Drug Comparison: Dovato vs Biktarvy

The latest data from the CDC shows that around 31,800 people got HIV in the US, a 12% drop from 2018. Since the peak of the epidemic in the mid-1980s, yearly infections have dropped by more than two-thirds. Recent estimates also show positive progress in the fight against HIV.

This progress is closely tied to advances in treatment. Among the most recommended options today are Dovato and Biktarvy, both backed by major guidelines. However, they differ in several important ways, from how effective they are at controlling the virus, to the types of side effects they cause.

This guide breaks down the differences between Dovato and Biktarvy, covering their efficacy, impact on weight, drug interactions, and real-world outcomes to give you a clearer sense of what to expect and which option may align better with your needs.

Efficacy of Dovato vs. Biktarvy

In the largest direct comparison trial, known as PASO DOBLE, both Dovato and Biktarvy performed similarly in keeping HIV suppressed. However, Dovato was associated with less weight gain.

On average, people taking Biktarvy gained about 4 lbs, while those on Dovato gained around 2 lbs. Weight gain exceeding 5% of body weight was also more frequent with Biktarvy (29.9%) than with Dovato (20%). The difference was more pronounced among individuals switching from certain older HIV medications.

A peer-reviewed observational study examined their use in both newly diagnosed and previously treated individuals. After 48 weeks, all newly treated patients on Biktarvy achieved undetectable HIV levels. In comparison, only 70% of those on Dovato achieved the same result. In previously treated patients, Dovato also fell short of Biktarvy in sustaining viral suppression.

Yet, a separate study found the opposite trend. Among treatment-naïve participants, 89% of those on Dovato achieved viral suppression, while 82.4% of those on Biktarvy did. In that same study, the average weight gain in the Biktarvy group was 4.2 lbs higher than in the Dovato group.

Another study explored outcomes for individuals who switched to either regimen while already maintaining undetectable viral loads. By the end of the study, 99.1% of the Dovato group and 97.2% of the Biktarvy group remained virally suppressed. No one in either group experienced a rebound in viral load.

What this means:

Available evidence shows that Dovato and Biktarvy offer similar levels of effectiveness in people who are already virally suppressed. In treatment-naïve individuals, the data are more mixed. Across studies, Dovato consistently shows a more favorable weight profile than Biktarvy.

Dovato vs. Biktarvy’s Mechanism of Action

The standard approach to HIV treatment uses a mix of different types of medications. These include drugs that block the virus in different ways, such as:

• • NRTIs
  • NNRTIs
  • Protease inhibitors
  • Integrase inhibitors (INSTI)

Currently, the most common treatment plan is the “2+1” method. This means starting with two NRTI drugs combined with one additional drug–either an NNRTI, a protease inhibitor, or an INSTI.

Dovato is a 2-drug regimen that contains:

• • Dolutegravir, an integrase inhibitor
  • Lamivudine, an NRTI

On the other hand, Biktarvy is a 3-drug regimen that contains:

• • Bictegravir, an integrase inhibitor
  • Emtricitabine, an NRTI
  • Tenofovir alafenamide, an NRTI

While Dovato doesn’t follow the older 2+1 structure, it is still recommended by major guidelines like the US Department of Health and Human Services (DHHS) and the World Health Organization (WHO).

Here’s how each component contributes to the overall effectiveness of Dovato and Biktarvy:

Good to know!

Emtricitabine is abbreviated as FTC because of its chemical name:

5-fluoro-1-(2R,5S)-[2-(hydroxymethyl)-1,3-oxathiolan-5-yl]cytosine

The “F” comes from the fluorine (5-fluoro), the “T” represents the thiolane (oxathiolane) ring, and the “C” stands for cytosine. This shorthand makes it easier to reference in scientific and medical contexts.

Similarly, lamivudine is abbreviated as 3TC, following the same logic.

