Earlier this week, a new, single tablet antiretroviral regimen to treat HIV/AIDS was approved by the United States Food & Drug Administration (US FDA). Almost instantly, the media dubbed it a ‘breakthrough’ in treatment, to be celebrated by the public health community globally.
The drug in question called Genvoya is made by U.S. pharmaceutical giant Gilead Sciences. According to USFDA, Genvoya can be used on patients above the age of 12 or weighing at least 35 kg and who have never been treated for HIV before, or on infected adults whose HIV is currently suppressed.
Genvoya, essentially, is a cocktail of older drugs with a new form of tenofovir, a powerful HIV inhibitor, which had not been previously approved. In its new avatar, tenofovir provides “lower levels of drug in the bloodstream, but higher levels within the cells where HIV-1 replicates. It was developed to help reduce some drug side effects. Genvoya appears to be associated with less kidney toxicity and decreases in bone density than previously approved tenofovir,” said USFDA in a press release.
According to Gilead Sciences, the new TAF-based regimen can enter cells -- including HIV-infected cells -- with more efficiency than the previous version of the drug. Further, it can be administered to patients at a significantly lower dose – with 91 per cent less tenofovir in the bloodstream. The fact that it can be given at much lower doses makes the new regimen less toxic to bones and kidneys, a common problem among HIV patients as they get older.
The FDA has noted that Genvoya is not recommended for patients with severe kidney impairment and should not be given in combination with other antiretroviral drugs, since it may interact with a number of commonly used medications.
There are two things one needs to know about this drug. First, it is not a new drug. It is a combination of four old drugs -- elvitegravir, cobicistat, emtricitabine, and tenofovir alafenamide (TAF). This is called a Fixed Dose Combination (FDC).
And while FDCs are good for improving adherence among patients, this is no magic pill. “Technically, this is simply not a breakthrough. No new drug has been discovered - older drugs have been brought together in the FDC form. This is important as it improves compliance, which is a great thing but to call it a breakthrough is a stretch,” said Dr Manish Kakkar, a public health specialist in communicable diseases at the Public Health Foundation of India (PHFI).
Second, the developing world - which is where the majority of the HIV/AIDS patients are - will not be exactly jumping with joy at this ‘breakthrough’ any time soon. According to medical humanitarian aid organisation, Doctors Without Borders (MSF), the drug will make little or no impact on patients in the poorer countries.
The drug will hit the stands on Monday but will take much longer to be available in Indian markets. The country at present shoulders the third highest PLHIV (People Living with HIV) burden, with over 20 lakh HIV positive patients. Of this, nearly 1.5 lakh are children, according to the National AIDS Control Organization (NACO). Additionally, India accounts for approximately 1.2 lakh new HIV infections and 1.5 lakh deaths annually.
MSF’s access campaigner in India Leena Menghaney went so far as to call this a PR gimmick, sponsored by the pharmaceutical company. “Registration (of new drugs) strategies of multinational pharmaceutical companies, like Gilead Sciences, is not in line with the needs of the developing world. This drug cannot be used, not in the cocktails pharmaceutical companies like Gilead want to sell them. Instead, they must be used in the combinations prescribed by the World Health Organization. If these drugs —the new form of tenofovir in particular — were registered individually, they can be used in WHO recommended combinations,” said Menghaney.
vidya.krishnan@thehindu.co.in
