Breakthroughs Blog: Contraceptives

Interested in more global health innovation news? Every week GHTC scours media reports worldwide to deliver essential global health R&D news and content to your inbox. Sign-up now to receive our weekly R&D News Roundup email. A clinical trial in four African nations found no substantial difference in HIV risk among women using three different methods of contraception—an injectable, progestin-only contraceptive, a nonhormonal intrauterine device, or IUD, and a progestin-based implant. However, the study—conducted by a consortium led by FHI 360—revealed high rates of HIV contracted among each group of women studied, prompting calls for deeper integration of HIV prevention and family planning services. The World Health Organization (WHO) will begin synthesizing and sharing findings from the Evidence for Contraceptive Options and HIV Outcomes, or ECHO trial, with WHO’s Guideline Development Group, which will convene at the end of July 2019. This group will consider the trial’s results, along with other research, to determine whether changes are needed to the global guidance on contraceptive use and issue recommendations at the end of August. A study performed by researchers at the University of Oxford, along with partners at five other institutions, has identified the human antibodies that prevent the malaria parasite from entering blood cells—potentially key to creating a highly effective malaria vaccine. The study was done as part of a clinical trial in Oxford of the first vaccine candidate that targets the RH5 malaria protein, a protein contained in the parasite which must bind to a human protein on red blood cells in order to infect them. This study demonstrated which human antibodies effectively block RH5 from binding, thus preventing the parasite from spreading through the blood. Another key finding of the study is the discovery of a new antibody which slows down the speed with which RH5 binds to red blood cells, giving antibodies that do block RH5 from binding more time to act. Researchers aim to use these findings to develop an improved RH5 vaccine that induces more of the effective antibodies. A new civil society group, the Drug Transparency Observatory, has formed in France to monitor the French government’s implementation of a resolution on the transparency of medicines markets adopted at the World Health Assembly last month. A statement released by the new group calls on the French government and all countries to not only implement the adopted resolution, but also the transparency measures included in the initial resolution draft, which go beyond just medicines pricing to include disclosure of research and development costs. The statement noted that the Drug Transparency Observatory will monitor “the advancement on the implementation of the transparency resolution in pricing, clinical trials, research and development, marketing and patenting.”

Interested in more global health innovation news? Every week GHTC scours media reports worldwide to deliver essential global health R&D news and content to your inbox. Sign-up now to receive our weekly R&D News Roundup email. Independent experts of a US Food and Drug Administration (FDA) advisory panel voted in favor of TB Alliance’s treatment for multi-drug resistant and extensively drug-resistant tuberculosis (TB)— pretomanid—as part of a three-drug combination regimen with Johnson & Johnson’s bedaquiline and linezolid. Although the FDA is not bound to follow the advice of its advisory panel, it usually does. The FDA granted priority review for pretomanid and the marketing application is based on interim data from the first 45 patients in an ongoing study with a total of 109 participants. Current treatments for TB involve a cocktail of drugs and multiple injections, making adherence difficult for patients. Thus, “having a three-drug oral regimen will be a benefit,” said Philip LoBue, a panel member who voted in favor of the treatment. The FDA is expected to make a final decision on pretomanid’s approval by the third quarter of this year. A new affordable option for combating post-partum hemorrhage—the number one killer of women during childbirth—was announced last week at the Women Deliver conference. The new device, Ellavi, is a high-quality uterine balloon tamponade (UBT) designed for low-resources settings that can be manufactured for US$10, as opposed to a typical cost of $200-250 for a UBT in most industrialized countries. Ellavi, developed by PATH and its South African partner Sinapi Biomedical, has achieved CE marking in Europe, signifying it meets regulatory requirements—an important mark of confidence that eases a product’s path to market in many countries. Ellavi is expected to be on the shelf initially in Kenya and Ghana by 2020, with plans for further expansion. PATH also announced the Nigerian National Agency for Food and Drug Administration’s marketing approval of Caya®—an updated, one-size-fits most, easier to grip, silicone-based diaphragm developed by PATH. Caya® will be introduced in Nigeria within the next year by DKT International, the largest family planning products and services provider in the country. Oxford-based Enesi Pharma has developed a needle-free instrument, called ImplaVax, that can deliver vaccinations under the skin with practically no pain for the patient. Instead of being in liquid form, the vaccine is formed into a tiny, solid stick measuring 0.85mm in diameter and 3.5mm long, with a point at the end, which the ImplaVax device injects into the patient. In addition to being pain-free, this solid dose vaccination does not need to be kept cool—a particular benefit for countries with warmer climates and unreliable cold chains. With ImplaVax, there is also no risk of needle breakage and as a pre-measured solid dose, it is easy to administer, allowing the potential for lower-skilled health workers to administer rather than doctors or nurses. ImplaVax is still being tested in animals with the hope of beginning the first human studies next year.

