Registration is the process by which a drug or other health commodity is approved for importation, marketing and use in a given country. Here is the current list of countries where the drug is registered.
If Truvada is registered and used for treatment, does it need separate regulatory consideration for use as PrEP?
Not necessarily. There is already a precedent of using ARVs for prevention in newborns to reduce the risk of HIV acquisition. These ARVs are used in HIV-negative infants without having an indication on their labels that they can be used as preventive agents. There is also regulatory precedent from the US Food and Drug Administration and the WHO, both recognizing Truvada as a choice for preventing HIV in adults at risk of HIV. The bottom line for advocates is there isn’t one clear regulatory pathway to PrEP access using TDF/FTC in countries where the drug is already registered. You can use advocacy to shape the outcomes.
If TDF/FTC isn’t registered, then daily oral PrEP can’t be introduced outside of a clinical research setting.
Gilead, the manufacturer of brand name TDF/FTC (Truvada), must submit the regulatory dossier for in country registration. A country can also request that this dossier be submitted. Advocates can apply pressure to both Gilead and the national drug authority to advance registration.
You don’t have to wait for TDF/FTC to be registered to begin to work towards PrEP access.
Are there any demonstration projects of daily oral PrEP or clinical trials of long-acting injectables happening in your country?
Great news! Demonstration projects and PrEP research are an excellent way to gather information that can help shape future roll out. It’s key to start planning, while demonstration projects are ongoing, for the policy and practical framework for broader introduction. This includes asking questions like the one below.
There may not be any PrEP demo projects in your country at present—but there could be. Here are some avenues to explore:
The PEPFAR DREAMS initiative, operating in 10 countries, is providing resources for high impact prevention in adolescent girls and young women. PrEP is an option for DREAMS programs. You can lobby PEPFAR to include your group in development and monitoring of DREAMS and to build PrEP into its plans.
Existing biomedical prevention research partners. Click here for a global map. These projects have community liaison officers that can be points of entry.
Are there any national documents such as guidance, position statements, national strategic policies in place addressing PrEP?
There are a range of documents that can and have been developed to frame PrEP use in different settings. Advocates can choose to focus on development of one or more of these documents as a key step and/or for implementation of existing tools.
Visit Access Basics for a description of a few different types of documents and samples from different countries — such as:
National Strategic Plans
National PrEP-specific Guidelines/Policies
What can advocates do to influence national policy and guidance?
Guidelines can spark change or sit on a shelf. To a large degree, it’s up to you. Each of the documents described above serves a slightly different function, and reaches a different audience. But all can and have been used to catalyze demand.
Some key considerations for advocates include:
Lobbying for the guidelines to be broad. PrEP is recommended for anyone who is at risk of HIV. A guideline that focuses on a specific population risks stigmatizing that group and putting the strategy out of reach of others who need or want it.
Helping to establish a pathway to guidelines in countries that say they are not ready. There’s a lot to consider in terms of where and how to make PrEP available so that people who want and need it can take it effectively. Some countries may feel more information is needed before crafting national guidelines. Advocates can guide the development of this process by asking: What additional information is needed? Who needs to be involved? What resources are needed? – And acting on the answers.
In the space of 12 months, the number of gay men in London diagnosed with HIV dropped by 40 percent. The man credited as being at the center of this unprecedented reduction is Greg Owen—unemployed, a former sex worker and homeless. This Buzzfeed News piece tells his remarkable story.