Gilead’s new HIV drug safe for patients above 12 years approved by USFDA

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Last week United States Food & Drug Administration (US FDA) approved a drug to treat HIV/AIDS. Considered as a breakthrough tablet, this drug instantly became the hope for AIDS patients and the public health community rejoiced. Genovoya, manufactured by a leading U.S. Pharmaceuticals company Gilead Sciences, is safe to be used on patients above the age of 12 and weighing 35 kgs and above as reported by The Hindu. The drug is to be used for those adults with suppressed HIV or the ones who have not received any form of treatment for the disease.

What may come as a surprise is, that Genovoya is not a new composition. It is a combination of various old drugs used for the treatment of this disease. Tenofovir, an HIV inhibitor, is the only new ingredient added. The ingredient is now approved by the USFDA for its ability to provide higher levels of the drug in the cells where HIV-1 replicates than in the bloodstream improving its effectiveness. Genovoya is also less toxic to the kidneys and does not affect bone density like the previous drugs as it can be administered in lower doses to patients. The drug is more efficient in entering the HIV-infected cells than any of the previous versions of the TAF-based regimen.  Here is everything you must know about HIV diagnosis.

However, Genovoya is not safe for HIV patients with kidney impairment and must not be prescribed in combination with any antiretroviral drugs due to a risk of drug interaction and the resulting severe side effects according to the FDA. Elvitegravir, cobicistat, emtricitabine, and tenofovir alafenamide (TAF) are the old drugs that have been combined to form this new drug in a Fixed Dose Combination (FDC). According to Dr. Manish Kakkar, a public health specialist in communicable diseases at the Public Health Foundation of India (PHFI) the drug cannot be termed as a breakthrough as it is no new formula. The fixed combination of previous drugs will improve the patient’s adherence to the Genovoya but it may not show breakthrough results and hence it cannot be termed as a magic pill that may cure AIDS/HIV patients overnight. Read: 9 factors that increase your risk for HIV

Genovoya will be sold in global markets from today but it may take a while before it reaches India. Unforutnately, India is the third largest country with people living with HIV with over 20 lakh HIV positive patients among which 1.5 lakhs are children according to the National AIDS Control Organization (NACO). Moreover, there are 1.5 lakh deaths of HIV patients annually and 1.2 lakhs new infections diagnosed. The introduction of Genovoya as the magic pill is more like a PR gimmick according to Leena Menghaney MSF’s access campaigner in India. The reports on the real-time effectiveness of the drug will reflect if it lives up to its name – the magic pill. Here’s why India is still struggling to get over this deadly disease.

 


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