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EMA adopts positive opinion on monthly vaginal ring to reduce HIV risk

EMA adopts positive opinion on monthly vaginal ring to reduce HIV risk

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3 years ago

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IPM’s dapivirine ring could give women in Sub-Saharan Africa first long-acting HIV prevention option; opinion paves way for WHO and National Regulatory Reviews

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Credit: Andrew Loxley, courtesy of IPM

SILVER SPRING, Md. (July 24, 2020)–The International Partnership for Microbicides (IPM) today welcomed a positive opinion from the European Medicines Agency (EMA) on the dapivirine vaginal ring for use by cisgender women ages 18 and older in developing countries to reduce their risk of HIV-1 infection. The monthly ring is the first long-acting HIV prevention product and is designed to help address women’s unmet need for new methods given the persistently high rates of HIV they face, especially in sub-Saharan Africa. Today’s news opens the door to next steps needed to seek approvals for the ring in countries where the need is most urgent.

“The EMA’s opinion is a significant step forward for women, who urgently need and deserve new, discreet options to manage their HIV risk on their own terms,” said Dr. Zeda F. Rosenberg, founding chief executive officer of IPM, the nonprofit that developed the dapivirine ring and is the product’s regulatory sponsor. “As we celebrate today’s news with the many partners around the world involved in the ring’s development, we also look ahead to the collective effort still needed to obtain country approvals to make the ring available to women in sub-Saharan Africa.”

The EMA’s Committee for Medicinal Products for Human Use reviewed the ring under the Article 58 procedure, which it conducts in cooperation with the World Health Organization (WHO) to facilitate access to essential medicines in low- and middle-income countries using the same rigorous standards as for products intended for use in the European Union. IPM submitted its Article 58 application in June 2017.

Global partnerships with researchers, trial communities in Africa, Europe and the United States, civil society, governments, industry and donors spanning 16 years of research and development led to today’s positive opinion.

“This achievement is a testament to what partnerships can accomplish,” continued Dr. Rosenberg. “We applaud the researchers in Africa, Europe and the US who expertly conducted studies that brought the ring to this exciting point–and especially thank the pioneering women who participated in the studies for their commitment to finding new woman-centered options that can fill a critical gap in the HIV prevention portfolio.”

Efficacy data, including additional data provided during the EMA’s review, showed that IPM’s dapivirine ring reduced women’s HIV risk by 35% with no safety concerns with long-term use. More recent data from open-label extension (OLE) studies of the product suggested greater HIV risk reduction, although those findings are based on statistical modeling and are therefore limited. The ring was also found to have a favorable safety profile in all clinical trials to date.

IPM submitted to the EMA for its assessment data from a package of studies, including two Phase III studies–The Ring Study led by IPM, and ASPIRE, conducted by IPM’s clinical trial partner the National Institutes of Health-funded Microbicide Trials Network (MTN)–two subsequent OLE studies, and a number of smaller safety studies.

In addition to working closely with the WHO during its review, the EMA’s evaluation also included the testimony of two women living in countries in Africa where there is a high burden of HIV.

As the EMA requested, IPM will also conduct additional research among cisgender women ages 18-25 to better understand the ring’s efficacy and to collect additional data on safety and potential ARV resistance. Results from the study could also inform strategies to support young women to use the ring consistently.

A potential new option to meet women’s needs

As the EMA indicated, the monthly ring could be an important option for women who choose not to or are unable to use the daily oral antiretroviral (ARV) pill known as PrEP (or pre-exposure prophylaxis), now becoming more widely available in Africa. Oral PrEP is highly effective, but not all women are able to use it. In addition, although condoms will be indicated for use with the ring, they are not practical for women who are unable to negotiate their use with male partners or who are at risk of sexual or intimate partner violence.

“Women in Africa have been left behind by progress against HIV for far too long, and today’s announcement is a landmark for women’s HIV prevention,” said Dr. Linda-Gail Bekker, professor of medicine and deputy director of the Desmond Tutu Health Foundation, immediate past president of the International AIDS Society and national principal investigator for South Africa on The Ring Study. “Offering women multiple methods like the monthly ring and daily oral PrEP is vital to controlling the epidemic and to ensuring their sexual and reproductive health and rights.”

The ring is designed to help reduce women’s HIV risk during vaginal sex. Women insert the product themselves and replace it every month. Made of flexible silicone, the ring slowly releases the ARV dapivirine locally to the site of potential infection, with minimal absorption elsewhere in the body.

