Appendix 1Patient Input Summary

1. Brief Description of Patient Group(s) Supplying Input

One patient group, the Canadian Treatment Action Council (CTAC), provided input for this drug review. CTAC is a national non-governmental organization that focuses on access to treatment, care, and support for people living with HIV and hepatitis C. CTAC’s organizational goals are to engage community members, service providers, policy-makers, and other relevant stakeholders to identify, develop, and implement policy and program solutions. Full CTAC membership is reserved for: a) individual people living with HIV (including hepatitis C co-infection); b) organizations, groups or projects with a substantial HIV mandate (including hepatitis C co-infection). Associate CTAC membership is open to any individual, organization, group, or project that supports CTAC’s mandate and objective.

In the last two years CTAC has received funding in excess of $50,000 from ViiV Healthcare. CTAC did not receive help from outside the organization to prepare this submission, or to collect and analyze data used in this submission.

2. Condition-Related Information

Data for this submission were obtained from seven patients with HIV (five men and two women) who attended a patient input consultation workshop in Toronto, Canada. The participants were in their 20s, 40s, or 50s, and had been receiving treatment for HIV for five to 34 years. In addition, survey data collected for a patient submission on dolutegravir was used to inform this patient submission.

HIV is a serious, life-threatening illness that threatens the immune system. Over time, if left untreated, HIV can compromise a person’s immune system to the point that the body may no longer be able to fight off opportunistic infections. Access to, administration of, and adherence to highly active antiretroviral treatment can control progression of HIV such that patients generally manage their condition as a chronic illness. However, patients with HIV are more susceptible to inflammation and non-infectious comorbidities, including bone fractures, renal failure, and liver and cardiovascular disease. Many of those living with HIV experience negative mental health outcomes, whether as a side effect from treatment, or from facing stigma, discrimination, and related stress. Stigma is one of the more prominent issues dealt with, as explained by one respondent, “I still cannot come to terms with the fact that I’m HIV-positive, and I’ve been positive for 25 years. I still run away from it, and I have a hard time talking about it….” This is further highlighted by another respondent from the dolutegravir (DTG) rilpivirine survey regarding their interaction with the medical community, “Local doctors feel ill-equipped to treat HIV due to inexperience because of low patient caseloads with the condition. Stigma also plays into it, I think. Unless they’re familiar, doctors still see HIV as something more difficult to live with than it actually is.” Another respondent (from the DTG rilpivirine survey) discussed the challenge of managing HIV while residing in a rural area, “I live in a rural area and have to travel about 100 km each way for my doctor’s appointments. I only see my doctor about every six months. Obviously if I had to travel that far more often it would be a challenge. For those who don’t have the support of family this could definitely be an obstacle.”

Many of those living with HIV experience intersecting vulnerabilities conditioned by the social determinants of health — the social and structural conditions in which people live, work — and are shaped by the distribution of money, power, and resources. Limited funding or services for addictions, mental health, housing, and food security can affect patients’ HIV treatment. One respondent from the DTG consultations noted that difficulties understanding stigma and its impact, and navigating HIV-specific social services and institutional systems, including disability insurance and mortgages, have presented specific challenges. One respondent stated, “I am worried about the fact that HIV is now viewed as chronic, manageable disease. I still have good and bad days but, if HIV is now seen as something other than a disability, will I be forced to go back to work, even when I’m not well?”

Respondents all noted substantial impact on caregivers looking after patients living with HIV. One respondent highlighted that the challenges his/her spouse faces in providing support is surrounding disclosure. According to the respondent, “hiding from friends and some of our family members that I am HIV-positive” has been extremely difficult and hindered the ability to acquire a social safety net” (from the DTG survey).

3. Current Therapy-Related Information

Data for this submission were obtained from seven patients with HIV who were receiving treatment for the past five to 34 years. These patients had been on their current therapy for five to 10 years with minor changes to therapy that were made due to other health problems or resistance that developed.

As a result of being on HIV treatment, many participants described noticeable improvements in their quality of life and ability to engage in daily activities. Discussing the overall impact of treatment on his life, one participant stated, “Not only do I feel healthy, I know I am thanks to the HIV medication. Without it, I would be dead by now.” When asked whether treatment had improved their quality of life another respondent answered, “In 1995, the doctors said I had 2 months to live, and that I’d better get my affairs in order. I never expected that I’d still be alive.” Another participant noted that, “My quality of life has improved. I’m now on a combination of drugs that has gotten me to an undetectable viral load.”

Respondents to the dolutegravir survey also indicated that their treatment was effective at suppressing their viral load; but some had experienced severe adverse effects to older treatments such as zidovudine.

The CTAC stated that the increased risk of experiencing comorbidities associated with HIV may be due in part to antiretroviral treatments themselves. In addition, not all patients with HIV are able to achieve viral suppression despite trying multiple treatment regimens. Further, treatment adherence is necessary for therapy to be effective and to minimize the development of drug class resistance that would necessitate a change in therapy. CTAC stated that having the maximum possible treatment options is of clinical importance.

4. Expectations About the Drug Being Reviewed

None of the patients surveyed had experience with doravirine. However, many expressed an interest in a drug with a new chemical composition that may provide another treatment option if resistance to other treatments is a problem. Differences in drug-drug interactions or adverse events noted for doravirine compared with some other treatments were considered important to the patients surveyed.

One participant noted that, “I like the fact that this medication has a new chemical composition. I like knowing the option is out there, since I am resistant to many, many of the current HIV drugs out there. My doctor told me, ‘The meds that you are on now are the last ones available that you can take.’” Another participant from the DTG rilpivirine survey noted that, “I don’t see replacing the ‘devil’ I know with the ‘devil’ I don’t know — at least on a personal basis. If I had to make changes — and that time could come since I’ve been on the present regime for quite some time.”