Side Effects of Truvada for PrEP

HIV is the human immunodeficiency virus. Getting into the human organism, it is spread by bodily fluids and ruins CD4 cells, which are responsible for the immunity. Also called T-cells, they fight infections and harmful external impacts. Once it appears in the body, HIV remains there for a lifetime and cannot be fully healed. Non-treated HIV progresses in the body and leads to its final stage, AIDS. It makes the body unable to combat opportunistic infections and viral cancers and finally results in death. People in the last stage of HIV live no more than three years.

There is no fully effective drug to get rid of HIV. But, it can be controlled. The HIV treatment is called highly active antiretroviral therapy. The HAART invention is the result of different researchers in the field of biochemistry and pharmacology. Their work began in the 1970s and ended with the successful result in the 1990s. The finally discovered in 1996 triple-drug therapy (now called HAART) showed great progress in converting the highly lethal disease into a controllable chronic illness. Prevention as treatment is very popular nowadays. The medications for pre-exposure prophylaxis help avoid the risks of being infected in mixed couples, where one of the partners is HIV-positive.

Overview of Truvada for PrEP

Truvada by Gilead Sciences is the only brand approved by the FDA (short for Food and Drug Administration of the USA), named for PrEP medication that is used for HIV treatment and prevention of being infected for people in the high risk groups. Truvada is also the only drug recommended by the CDC (this stands for the Center for Disease Control and Prevention). PrEP is used in healthy people who have contact with virus carriers to minimize the risks of exposure.

The research on different groups of people revealed that the medication can decrease the risk of HIV infection in MSM and transsexual couples by 42-53%, and by 75% for heterosexual couples with one HIV-infected partner. If taken properly, its effect can be extremely high, up to 92-99%. To have the maximum effect, the FDA recommends using the medication 7 days a week. The pill contains two active ingredients: 300 mg of tenofovir disoproxil fumarate and 200 mg of emtricitabine. It is taken orally at the same time once a day. The drug works by blocking the HIV reverse transcriptase enzyme and prevents the virus from replicating.

What Are the Side Effects of Truvada?

Truvada is considered to be safe and well-tolerated for most people. But some side effects can appear, so it’s recommended that you consult a doctor if you have any unusual symptoms. Let us look at the most frequent problems patients tell about:

• skin rash is a rather frequent effect of Truvada. About 7% of people taking the drug have this symptom at the beginning. It goes away;
• weight loss is noticed in 3% of patients in clinical testing. There is no information about weight gain;
• stomach disorders are also rather frequent in the early stages of drug intake. Diarrhea and nausea were an issue in 9% of patients, stomach aches in 4% of tested people, 2% of them had emesis. All these troubles can leave after some time if a person continues taking the drug regularly;
• depression is also one of the frequent symptoms in the first weeks and months. Nine percent have it. If the signs of suppressed mood don’t disappear, you should consult a doctor;
• fatigue is met in 9% of cases and usually disappears after some time;
• 5% of people on Truvada experienced insomnia. It passed after continuing to take the drug;
• some patients complained about a sore throat. The statistics say that no more than 5% of Truvada recipients have this problem and it leaves after some time;
• painful muscles, bones, and joints can also disturb some people. There is no exact information about how often it happens;
• in rare cases (affects 1 in 100-1000 patients), Truvada can cause pancreatitis — a pancreatic gland inflammation. Consult your doctor immediately if you have severe abdominal pain;
• diabetes itself is not a disease that can be caused by Truvada. But if you have such symptoms as dry skin, tiredness, headache and dizziness, low blood pressure, short memory, tiredness, muscle ache, and weight loss, you should be cautious and call your healthcare provider, as those signs may signal that you have nephrogenic diabetes insipidus. In the case of the disease, kidneys don’t work properly and it can end in dehydration. If it worsens, you will have to stop using Truvada;
• hair loss is not considered to be a side effect of Truvada and was not revealed in clinical testing. If your hair falls out, consult a doctor;
• there is also no proof that Truvada can cause acne, so if this problem occurs, the doctor’s advice is needed;
• some people complain about constipation. No clinical testing says that it’s because of Truvada. So, if you have such a problem, your health provider will tell you what to do.

In laboratory testing, the most frequent side effects are headache (4.5%), stomach ache or nausea (9%) and weight loss (2-3%).

How Long Do Truvada Side Effects Last?

Common Truvada side effects usually appear during the initial stage of taking the medication and can weaken and fully disappear in several days or weeks. Some negative consequences are milder, some of them are more severe. Much depends on the state of your overall health when beginning to take Truvada. There are also the effects, which you feel during the first stages of using the medicine and the ones that appear after taking the pill for some time.

