Dovato

Dolutegravir and lamivudine are both generally well tolerated. Side effects occurring in at least 2% of study participants receiving Dovato included headache, nausea, diarrhea, insomnia, fatigue, and dizziness. INSTIs are associated with weight gain. Dolutegravir can cause a small, reversible increase in kidney function test (serum creatinine) within the first few weeks of treatment that does not affect actual kidney function. There have been rare reports of depression and suicidal ideation with INSTIs, primarily in people with a history of psychiatric illnesses. HHS guidelines recommend closely monitoring people with pre-existing psychiatric conditions. Prior to initiation, test for hepatitis B virus (HBV). Severe exacerbations of HBV have been reported in people with HBV co-infection who have discontinued Dovato (due to elimination of the lamivudine component, which also treats HBV). Monitor liver enzymes closely. Initiation of HBV therapy may be warranted upon Dovato discontinuation. Call your health care provider right away if you develop any of the following signs of hepatitis: yellowing of the skin or whites of the eyes; dark or tea-colored urine; pale-colored bowel movements; nausea or vomiting; loss of appetite; or pain, aching, or tenderness on the right side below the ribs.

Do not take Dovato with Epivir-HBV or the antiarrhythmic dofetilide (a heart medication). When taking carbamazepine or rifampin, take an additional dose of dolutegravir (in the form of one Tivicay tablet) 50 mg 12 hours after taking your Dovato dose. When starting or stopping dolutegravir by people on metformin, dose adjustment of metformin may be necessary to maintain optimal glycemic control or tolerability. Do not take with oxcarbazepine, eslicarbazepine, phenytoin, or phenobarbital.  Dovato should be taken two hours before or six hours after taking laxatives or antacids, the ulcer medication sucralfate, oral iron or calcium supplements/vitamins, or buffered medications. It can be taken with iron- or calcium-containing supplements/vitamins if taken together with food. Acid reducers (Pepcid, Zantac, Tagamet) and proton pump inhibitors (for example, Aciphex, Dexilant, Prilosec, Prevacid, Protonix, and Nexium) are okay to use.

Avoid use of sorbitol-containing medicines with lamivudine; there are many, such as acetaminophen liquid (Tylenol liquid and others). There are no known drug-drug interactions with Daklinza, Epclusa, Harvoni, Olysio, Sovaldi, Viekira Pak, or Zepatier. Not intended to be taken with other HIV medications, unless prescribed that way. 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.

Basically, this medicine is Triumeq without the abacavir component (brand name Ziagen, also found in Epzicom). Dovato is now available in a blister pack option (on foil-backed sheets instead of in a bottle). The benefits of using a two-drug regimen for HIV include less exposure to HIV medication while maintaining viral suppression and minimizing the potential for side effects. At one, two, and nearly three years into the GEMINI-1 and GEMINI-2 studies, DTG + 3TC was found to be non-inferior to the triple drug regimen of DTG + Truvada (emtricitabine and tenofovir DF combined in one pill). Dovato has also been successful for treatment-experienced people switching to it after being undetectable (viral load less than 50 copies per mL). The TANGO study evaluated treatment switch from TAF-containing regimens with three or more drugs and at both 48 and 96 weeks, found Dovato to be non-inferior to the three-drug regimen standard of care. Weight gain is being increasingly recognized as a side effect of INSTIs. Although dolutegravir is a preferred medication during pregnancy as well as for people who are trying to conceive, U.S. HIV perinatal treatment guidelines suggest using three-drug regimens for these individuals. Find the discussion on page C-55 of perinatal guidelines at hivinfo.nih.gov. Pregnant individuals can voluntarily enroll in the Antiretroviral Pregnancy Registry through their provider;

GO TO apregistry.com

Dr. Melanie Thompson:

Dovato is the only two-drug regimen recommended for initial therapy, although it has some limitations. Dovato does not treat hepatitis B, so it should not be taken by people with hepatitis B (HBV) unless a drug such as entecavir that is active against HBV is also given. In most cases, people with HBV should begin a regimen containing tenofovir (TAF or TDF) and 3TC or FTC. Also, Dovato should not be the initial choice of therapy if the viral load is above 500,000 copies/mL. In addition, resistance testing should be conducted before starting Dovato for initial therapy because 3TC resistance is sometimes transmitted and could compromise the effectiveness of Dovato. Dovato, therefore, is not recommended for “rapid” or “same day” start before lab results are available. Before starting Dovato, resistance testing, hepatitis B serology, and viral load should be conducted to guide choice of therapy. As with other INSTI-containing regimens, Dovato should not be used as initial therapy for people who acquired HIV after taking Apretude unless an INSTI genotype is available and shows sensitivity to dolutegravir. People with suppressed virus on a TAF-based regimen who have never experienced prior treatment failure and who don’t have hepatitis B may safely switch to Dovato. Possible INSTI side effects like insomnia and new or worsening depression also apply to Dovato. Drug interactions of note include an increase in the levels of dofetilide (which is contraindicated), metformin, and some other drugs when taken with dolutegravir. Talk with your clinician if you are taking metformin when you begin Dovato. Dolutegravir levels decrease with some seizure or tuberculosis medicines and St. John’s wort. Managing drug interactions is tricky, so be sure any clinician who is prescribing drugs for you knows all of the medicines you are taking, including over-the-counter drugs and supplements. Dolutegravir increases serum creatinine by 0.1-0.15 mg/dL within a few weeks of beginning therapy, but this is due to inhibition of creatinine secretion in the kidney rather than true kidney toxicity. As with all INSTIs, Dovato should be taken 2 hours before or 6 hours after aluminum, magnesium, zinc, calcium or iron supplements, although calcium and iron may be taken at the same time as Dovato if taken with a meal.

The price of Dovato is higher than the price of Tivicay alone, representing quite an inflated price for a month of generic 3TC whose wholesale acquisition cost is as low as $75/month.

Activist Joey Wynn:

Some folks are looking to take fewer medications; a two-drug combo could be for you if that is your priority. This combo is still a hard “no” for anyone on metformin for diabetes or on a tuberculosis (TB) therapy, unless you take an extra dolutegravir pill to compensate for the interaction. Overall, this is a good choice, and very underrated; talk to your provider to see if this is right for you, especially if you want to reduce the number of medications you take daily