Viral load as low as 400 copies/ml six months after starting ART is associated with a significant ten-year mortality risk

Michael Carter
Published: 05 July 2017

A viral load as low as 400 copies/ml six months after starting HIV therapy is associated with a substantial ten-year mortality risk, investigators from the United States report in the online edition ofAIDS. People with a viral load between 400 and 999 copies/ml had a 20% mortality risk, similar to the 23% risk observed in people with a viral load between 1000 and 4 million copies/ml. In contrast, the mortality risk was only 14% for individuals who rapidly achieved complete viral suppression – a viral load below 20 copies/ml.

“A single viral load measurement collected six months after initiating ART [antiretroviral therapy] remains highly informative regarding the risk of death over 10 years,” write the authors.

The aim of ART is rapid and sustained suppression of viral load to below the limit of detection (between 50 to 20 copies/ml depending on testing assay). Treatment guidelines suggest that viral load should be undetectable six months after the initiation of treatment. Newer antiretroviral drug combinations, especially those containing an integrase inhibitor, suppress viral load more rapidly.

Ongoing low-level viral replication despite therapy is associated with the emergence of drug-resistant virus, causing treatment failure and an increase in the risk of HIV- and non-HIV-related illnesses. Small increases in viral load once complete suppression has been achieved, above the limit of detection on occasional tests, so-called viral load `blips`, do not predict treatment failure and are not problematic. This study looked at the failure of treatment to achieve viral suppression after six months.

Analysing viral load measurements taken six months after ART initiation, a team of US investigators sought to determine the level of low-level viraemia (up to 1000 copies/ml) which was associated with an increased risk of all-cause mortality over ten years.

Their study population consisted of approximately 8000 adults who initiated ART between 1998 and 2014. Study participants were followed until death or for up to ten years.

Median age at baseline was 40 years; 83% of participants were male; 62% were in the men who have sex with men risk group; 45% were white and 12% reported ever injecting drugs. The median pre-ART viral load was 75,000 copies/ml and the median year of ART initiation was 2007. Approximately a third of people had been diagnosed with AIDS before starting treatment.

The median period of follow-up was 6.2 years, during which time there were 863 deaths.

Over half (57%) of viral load measurements six months after starting therapy were below 20 copies/ml, with 15% measured at 1000 copies/ml or higher.

As expected, compared to a viral load below 20 copies/ml, a viral load above 999 copies/ml was strongly associated with an increased risk of all-cause mortality over ten years (HR = 1.96; 95% CI, 1.56-2.46). A slightly increased risk of mortality was discernible at a viral load as low as 130 copies/ml (HR = 1.39; 95% CI, 1.02-1.88).

“While we observed an increased hazard of death with low-level viral loads, discernible at 130 copies/ml,” write the authors, “this association was largely driven by the elevated mortality risk experienced by patients with viral load between 400 and 999 copies/ml.”

The average ten-year mortality risk for people with a viral load below 20 copies/ml was 13%, similar to the 14% risk observed in individuals with a viral load between 20 and 400 copies/ml. The ten-year mortality risk was 20% for people with a viral load between 400 and 999 copies/ml, comparable to the 23% risk for people with a viral load of 1000 copies/ml or higher.

“Low-level viral loads between 400 and 999 copies/ml shortly after starting ART appear to place patients at a significantly higher 10-year risk of death than patients with viral loads under 20 copies/ml, and occurrences of viral loads in this range may need to be treated similarly as viral load that exceed 1000 copies/ml,” conclude the authors. “Given the importance of rapidly achieving virologic suppression after initiating treatment, further investigation of the causes of unsuppressed viral loads between 400 and 999 copies/ml is warranted.”

The authors suggest that incomplete viral suppression six months after starting treatment may be a marker for several problems. Apart from lack of adherence to treatment or poor retention in care, incomplete viral suppression might be a consequence of undetected drug resistance, or of drug-drug interactions that lead to low levels of antiretroviral drugs. Planning in advance to prevent these problems from undermining treatment, and prompt investigation of any problems, are likely to improve the chances of viral suppression

Florida Phasing Out Project AIDS Care, Other Medicaid Waivers

Thousands of Floridians living with AIDS could be losing financial assistance they say is essential to living a normal life, and some AIDS groups are worried the state won’t carry through on its promises.

On a recent Tuesday morning, Brandi Geoit sits at a conference table at the West Coast Aids Foundation headquarters. Across from her in the small New Port Richey office with butter-yellow walls is Dwight Pollard, a 61-year-old man living with AIDS.

