Health

All Clinicians Have Unforgettable Patients: This One Has HIV

MEXICO CITY — Nelly Mugo, MB ChB, from the Kenya Medical Research Institute and the University of Washington in Seattle, was counseling a woman about her recent HIV diagnosis when the patient caught her off guard.

“I came to you guys 2 years ago and had a baby,” she recalls her patient saying. Mugo’s colleagues at the maternity wing of an urban hospital in Nairobi helped deliver the woman’s baby. “I was negative. Nobody told me that I was at risk for getting HIV.”

Some clinicians might think it should have been obvious to the patient — a woman in sub-Saharan Africa — that she was at risk for HIV. But that’s not what Mugo thought.

She said she found herself reviewing every time the woman had visited a family planning clinic before her pregnancy or came to the hospital during her pregnancy. A provider could have mentioned the HIV rate in the woman’s community during any of those visits. She could have explained that the risk for HIV increases during pregnancy and the postpartum preiod, or recommended HIV pre-exposure prophylaxis (PrEP) to protect her from the virus.

But none of that happened.

And now the woman was sitting in Mugo’s office with HIV and angry about it. To Mugo, it felt personal.

“We failed her,” she said.

That was one of several moments that made Mugo question the wisdom of segregating HIV prevention and care from sexual and reproductive healthcare for women, she explained here at the International AIDS Society (IAS) 2019 Conference on HIV Science.

Two major studies — the Tsepamo trial and Evidence for Contraceptive Options and HIV Outcomes Trial (ECHO) (NCT02550067) — one of which Mugo was part of, revealed what Mugo had experienced in that office: Siloing HIV prevention from obstetric–gynecologic care and segregating sexual and reproductive health from HIV care have led to irreversible changes to women’s health.

But integrating services in the context of physician shortages and overburdened providers will be hard.

“This is one of the big public health issues at this conference,” said Anton Pozniak, MD, from Chelsea and Westminster Hospital NHS Foundation Trust and Imperial College London, who is president of the IAS.

“We must really rely on the scientific evidence to push the agenda now. And the science has said that we should put these things together,” he told Medscape Medical News.

Imagine you’re a woman who does domestic work in Mugo’s home — Mugo has. She thinks about this woman, who lives in a high HIV-prevalence area, but may not know just how high her risk is. In fact, she may not think she’s at risk at all.

Women and their providers often underestimate HIV risk, as reported by Medscape Medical News.

In ECHO, Mugo and her colleagues found that the rate of HIV infection in South African women taking three forms of long-acting contraception was considerably higher than the 2.28% observed in 2015.

ECHO Trial

Overall, the HIV rate in ECHO was 4.51%, but women in the city of Ladysmith, South Africa, had a rate of 6.80%.

When a busy woman like Mugo’s domestic worker does think about her own health, she might think about the family planning clinic she visits every 3 or 6 months to receive contraception, Mugo said. To do that, she must request a day off, wake up early, get her children off to school, and then head to the clinic. There, she lines up, first to get her records, then to pay for her appointment.

The wait can be hours, Mugo said. When the woman finally gets to see the doctor or nurse, there is a good chance that the only option available is the injectable depot medroxyprogesterone acetate (DMPA, Depo-Provera).

Medication stockouts are common in parts of Africa, said Renee Heffron, PhD, from the University of Washington.

In the exam room, there isn’t much time to talk about anything else, even if she knows she is at risk for HIV (which she may not), and even if she knows about the combination of emtricitabine and tenofovir disoproxil fumarate (Truvada, Gilead Sciences) for prevention (which is unlikely).

If she does manage to ask about it, and the provider knows about it as well and is willing to prescribe it, it means a referral to an HIV clinic, Mugo said.

If the patient manages all that, she starts the process over; another day off request, another early day, another long line, another expense. And this is extra, an appointment beyond whatever clinic visits she and her children have to make for other health issues.

It puts everyone in a difficult position. “I have a house to run. I have children,” Mugo said she imagines thinking as the employer. “Can she really have four appointments in a month and not be at work?”

Each appointment is another point where you’re going to lose women, said Mugo’s colleague Helen Rees, MB BChir, from the University of the Witwatersrand in Johannesburg. “Whenever you split services, you lose people.”

Mugo said she does not want to see contraception services integrated into HIV prevention programs, though. Still, it’s common for providers who do not treat HIV to “feel HIV is not my business.”

So what happens, Mugo said, is that an HIV-negative woman who can get contraception but not HIV prevention might acquire HIV, as Mugo’s patient did. And once she has HIV, she can “end up pregnant just because she couldn’t access family planning,” said Heffron.

Or, as Jacque Wambui, a woman living with HIV in Nairobi, Kenya, said, it’s the same woman.

“It’s the Same Woman”

“Same woman, same body, same things she needs to prevent HIV and pregnancy,” Wambui told Medscape Medical News. “There has been so much focus on family planning,” she said as she pointed in one direction. And “so much focus on HIV,” she said as she pointed in the opposite direction.

Nobody realized it’s the same person.

Then she squared her shoulders and looked straight ahead. “Nobody realized it’s the same person.”