Interested in more global health innovation news? Every week GHTC scours media reports worldwide to deliver essential global health R&D news and content to your inbox. Sign-up now to receive our weekly R&D News Roundup email.Contraceptive jewelry may one day offer women a new approach to meet their family planning needs. Researchers from FHI 360 are exploring using transdermal patch technology to administer contraceptive hormones through patches applied to areas of jewelry—such as earrings, watches, rings, or necklaces—that are in contact with skin, allowing the drug to be absorbed into the body. Initial testing on animals suggests that contraceptive jewelry may deliver sufficient amounts of hormones to provide contraception, however no human testing has been performed to date. Researchers believe the tool could help improve adherence among certain women and allow for more discreet use of contraception, as well as serve the needs of women in developing countries who may have limited access to health care services and long-acting contraceptives such as injectables, implants, and intrauterine devices. Innovators at Cardiff Medicentre and Picofluidics have developed a specific type of microneedle that can be produced for approximately one-tenth of the cost of those currently on the market. Trials have confirmed the viability of their plasma treatment technology that enables the cost-effective production of collections of many thousands of microneedles, which are used to deliver medicines or vaccines, often in the form of a patch applied to a person’s skin. The developers hope to collaborate with partners to commercialize the technology, which they see as having many potential uses including pain-free injection of medications such insulin, vaccines, or intradermal fluid removal for diagnostic purposes and early disease detection. Scientists at Centenary Institute have uncovered a new avenue to improve treatment of drug-resistant tuberculosis (TB) by increasing the effectiveness of the immune system using widely-available anti-platelet drugs, including aspirin. Researchers used fluorescent microscopy in animal models to observe the build-up of blood clots and the activation of platelets around sites of infection, confirming that TB bacterium hijack platelets from the body's blood clotting system to weaken the immune system. Using anti-platelet drugs to treat the infection, researchers were able to prevent the hijacking, enabling the body to better control the infection. This study provides evidence that platelets have been found to worsen TB and “opens up the possibility that anti-platelet drugs could be used to help the immune system fight off drug resistant TB.”

Interested in more global health innovation news? Every week GHTC scours media reports worldwide to deliver essential global health R&D news and content to your inbox. Sign-up now to receive our weekly R&D News Roundup email. According to clinical trial results recently published in the New England Journal of Medicine, tafenoquine—a new single-dose oral antimalarial drug developed by Medicines for Malaria Venture and GlaxoSmithKline—significantly lowered the risk of the recurrence of malaria caused by the Plasmodium vivax (P. vivax) species of the parasite. P. vivax malaria affects approximately 7.5 million people annually and often lies dormant in the liver even after initial treatment, causing debilitating recurring malaria episodes. This single-dose treatment could significantly boost cure rates, as adherence to the standard two-week drug course is difficult in low-resource regions in Southeast Asia, Latin America, and parts of North Africa where this form of malaria is endemic. Based on the results of this clinical trial, the US Food and Drug Administration has already approved tafenoquine for use in July 2018, followed by the Australian Therapeutic Goods Administration in September 2018. A new, long-acting contraceptive designed to be self-administered by women using microneedle skin patch technology could provide a valuable new family planning option, particularly for women in low-resource settings where access to healthcare can be limited. When the patch is applied to the skin, microscopic needles break off and remain under the surface of the skin where biodegradable polymers slowly release the contraceptive drug, levonorgestrel. In animal testing, an experimental microneedle patch provided a therapeutic level of contraceptive hormone for more than a month with a single application. Experimental patches designed for humans have been developed but not yet tested. If the microneedle contraceptive patch does eventually reach the market, it could become the first self-administered, long-acting contraceptive that does not require a conventional needle injection.A new rapid DNA and RNA sequencing device could offer potential to instantly diagnose viruses such as Ebola or Zika at the point of care during an outbreak. Researchers at the French agricultural research institute CIRAD have found a way to use a device known as the Oxford Nanopore MinION device, which can sequence DNA and RNA in real time, to identify plant viruses—and potentially animal and human viruses too. The CIRAD team was able to test and validate the use of this portable device to identify plant viruses quickly and early in the infection process—avoiding the time-consuming and potentially dangerous task of transferring contaminated samples to a lab. The device’s ability to rapidly and accurately detect a virus in plants is a step forward in providing real-time detection of viruses with a mobile device, which would be especially useful in low-resource settings and remote areas. This device has the potential to help public health officials manage outbreaks by reducing the time between taking a sample and diagnosing it as carrying a particular virus—enabling the detection of potential outbreaks at an earlier stage than was previously possible.