Isentress HD (and Isentress)
Isentress: One 400 mg film-coated tablet twice daily, with or without food, for people with HIV treatment experience or individuals who are new to HIV therapy.
Must be taken in combination with another antiretroviral(s) from a different drug class.
Isentress HD is for adults and children weighing at least 88 pounds (40 kg). Isentress is for adults and children weighing at least 4.4 pounds (2 kg). Both Isentress HD and Isentress can be taken with or without food.
Isentress (but not Isentress HD) pediatric formulations are available as an oral suspension. Isentress dosing is based on weight for children less than 55 pounds; see package insert for dosing and mixing instructions. Dosing of the granules for oral suspension is not equivalent to tablets. Do not substitute oral suspension for film-coated tablets.
Take missed dose as soon as possible, unless it’s closer to the time of your next dose. Do not double up on your next dose.
- See package insert for more complete information on potential side effects and interactions.
isentresshd.com
isentress.com
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Dr. David Hardy says:
Isentress HD was approved by the FDA in May 2017. It was developed to offer PLWH the option for a once-daily Isentress regimen. The total daily Isentress dose is 1,200 mg/day (600 mg x 2) along with two NRTIs (one tablet of Truvada, Epzicom, or Descovy). It’s hard to imagine what the advantage of taking two Isentress HD plus another pill, all once-daily, would be over taking one of the STRs. Isentress was the first integrase approved, in 2007. Initially, it has to be taken twice daily (two tablets 8–12 hours apart). Early clinical trials demonstrated very rapid (and still the most rapid) drops in viral loads (compared to protease inhibitor and NNRTI regimens), suggesting that it was more potent than older classes of antiretrovirals. However, we soon learned that this rapid drop in viral load did not correlate with resistance to HIV resistance, as this occurs with Isentress at a rate similar to that for Atripla. At the time when Isentress was approved, it provided a critical new medication for many PLWH who had run out of treatment options and kept them alive. Isentress is one of, if not, the antiretrovirals with the fewest side effects. With the development of newer once-daily integrase inhibitors (Tivicay) and STRs (Genvoya, Biktarvy), the use of Isentress has waned in favor of simpler ART regimens.
Isentress HD cannot be used with rifampin, but Isentress can; increase Isentress to 800 mg twice daily when using with rifampin. Remember to decrease the raltegravir back to its original dose when you finish taking rifampin. There are no data on dosing of the chewable tablets with rifampin. There is no need to increase the raltegravir dose with rifabutin. With both Isentress HD and Isentress, avoid Gaviscon and other antacids containing aluminum or magnesium. Calcium-containing antacids like Tums (calcium carbonate) can be used with Isentress, but not Isentress HD. Other acid reducers (such as Pepcid, Zantac, Prilosec, and Prevacid) are okay to use. Raltegravir is not recommended with carbamazepine or phenobarbital. Raltegravir can be used with Daklinza, Harvoni, Olysio, Sovaldi, Viekira Pak, Zepatier, or Epclusa. Unlike Isentress, Isentress HD cannot be used with Intelence or boosted Aptivus. Tell your provider or pharmacist about all medications, herbals, and supplements you are taking or thinking of taking, prescribed or not, as there are other drug interactions which are not listed here.
• See package insert for more complete information on potential side effects and interactions.
In general, raltegravir is very well tolerated with infrequent side effects. Those reported in up to 3–4% of study subjects include insomnia, nausea, and headache. The side effect profile in children is comparable to adults. Isentress may cause elevated levels of creatine kinase (a muscle enzyme). Inform your provider or pharmacist if you have a history of rhabdomyolysis, myopathy, or increased creatine kinase, or if you also take medications that may contribute to these conditions such as statins, fenofibrate, or gemfibrozil (cholesterol medications). There have been rare reports of depression and suicidal ideation, primarily in patients with a history of psychiatric illnesses, in people receiving INSTI-based regimens. The DHHS guidelines recommend closely monitoring people with pre-existing psychiatric conditions on an INSTI. Chewable tablets contain phenylalanine, which can be harmful to patients with phenylketonuria.
The newer formulation of Isentress HD was approved in 2017. While the previous version, Isentress, was well tolerated and highly effective, its twice-daily dose was seen by some as a small hindrance. Raltegravir-based regimens may be preferred for patients with high cardiovascular risk. Isentress is the preferred INSTI medication in HIV treatment guidelines for pregnancy, 400 mg twice a day in combination with 2 NRTIs. In pediatric HIV guidelines, Isentress was downgraded in 2017 from “preferred” to an “alternative” part of an initial regimen last year for children ages 6–12.
New preliminary data from an observational study in Botswana suggest that there may be an increased risk of birth defects in infants born to those who were receiving dolutegravir at the time of conception. It is unclear if other integrase inhibitors also carry this risk. Consult your provider to discuss guidance on how to manage regimens containing dolutegravir or a different integrase inhibitor if there is any possibility of conception.
Activist Moisés Agosto-Rosario says:
Isentress and Isentress HD are both the brand names for the integrase inhibitor known as raltegravir. It is prescribed to treat HIV infection in patients with multi-drug resistance who have not taken integrase inhibitors before, as well as for individuals initiating treatment for the first time. The differences between regular Isentress and the HD version are the contained dose and the frequency that it is taken. With regular Isentress, you take one 400 mg pill twice a day, while with Isentress HD you take two 600 mg pills once a day. Isentress (not HD) can also be prescribed to children as an oral suspension or as chewable tablets. If a skin rash or an allergic reaction develops, stop the drug and call your provider. Liver and kidney functions must be monitored