It would be fine for a woman with HIV to get pregnant if she were on effective treatment; after all, medications are effective enough to prevent a mother from transmitting the virus to her infant (PLoS Med. 2017;14:e1002329).

But they aren’t always.

In many African countries, the non-nucleoside reverse transcriptase inhibitor efavirenz (Sustiva, Bristol-Myers Squibb) is the backbone of HIV treatment.

That’s a problem for pregnant and postpartum women, said Deborah Birx, MD, Ambassador-at-Large and head of the US President’s Emergency Plan for AIDS Relief (PEPFAR).

Efavirenz, in combination with Truvada (sold as Atripla), has been associated with birth defects in babies born to women using the drug. It has also been linked to fatigue and depression in the women themselves (Neuroimmunomodulation. 2005;12:293-298).

“So you’re asking a woman with a newborn who is not sleeping to take a drug that makes her feel more fatigued,” Birx told Medscape Medical News. In addition, efavirenz is associated with lower rates of viral suppression than dolutegravir (Tivicay, GlaxoSmithKline). Each year, up to 1 million people in PEPFAR countries stop treatment with efavirenz-based regimens because of adverse effects.

She called dolutegravir a “game changer for people’s ability to be virally suppressed.”

At least that was the hope.

Instead, “everything ground to a halt” last year after data from more than 400 women taking dolutegravir at conception showed what Birx called “a weak signal” of neural tube defects among babies born to those women.

The overall rate of neural tube defects in infants was higher in women taking dolutegravir at conception than in women without HIV (0.94% vs 0.10%). This is in the context of no folate supplementation, said Rebecca Zash, MD, from Beth Deaconess Medical Center in Boston, when she presented results from a study on the rate of defects at the IAS meeting last year (N Engl J Med. 2018;379:979-981).

The US Food and Drug Administration and the World Health Organization (WHO) issued guidelines in advance of Zash’s 2018 presentation, recommending that women who might get pregnant not take dolutegravir unless they are on a “consistent” contraceptive.

That meant that women were required to produce proof from their family planning clinic that they had received a shot of Depo or another long-acting contraceptive before they were given a prescription for dolutegravir, Birx explained.

Other countries withheld the drug from everyone until the signal was resolved, saying it was unfair to roll it out to some people and not others. In higher-income countries, physicians tended to steer women toward older drugs with more monitoring, as reported by Medscape Medical News.

The 2018 conference was alight with protests from African women demanding the option to choose dolutegravir on an individual basis, and Wambui was in the center of that outcry. But when she returned home to Nairobi and asked her HIV provider for dolutegravir, she was turned away, not once or twice, but three times.

Wambui, who had never used contraception, was not going to start — when she was 46 years old — just to satisfy a blanket guideline.

Her doctor finally conceded and prescribed dolutegravir in January. But Wambui had to sign a consent form stating that she understood the signal for neural tube defects. Since starting dolutegravir, Wambui reports that she is less fatigued than when she was on efavirenz.

Now think back to Mugo’s domestic worker.

If she were to acquire HIV, in addition to taking days off to visit the HIV clinic for treatment, she would have to take a day off to visit the family planning clinic and convince her overburdened provider to sign a form saying that she is using long-acting contraception.

In practice, what the reluctance to prescribe dolutegravir really has meant for almost all of the 9 million women of reproductive age in PEPFAR countries is that they have no access to the drug, Birx said.

Zash’s update on the dolutegravir signal was highly anticipated at the IAS meeting this year.

New Dolutegravir Data

If the rate of neural tube defects stayed the same or even edged down slightly, “we’d remain in this grey zone,” said Pozniak. And if we remained there for another year or two, women’s access to this drug might disappear, he said.

Excitement about the updated results was so great that many conference attendees crashed what was supposed to be a news conference on the second day of the meeting, with academics posing questions to the researchers during the standing-room-only event.

Zash’s news was good for women living with HIV. Instead of the neural tube defect rate staying at 0.94% for women using dolutegravir at conception, it dropped to 0.3% (N Eng J Med. Published online July 22, 2019). In Brazil, a country with standardized folate supplementation, none of the babies born to women using dolutegravir at conception developed neural tube defects.

The results prompted Robert Redfield, MD, director of the Centers for Disease Control and Prevention, and colleagues to explain that if the signal continues to weaken, the delays in use of dolutegravir in all people with HIV, including women of childbearing potential, “will represent missed opportunities for improving global and individual health” (N Eng J Med. Published online July 24, 2019).

The results mean PEPFAR can move forward and offer dolutegravir to everyone with HIV, Birx said.

Still, she said, she has not forgotten the 9 million women who have been unable to access it.

“To reverse the perception of the level of risk with dolutegravir is going to take another full year,” Birx told Medscape Medical News. “So we will have lost 2 years of access to this drug that will save women’s lives.”

In North America, where dolutegravir has been used for the past 15 months, Zash’s update did not completely assuage concerns about the defect.

