Food and Drug Administration (FDA) today (August 12, 2013) approved the second HIV integrase inhibitor, dolutegravir, which will be marketed under the brand name Tivicay by ViiV Healthcare. Phase 3 studies showed that dolutegravir works as well as raltegravir (Isentress) or Atripla and is. HIV Infection. Indicated in combination with rilpivirine as a complete regimen for the treatment of HIV-1 infection to replace the current ART regimen in adults who are virologically suppressed (HIV-1 RNA.
Dolutegravir can cause serious, life-threatening side effects. These include allergic ( ) reactions and problems.Contact your health care provider right away if you develop a rash while taking dolutegravir. Stop taking dolutegravir and get medical help right away if you develop a rash with any of the following signs or symptoms of a hypersensitivity reaction:.
Fever. General ill feeling. Tiredness. Muscle or joint aches.
Blisters or sores in your mouth. Blisters or peeling skin. Redness or swelling of your eyes.
Swelling of your mouth, face, lips, or tongue. Trouble breathingSome people taking dolutegravir have had serious liver problems. People with a history of (HBV) or (HCV), or who have elevated results on liver function tests may have an increased risk of developing new or worsening liver problems while taking dolutegravir. Liver problems have also occurred in people taking dolutegravir who have no history of liver disease. Liver function tests may be done before and during treatment with dolutegravir.Contact your health care provider right away if you have any of the following symptoms that could be signs of liver problems:.
Yellowing of your skin or whites of your eyes ( ). Dark-colored urine. Light-colored bowel movements. Nauseaor vomiting. Loss of appetite. Pain, aching, or tenderness on your right side below your ribsDo not take dolutegravir if you take dofetilide (a medicine used to treat an irregular heartbeat). Taking dolutegravir and dofetilide can cause side effects that may be life threatening.While taking dolutegravir, it is important to keep all of your appointments with your health care provider.
What is dolutegravir?Dolutegravir is a prescription medicine approved by the U.S. (FDA) for the treatment of HIV in combination with:. Other HIV medicines in adults and children who weigh at least 66 lb (30 kg), or.
(brand name: ) in adults to replace their current HIV medicines when their health care provider determines that they meet certain requirements.Dolutegravir is always used in combination with other HIV medicines.Dolutegravir belongs to a group of HIV drugs called inhibitors. Integrase inhibitors block an HIV called integrase. By blocking integrase, integrase inhibitors prevent HIV from multiplying and can reduce the amount of HIV in the body.HIV medicines can’t cure HIV/AIDS, but taking a combination of HIV medicines (called an HIV ) every day helps people with HIV live longer, healthier lives.
HIV medicines also reduce the risk of HIV. What should I tell my health care provider before taking dolutegravir?Before taking dolutegravir, tell your health care provider:. If you are allergic to dolutegravir or any other medicines. If you have or have ever had liver problems, including B infection (HBV) or hepatitis C virus infection (HCV).
If you have any other medical conditions. If you are pregnant or plan to become pregnant.
Dolutegravir may harm your unborn baby. You should not take dolutegravir at the time of becoming pregnant or during the first 12 weeks of pregnancy. Your health care provider may change your medicine during this time in your pregnancy.
If you become pregnant, your health care provider will perform a pregnancy test before you start treatment with dolutegravir. You should also consistently use effective birth control (contraception) during treatment with dolutegravir. Tell your health care provider right away if you are planning to become pregnant, you become pregnant, or think you may be pregnant during treatment with dolutegravir. If you are breastfeeding or plan to breastfeed. Do not breastfeed if you have HIV or are taking dolutegravir. If you are using -based birth control (such as pills, implants, or vaginal rings).
For more information about using birth control and HIV medicines at the same time, view the infographic. About other prescription and nonprescription medicines, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Dolutegravir may affect the way other medicines or products work, and other medicines or products may affect how dolutegravir works. Taking dolutegravir together with certain medicines or products may cause serious side effects. Do not take dolutegravir if you take dofetilide. Taking dolutegravir and dofetilide together can cause side effects that may be serious or life threatening. How should I take dolutegravir?Dolutegravir (brand name: Tivicay) comes in tablet form in the following strengths:.
10 mg. 25 mg.
50 mgTake dolutegravir according to your health care provider’s instructions.Take dolutegravir by mouth, with or without food. If you are taking any other medicines, carefully follow instructions on how to take them with dolutegravir.Always take dolutegravir in combination with other HIV medicines.If you take too much dolutegravir, contact your health care provider or local poison control center (1-800-222-1222) right away, or go to the nearest hospital emergency room.For more information on how to take dolutegravir, see the. What side effects can dolutegravir cause?Dolutegravir may cause side effects. Many side effects from HIV medicines, such as nausea or occasional dizziness, are manageable.