We will talk about them in further detail, but the main thing you should know in case you feel bad taking medicines, not only PrEP, but any pharmaceutical product, and those unpleasant symptoms do not pass for a long time, you should seek medical advice. Obviously, if the side effects you observe are serious ones, which demand immediate medical intervention, you should not wait and go to your doctor at once. The delay in this case can cause serious damage to your health. As for the common and light unwanted symptoms, you can monitor your condition and see if they stay for a long while or worsen.

Common Negative Consequences After Taking Truvada

Most common side effects that can be caused by Truvada are:

• stomach disorders, such as nausea, vomiting, diarrhea, stomach ache;
• fatigue and depression;
• headache, giddiness;
• sleeping disorders;
• respiratory tract infections, sinusitis, sore throat;
• rash and itching;
• neuropathy of extremities, changing feet and hands color, form and location of body fat;
• high level of cholesterol.

These consequences can be felt during the first days or a couple of weeks of taking the medicine. Later, they can go away. You should consult your health provider if you have depressive mood changes, loss of appetite, stomach aches, changes in color and quantity of urine, signs of allergy or a new infection.

Serious Side Effects

Although there can be more severe negative consequences, you should be careful about them and a consultation with a doctor for help is necessary. Severe side effects are rather rare, but you should be cautious and immediately call the doctor if you have:

• osteopenia, bone density loss, and softness. If you have any problems with bones, especially if they break easily, you should take measures. Talk to your healthcare provider, this may be a very serious adverse effect of your drugs;
• immune reconstitution inflammatory syndrome. We will tell you about this one in more depth in the coming sections. One thing we want to mention here is that the IRIS is not always a reason to stop taking ART;
• problems with kidneys and liver. This one includes the entire group of signs and adverse reactions which we will talk about separately;
• lactic acidosis;
• acute hepatitis B exacerbation.

Let us talk in more detail about each issue.

Problems with Bone Density

Osteopenia means losing bone mass and a decrease in their density. In 13% of people who were tested during over 1.5 years, bone loss by 5% was noticed. Of those patients, 1.7% had broken bones, which can be associated with the treatment. In another study, tenofovir could be the cause of the decrease of mineral bone density and an increase of biochemical bone metabolism, which led to thinning and softening of bones in adults, and slowing of bone growth in children. In case you feel bone anomalies, the doctor will do special tests to check if you have bone loss. There was no special research on the question of whether calcium and vitamin D supplements are really effective, but they can be helpful for bone loss prophylaxis.

Kidney and Liver Damage

Tenofovir and emtricitabine contained with Truvada are mostly excreted by the kidneys. The drug showed itself as tolerant to kidney medication, and in the 1.5 year study, less than 1% of tested people showed the decrease in renal function. Worse results were noticed in older people or in people who have other risk factors. The patients under 40 didn’t experience negative effects.

It is recommended that patients should monitor their kidneys every six months, for the ones with lower kidney function, monitoring can be more frequent. Blood analysis will be done on the eve, and over the whole period when you are on Truvada to analyze how your kidneys work. If you have such symptoms as bone and muscle aches, weakness, tiredness, nausea and emesis, back pain, poor urination, your health provider can change the dosage of Truvada for you. In case of more severe problems, you should stop taking the drug to avoid kidney failure. No testing revealed that Truvada can cause kidney stones.

In very rare cases, Truvada can affect the liver. Be concerned if you notice that your skin or white parts of your eyes have changed their color to yellow. If you have dark urine and white or pale stool, stomach troubles, like pain and swelling, nausea, or loss of appetite for a long time, see your doctor immediately, and you may be advised to avoid Truvada. Most severe liver problems may cause death.

Lactic Acidosis

Taken with some other antiretroviral medications or separately, in very rare cases, Truvada can cause lactic acidosis, which means too much lactic acid that accumulates in the blood. This can be life threatening. There were even cases of lethal outcomes. That is why it’s very important to be careful if you have a weakness, quickly become exhausted, have difficulty breathing, have muscle pain, stomach disorders with pain, cold and pale extremities, lightheadedness, heart palpitation, and arrhythmia, feel confusion, and smell like fruit. Don’t delay calling your health specialist, as these may be the signs to stop taking the pills.

Truvada and Hepatitis

The best practiсe is to be checked for hepatitis B before starting to take Truvada. The drug is not approved for chronic viral infection of HBV treatment. The problem in patients with hepatitis B can appear after they quit prophylaxis. It can be a severe exacerbation of the illness that causes extreme damage to the liver, and can lead to its failure.