Geoit tells him a new Florida law means patients like him could lose some of the financial help they’re getting through Medicaid.

“We’re not sure if you would keep your Medicaid because you’re still pending for your social security. And you haven’t qualified for Medicare yet because you’re still not old enough,” Geoit said.

Pollard no longer works, and depends on a special Medicaid waiver to cover his health care costs. Medication alone can cost $15,000 a month.

His partner, Ed Glorius, was sitting next to Pollard as he heard the news.

“It just doesn’t make sense,” Glorius said. “It doesn’t make sense to put people’s lives in turmoil. We’re better off than most and I’m freaking out. I’m waking up first thing in the morning thinking about this every day.”

Pollard is one of about 8,000 Floridians with AIDS who get help paying for doctor visits, medications and various home health services through this Medicaid waiver fund, which is called Project AIDS Care. Last month, Gov. Rick Scott signed a bill formally eliminating this waiver for AIDS, along with waivers for cystic fibrosis, developmental disabilities and elder care.

Florida’s Agency for Health Care Administration said while the waiver is going away, AIDS patients in Florida will not see a loss or gap in services. The agency declined repeated requests for interviews, but issued a written statement, explaining transition into a Medicaid Managed Medical Assistance plan.

“We will continue to provide the same services through the same providers for these individuals. The PAC (Project AIDS Care) waiver is essentially a waiver that expanded Medicaid eligibility to those diagnosed with HIV/AIDS and allowed the recipients to access needed medical services (e.g., physician services) and drugs. Given the advances in pharmaceuticals available to treat HIV/AIDS, most PAC recipients in the waiver only need those medical services and case management. With this transition, their eligibility will be maintained and they will continue to have access to the medical services, drugs and case management under the MMA waiver through the health plans. They will see no reduction in services and will be able to continue to see the medical professional they always have.”

The agency said patients will go into the Medicaid Long Term Care program starting this month. Everyone will be transitioned into it by Jan. 1, 2018.

But Geoit estimates 90 percent of her clients will not meet the requirements for long term care, which normally applies to people needing round the clock nursing.

She said her clients will definitely lose certain services that Medicaid doesn’t cover. Massages for those with neuropathy? Gone. Pest control? Gone. And services that are currently covered – like delivered meals, adult diapers and wheelchair ramps – could be lost, too.

So, she’s asked the state to clarify how it’s now different.

“When we asked them, they said, ‘Don’t worry. Reassure your client that they’ll be taken care of.’ And when we asked them point-blank what happened, you know, we were under the impression that a single adult still does not qualify for Medicaid. Has this changed? And they ended the conference call,” Geoit said.

Her program – a non-profit – exists only to manage the Project Aids Care waiver money for 325 clients in seven counties including Pasco, Pinellas and Hillsborough. With the new law, Geoit said her foundation will shut its doors by the end of the year.

For Dwight Pollard and his partner, the State Agency for Health Care Administration’s lack of answers is a concern.

“You don’t need the stress of how you’re going to pay or how you’re going to do this,” Pollard said.

But that’s his reality. And Pollard said until the state agency can give clear answers, he’ll keep searching for other programs that can help pay for his life saving medications.

Aministration launches new campaign to enroll young adults during Open Enrollment

Date

2016-09-27
Title
Administration launches new campaign to enroll young adults during Open Enrollment
Contact
press@cms.hhs.gov

Administration launches new campaign to enroll young adults during Open Enrollment
New outreach platforms, better mobile experience, and strong partners will help reach young adults

Today, as the White House convenes the Millennial Outreach and Enrollment Summit, the Centers for Medicare and Medicaid Services (CMS) announced additional initiatives to reach young adults during Open Enrollment and help them find affordable coverage through HealthCare.gov. Young adults had the highest uninsured rates before the Affordable Care Act and have seen the sharpest drop in uninsured rates since 2010. Yet millions of young adults remain uninsured, showing that there is more work to do to equip younger Americans with the tools and information they need to access coverage through the Health Insurance Marketplace. Today, we are announcing new strategies, new tools, and new partnerships to reach young people and help them get covered.

More than 9 in 10 Marketplace-eligible young adults without health insurance have incomes that could qualify them for tax credits to make plans affordable, but that fact hasn’t fully penetrated the millennial community, and we want to change that,” said Kevin Counihan, HealthCare.gov CEO. “This year, we’ll be using new tactics and strategies to reach young adults where they are and deliver the message that they have affordable coverage options. These new tactics will both benefit young Americans and strengthen the Marketplace risk pool.”

