Cimduo and Temixys
3TC/TDF lamivudine/tenofovir DF
Standard DoseOne tablet once daily without regard to food for adults and children weighing at least 77 pounds (35 kg). Tablet contains 300 mg lamivudine (3TC) and 300 mg tenofovir disoproxil fumarate (TDF). Must be taken in combination with another antiretroviral(s) which does not contain the medications (or their equivalents) in this drug combination.
Take a missed dose as soon as possible, unless it is closer to the time of your next dose. Do not double up on your next dose.
The dosing frequency needs to be adjusted for people with decreased kidney function. Cimduo and Temixys should not be used if CrCl is less than 50 mL/min or if you are on dialysis.
See the individual drugs contained in Cimduo and Temixys: Epivir and Viread.
See package insert for more complete information on potential side effects and interactions.
ManufacturerMylan Specialty L.P.
Potential Side Effects and Toxicity
Most common adverse events (in more than 10% of people taking it) are headache (14%), pain (13%), depression (11%), diarrhea (11%), and rash (18%) (when studied in combination with efavirenz). Rare skin discoloration on palms and soles may also occur. The TDF in Cimduo is associated with long-term decreases in bone mineral density (BMD). BMD monitoring should be considered in people who have a history of bone fracture due to disease or are at risk for osteopenia or osteoporosis. While calcium and vitamin D levels can be checked to assess the need for these supplements, talk with your provider before starting on your own. TDF can cause kidney toxicities. Tell your provider about any pain in extremities, persistent or worsening bone pain and fractures, with or without muscular pain or weakness, as well as any concerning changes in urinary habits, as these could be signs of kidney problems. Routine monitoring of estimated creatinine clearance, serum phosphorus, urine glucose, and urine protein should be performed in all individuals with mild kidney impairment. If you have HIV and HBV, guidelines recommend treatment for both viruses. Cimduo can be used to treat HIV and HBV simultaneously. If you are co-infected with HBV and HIV, you should not stop Cimduo without medical supervision because it can cause your HBV to flare and cause you to experience signs and symptoms of acute hepatitis. HBV should be closely monitored by your provider. Cimduo contains lactose, which can cause some abdominal discomfort, especially in patients sensitive to lactose.
Potential Drug Interactions
Do not take with Epivir-HBV, Hepsera, Descovy, or Vemlidy (TAF), used for the treatment of hepatitis B. Tenofovir decreases the concentration levels of Reyataz, therefore when Reyataz is taken with Cimduo or Temixys, it is recommended that Reyataz 300 mg is taken with Norvir 100 mg (all as a single daily dose with food). In addition, Reyataz/Norvir, Prezista/Norvir, and Kaletra increase tenofovir concentrations; therefore, it is recommended patients be monitored for TDF-associated adverse events, particularly decreases in kidney function. Avoid taking Cimduo with drugs that negatively affect the kidneys, including chronic use or high doses of anti-inflammatory drugs for pain like Advil or Motrin (ibuprofen) and Aleve (naproxen). Avoid administration of sorbitol with Cimduo and Temixys. Hepatic (liver) decompensation, some fatal, has occurred when using lamivudine and interferon alfa (with or without ribavirin) for hep C treatment. (Of note, interferon alfa is no longer used for the treatment of hepatitis C). Cimduo and Temixys may be used with hepatitis C drugs Harvoni or Zepatier, depending on the third drug in the HIV regimen; monitor for tenofovir toxicities if used with Epclusa. 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 not listed here.
This slightly different version of Truvada was approved by the FDA in 2018. It contains 3TC instead of Truvada’s FTC. The two meds are essentially equivalent. The niche for Cimduo is that it may be a cheaper option for some insurance plans because it contains generic drugs. It also allows for some new or unique co-formulations (such as with Delstrigo, Symfi, and Symfi Lo). Cimduo has received DHHS HIV treatment guidelines recommendation as a component for initial ART in most people with HIV when combined with dolutegravir or raltegravir. TDF is falling out of favor since the newer formulation tenofovir alafenamide, or TAF, was approved. TAF is safer on kidneys and bones than TDF. Unlike Truvada, Cimduo is not approved for PrEP (HIV prevention). DHHS treatment guidelines recommend Cimduo, Truvada, or Descovy (which contains TAF) over Epzicom as the preferred NRTI component for initial therapy (unless Epzicom is paired with Tivicay). Kidney function must be monitored before and during treatment with Cimduo and it may not be a good option for patients with underlying kidney problems. When the virologic efficacy of Cimduo was compared to Truvada (each combined with Sustiva or nevirapine or a boosted PI) in a study, Cimduo was associated with higher rates of virologic failure compared to Truvada when paired with an NNRTI; however, there was no difference in the rates of virologic failure when paired with a boosted PI. It should be noted the people in the study who were taking Cimduo generally had higher viral loads, lower CD4 counts, and were more likely to be using injection drugs at the start of the study compared to patients taking Truvada. Another study examining historical data noted viral resistance was more common with Cimduo than with Truvada, however this was not observed in clinical trials. Cimduo is recommended by DHHS as one of the preferred NRTI combination components of an ART regimen in pregnancy. Another drug containing the same medications as Cimduo (and at the same doses), Temixys, is FDA approved and now commercially available in the United States.
Dr. Ross Slotten says:
Cimduo is the second generic two-nucleoside fixed-dose combination tablet approved by the FDA (generic Epzicom—lamivudine/abacavir was the first). Cimduo contains lamivudine and TDF. Combined with efavirenz, it is virtually equivalent to Atripla, although lamivudine (3TC) replaces emtricitabine (FTC). Yet what value it adds to the anti-HIV armamentarium is unclear. With TDF-containing regimens on the wane, I don’t see a significant role for Cimduo in the future. Once again, lower cost is touted as its main advantage over Truvada and Descovy, but that is a misleading issue in my mind, as I mentioned earlier.
Activist Bridgette Picou says:
Temixys contains two medications, lamivudine and tenofovir DF. It is taken with other HIV medications and is a fixed-dose tablet, so it cannot be dose adjusted. You will also need to have your hepatitis B status monitored before starting or stopping therapy as suddenly stopping may cause your hepatitis infection to flare. Temixys can be taken with or without food. Another benefit is it should cost less than some of the other tenofovir-containing regimens. Cimduo is a lower cost alternative HIV medication. It is a fixed-dose, two-drug combo medication containing lamivudine and tenofovir DF. Some side effects like headache and depression have been reported. With the TDF component you should have regular kidney function monitoring and bone density testing. Other than that, it is considered an effective treatment when combined with other HIV medications.