“Today’s announcement brings us closer to a future where every woman has the opportunity to protect herself against HIV,” said Paul Stoffels, MD, vice chairman of the executive committee and chief scientific officer at Johnson & Johnson, which granted IPM the rights to dapivirine and is partnering closely with the nonprofit to plan for the ring’s potential rollout. “If we continue investing in the development of innovations like the dapivirine ring–and ensuring that they are accessible to those who need them most–I have no doubt we will see a day when HIV is a disease of the past.”

Although new HIV infections are declining overall, biology and gender inequities make women more susceptible to infection than men. Every day, nearly 1,400 women in sub-Saharan Africa acquire HIV.

“Even as HIV/AIDS has increasingly become an epidemic borne by women and girls, the response to it has not kept pace,” said Dr. Peter Piot, director of the London School of Hygiene & Tropical Medicine and the founding executive director of UNAIDS. “As the first long-acting tool for HIV prevention, the dapivirine ring could help change the course of the epidemic for women.”

Next steps for potential country approvals and introduction

Given the urgency for women, IPM has been working with partners to shorten the time to potential introduction as much as possible, but rolling out the ring will require a collective effort by a range of global stakeholders, particularly as responding to COVID-19 alongside other priorities continues to challenge health systems. With strong political will and funding, it may be possible to begin making the dapivirine ring available sometime in 2021 in some communities in Africa where the need is urgent, pending several next steps, including:

  • WHO guidelines and prequalification: WHO will review evidence on the ring as part of its guideline process and consider using an abbreviated review of the product for prequalification, a quality assurance designation for medicines that facilitates access to medicines that meet global standards for quality, safety and efficacy.
  • Regulatory reviews in Africa: In parallel, the ring will be reviewed by regulators in each country where it would be used and, if approved, adopted into national HIV prevention policies. Because the EMA’s Article 58 opinion is recognized by many countries in Africa and IPM is submitting to those countries through a process coordinated by the WHO, it may help accelerate national reviews. IPM plans to submit the first applications this year to countries in eastern and southern Africa where the need remains high, studies of the ring took place and where IPM can build on oral PrEP implementation (Kenya, Malawi, Rwanda, South Africa, Tanzania, Uganda and Zimbabwe).
  • US regulatory review: IPM will also submit to the US Food and Drug Administration in 2020.
  • Continued market and implementation research: Market and implementation research has been underway with partners for several years to inform demand creation strategies; develop information, education and communications (IEC) materials for women and healthcare providers; create product delivery models; and to map the supply chain networks needed for rollout.
  • Ring rollout: IPM will also continue working with governments, funders and other partners to discuss and plan for ring introduction.

“Women across Africa have been asking and waiting for new tools that put women in charge of their own health, so we welcome today’s announcement,” said Yvette Raphael, who leads the Advocates for the Prevention of HIV in Africa. “We now look to governments and funders, always in consultation with communities, to make sure the dapivirine ring reaches the women who need it.”

IPM is collaborating with MTN to study the monthly ring among adolescent girls, pregnant women and breastfeeding women, who are also at elevated HIV risk. Results from these studies could inform next steps on potentially expanding the indication for the ring to these groups in the future.

Given today’s news, IPM will accelerate development of follow-on rings that could help meet women’s HIV prevention needs at different times in their lives, including a longer-acting three-month dapivirine ring and a multipurpose prevention ring designed to offer both HIV prevention and contraception. Both products recently completed Phase I safety clinical trials.

###

IPM is grateful for the generous support of our current donors whose investment in our work has brought us to today’s positive opinion: the Danish Ministry of Foreign Affairs, the German Federal Ministry of Education and Research (BMBF) through the KfW Development Bank, Irish Aid, the Ministry of Foreign Affairs of the Netherlands, UKaid from the Department for International Development, the American people through the United States Agency for International Development (USAID) in partnership with the US President’s Emergency Plan for AIDS Relief (PEPFAR), and the Bill & Melinda Gates Foundation.