New Digital Platforms

For the first time, Open Enrollment outreach will take advantage of online platforms that cater almost exclusively to young adults. Today, we are announcing the first of these new efforts: outreach utilizing Twitch, a social video platform and community for gamers. This effort will feature HealthCare.gov pre-roll before videos, a homepage takeover, and ongoing efforts with streamers on Twitch to amplify our message throughout Open Enrollment. Twitch currently attracts close to 10 million daily active users who, on average, spend 106 minutes per person per day on the site. According to ComScore, Twitch’s core demographic of 18-34 year-olds have above average uninsured rates.

Mobile 2.0

According to ComScore, 1 in 5 millennials access the internet exclusively through mobile devices. Last year, consumers could easily enroll in coverage at HealthCare.gov through mobile devices, but if they wanted to actually shop around and compare plans, the mobile interface could be difficult and time consuming. This year, consumers will find an end-to-end, mobile optimized experience, including a new state-of-the-art shopping process that for the first time offers improved ability to comparison shop on their phone or tablet. Rather than clicking on tiny boxes or zooming in on hard-to-read screens, consumers will now find intuitive navigation and a streamlined interface to compare plans.

Targeted and Coordinated Partner Campaigns

During 2017 Open Enrollment, CMS and stakeholders will organize a young adult social media outreach campaign under one umbrella: #HealthyAdulting. As part of this coordinated campaign, longstanding Open Enrollment partners will be stepping up their social media engagement and will coordinate with each other to maximize the impact of that social media work in driving enrollment. CMS will be joining with partners to communicate with young people on the digital platforms they prefer – including Facebook, Twitter, and Tumblr – and engaging in a conversation under a unified #HealthyAdulting message about issues young people care about, whether that’s mental health, women’s wellness, reproductive health, or diabetes prevention.

Together, partners in the #HealthyAdulting campaign reach almost five million social media followers, meaning trusted voices will be raising awareness about Open Enrollment among young adults. Participating organizations include: The American Congress of Obstetricians and Gynecologists, American Diabetes Association, American Hospital Association, American Medical Student Association,  the League of United Latin American Citizens, Mental Health America, Autism Speaks, March of Dimes, Mocha Moms, My Halal Kitchen, National Council of La Raza,  National Action Network, National Partnership for Women & Families, the National Latina Institute for Reproductive Health, National Women’s Law Center, Out2Enroll, Planned Parenthood Federation of America, Raising Women’s Voices, Truth Initiative, the United Methodist Church, and Young Invincibles. Specific social media activities our partners are planning include:

  • National Council of La Raza will engage their 56,600 Twitter followers by hosting a twitter storm supported by the League of United Latin American Citizens targeting young millennial Latinos and immigrants to discuss the value proposition of healthcare.
  • The National Action Network, a leading civil rights organization founded by Reverend Al Sharpton, will engage their over 500,000 followers using #HealthyAdulting to reach out to young adults.
  • March of Dimes will host a Facebook Chat for its 630,000 followers about prenatal care and preventive services covered as essential benefits under Marketplace plans.
  • The Planned Parenthood Federation of America will engage their 837,000 followers in a Facebook live-stream led by the National Latina Institute for Reproductive Health addressing the state of Latina health.Meanwhile, we are also introducing new partnerships for 2017 with partners that have strong social media followings among young adults. Examples of new partnerships in 2017 include:
  • Tumblr will produce and promote a #HealthyAdulting event that will brand the movement of young adults taking ownership of their health and life choices by gaining health insurance and taking advantage of preventive services and wellness visits.
  • My Halal Kitchen will host Facebook conversations for its 1.3 million followers about healthy living, mental and emotional wellness, and heart health.
  • Autism Speaks will engage its 217,000 Twitter followers by hosting a Twitter chat on the prevalence of autism among young adults, autism screening as a covered benefit, and additional resources the community can use to get the best care.

