular liver enzyme tests are recommended during the lifetime of patients.

Clinical Trials

Dolutegravir safety was assessed in three international studies, known as SPRING-2, SINGLE, and FLAMINGO trials. From 808 participants included in SPRING-2 tests, eventually, only 2% stopped taking the medicine because of severe side effects. In SINGLE trials (833 subjects), 4% of people who received 50 mg once daily had to discontinue the treatment. In a group named FLAMINGO (243 patients who took 50 mg once a day) 3% of people finished taking this drug.

A few other similar trials showed around the same rate of severe side effects. Clinical trials also show that pediatric patients have similar responses to the treatment as adults. It’s worth mentioning that a multicenter open-label study of dolutegravir in pediatric patients was done in the USA. The examinees were teenagers from 12 to 18 years old with HIV-1. In conclusion, it was stated that dolutegravir was well tolerated, and none of the side effects could be related to the treatment. This medicine was considered to be safe for treatment in this age group.

Tivicay and Neuropsychiatric Side Effects

Taking Tivicay dolutegravir can cause neuropsychiatric side effects, most common are insomnia, anxiety, depression, and psychosis. Less than 1% of people suffer from such symptoms. You can have a headache or paresthesia, or even bipolar depression, suicidal thoughts, hypomania, or nightmares. Patients often complain of problems with poor concentration and slow thinking. There is feedback from a lot of people that they have two or more such neuropsychiatric events.

For instance, neuropsychiatric adverse events were observed in 2019 by the researchers from Germany (ICH Study Center Hamburg; Department of Medicine II, University of Schleswig-Holstein, Campus Kiel) and Spain (Department of Infectious Diseases, University Hospital Germans Trias i Pujol; Fight AIDS Foundation, Badalona, Barcelona). More than 6,400 patients from different countries, who were involved in these studies, had mild and moderate adverse reactions. Only around 3.5% of people stopped their treatment because of the severe side effects. Those were mostly elderly female patients and those who started taking abacavir at the same time with dolutegravir.

Changes in Body Fat – Weight Gain

The issues like weight gain or loss of appetite, as well as changes in body fat, often make people feel bad. Gaining weight can be an unwanted side effect when you are taking this medication, but you can keep it under control by changing your habits and lifestyle. You can exercise more if your doctor tells you to. It can be quite successful if you want to fight fat on your back and belly. There is no reason to stop the treatment if you reduce this effect with the help of making slight changes in your diet and everyday physical activities. At the same time, you may notice that fat in the arms and legs decreases. This may be also the consequence of dolutegravir intake.

Renal Dysfunction and Liver Damage

Being treated with dolutegravir, you can go through a renal dysfunction. Kidney disease is a serious problem for HIV-positive people, and it is important to control the level of creatinine to make sure that your kidneys work fine. The studies show that the concentration of dolutegravir in plasma reduces if a patient has severe renal impairment. Such patients may need their dosage corrected. If dolutegravir concentration decreases, the therapeutic effect may be lost or there could be a resistance developed to Tivicay or other antiretroviral medications taken at the same time.

The online medical journal Nephrology Dialysis Transplantation has published detailed research of ARV drugs, including dolutegravir, on the renal system. The scientists came to the conclusion that dolutegravir itself is not associated with the formation of kidney stones, but some protease inhibitors may cause this renal impairment. Sometimes people who take ART may have frequent urination, but this is not a sign of some renal problems. In this case, you should check your blood sugar level.

As for the liver damage, ART drugs may cause serious hepatic problems, especially to patients who already have liver diseases. In clinical trials, the rates of ALT (alanine aminotransferase) and AST (aspartate aminotransferase) levels were higher in patients with hepatitis B and/or C. These are the enzymes that increase when you have some problems with liver function. The patients who took 50 mg in a day had abnormal test results in 18% of cases. And only 3% of healthy individuals had any problematic AST/ALT ratio. If patients took 50 mg twice a day, problems with liver biochemistry were observed in 13% and 8% accordingly.

Precautions and Warnings: How to Take Tivicay Safely?

Note that there are 10, 35 or 50 mg tablets, and they are in different colors. There is a number on each tablet for your convenience to avoid confusing the dosage. You can keep to your usual diet and take tablets with or without food. There is not much significant information about amount of water recommended for drinking and taking this medicine. Still, it’s worth remembering that in rare cases, Tivicay intake may lead to dehydration, so, it’s better to drink more.

An adult dose is usually one 50 mg tablet, which you should take once a day (if weight starts from 40 kg). This is recommended for people who start antiretroviral therapy for the first time. One 50 mg tablet should be taken twice a day by people who have already had some treatment before, or they have HIV that is resistant to other integrase inhibitors. Also, such a dose is meant to be taken with other ARV meds.

Your doctor can recommend that you to adjust a dose depending on your weight. In case you take it with other integrase inhibitors, this must be discussed beforehand. Pregnant women, and those who are getting ready to conceive a child, should consult a doctor, as it is necessary to be completely sure that the treatment will not result in birth defects. You must not breastfeed while having HIV or taking dolutegravir.

You must not take dolutegravir with dofetilide as the negative effects may be dangerous or even life threatening. You should consult your doctor about all the medicines and nutritional supplements you are taking, even if this is just some vitamins or herbal products.

Ask Your Doctor About Side Effects

Even though a lot of people who use this medication do not usually have any serious side effects, it’s still important to stay in contact with your doctor. Any medical specialist takes into account all the details of your health history and current condition, and evaluates if benefits are greater than the risks. And if you feel that any of the side effects you have continue for a long time or even worsen, know that it is time to visit your doctor and ask him to give you some advice. Maybe you’ll have to stop taking this drug, or correct the dose.

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