Deborah Money, MD, from the University of British Columbia in Vancouver, Canada, said she has always been cautious about prescribing new medications to women with HIV who are pregnant because they aren’t tested in such women in clinical trials. Although these new data will “slightly modify” how she and her colleagues counsel women about dolutegravir, “it again highlights the value of prescribing medications that have long track records of safety to women of reproductive potential,” she said.

But to bridge this gap between the HIV-negative woman who becomes HIV-positive and to provide the care that might improve outcomes on both sides of the status line, experts at IAS seemed to agree that integration is essential.

Bridging the HIV-Status Line

On the HIV-negative side of the line, several Planned Parenthood chapters in the United States have begun to offer HIV prevention drugs specifically to women. Still, there are enough providers who refuse to prescribe PrEP to their female patients — PrEP clinics are largely designed for gay and bisexual men — that SisterLove, a nonprofit advocacy organization in Atlanta, plans to open its own PrEP clinic for women.

In private practice, “I wish we could even get gyn docs to offer HIV testing,” said Melanie Thompson, MD, from the AIDS Research Consortium of Atlanta.

Once a woman passes through to the HIV-positive side of the line, the Ryan White system pays for integrated and wrap-around services for people with HIV.

“It is tempting to think that the HIV expert should focus on ART management and leave the rest to generalists,” Thompson told Medscape Medical News. “There are circumstances in which this will work fine. But if this results in the woman seeing one person to manage her antiretrovirals, another to manage her reproductive health, and another to manage her blood pressure and lipids, we are setting a high bar for adherence. And she is not getting integrated care.”

Not all Ryan White clinics use their funding in the same way, either. In Houston, where Tom Giordano, MD, runs the Ryan White–funded Thomas Street Health Center, infectious disease doctors act as primary care providers. But gynecologic care and contraception services, provided by staff obstetrician–gynecologists, require a separate appointment.

In that clinic, the reality is that the infectious disease doctors “don’t have the time or expertise to cover Paps and birth control in their regular visits,” Giordano told Medscape Medical News.

Although many physicians agree that, in theory, services should be integrated and women should have a “one-stop-shop” to meet all their needs, in practice this is more difficult.

And “we now have a shortage of HIV care providers in the United States, as well as globally,” Thompson pointed out.

For Mugo, who is as much a provider as she is an advocate for care integration, it is not fair to lay all this at the feet of providers.

“I have as many questions as anyone,” she said. “It’s more of a health-system issue, and we shouldn’t burden the provider with all of it.”

Still, she thinks training might be a solution. Catching providers while they are still in school teaches physicians to integrate care from the beginning. “But once I’m in practice, it becomes a bit harder.”

Integration and Value-based Care

During a session at the International AIDS Conference last year, Ava Avalos, MD, from the Botswana–Harvard AIDS Institute Partnership, was thinking of #metoo and the Women’s March. “This is not a year for us as women to be polite,” she said in a large auditorium.

“We have waited too long,” she explained. “Contraception has to be elevated to one of the number one priorities.”

At the end of that session, Avalos, many of the ECHO investigators, and others came up with an idea. HIV providers have integrated TB and HIV care. They have integrated the prevention of mother-to-child transmission into HIV care. Why can’t they generate a plan to systematically integrate HIV prevention and care with reproductive and sexual health for women?

“I’m very serious about this,” said Rees, who is a member of the ECHO consortium. At the time, she suggested that the “WHO, Family Planning 2020, and AVAC take this on and have expert meetings to develop an integration index we can start to adopt.”

One year later, though, that index “hasn’t been taken up,” Rees told Medscape Medical News.

In the days of scarce resources, no one can afford to duplicate and have siloed services.

It will take pressure from patients to make that happen, she said. And it will take physicians like Mugo, who have seen the impact of separate services on women’s HIV and reproductive health outcomes.

With a move toward a value-based model of care — where physicians don’t see a woman for every small thing but instead spend time giving higher-quality care to women with more complex needs — physicians will be happier too, Rees said.

“In the days of scarce resources, no one can afford to duplicate and have siloed services,” she said. In parts of Africa, that could mean sending a woman on PrEP home with HIV self-tests, and only having her return if she tests positive. And technology might someday allow women to administer their own subcutaneous Depo injections.

If that were possible, she asked, how often would a physician really need to see a patient? If clinicians could “scale down” contacts that are brief check-ins, it could open the door to “more time for quality contact.”

ECHO was funded by the Bill and Melinda Gates Foundation, the US Agency for International Development and the PEPFAR , among other organizations. The National Institute of Allergy and Infectious Diseases funds the Botswana surveillance project. Mugo, Pozniak, Rees, Heffron, Birx, Zash, Money, Giordano, and Avalos have disclosed no relevant financial relationships. Thompson reports that her institution has received research funding from Bristol-Myers Squibb, CytoDyn, Gilead Sciences, GlaxoSmithKline, Merck Sharp Dohme, Roche Laboratories, Taimed, and ViiV Healthcare.

International AIDS Society (IAS) 2019 Conference on HIV Science: Abstracts MOAX0105LB, MOAX0104LB, LBPEC25, and LBPEC23. Presented July 22, 2019.

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