A Smart + Strong Site
Subscribe to:
POZ magazine

Back to home » Treatment News » Top Stories

Most Popular Stories
Undetectable Viral Load Essentially Eliminates Transmission Risk in Straight Couples
FDA Approves New Single-Tablet HIV Regimen, Triumeq
Life Expectancy for Young People With HIV Is Nearly Normal
A 15-Year Jump in Life Expectancy for People With HIV
Scientists Devise Method of Snipping HIV From Immune Cells
Monkey HIV Vaccine Success Opens Door for Human Trials
HIV Combo Pill Less Toxic Thanks to New Form of Tenofovir
What's That Mean?
(just double-click it!)

If you don't understand one of the words in this article, just double-click it. A window will open with a definition from mondofacto's On-line Medical Dictionary. If the double-click feature doesn't work in your browser, you can enter the word below:

Most Popular Lessons
Aging & HIV
The HIV Life Cycle
Herpes Simplex Virus
Syphilis & Neurosyphilis
Treatments for Opportunistic Infections (OIs)
What is AIDS & HIV?
More News

Have medical or treatment news about HIV? Send press releases, news tips and other announcements to news@aidsmeds.com.

Click here for more news


August 14, 2012

Generic-Based Regimen in U.S. Could Save Nearly $1 Billion in First Year of Use

by Tim Horn

AIDS 2012Though it won’t be quite as convenient and could have a slight negative effect on HIV survival expectations, prescribing a generic equivalent to Atripla (efavirenz plus tenofovir and emtrictabine) could end up saving United States drug-coverage entities close to $1 billion in the first year alone. This is the conclusion of mathematical modeling conducted by Rochelle Walensky, MD, of Harvard Medical School and her colleagues, presented Friday, July 27, at the XIX International AIDS Conference (AIDS 2012) in Washington, DC.

"A switch from first-line branded to generic antiretrovirals will result in a lifetime average savings of $42,500 [per patient] and a modest survival loss of 0.37 quality-adjusted life years [roughly four months]," said Walensky, who noted that the estimates are based on very conservative modeling and may therefore downplay the actual cost savings and over-estimate the survival loss.

Walensky’s group used Atripla as an example for a variety of reasons. First, because it has long been a Department of Health and Human Services-preferred treatment regimen for people initiating therapy for the first time because of its strong long-term efficacy, overall safety profile and ease of use. Second, because a generic version of lamivudine—a nucleoside analog that works similarly to the emtricitabine in Atripla—is currently available and a generic equivalent of efavirenz is expected to be approved within the next year.

“We’re looking at the possibility of a potent, largely generic, first-line regimen in the U.S.,” Walensky explained. Generic efavirenz and lamivudine, she added, would be combined with Viread-brand tenofovir (Viread's patent does not expire until 2017).

Though Walensky and her colleagues note that the cost of the regimen will be less than Atripla—the average wholesale price (AWP) of which is currently $2,080 a month—some drawbacks are possible.

“Though still once-daily,” Walensky said, “a generic regimen will have an increased pill burden—three versus one pill—which may result in poorer adherence and virologic outcomes.” Additionally, replacement of emtricitabine with lamivudine may diminish the potency as a first line-regimen. It may also diminish the potency of second-line regimens, assuming that lamivudine, compared with emtricitabine, is more likely to lead to resistance mutations that can hinder the use of other nucleoside analogs.

Taking these variables into consideration, Walensky’s group performed some mathematical modeling that assumed the worst in terms of treatment adherence and regimen potency. The model compared outcomes for hypothetical patients starting therapy for the first time—averaging 43 years of age and a pre-treatment CD4 count of 317 cells—using Atripla or Viread plus generic efavirenz and lamivudine.

Worst-case scenario—assuming there really is a potency difference between Atripla and generic efavirenz and lamivudine plus Viread—78 percent of people living with HIV starting the generic regimen would have undetectable viral loads within 24 weeks (dubbed “early suppression” by the researchers) compared with 85 percent of those receiving Atripla. Long-term treatment failure, defined as those who achieved undetectable viral loads within 24 weeks but experienced a virologic rebound after six months of therapy, could potentially occur in 5.41 patients for every 100 patient-years of generic-equivalent treatment, compared with 2.5 per 100 patient-years of Atripla treatment.