In addition, IPM also extends its thanks to donors whose previous support contributed to the ring’s development, including: Belgian Development Cooperation; Canadian International Development Agency (CIDA); European Commission (EuropeanAID Cooperation Office/AIDCO); Federal Ministry for Economic Cooperation and Development, Germany (BMZ); M.A.C. AIDS Fund; The Government of Flanders; Ministry of Foreign Affairs, France; Ministry of Foreign Affairs and Cooperation, Spain (AECID); Ministry for Foreign Affairs, Sweden; Norwegian Agency for Development Cooperation (Norad); OPEC Fund for International Development (OFID); Rockefeller Foundation; Swedish International Development Cooperation Agency (SAREC); The World Bank; and United Nations Population Fund (UNFPA).

See the EMA’s release on today’s news here. Also see MTN’s release and NIAID’s release.

About dapivirine: Dapivirine is a non-nucleoside reverse transcriptase inhibitor that blocks HIV’s ability to replicate itself inside a healthy cell. IPM holds an exclusive worldwide license for dapivirine from Janssen Sciences Ireland UC, one of the Janssen Pharmaceutical Companies of Johnson & Johnson. The license is designed to ensure that women in low-resource settings have affordable access to any dapivirine-based vaginal HIV prevention method.

About IPM: IPM is a nonprofit organization dedicated to developing new HIV prevention tools like the dapivirine ring and other sexual and reproductive health technologies for women, and making them available in developing countries. IPM has offices in the United States, South Africa and Belgium. Please visit http://www.IPMglobal.org.

Media Contact
Katy Lenard
klenard@burness.com

Original Source

https://www.ipmglobal.org/content/milestone-women%E2%80%99s-hiv-prevention-european-medicines-agency-adopts-positive-opinion-monthly

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“That 70s Show”

The hit TV series "That 70s Show" aired from 1998 to 2006 and focused on six teenage friends living in Wisconsin in the late 70s. The irony was that the…

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30 mins ago

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September 22, 2023

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The hit TV series “That 70s Show” aired from 1998 to 2006 and focused on six teenage friends living in Wisconsin in the late 70s. The irony was that the actors playing the teenagers were not born in the late 70s and had never experienced life during that period. Many alive today cannot fathom a lifestyle devoid of the internet, cable television, mobile phones, and social media. Oh…the horrors.

Yet, today, almost 50 years later, financial commentators, many of whom were not alive at the time, suggest that inflation and yields will repeat “That 70s Show.” Understandably, the increase in inflation and interest rates from their historic lows is cause for concern. As James Bullard noted, “Inflation is a pernicious problem,” which is why the Federal Reserve lept into action.

“When the US Federal Reserve embarked on an aggressive campaign to quash inflation last year, it did so with the goal of avoiding a painful repeat of the 1970s, when inflation spun out of control and economic malaise set in.” – CNN

That concern of “spiraling inflation” remains the key concern of the Federal Reserve in its current monetary policy decisions. It has also pushed many economists to point back at history, using “That 70s Show” period as the yardstick for justifying their concerns about a resurgence of inflation.

“The chair of the Federal Reserve at the time, Arthur Burns, hiked interest rates dramatically between 1972 and 1974. Then, as the economy contracted, he changed course and started cutting rates.

Inflation later roared back, forcing the hand of Paul Volcker, who took over at the Fed in 1979, Richardson said. Volcker brought double-digit inflation to heel — but only by raising borrowing costs high enough to trigger back-to-back recessions in the early 1980s that at one point pushed unemployment above 10%.

‘If they don’t stop inflation now, the historical analogy [indicates] it’s not going to stop, and it’s going to get worse,’ said Richardson, an economics professor at the University of California, Irvine.”

However, such may be an oversimplification to suggest Burns was wrong and Volker was right. The reason is the economy today is vastly different than during “That 70s Show.”

Today Is Very Different Than The 1970s

During the 70s, the Federal Reserve was entrenched in an inflation fight. The end of the Bretton Woods and the failure of wage/price controls combined with an oil embargo sent inflation surging. That surge sent markets crumbling under the weight of rising interest rates. Ongoing oil price shocks, spiking food costs, wages, and budgetary pressures led to stagflation through the end of that decade.

What was most notable was the Fed’s inflation fight. Like today, the Fed is hiking rates to quell inflationary pressures from exogenous factors. In the late 70s, the oil crisis led to inflationary pressures as oil prices fed through a manufacturing-intensive economy. Today, inflation resulted from monetary interventions that created demand against a supply-constrained economy.

Such is a critical point. During “That 70s Show,” the economy was primarily manufacturing-based, providing a high multiplier effect on economic growth. Today, the mix has reversed, with services making up the bulk of economic activity. While services are essential, they have a very low multiplier effect on economic activity.

