lamivudine/tenofovir DF (3TC/TDF)
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 in this drug from the same drug class.
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.
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, 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 such as Daklinza, Harvoni, Olysio, Sovaldi, Viekira Pak, or Zepatier, depending on the third drug in the HIV regimen. Monitor for tenofovir toxicities if used with Epclusa. Avoid use of sorbitol-containing medicines with lamivudine. 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 FDA approved last year. It contains 3TC instead of Truvada’s FTC. The three 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 that 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, Temixys, was FDA approved but is not commercially available.
Dr. David Hardy says:
Cimduo became the second generic two-nucleoside fixed-dose-combination tablet when it was approved by the FDA in March 2018 (see Epzicom). Like the FDA approval of Symfi and Symfi Lo (also manufactured by Mylan; see that page), Cimduo was approved based upon pharmacokinetic bioequivalence data, not clinical trial data, as the two agents in it, tenofovir DF and lamivudine, were already approved as antiretroviral medications (see Symfi/Symfi Lo). Similar to Symfi and Symfi Lo, Cimduo is not an exact generic version of Truvada, as lamivudine is used in place of Emtriva (emtricitabine), but even the FDA accepted clinical data from trials using tenofovir DF plus lamivudine in their original review and approval of Truvada, so the difference between Cimduo and Truvada is minimal and not clinically important. Comparing the cost of Cimduo: the wholesale acquisition cost (WAC) for a 30-day supply is $1,005, compared to $1,676 for both Truvada and Descovy, $1,292 for Ziagen, and $185–$1,116 for generic abacavir/lamivudine.
Activist Moisés Agosto-Rosario says:
Cimduo is a fixed-dose combination containing lamivudine and tenofovir DF, and is to be used in combination with other antiretrovirals. It has proven to be highly effective and relatively safe. The most common adverse effects are associated with tenofovir DF: potential kidney damage and bone density loss. Similar to other HIV drugs, it is important to monitor liver functions. Cimduo was developed by Mylan.