Truvada / Cimduo and Temixys / Viread
emtricitabine, tenofovir DF FTC and TDF (two NRTIs) / lamivudine, tenofovir DF 3TC and TDF (two NRTIs) / tenofovir DF TDF (NRTI)
Standard Dose
Truvada, Cimduo and Temixys: One tablet once daily, with or without food, for adults and children weighing at least 77 pounds (35 kg). Viread: One tablet once daily, for adults and children at least 2 years old weighing at least 22 pounds (10 kg). All must be taken in combination with another antiretroviral(s) from a different drug class.In children weighing 37–76 pounds (17–34 kg), Truvada dose is based on body weight (see package insert for weight-based dosing). Pediatric Truvada tablets are available in the following FTC/TDF dosages: 100/150 mg, 133/200 mg and 167/250 mg. In children, Viread dose is based on body weight (see package insert). Viread tablets are available in the following dosages: 150 mg, 200 mg, 250 mg and 300 mg tablets, and oral powder (40 mg/g in 60 g packets). Truvada and Viread tablets can be dissolved in water, grape juice, or orange juice with minor stirring and pressure from a spoon.
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. Dosing frequency needs to be adjusted for people who have decreased kidney function. The dose of Truvada and Viread should be adjusted if CrCl is less than 50 mL/min and Truvada should not be used if CrCl is less than 30 mL/min or if you are on dialysis. Cimduo and Temixys should not be used if CrCl is less than 50 mL/min or if you are on dialysis.
- See also Emtriva and Epivir.
- See package insert for more complete information on potential side effects and interactions.
- Generic Truvada and Viread are available.
Manufacturer
Gilead Sciences, Inc.gilead.com; truvada.com, viread.com
(800) GILEAD-5 (445-3235)
Mylan Specialty L.P.
mylan.com; cimduo.com
(877) 446-3679
Celltrion, Inc.
celltrion.com
contact@celltrion.com
AWP
Truvada: $2,210.74/monthgeneric: $2,100.20/month
Viread: $1,504.20/month
generic: $1,215.94/month
Cimduo: $1,354.28/month
Temixys: $1,020.00/month
Potential Side Effects and Toxicity
Overall well tolerated, but some people may experience headache or gastrointestinal distress. Rash and depression may be seen with Cimduo and Temixys. Rare skin discoloration on palms and soles may occur with Truvada. TDF is associated with long-term decreases in bone mineral density (BMD). TDF can cause kidney toxicities. Tell your provider about any pain in extremities, persistent or worsening bone pain, as well as any concerning changes in urinary habits. Routine monitoring of estimated creatinine clearance, serum phosphorus, urine glucose, and urine protein should be performed in individuals with mild kidney impairment. Prior to initiation, people should be tested for hepatitis B virus (HBV) infection. Severe exacerbations of hepatitis B have been reported in people co-infected with HBV who have discontinued these medications. Monitor liver enzymes closely in people co-infected with HBV and, if appropriate, initiation of anti-hepatitis B therapy may be warranted upon drug discontinuation. Call your health care provider right away if you develop any signs of hepatitis. Truvada contains lactose, which can cause some abdominal discomfort.
Potential Drug Interactions
increase TDF concentrations, so monitoring is recommended for TDF-associated adverse events, particularly decreases in kidney function. Avoid taking TDF with drugs that negatively affect the kidneys, including chronic use or high doses of anti-inflammatory drugs for pain such as aspirin, Advil or Motrin (ibuprofen) and Aleve (naproxen). TDF may be used with hepatitis C drugs Harvoni or Zepatier, depending on the third drug in the HIV regimen; monitor for TDF 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.
More Information
Don’t believe the lawsuit advertisers: Truvada (and TDF) is a safe medication to take. Pregnant individuals can voluntarily enroll in the Antiretroviral Pregnancy Registry through their provider; go to apregistry.com.
Doctor Comments
Dr. Melanie Thompson:
TDF has a high genetic barrier to resistance and potent activity against hepatitis B. It is generally taken with FTC or 3TC as Truvada, Cimduo, and Temixys. Cimduo and Temixys include generic TDF and 3TC. They are essentially the same drugs made by different generic manufacturers but they are considered “brand” drugs because they are combinations for which there is no other brand precedent. The good news for consumers is that this allows copay cards to be used to lower out-of-pocket costs. The bad news is that this allows companies to maintain drug prices that are less than that of Truvada, but still unnecessarily high. While diarrhea, nausea and fatigue were the most common side effects seen in early clinical trials, side effects of highest concern include a potential for kidney toxicity, mostly mild but occasionally serious, and decrease in bone density. Serious toxicities are most often seen in people with other risks for kidney disease or low bone density, including older age or comorbidities, or when taken in combination with the boosters ritonavir or cobicistat. TDF also lowers LDL and HDL cholesterol and is associated with a bit of weight loss. TDF/FTC is safe in pregnancy. Generic TDF/FTC has been around since 2020 in the U.S., but only at a very high price, barely less than that of Truvada. Now, however, generic TDF/FTC is available from multiple manufacturers and may be priced as low as $25–35 per month.
Activist Comments
Activist Joey Wynn:
Truvada does not have a negative impact on cholesterol levels and weight. At one point over 75% of people on therapy had a Truvada-based component in their regimen for over 10 years, so most people do not experience the side effects seen in a few. Cimduo and Temixys are hybrids between generic and brand medicines, and definitely have a niche inside the private insurance payor world. The optimal groups to use this would be benefiting people during pregnancy and those seeking an NRTI therapy. Neither is approved for PrEP at this time, but would be worth the effort to make it happen.