Considering a 75 percent price reduction for the two generic drugs—an assumption based on price reductions seen when other drugs became available generically, notably Zocor-brand simvastatin for high cholesterol (66 percent), Methylin-brand methylphenidate for ADHD (72 percent) and Coumadin-brand warfarin for blood clots (85 percent)—Viread plus efavirenz and lamivudine would cost $9,200 a year ($766 a month).  

This, Walensky said, would save the U.S. health care system $920 million in the first year alone.

If the price reduction for the two generics didn’t exceed 20 percent, the U.S. health care system would still save $200,000 in the first year. And if there was a 95 percent reduction in the price for the two generic drugs, the system would save approximately $1.1 billion in the first year.  

Atripla’s annual price was calculated at $15,900, with the model including a 23 percent price reduction to entice U.S. health care systems to cover its cost.

Over the span of a lifetime, the total cost to the health care system for someone living with HIV not started on antiretroviral treatment would be $131,200. Among those who begin therapy with brand-name Atripla, the lifetime cost was calculated to be $342,800. For those who begin therapy with the generic-based regimen, the lifetime cost was calculated to be $300,300—a savings of approximately $42,500 per person.  

Walensky’s team also calculated patients’ quality-adjusted life-years (QALYs), which take into account both the quantity and quality of life generated by a specific health care intervention. Without the use of any antiretrovirals, the hypothetical patients used in the model could expect a little more than four years of healthy living (4.05 QALY). With the generic regimen, the worst-case scenario QALY is bumped up to 12.05. With the use of Atripla, the calculated QALY is somewhat higher at 12.45—a 4.5-month survival advantage.

These findings, while economically encouraging, raised some important questions for Walensky and her colleagues. “Are we, as a society, ready to forgo small individual survival benefits for large national savings? Do we recognize that economic savings will vary among payers—for example state AIDS Drug Assistance Programs, state Medicaid programs and the U.S. Veterans Administration? Are we prepared for the fact there is no guarantee that money saved will be reinvested in HIV care?”

Such reinvestment, Walensky noted, is an important issue. She explained that President Obama’s 2012 National HIV/AIDS Strategy is explicitly financed, not by new funds, but by “repurposed” money. “If investment in the national HIV mission required ‘redirected’ financing, $1 billion saved from use of generic drugs might be an attractive source for this national reinvestment.”

Search: hiv, cost, generics, atripla, lamivudine, efavirenz, viread, walensky, aids 2012

Scroll down to comment on this story.


(will display; 2-50 characters)


(will NOT display)


(will display; optional)

Comment (500 characters left):

(Note: The AIDSmeds team reviews all comments before they are posted. Please do not include ":" "@" "<" ">" in your comment. The opinions expressed by people providing comments are theirs alone. They do not necessarily reflect the opinions of Smart + Strong, which is not responsible for the accuracy of any of the information supplied by people providing comments.)

Comments require captcha.
Please enter this number for verification:

| Posting Rules

Show comments (20 total)

[Go to top]

Quick Links
About HIV and AIDS
The Cure
Lab Tests
Clinical Trials
HIV Meds
Starting Treatment
Switching Treatment
Drug Resistance
Side Effects
Hepatitis & HIV
Women & Children
Fact Sheets
Treatment News
Community Forums
Conference Coverage
Health Services Directory
POZ Magazine
AIDSmeds on Twitter

Conference Coverage

XX International AIDS Conference
(AIDS 2014)
Melbourne, Australia
July 20 - 25, 2014

21st Conference on Retroviruses and Opportunistic Infections
(CROI 2014)
Boston, MA
March 3 - 7, 2014

7th International AIDS Society Conference on HIV Pathogenesis, Treatment and Prevention
(IAS 2013)
Kuala Lumpur, Malaysia
June 30 - July 3, 2013

more conference coverage

[ about AIDSmeds | AIDSmeds advisory board | our staff | advertising policy | advertise/contact us]
© 2016 Smart + Strong. All Rights Reserved. Terms of use and Your privacy.
Smart + Strong® is a registered trademark of CDM Publishing, LLC.