Introduction

The fixed-dose combination of dolutegravir / rilpivirine (trade name: Juluca) has been approved in Germany since May 2018 for the treatment of type 1 HIV in adults. It can be used in people who are already receiving successful treatment against the virus.

The human immunodeficiency virus (HIV) multiplies in cells of the immune system and destroys them. Without proper treatment, the immune system of most patients with an HIV infection weakens so much that they become seriously ill. This stage is called “AIDS” (acquired immunodeficiency syndrome).

Although the currently available medications can't cure HIV, they can prevent immunodeficiency permanently. But in some people the medication may become ineffective over time, allowing the viruses to multiply more again.

The drug combination of dolutegravir / rilpivirine inhibits a protein which the virus needs to multiply.

Application

One tablet containing 50 mg of dolutegravir and 25 mg of rilpivirine is taken once daily with a meal.

Other treatments

Patients with HIV usually receive individual combination treatment against the virus. This type of treatment takes into consideration which treatments were tried before and why they were stopped. It is possible, for instance, that the previous treatment was ineffective or caused side effects that were too severe.

Assessment

In 2018, the Institute for Quality and Efficiency in Health Care (IQWiG, Germany) looked into the advantages and disadvantages of dolutegravir / rilpivirine compared with individual combination treatment for people with HIV.

To answer this question, the manufacturer submitted two on-going studies involving 1,024 people. While half the participants continued individual combination treatment, the other half were switched to treatment with dolutegravir / rilpivirine. Only people who didn't need to switch medication were involved in both studies. These were the results after 48 weeks:

What are the advantages of dolutegravir / rilpivirine?

No advantages of dolutegravir / rilpivirine were found compared with continued individual treatment.

What are the disadvantages of dolutegravir / rilpivirine?

  • Treatment stopped due to side effects: The studies suggest a disadvantage of dolutegravir / rilpivirine compared with continued individual treatment. 4 out of 100 people in the dolutegravir / rilpivirine group stopped the treatment due to side effects, compared to only about 1 out of 100 in the individual treatment group.
  • Gastrointestinal problems: The studies suggest a disadvantage in terms of these side effects as well: 24 out of 100 people who took dolutegravir / rilpivirine experienced gastrointestinal problems, compared to 16 out of 100 people who had individual treatment.
  • Disorders of the nervous system: The study suggests that the fixed combination has a disadvantage here as well: disorders of the nervous system occurred in 15 out of 100 people with dolutegravir / rilpivirine , while only 8 out of 100 people who had individual treatment experienced the same.
  • Psychiatric disorders: Here too, there was evidence of a disadvantage: These side effects occurred in 12 out of 100 people who used dolutegravir / rilpivirine, compared to only 6 out of 100 people who had individual treatment.
  • Diseases of the skin and subcutaneous tissue: The studies suggest that the fixed combination has a disadvantage here, too. This group experienced side effects such as skin rash more often than the group with individual treatment. But this disadvantage only affected people who had at least 500 CD4+ cells per microliter (µL) of blood when they started treatment. These cells are part of the immune system, and an HIV infection can cause their numbers to drop considerably. No difference was found in people with less than 500 CD4+ cells per microliter of blood.

No differences

  • Life expectancy: A total of 2 people died during the course of the studies.
  • Number of AIDS-related illnesses: Bacterial, viral and fungal infections are more likely if the immune system is weakened due to HIV. Some types of tumors are also more common. The success of a particular treatment can be measured by whether these illnesses are less common. There were no differences here either.
  • Severe side effects: These occurred in 6 out of 100 people in all groups.
  • There were also no differences concerning symptoms of the disease or general health.

What remains unanswered?

  • Health-related quality of life: The manufacturer didn’t provide any data on this.

More information

This information summarizes the main results of a review produced by the Institute for Quality and Efficiency in Health Care (IQWiG, Germany). The review was commissioned by the German Federal Joint Committee (G-BA) as part of the “early benefit assessment of medications.” On the basis of this review and the hearings received, the G-BA passed a resolution on the added benefit of dolutegravir / rilpivirine (Juluca).