Collaborating with Federal Partners and Programs

As we get closer to Open Enrollment, we are also working with federal partners to reach people enrolled in their programs who may need and want Marketplace coverage, with a particular focus on reaching young adults. Today we are announcing two new efforts:

  • The Department of Defense will include information about the Marketplace in the Transition Assistance Program, Transition GPS (Goals, Plans, Success) curriculum; more specifically, in the Personal Financial Planning module. The program, run through the Defense Transition Assistance Program Office, will inform transitioning Service members about health insurance options for their family, including HealthCare.gov coverage and possibility of qualifying for Marketplace financial assistance. Since this course is continually being offered, many Service members will lose their military coverage outside of Open Enrollment but would be eligible to sign up for Marketplace coverage through a special enrollment period.  Approximately 200,000 transitioning Service members, many of whom are under the age of 35, will receive this information annually.
  • The Medicaid and Children’s Health Insurance Programs (CHIP) will work in coordination with HealthCare.gov to get more and better information to young adults aging out of these programs at age 19, to others exiting Medicaid or CHIP coverage, and to people who apply for these programs but have incomes too high to qualify. Federal law requires states to transfer these individuals’ account information from Medicaid or CHIP to the Health Insurance Marketplace, but the Marketplace has had limited ability to conduct outreach to this group to date. New this year, the Marketplace will be able to contact millions of these individuals via email and mail, and provide information about financial assistance and Marketplace coverage options during Open Enrollment. Almost half of the individuals in this group are age 18-34. In addition, CMS will be releasing new guidance for states outlining best practices for communicating with individuals leaving Medicaid or CHIP and for sharing information with the Marketplace to facilitate direct outreach and to make it easier for individuals to complete a Marketplace application using information they have already provided to their state Medicaid or CHIP program.

In addition, as previously announced, the Internal Revenue Service will conduct new outreach this year to uninsured people who paid the individual responsibility penalty or claimed an exemption, letting them know that tax credits are available for Marketplace coverage and providing information about their health coverage options. Young adults are overrepresented among those who paid the fee: about 45 percent of taxpayers paying a penalty or claiming an exemption were under age 35, compared to about 30 percent of all taxpayers in 2014. Experts have suggested reaching out to those who paid the fee or claimed an exemption to make sure they are aware of their options to enroll in coverage, an approach already implemented in Massachusetts.

Getting Ready for Open Enrollment

We’re putting the finishing touches on our plans for Open Enrollment 4. Between now and November 1, you’ll see a series of announcements from us about what’s new, what’s better, and what to expect during this Open Enrollment – including new tools for consumers, new outreach tactics and targeting strategies, and more information about continued access to affordable coverage. Today’s announcement is the first in this series.

Americans can sign up for affordable health plans that meet their needs and their budgets at HealthCare.gov or their state Marketplace websites beginning November 1. Open Enrollment runs through January 31, 2017. Health coverage can start as soon as January 1, 2017 for consumers who sign up by December 15, 2016.

Over 25% of HIV+ Women in US Use Medical or Recreational Marijuana

 

Author: Mark Mascolini


11 January 2013

More than one quarter of HIV-positive women in the US Women’s Interagency HIV Study (WIHS) used prescribed marijuana for therapeutic reasons, and a similar proportion used marijuana for both medical and recreational reasons. Daily use of marijuana rose from 1994 to 2010.
Some research suggests that marijuana may reduce certain HIV symptoms. Medical marijuana use has become legal in some parts of the United States. But research has not addressed medical marijuana use in people with HIV infection.
This study involved 2776 HIV-positive women enrolled in WIHS between October 1994 and March 2010 in one of six US cities. WIHS participants make study visits every 6 months during which they answer an array of questions about health and behavior. Researchers used multivariate logistic regression analysis to identify predictors of any and daily marijuana use. For this study medical marijuana meant marijuana prescribed by a doctor.
Over the 16-year study period, prevalence of current marijuana use fell significantly from 21% to 14%. But daily marijuana use doubled from 3.3% to 6.1% in all women studied and almost tripled from 18% to 51% among current marijuana users.
In 2009 more than one quarter of women reported purely medicinal marijuana use (26%) or both medicinal and recreational use (29%).
Reasons cited most often for using marijuana were relaxation, appetite improvement, reduction of HIV-related symptoms, and social use.
Daily marijuana use was associated with higher CD4 count, quality of life, and older age. Demographic traits and risk behaviors did not predict daily marijuana use.
The researchers conclude that “both recreational and medicinal marijuana use are relatively common among HIV-infected women in the United States.”
Source: Gypsyamber D’Souza, Pamela A. Matson, Cynthia D. Grady, Shadi Nahvi, Dan Merenstein, Kathleen M. Weber, Ruth Greenblatt, Pam Burian, Tracey E. Wilson. Medicinal and recreational marijuana use among HIV-infected women in the Women’s Interagency HIV Study (WIHS) Cohort, 1994-2010. JAIDS. 2012; 61: 618-626