HIV positive patients take a daily ‘cocktail’ of antiretroviral drugs that keep the virus at bay. If they don’t take every pill strictly as prescribed, the effectiveness is reduced.
That’s why pharmaceutical companies are developing pills that combine several drugs in one daily dose.
If approved by regulatory agencies, a pill nicknamed ‘Quad’ would be the first of these single-tablet pills to contain an HIV integrase inhibitor.
The study was conducted by Gilead Sciences in collaboration with Harvard Medical School and Katholieke Universiteit Leuven in Belgium. The results announced are part phase 3 clinical trials for an ongoing study to determine safety and efficacy of the pill.
Last month, an FDA panel recommended that Quad be approved for patients who have not taken HIV drugs before. The agency is expected to make a decision by the end of August.
Quad combines the new integrase inhibitor elvitegravir (EVG) with with cobicistat (COBI) plus emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF). FTC/TDF is part of the recommended treatment for an adult beginning treatment, while EVG/COBI is a variable.
EVG and other integrase inhibitors block HIV from integrating fully into human cells, essentially stopping it from replicating. COBI is the part of the formulation that allows EVG to be integrated into the drug.
There are currently other one-pill-a-day HIV treatments on the market, such as Atripla. But if approved, Quad would be the first to have an integrase inhibitor like EVG.
Quad’s first clinical trial assigned 700 patients in North America to take one of two single pill regimens – either Quad, or Atripla, which is currently considered the “gold standard” for single pills.
The group taking Quad had slightly better outcomes in suppressing viral loads – or how much HIV is in the body – to undetectable levels. Quad had 88 percent of patients at that level, compared to 84 percent for Atripla.
Side effects were similar for both groups. More had mild nausea with Quad, but less likely to have dizziness, abnormal dreams, insomnia, and rash.
In the second trial, 708 patients who had not taken anti-HIV drugs before were assigned to either Quad or a two-pill treatment. Ninety percent of the Quad group ended with undetectable viral loads, versus 87 percent in the two pill group.
Almost four percent of the Quad group had to discontinue treatment, compared to over five percent in the two pill group. But more Quad patients had kidney complications compared to other HIV treatments.
The study was published in June 2012.
In the United States, an estimated 1.1 million people are infected with HIV (Human immunodeficiency virus), the virus that causes AIDS (acquired immune deficiency syndrome). HIV is transmitted through sexual contact of bodily fluids (blood, semen) with mucus membranes (oral, vaginal, anal), and the introduction of infected blood products into the bloodstream (commonly sharing intravenous needles, less commonly blood transfusions).
Mothers with HIV transmit the infection to their child in utero about 25% of the time in the absence of treatment. Early infection with HIV may produce flu-like symptoms of fever, nausea and vomiting, headache, and fatigue, then disappear. HIV may take up to ten years to progress to AIDS. The virus destroys CD4+ white blood cells and opens the body up to diseases and infections that the body would normally be able to fight off (pneumocystis pneumonia, cytomegalovirus, fungal infections, toxoplasmosis) and rare cancers (Kaposi’s sarcoma, Burkitt’s lymphoma, primary lymphoma in the brain).