Tuesday, January 12, 2016

India Adds More HIV/AIDS, Cancer Drugs To Essential Medicines List

The government has revised its list of essential medicines to add drugs for diseases ranging from cancer and HIV/AIDS to hepatitis C, in a move aimed at making them more affordable.

The update to the National List of Essential Medicines (NLEM) is just the third since it was compiled in 1996.

It increased the list to 376 medicines from 348 and includes drugs ranging from analgesics and antivirals to contraceptives, cardiovascular and anti-tuberculosis drugs.

Reuters reported in April that more HIV/AIDS and tuberculosis medicines were likely to be added to list, which is posted on the Central Drug Standard Control Organisation's (CDSCO) website.

"The NLEM 2015 has been prepared adhering to the basic principles of efficacy, safety, cost-effectiveness; consideration of diseases as public health problems in India," a notice on the website said.

India had been criticised because the former list left out some life-saving drugs.

The new list takes cues from the World Health Organisation's 2015 list of essential drugs, which the United Nations agency defines as those that satisfy the priority healthcare needs of people and ensure affordability.

The revision comes after months of deliberations by a committee of experts formed by the government last May. Views of the pharmaceutical industry and NGOs were also considered, the CDSCO said.

The committee recommended that the list, which is effective immediately, be revised every three years.

In initial thoughts, industry executives said they were yet to study the list's impact.

"We will be seeking clarification and a better understanding of its implications," said Ranjana Smetacek, director general of the Organisation of Pharmaceutical Producers of India (OPPI) which represents large foreign drugmakers.

The Indian Pharmaceuticals Alliance, which represents large local drugmakers, did not respond to requests for immediate comment.

It is likely that medicines in the new list will be brought under price control, as was done with the previous list, some in the industry said.

Drug pricing is a contentious issue in the country, as nearly 70 percent of the population lives on less than $2 a day and health insurance is inadequate.

India contributes roughly 1 percent of its total gross domestic product to healthcare, among the lowest levels of funding in the world.

Industry executives say drug prices in the country are also among the lowest in the world.

India's drug pricing regulator has struggled in the past year to implement price caps and expand them to cover more drugs.

When it fixed prices of about 100 medicines citing public interest last year, the industry fired back with lawsuits.

The government soon curbed the National Pharmaceutical Pricing Authority's (NPPA) powers, restricting it from fixing the price of medicines not on the essential medicines list.

Price caps cover roughly 30 percent of the drugs sold in the country.

India reports 32 percent declining in HIV/AIDS

India is estimated to have registered a 66 per cent decline in new HIV infections from 2000 and 32 per cent decline from 2007, according to the latest round of HIV sentinel surveillance and estimations conducted by the National AIDS Control Organisation (NACO), released by the Union Health Ministry.

There were around 86,000 new HIV infections in 2015. The report noted that Andhra Pradesh and Telangana, Bihar, Gujarat and Uttar Pradesh currently account for 47 per cent of the number of total new infections among adults with each of these States contributing 7,500 or more new infections in 2015.


West Bengal and Rajasthan registered more than 5,000 new HIV infections, but less than 7,500 new infections, while Maharastra, Odisha and Tamil Nadu have new infections in the range of 3,000-4,000. Chhattisgarh, Delhi, Haryana, Jharkhand, Karnataka, Madhya Pradesh and Punjab have 1,000-2,400 new infections among adults and the rest of the States have less than 1,000 new adult HIV infections in 2015.


New infections among adults have declined by 50 percent or more in the State of Andhra Pradesh and Telangana, Karnataka, Maharashtra, Manipur and Odisha during 2007-2015. Bihar, Jharkhand, Kerala, Mizoram, Nagaland, Rajasthan and Uttarakhand are the states where annual new infections declined by 32-47 percent during the same period.

However a rising trend in new infections among adults during 2007-2015 has been detected in Assam, Chandigarh, Chhattisgarh, Gujarat, Sikkim, Tripura and Uttar Pradesh.

The report further noted that since 2007, the number of AIDS-related deaths declined by 54 percent in 2015 with an estimated 67,600 people dying of AIDS-related causes nationally.

The annual number of AIDS deaths has declined by 70-81 per cent during 2007-2015 in Karnataka, Maharashtra and Tamil Nadu. Annual AIDS related deaths declined by 60-70 percent from baseline values of 2007 in Andhra Pradesh and Telangana, Goa, Himachal Pradesh and Nagaland, while a decline of 40-47 percent was estimated in Chhattisgarh, Gujarat and Punjab.

Injectable HIV Treatment Would Change Lives

This month ViiV Healthcare and Janssen Sciences announced that Phase III trials for a bimonthly HIV treatment injection would begin in mid-2016. This year the two 

companies will be evaluating the commercialization of a long-acting formulation to be used as an injectable maintenance treatment for patients who have achieved viral suppression. 

Injectable treatments have been the buzz in HIV treatment research for a while, but this announcement represents a tangible hope that a new form of treatment is within our grasp. In a few years, many people living with HIV might be able to throw away their pillboxes for good.

