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FDA Approves Single Dual-Drug Pill for HIV

HIV released from cell

Illustration of HIV released from the surface of an infected cell (Bette Korber, Los Alamos National Lab)

9 Apr. 2019. The Food and Drug Administration approved a daily pill with 2 drugs to lower viral loads in people with HIV, but who have not yet taken other HIV drugs. The medication, brand-named Dovato, is marketed by ViiV Healthcare in London, and can replace a 3-drug combination pill previously prescribed for this population.

According to Centers for Disease Control and Prevention, some 1.1 million people in the U.S. are living with HIV infections that can lead to AIDS, with 15 percent of this population not yet diagnosed. While the number of new HIV cases is stable, nearly 39,000 new cases were reported in 2017. Globally, according to World Health Organization, some 37 million people were living with HIV in 2017, with 1.8 million new cases reported. While nearly 22 million people were taking antiretroviral treatments for HIV infections, some 940,000 people died of HIV-related causes in 2017.

Dovato is a combination of antiretroviral drugs that reduces the viral load, or amount of HIV in the body: lamivudine and dolutegravir, with 300 milligrams of lamivudine and 50 milligrams of dolutegravir. FDA approved the drug for adults with no antiretroviral treatment history and no known resistance to Dovato’s ingredients. Lamivudine, the largest ingredient in Dovato, interferes with the conversion of viral RNA into DNA, and thus stops the virus from multiplying. Dolutegravir prevents viral DNA from integrating into T-cells in the immune system, thus strengthening the immune system’s response to prevent infections from the virus.

“Currently, the standard of care for patients who have never been treated is a three-drug regimen,” says Debra Birnkrant, FDA’s director of antiviral products in an agency statement. “Having a drug-sparing treatment available that uses fewer drugs is beneficial to patients who may have issues taking multiple medications over a long period of time.”

FDA based its approval in part on results of 2 similar late-stage clinical trials, with the code-names Gemini 1 and Gemini 2. Each trial enrolled more than 700 participants having HIV and no previous treatments, testing the combination of lamivudine and dolutegravir in Dovato, against a trio of HIV drugs dolutegravir, emtricitabine, and tenofovir. The results show each drug combination about equally as effective in reducing HIV viral load. The most common adverse reactions to the Dovato drug combination were headache, diarrhea, nausea, insomnia and fatigue.

Dovato comes with a warning that people infected with HIV and hepatitis-B should also take a treatment for hepatitis-B, or find some other HIV treatment. Some people with both diseases taking lamivudine developed severe liver problems and liver failure when they stop taking drugs containing lamivudine. FDA also advises against taking Dovato for women at the time of conception through the first trimester of pregnancy, because of a risk of neural tube defects resulting in spina bifida and anencephaly in babies, from exposure to dolutegravir.

ViiV Healthcare is a company established by drug makers GlaxoSmithKline and Pfizer in 2009, joined later by Japanese pharmaceutical enterprise Shionogi, to develop treatments for HIV infection. The company says it not only discovers new drugs for HIV, but also works with public health authorities and non-governmental organizations to reduce the stigma of HIV, encourage testing for the disease, and strengthen communities of people with HIV and their families.

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Disclosure: The author owns shares in Pfizer.

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