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AIDS and HIV Information

AIDS and HIV Information

Can Genvoya Be Crushed?

Can Genvoya Be Crushed


Genvoya is a complete anti-HIV regimen, containing a fixed-dose combination of elvitegravir, cobicistat, emtricitabine, and tenofovir alafenamide. There is no data available if crushing or splitting tablet will affect the drug’s absorption and bioavailability. However, the manufacturer (Gilead Sciences) recommends swallowing the tablets whole. If you are unable to take the tablet orally or if you have concerns about the drug’s dosing and timing, consult your healthcare provider.

Experts believe that the INSTI-containing regimen is a good initial treatment for individuals who have not received any antiretroviral meds in the past, also referred to as “treatment-naïve patients.” Genvoya is safe to use in children provided they are ≥12 years of age and weigh at least 35 kilograms. Those under a stable regimen with suppressed viral load of at least six months can switch to Genvoya if their doctors deem it necessary.

When oral administration is an issue

Before the advent of once-daily one-tablet regimen, taking HIV treatment was such an ordeal. Patients need to take one or several pills at different times of the day. Non-adherence is a threat to successful treatment and may even cause viral resistance. But patients find it hard to keep up, especially when pill burden is coupled with intolerable side effects. When the first co-formulated antiretroviral drug Combivir was released in the late 1990s, some prescribers doubt if it could make a difference. After all, the regimen still required twice daily dosing and the two-pill burden was only reduced to one. However, Combivir, which is composed of lamivudine (3TC) and zidovudine (AZT), became enormously popular among patients and prescribers alike. It even spurred the development of other co-formulated regimens, such as Truvada, Epzicom, and Trizivir. Combivir is rarely used nowadays because of zidovudine’s toxicities, but we already have better and safer once-daily, single tablet regimens (STR), in the form of Genvoya, Triumeq, and Stribild.

You think patient adherence will no longer pose a threat, at least in first-world countries, where complete fixed-dose regimens are readily available. Yet, there’s another issue that threatens patient adherence. There are more than 20 FDA-approved antiretroviral drugs in the market and majority of these drugs are in tablet form. The limited availability of alternative antiretroviral formulations is a problem for patients who are unable to take medications orally due to other comorbid conditions, which is common in HIV-infected patients. Some people just can’t swallow pills. Now that antiretroviral therapies (ART) are making patients live longer—many of them will seek hospital inpatient services for medical conditions typical in an aging population, including diabetes, cardiovascular problems, and certain forms of cancer. Drug adherence is crucial for long-term viral suppression, but it proves to be difficult in this setting.

“Do not crush” antiretroviral drugs

If a patient has dysphagia (difficulty swallowing) or phagophobia (fear of swallowing) or just unable to take pills for other reasons, the medication is crushed or split in smaller pieces; capsules are opened, and the contents are mixed with small amount of water or applesauce. Better yet, other commercially available preparations are sought; some drugs have a liquid, powder, or intravenous solution form. Unfortunately, there are no alternative formulations available for Genvoya and many other STRs. Whether a pill can be crushed, split, or opened depends on its components and formulation. Crushing or splitting Genvoya has not been studied, thus it is not recommended. For individual drug components, please see table below.

Genvoya Drug Components

Solubility

Oral Liquid Preparation

Elvitegravir

Insoluble in water

Not available

Emtricitabine

Soluble in water

10mg/ml oral solution

Tenofovir alafenamide

Soluble in water but has a bitter and burnt aromatic taste

Not available

Cobicistat

Insoluble in water

Not available


Elvitegravir and cobicistat is only available in tablet form. Both are insoluble in water. No data is available on crushing and splitting these tablets. The manufacturer recommends swallowing them whole. Emtricitabine comes in capsule form and its contents are soluble in water, but there is no data available on opening capsules. It does have a flavored oral liquid preparation available at 10mg/ml. The NRTI tenofovir alafenamide is soluble in water but it has a bitter and burnt flavor. There are currently no pharmacokinetic studies available on crushed vs whole tablet administration. The tablet lacks enteric coating, so it readily disintegrates in water, orange juice, or grape juice. Tenofovir is moisture sensitive and must be consumed immediately after mixing.

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