Patients with HBV should be under the close monitoring during several months after the last Truvada pill. The clinical control and laboratory blood tests will help avoid serious problems. If it is needed, the treatment with anti-hepatitis therapy can be prescribed. For people who are not HBV-positive, vaccination is the best way to avoid the problem.

Immune Reconstitution Syndrome

Immune restoration disease is the state of body when it has the exaggerated reaction on pathogens and the previously latent infections. This reaction can appear as a result of immune system recovery after taking Truvada. There are two kinds of immune reconstitution syndrome:

• the first one is called “unmasking,” it relates to the undiagnosed before infections;
• the other type is “paradoxical,” it means worsening of previously treated illnesses.

When this syndrome develops, it can seem that you have got a new malady. As a fact, though, it is the reaction of your body to the old infection you had before, which is perceived by your body and the improved immunity with increased inflammation. That is why the disease is also called IRIS — immune reconstitution inflammatory syndrome. The signs of such diseases as tuberculosis, pneumonia, or mycotic infection can appear, and you should tell your doctor about it. The antibiotics or antifungal medications will be prescribed to eliminate the negative reactions and combat the disease.

Long-Term Side Effects of Truvada

Long-term Truvada intake may increase the risk of bone density loss (13% of people) and kidney troubles (less than 1%). If problems appear and don’t go away, the health provider can advise you to stop using the drug, and change it for another medicine. However, tenofovir and emtricitabine often come as a part of other ART schemes. Changing the medication can bring more difficulties than benefits, this is why you should never make this decision without a doctor’s advice.

There can also be metabolic changes, like enhancing of cholesterin, glucose, and triglyceride levels in the blood. It can increase the risks of cardiovascular diseases. The symptoms of the disorders related to the metabolism of fats and sugars are fatigue, vertigo, concentration loss, frequent urination, and thirst. People who smoke, have hypertension, poor overall health, diabetes, heart disease in family history, elderly, and those who are overweight, are in the risk group. It is important to be under close monitoring while treating. Healthy nutrition is also helpful.

The liver also plays a role in processing anti-HIV medications. Patients with hepatitis B or C, or having opportunistic infections, may take other medications. This can become too hard of a task for the liver, and result in its severe impairments. People who abuse alcohol or recreational drugs may face the same problems for the same reasons. Smoking, including passive, can worsen the problem, too.

However, the advantages of anti-HIV treatment exceed the risks. Special diet and health control are highly recommended throughout the duration of treatment. For those who take Truvada as a part of ART, it means that they have to take care of their lifestyle and eat healthy for their whole lives. Proper nutrition, including calcium and vitamin D, exercising and getting enough sun can help.

Important User Tips: How to Prevent Adverse Reactions?

So, how do you avoid risks of adverse reactions and stay healthy? The main rule is: never start using Truvada without the approval of your healthcare specialist. Before and while taking the pills, tell your doctor if you have health problems and what they are (especially the diseases related to kidneys, liver, heart, and bones). The same works for those who plan pregnancy or breastfeed a baby. Do not fail to mention all the medications you take, as well as your pernicious habits.

It is very important to take all the tests and be sure that you’re HIV-negative to start and continue taking Truvada as PrEP. Take HIV-1 tests before the administration, and every three months while you take Truvada. Continue using methods to protect yourself during sexual contact and be tested for sexually transmitted infections, take the drug regularly, and never miss the dose.

Strictly observe the dosage. For adults, it is 1 pill of 200 mg emtricitabine and 300 mg tenofovir a day. If you skipped for some reason, never take a double dose to avoid more risks of severe adverse reactions.

Remember that Truvada is a prescription drug, approved by the FDA for HIV treatment and prophylaxis. Never use the drug for off-label purposes without consulting a specialist. Some clinical tests in heterosexual men and women in Kenya and Uganda showed that Truvada as PrEP had decreased the risk of being herpes infected by 30%. However, similar tests on homosexual men in USA, South America, and some African countries gave unclear results on this question. Don’t drink grapefruit juice while taking Truvada, as it can increase the tenofovir level in your body and lead to the overdose symptoms.

When to Seek Medical Help?

Always consult your healthcare provider in cases where you feel something is wrong. When you know which symptoms require your special attention, you can make a decision as to whether the negative consequences of the tenofovir intake can wait, or if you need your doctor’s help immediately. There is no reason to panic every time you have digestion disorders or migraines. Seek medical help in serious cases of adverse effects after taking Truvada pills. Immediately call the doctor if you feel trouble with your liver or kidneys, have such symptoms as weakness, fatigue, abdominal ache, abnormal heartbeat, dyspnea, changes in color of urine and stool, or painful muscles and bones.

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