The current oral regimen continues to be a reason for poor adherence to HIV treatment. Also, the daily pill can sometimes be viewed as a symbol of second-class status. 

No matter how healthy I am, people still see someone whose health is subpar.

In the U.S., the majority of people living with HIV are not able to stay on treatment and maintain viral suppression. The possibility of a bimonthly injection wouldn’t just improve adherence to medication and reduce transmission, it would revolutionize the lives of HIV-positive people.

If you are not living with HIV, just try to imagine it for a second. Imagine being a young person and being told that you can still live a long and healthy life, but only if you adhere to this daily regimen with few to no mistakes. Sounds simple enough, but factor in trying to carry the enormous weight of HIV stigma and concealing 

your diagnosis to the outside world — as most initially try to do — and you have 365 reasons to fail. For so many, a bottle of pills isn’t just a bottle of pills, but an embarrassing reminder to yourself and others, that you contracted a virus that is avoidable.

That sounds harsh. HIV shouldn’t have to be something people are ashamed of. But what should be does not change the reality of the majority of people with HIV who are utterly mortified and almost paralyzed by the idea of people finding out their status.

Now, imagine being told that all it will take to keep you healthy and living the life you want is six doctor visits a year. Sure, it may not still ideal, but what disease is? It is a hell of a lot better than the alternative. An HIV injectable treatment represents an opportunity to resume life knowing that you are virally 

suppressed even if you are not quite ready or able to take on managing your virus full time.

Today, managing HIV doesn’t just require a daily pill. It requires a person to develop an entirely new state of mind — one that requires strength, an awareness of what it means to be positive today, and the support of friends and loved ones. If that were so easy to come by, HIV wouldn’t still be the problem that it is.

An injectable treatment would remove the daily reminder of a disease that shouldn’t but often does hold people back. It would mean the freedom of waking up and going about your day without a siege of panic because you forgot to take your medication. It would mean the removal of shackles to a pill bottle so sleepovers can be spontaneous and packing for vacations is done sans stress. Frankly, an injectable treatment would simply mean a better life.

Indiana town adopts B.C.’s HIV-treatment model after outbreak

A small Indiana community where two out of every five residents are considered at high risk of HIV infection is reaching out to B.C. experts for help.

Austin, Ind., is suffering through an unprecedented outbreak of the disease. With a population of 4,200, 10 per cent are currently injecting prescription opioid drugs on a daily basis, said Diane Janowicz, assistant professor at the Indiana University School of Medicine.

Since last year, 184 new HIV infections have been identified.

“Thirty-nine per cent of the population are identified as high risk. That’s an incredibly high prevalence compared to other parts in the U.S.,” Dr. Janowicz said.

The university, working with the National Institute on Drug Abuse, has asked for help from the BC Centre for Excellence in HIV/AIDS. The intention is for the centre to bring its so-called treatment-as-prevention model of health care to the beleaguered community. Treatment-as-prevention is a collection of antiretroviral treatments that reduce the HIV virus load in blood and vaginal and rectal fluids, to decrease the risk of HIV transmission.

B.C. has seen a steady decrease in the number of deaths resulting from HIV since the introduction of an intense antiretroviral therapy program that began in 1996. There has been a 90-per-cent decrease in the number of new cases since 30 years ago.

As of last year, only 250 cases of HIV were recorded in B.C.

In Austin, the outbreak began last year and is linked to intravenous injection of opiate pain medication that users crush. It has prompted a warning from the U.S. Centers for Disease Control and Prevention to alert health officials to be on guard against clusters of HIV and hepatitis C infections.


“Indiana University will bring their colleagues here to see how we implemented our strategies in British Columbia, to learn about our treatment programs and to see how we have made the improvement happen,” said Julio Montaner, director of the BC Centre for Excellence of AIDS/HIV.

“It’s easier said than done. This program is very complex and it is difficult to implement,” he said.

For example, he said it can be difficult for doctors to reach patients and ensure they have access to the kinds of drugs and programs needed for the therapy to be effective.

A state epidemiologist said in a news report in the Indy Star last year that fewer than half those diagnosed with HIV had been prescribed antiretroviral treatments.

Prior to the outbreak in Austin, there was only one clinic providing health care in the town.

The Indiana team, including the B.C. doctors, plans to use mapping technology to examine risk factors for HIV transmission. Other research will investigate the clustering of HIV transmissions. And scientists will evaluate how to counter the damage of injection-drug use through harm-reduction services.

“The situation in Indiana marks a critical need for implementing best practices in harm reduction and HIV prevention. Treatment-as-prevention is a model for opening up access to early HIV treatment and care, for reducing stigma and for targeted disease elimination,” Dr. Montaner said in a news release.

“Providing sustained, consistent treatment and care ensures that an individual’s viral load decreases, dramatically reducing the likelihood of disease progression and secondarily stopping HIV transmission.”

B.C.’s treatment model has also been widely adopted in other jurisdictions of the world including China, Latin America and Europe.

“The BC Centre for Excellence in HIV/AIDS is recognized internationally for [its] outstanding work in providing access to treatment and care for those affected by or at high risk of HIV in urban and rural areas in British Columbia,” Dr. Janowicz said.