One of the primary reasons is that services require lower wage growth than manufacturing.

Wages vs Inflation

While wages did rise sharply over the last couple of years, such was a function of the economic shutdown, which created a supply/demand gap in the employment matrix. As shown, full-time employment as a percentage of the population fell sharply during the pandemic lockdown. However, with full employment back to pre-pandemic levels, wage growth declines as employers regain control over the labor balance.

Full Time Employees To Population

Furthermore, the economic composite of wages, interest rates, and economic growth remain highly correlated between “That 70s Show” and today. Such suggests that while inflation rose with the supply/demand imbalance created by the shutdown, the return to normalcy will lower inflation as economic activity slows.

Economic composite index vs Inflation

With a correlation of 85%, the inflationary decline will be coincident with economic growth, interest rates, and wages.

Economic composite correlation to inflation

Unlike “That 70s Show,” where economic growth and wages were rising steadily, which allowed for higher levels of interest rates and inflation, There is a singular reason why a repeat of that period is quite impossible.

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The Debt Burden And Economic Weakness

What is notable about “That 70s Show” is that it was the culmination of events following World War II.

Following World War II, America became the “last man standing.” France, England, Russia, Germany, Poland, Japan, and others were devastated, with little ability to produce for themselves. America found its most substantial economic growth as the “boys of war” returned home to start rebuilding a war-ravaged globe.

But that was just the start of it.

In the late ’50s, America stepped into the abyss as humankind took its first steps into space. The space race, which lasted nearly two decades, led to leaps in innovation and technology that paved the wave for the future of America.

These advances, combined with the industrial and manufacturing backdrop, fostered high levels of economic growth, increased savings rates, and capital investment, which supported higher interest rates.

Furthermore, the Government ran no deficit, and household debt to net worth was about 60%. So, while inflation increased and interest rates rose in tandem, the average household could sustain its living standard. The chart shows the difference between household debt versus incomes in the pre- and post-financialization eras.

income vs debt ratios

With the Government running a deep deficit with debt exceeding $32 trillion, consumer debt at record levels, and economic growth rates fragile, consumers’ ability to withstand higher inflation and interest rates is limited. As noted previously, the “gap” between income and savings to sustain the standard of living is at record levels. The chart shows the gap between the inflation-adjusted cost of living and the spread between incomes and savings. It currently requires more than $6500 of debt annually to fill the “gap.“

Consumer Spending Gap

It Is Not The Same

While the Fed is currently engaged “in the fight of its life,” trying to quell inflation, The economic differences are vastly different today. Due to the heavy debt burden, the economy requires lower interest rates to sustain even meager economic growth rates of 2%. Such levels were historically seen as “pre-recessionary,” but today, they are something economists hope to maintain.

Graph showing Economic growth by cycle with data from 1790 to 2020.

This is one of the primary reasons why economic growth will continue to run at lower levels. Such suggests we will witness an economy:

  • Subject to more frequent recessionary spats,
  • Lower equity market returns, and
  • A stagflationary environment as wage growth remains suppressed while the cost of living rises.

Changes in structural employment, demographics, and deflationary pressures derived from changes in productivity will magnify these problems.

While many want to suggest that the Federal Reserve is worried about “That 70s Show,” we would be lucky to have the economic strength to support such a concern.

The Fed’s bigger worry should be when the impact of higher rates causes a financial break in a debt-dependent financial system.

The post “That 70s Show” appeared first on RIA.

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International

Federal Reserve trails global counterparts in balance sheet reductions, data reveals

Quick Take The Federal Reserve’s balance sheet of total assets has seen a reduction of an additional $75 billion in the past week, with total assets…

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58 mins ago

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September 22, 2023

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Quick Take

The Federal Reserve’s balance sheet of total assets has seen a reduction of an additional $75 billion in the past week, with total assets now slightly surpassing the 8 trillion mark. For context, prior to the COVID-19 pandemic, the Fed’s balance sheet was approximately $3.5 trillion.

Despite the considerable distance yet to be covered, substantial efforts have been made to reduce the balance sheet via quantitative tightening, achieving a reduction of about 5.5% year to date.

It is interesting, however, to juxtapose this with other leading global central banks. The Bank of England (BOE) has surpassed the Fed’s reduction rate with a 6.5% decrease, the People’s Bank of China (PBoC) at 7.5%, and both the Bank of Japan (BOJ) and the European Central Bank (ECB) have outpaced with reductions exceeding 10%.