Side Effects of Dovato vs. Biktarvy

Dovato and Biktarvy cause similar side effects, as their active ingredients belong to the same drug classes. Commonly reported symptoms in clinical trials include:

• • Headache
  • Nausea
  • Diarrhea
  • Fatigue
  • Insomnia
  • Dizziness
  • Weight gain
  • Mood changes (such as anxiety or depression)
  • Abdominal distension

Weight gain is among the earliest metabolic effects observed with HIV treatment. As noted earlier, multiple comparative studies have shown that Biktarvy is associated with greater weight gain.

Many studies have looked at how different HIV medications affect weight. Most of them show that tenofovir alafenamide (a component of Biktarvy) and INSTIs are more likely to cause weight gain. Among the INSTIs, bictegravir (in Biktarvy) and dolutegravir (in Dovato) are linked to the most weight gain.

Given this, the combined presence of bictegravir and tenofovir alafenamide in Biktarvy, compared to only dolutegravir in Dovato, may help explain Dovato’s more favorable impact on body weight.

For other side effects, most comparative studies show similar overall rates between the two regimens. However, data presented at the recent HIV Glasgow conference reported that individuals who switched from Dovato to Biktarvy experienced less nausea (3.9% vs. 23.2%) and fewer cases of abdominal discomfort (16.8% vs. 40.2%).

Treatment Persistence/Durability of Dovato vs. Biktarvy

Drug persistence (or treatment durability) refers to how long patients stay on a medication without switching or discontinuing. This is influenced by, but not limited to, side effects, drug interactions, cost, or pill fatigue.

In a real-world study, more people stayed on Dovato (98%) after one year compared to Biktarvy (90%). On average, patients remained on Dovato for approximately 3.4 years, compared to 2.7 years for those on Biktarvy. Tolerability issues were a more common reason for stopping Biktarvy.

Medical Insight

HIV treatment works by keeping the virus at undetectable levels.

If someone stays on therapy consistently, the virus doesn’t get a chance to multiply or mutate. Stopping and restarting treatment or frequently switching regimens can lead to drug resistance, making it harder to control the virus and limiting future treatment options.

The longer a person stays on a well-tolerated, effective regimen, the better their immune system remains.

Approved Indications of Dovato vs. Biktarvy

Both Dovato and Biktarvy are FDA-approved as complete regimens for the treatment of HIV-1 infection. They can be used in:

• • People who are treatment-naïve (never received antiretroviral therapy) or,
  • Those who are switching from another regimen while maintaining a suppressed viral load (HIV-1 RNA <50 copies/mL).

The differences lie in the age and weight criteria, and the resistance profiles required for use.

Dovato is approved for adults and adolescents aged 12 years and older, provided they weigh at least 25 kg (~55 lbs). In contrast, Biktarvy is approved for a broader group, including pediatric patients weighing at least 14 kg (~31 lbs).

Additionally, both drugs are intended for individuals without known or suspected resistance to any of their active ingredients. Otherwise, the treatment may become less effective or even fail entirely, resulting in virologic failure.

Dosage and Administration of Dovato vs. Biktarvy

Dovato comes in a single fixed-dose strength containing 50 mg of DTG and 300 mg of 3TC. Meanwhile, Biktarvy has two strength options with weight-based dosing:

Both drugs are single-tablet regimens taken once daily, with or without food.

Coadministration with Other Drugs

Here’s a side-by-side comparison of the drug-drug interactions of Dovato and Biktarvy, based on their FDA prescribing information:

Summary

Dovato and Biktarvy are both strong options for HIV treatment, especially for people who are already virally suppressed. In newly diagnosed individuals, the data is mixed. Some studies show Biktarvy has better results, while others favor Dovato.

One clear difference is in weight gain. Dovato consistently leads to less weight gain than Biktarvy, likely due to its simpler two-drug formula. Biktarvy, which contains three drugs, has ingredients more strongly linked to weight increases. Side effects are generally similar, but some people report more nausea and stomach issues with Dovato.

When it comes to staying on treatment long-term, more people stick with Dovato, possibly because it’s better tolerated. Both drugs are once-daily pills, backed by major treatment guidelines.

The better choice depends on your health history, side effect concerns, and budget, but both options are proven to keep HIV under control.

Frequently Asked Questions

Sources

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