See the AIDS info fact sheet on for more information.Some side effects of dolutegravir can be serious. Serious side effects of dolutegravir include allergic reactions and liver problems. (See section above: What are the most important things to know about dolutegravir?)Other possible side effects of dolutegravir include:. Changes in liver test results. People with a history of HBV or HCV infection may have an increased risk of developing new or worsening changes in certain liver test results during treatment with dolutegravir. Changes in your (called or IRIS).
IRIS is a condition that sometimes occurs when the immune system begins to recover after treatment with an HIV medicine. As the immune system gets stronger, it may have an increased response to a previously hidden infection.
Trouble sleeping, tiredness, and headache, which are among the most common side effects of dolutegravir.Tell your health care provider if you have any side effect that bothers you or that does not go away.These are not all the possible side effects of dolutegravir. To learn more about possible side effects of dolutegravir, read the or or talk to your health care provider or pharmacist.You can report side effects to FDA at 1-800-FDA-1088 (1-800-332-1088). How should dolutegravir be stored?. Store dolutegravir at room temperature, 68°F to 77°F (20°C to 25°C). Keep dolutegravir in the container that it came in and keep the container tightly closed. If the container has a small packet of drying agent (called a desiccant), do not remove it. The desiccant protects the medicine from moisture.
Do not use dolutegravir if the original seal over the container opening is broken or missing. Throw away dolutegravir that is no longer needed or expired (out of date). Follow on how to safely dispose of unused medicine. Keep dolutegravir and all medicines out of reach of children. Where can I find more information about dolutegravir?More information about dolutegravir is available:. The.
The Patient Counseling Information section of the label includes information for people taking dolutegravir. Dolutegravir-related, from the AIDS info database of study summaries.
A list of, from AIDS info.Manufacturer InformationViiV HealthcareMain number: 877-844-8872Patient assistance (ViiV Connect): 844-588-3288The above Patient Version drug summary is based on the following FDA label(s):.

For HIV Infection 'Was taking truvada and 400 mg sustiva but could not get my viral down beyond 180-200. Got off Sustiva and went on Tivicay/Truvada and within one month my viral load dropped to 70 and my cd4 rose to over 300 for the first time. Now my cd4 is up to 340 from 280 and my viral load is down to 40. Getting off of sustiva was the best decision I ever made. No more side effects and no more worrying about eating and taking med. Two pills a day is all that I take.
I'm very pleased and have zero side effects and am finally very close to undetectable.' For HIV Infection 'Got from VL120000 to undetectable in just a month, take it with Truvada once a day (I don't mind taking 2 pills a day at all), CD4 went from 530 to 980, a great combination for me with almost no side effects (was having some mild headaches, they are gone now). It's been 2 months since I started and I feel much better now, gained about 10lbs back. You must NOT wait to start your treatment, there is no benefit to it, don't let the virus kill your brain cells, destroy your immunity system, start ASAP.
I just wish I could have started sooner (insurance problems, the drugs are way too expensive). For HIV Infection 'Though highly effective on what it needs to do, the side effects for me were not worth taking this medication. I'm a non-smoker, non-drinker, no drugs and eat healthy with regular exercise. Before taking this (in combination with Truvada) I was bursting with energy and in the course of six months it seriously took the life and joy out of me. Waking up unrefreshed and feeling numb and exhausted and snappy. Been off Tivicay for a few days now and started Stribild.
Feel so much better, happier and energetic.' For HIV Infection 'I've been on Tivicay for about 5 months now. I have more energy and no common side effects except for two very important ones to me.The first one is the 'wasted look' on my face. I began to notice this a about month a go. My cheeks have becomes more hollow, I'm terrified to think what they'll look like a year or two from now.
I just don't want to be prejudice against for having HIV.The second problem is my liver. My recent blood test showns that it's 50% above normal. I don't drink, smoke, I don't know what to do now. I don't want to end up having to go to dialysis weekly.' For HIV Infection 'Started to Tivicay and Epzicom on May 6th.
Viral load was 200,000 and CD4 was 208. After 6 weeks my viral load was 367 and CD4 was 337. Doctor said it was working very well and I don't have to go back for Labs until September. The first 2-3 weeks were pretty rough with diarrhea, headaches and very low energy, but I'm feeling a bit better now. I was freaked out that the test did not come back as undetectable, but I asked my expert doctors and they said my results have been superb so far.
I think people get hung up on being undetectable very quickly. If you start with a high viral load above say 100,000 it can take a few months to reach undetectable.'