This continuation of quantitative tightening will put further pressure on bond yields, with the U.S. 10-year treasury yield rising to 4.5%.

This data underscores the concerted global effort by central banks to rebalance their respective financial territories, navigating the delicate path of recovery in the post-pandemic world.

Fed Balance Sheet: (Source: FRED)

The post Federal Reserve trails global counterparts in balance sheet reductions, data reveals appeared first on CryptoSlate.

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Britain’s Parliament Demands That Rumble, X Deplatform Russell Brand

Britain’s Parliament Demands That Rumble, X Deplatform Russell Brand

Authored by Andrea Widburg via American Thinker (emphasis ours),

Two…

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59 mins ago

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September 22, 2023

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Britain's Parliament Demands That Rumble, X Deplatform Russell Brand

Authored by Andrea Widburg via American Thinker (emphasis ours),

Two hundred and fifty years ago, Great Britain bequeathed to us our notions of due process and free speech. That country, however, no longer exists. Instead, we have a country that is demanding that Russell Brand, who has been accused of alleged sexual wrongdoing that occurred decades ago (charges he denies), must be deplatformed from Rumble, a site built upon free speech. Fortunately, Rumble is standing strong.

Image: Russell Brand. YouTube screen grab.

Russell Brand has admitted that he was a sex and drug addict. Then, he cleaned up his act. I don’t doubt that he did regrettable things during his years of debauchery, although whether he did anything illegal or even outside the bell curve of a sex-saturated society has never been examined in a law court of law.

During those same years of debauchery, Brand was an out-and-proud leftist, as well as an edgy (very edgy) comedian. Now, though, during his years of clean living, Brand has become something of a libertarian, talking to people like Tucker Carlson and Ben Shapiro because he stood against COVID and vaccine madness.

Given that Brand has been red-pilled and is becoming redder by the day, many conservatives think it’s not a coincidence that he has suddenly been accused of sexual wrongdoing dating back a couple of decades. Regarding the specific accusations, I haven’t read the details and, frankly, I’m not interested.

The fact is that I’m very suspicious of charges floating up after decades. The “he said-she said” dynamic that bedevils many sex crimes is multiplied by the passage of time. That’s why we have statutes of limitations. Indeed, much as I think Joe Biden is capable of sex crimes, the only reason I believed Tara Reade’s allegations was because her mother called Larry King and discussed the issue when it happened.

[ZH: X received a letter as well...]

 The letter acknowledges in its opening sentence that there is no proof that Brand misbehaved. There are only “allegations.” The same letter, from Dame Caroline Dinenage, the Committee’s chair and, believe it or not, a conservative MP, says that the Committee is “concerned that he may be able to profit from his content on the platform.” In other words, based on allegations of long-past crimes, the British Parliament would like to see someone deprived of his income. (And yes, I assume Brand is rich, but it’s the principle of the thing.) The Committee’s sole concern is that “creators are not able to use the platform to undermine the welfare of victims of inappropriate and potentially illegal behaviour.” As far as I know, there aren’t victims. There are only accusers who have managed to survive for decades without talking. After a fair trial (something increasingly unlikely in the third decade of the 21st century), we can revisit whether there are actual victims. To his great credit, Pavlovski wrote a polite “stick it up your derriere” letter in response:

I especially love this bit:

We regard it as deeply inappropriate and dangerous that the UK Parliament would attempt to control who is allowed to speak on our platform or to earn a living from doing so. Singling out an individual and demanding his ban is even more disturbing given the absence of any connection between the allegations and his content on Rumble. We don’t agree with the behavior of many Rumble creators, but we refuse to penalize them for actions that have nothing to do with our platform.

That’s exactly right. The final sentence—“We emphatically reject the UK Parliament’s demands”—is something that would have made America’s Founders proud.

It’s deeply disturbing that a government would try to destroy an individual based on ancient allegations. What’s sad about this action is that it was Britain that bequeathed to us our fundamental concerns with free speech (the First Amendment) and due process (the Fifth Amendment). George Orwell saw it coming, but that doesn’t mean we have to be happy that it’s here.

[ZH reactions have been sharply critical of the UK government's move to deplatform someone who hasn't been convicted of anything. In particular, Elon Musk has had Brand's back]:

Tyler Durden Fri, 09/22/2023 - 05:00

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